american proﬁciency innovative solutions. - api-pt.com

American

Proficiency

Institute

G uide

Innovative Solutions.

Technical Excellence.

2 | 800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com

CONTACT US

HOURS

Monday thru Friday – 8:00am to 5:00pm EST

EMAIL

[email protected]

International: [email protected]

[email protected]

[email protected]

[email protected]

PHONE

Toll Free: 800-333-0958

International: +1-231-941-5887

FAX

855-900-6119

REMITTANCE ADDRESS

American Proficiency Institute Department 9526

PO Box 30516 Lansing, MI 48909-8016

ADDRESS

American Proficiency Institute 1159 Business Park Drive Traverse City, MI 49686

http://www.api-pt.com/

mailto:[email protected]





Table of Contents

Highlights and Features 4-6Program Overview 7Enrollment Information 8-92020 Order Form 10-112020 Shipment Calendar 12Treatment of Proficiency Testing Samples 13Confidentiality Provisions 13

Confidentiality 13Policy for Use of Reports by Individuals and Organizations 13

Activities Subcontracted by API 14Sample Homogeneity and Stability 14

Homogeneity Testing 14Stability Testing 14

Grading Standards 15-18CLIA ’88 and Grading 15 Evaluation Reports 15-17Metrological Traceability and Measurement Uncertainty of Assigned Values 17 Advice on Interpretation of Statistics 17-18“Results Not Graded” – What’s Next? 18

Program Analysis 19-132Chemistry 19-43Urine Chemistry and Body Fluid Analysis 44-49Hematology 50-59Miscellaneous Hematology 60-66Andrology 67-69Coagulation 70-79Urinalysis, PPM, and Misc. Tests 80-87Microbiology 88-113Immunology 114-125Immunohematology 126-132

Paperless Proficiency Testing Instructions 133-158Entering Results 133-138Managing Sub-Users 139-145Viewing Evaluation Reports 146-151DataDashboard 152-158

Continuing Education 159-163Appendix A: Cell Count/Hematology/Sedimentation Rate Instrument List 164-165Appendix B: Analytes Included in Molecular Multiplex Panels 166-168Glossary of Abbreviations and Terms 169-170Index 171-174



Highlights and Features

Accepted by All Major U.S-Based Regulatory Agencies!

CAP – College of American Pathologists – Please refer to individual programs to confirm CAP acceptance.

CMS – Centers for Medicare and Medicaid Services and all State Regulatory Agencies (e.g. New York State, New Jersey, Texas)

COLA

The Joint Commission

HFAP/AOA – Healthcare Facilities Accreditation Program

ISO Accredited!

API is accredited as a proficiency testing provider to the requirements of ISO/IEC 17043:2010. We are accredited by the American Association for Laboratory Accreditation (A2LA) under certificate number 3094.01 (www.A2LA.org). A2LA is a signatory to all existing International Accreditation Forum (IAF) international recognition agreements. Programs included under the scope of this accreditation are marked with a in this user guide.

Outstanding Features and Services!

API offers outstanding features and services that can help you easily manage your proficiency testing!

Enter, review, submit, and print your results online.

Receive email notifications about upcoming shipments, tracking information, due date reminders, andmore!

Set-up and manage sub-user accounts for your staff, with the option to assign specific sample sets andgrant permissions on an individual basis.

View and print evaluation reports, grading criteria, and participant data summaries.

Utilize API ImageViewer for all virtual images including Blood Cell Identification, Provider-PerformedMicroscopy, and more!

Create free Continuing Education accounts for you and your staff and earn up to 18 free credits per year!

Track your Proficiency Testing performance using the new API DataDashboard – Easily view PTperformance over the six most recent test events using customizable graphs. See pages 152-158 for more information on API DataDashboard, including how to access it.

API DataDirect – Proficiency Testing Reporting Made Easier!

Using their laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to API using API DataDirect, a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time!



API currently works with the following LIS and middleware companies:

Contact our DataDirect Specialists for more information or to request a demonstration at [email protected] or 800-333-0958.

Free Continuing Education!

Physicians, Medical Laboratory Scientists (MLS), and Medical Laboratory Technicians (MLT) can earn up to 18 free CME or CMLE credits per year through an arrangement between API and the American Society for Clinical Pathology (ASCP). Multiple credits are offered each year in Chemistry, Microbiology, Hematology, and Immunology. Credits are also occasionally offered in Blood Banking, Coagulation, Microscopy, and Laboratory Management. Each educational exercise is available for between three and four months. The number of exercises available at any one time will vary and the number of earned credits depends on individual participation. See pages 159-163 for more information on how to set up CE accounts for your laboratory staff.

The acceptability of the credits provided by API is up to the organization requiring you to earn continuing education credits. Please check with the organization setting your requirements to determine if these credits will be accepted.


http://www.ascp.org/


Verification Programs

CLIA regulations state that laboratories are not to test proficiency testing samples during the proficiency testing event with more than one method unless that is how they test patient specimens. This restriction applies to both regulated and non-regulated analytes.

If a laboratory uses multiple methods to test an analyte, then they must designate one of the methods as “primary” and test the proficiency samples using that method. After the proficiency testing due date has passed, laboratories may test proficiency testing samples using multiple methods.

API’s Verification Programs (programs that begin with a letter) offer laboratories the convenience of using PT samples and statistics to verify back-up methods, while still remaining compliant with CLIA regulations. Verification programs are to be tested and resulted during the noted verification testing period, which is printed on the packaging for each set of verification samples.

Where available, verification programs are listed in the main body of this user guide along with regular PT programs. Scores from verification programs are not reported to regulatory agencies (e.g. CAP, CMS, or The Joint Commission). However, API will provide online evaluations for verification programs when evaluations for primary programs are released.

Off-Schedule Testing

Remedial Proficiency Testing

API offers remedial proficiency testing to laboratories who need specimens for additional testing, beyond their regular proficiency testing. This is generally required by an accrediting/regulatory agency when a laboratory has had poor performance on a particular analyte in two of three test events.

Remedial proficiency testing includes blind samples, customized instruction forms, and worksheets. API will grade the results and provides a letter to the laboratory evaluating the performance. It is the laboratory’s responsibility to forward the letter of evaluation on to the accrediting/regulatory agency.

Troubleshooting Samples

API offers troubleshooting samples at a nominal charge. Troubleshooting samples are generally ordered when a customer has had one failed event and would like to obtain a new, identical set of samples to retest in order to help determine the cause of the failure. This is often documented as part of their corrective action process.



Program Overview



Enrollment Information

Design and Implementation of API Proficiency Testing

API’s proficiency testing program was developed in the early 1990s to meet CLIA’s proficiency testing requirements for physician office laboratories. Since then, API has expanded to cover all areas of laboratory medicine and now services over 20,000 laboratories. Our program is open to testing facilities around the world who are interested in a proficiency testing format that is sent 2-3 times per year, with 2-5 samples per testing event.

How to Order

Enrolling in API Proficiency Testing is easy! The current API Catalog and Order Form are located on the API website. Simply click the “Catalog” link, located at the top of our homepage, and download the PDF versions of the Catalog and the Order Form. They can also be found in the “Getting Started/Ordering” section of the Knowledge Base.

The Order Form file also contains information that may be helpful in program selection for Hematology and Coagulation instruments, as well as a credit card form for transmitting payment information.

Our Customer Service Representatives and Technical Specialists are available to answer any questions regarding program selection and order placement. Once you’ve determined which programs you wish to order, complete the Order Form and email or fax it to API Customer Service.

Renewal Orders (Current Customers Only)

Renewal reminder notifications will be sent to all current customers, usually beginning in August. Once notifications are sent, customers should review the generated renewal form for accuracy. If necessary, customers can request revisions to the renewal order form. Customers may renew online (which includes an option to request changes), by phone, by fax, or by mail. API recommends that renewal orders be placed no later than November 15th to guarantee product availability.

International customers working with a distributor will be contacted by their distributor to make renewal arrangements.

Partial Year Orders

API will gladly accept new orders and order changes throughout the year and will make every effort to accommodate them, based on sample availability. Prices (excluding fees and binders) will be prorated for orders received after the first shipment(s) have closed.

Order Additions & Cancellations

Current customers can request additional programs by contacting API Customer Service via telephone, email, or live chat. Requests can also be made by submitting a completed order form to Customer Service by email or fax. Ordering additional programs may require additional shipping charges for international and non-continental U.S. locations.

Cancellation requests can be made by email, telephone, and live chat. API will credit the facility for the cost of the unshipped specimens if notification is received four or more weeks prior to the next scheduled shipment. In accordance with our cancellation policy, all credits expire within 120 days of the issuance date of the credit



memo. Please note: Additional shipping and handling charges, including the shipping and processing fee, are nonrefundable.

Price Estimates

If you are currently ordering proficiency testing with another provider, we would be happy to create a customized price and product comparison for your facility. To take advantage of this service, please email the order confirmation for your current proficiency testing order to [email protected]. Be sure to include the facility name, shipping address, phone number, and your contact information (email address and direct phone number, if applicable).

International and Non-Continental U.S. Customers

API is able to service international locations and non-continental U.S. customers. Some locations, including the state of Hawaii, U.S. territories and commonwealths, as well as international locations, may require import permits for API shipments. Local authorities can assist you in determining if any permits are required for your location. Please note: It is the responsibility of the testing facility to obtain any required import permits.

Additional shipping charges for international and non-continental U.S. locations may apply. Please contact Customer Service at [email protected] for more information.




2020 Order Form Innovative Solutions. Technical Excellence.

800.333.0958 | www.api-pt.com 1/2

Product and prices apply to domestic orders only. Contact API for product availability and pricing for international requests.

To Order: a. Complete the order form in its entirety.b. Ensure the “Total” includes the $103 Shipping and Processing fee.c. Select from the following choices to submit your order:

Email your order to [email protected] Fax the order form to us at 855-900-6119 Mail orders with payment to:

American Proficiency InstituteDepartment 9526P.O. Box 30516Lansing, MI 48909-8016

d. Call us at 800-333-0958 and speak with a Customer Service Representative if you have any questions.

Accrediting Information

CLIA # TJC # CAP/LAP ID# State ID# COLA ID# API# (existing)

Laboratory Type (Please select one)

Air Force Hospital / Clinic Hospital Laboratory ≤ 100 Beds Hospital Laboratory 301 - 400 Beds Manufacturer

Army Hospital / Clinic Hospital Laboratory 101 - 200 Beds Hospital Laboratory > 400 Beds Navy Hospital / Clinic

Clinic / Physician Office Lab Hospital Laboratory 201 - 300 Beds Independent Laboratory VA Hospital / Clinic

Laboratory Information System (LIS) (Please select one)

Allscripts Epic McKesson Horizon Meditech Sunquest

Cerner Healthland McKesson Paragon Orchard Other:

ClinLab LabDAQ-CompuGroup Medhost (HMS) SCC Soft YES! I would like to learn more about uploading PT results using my LIS.CPSI Labtrak Medicus Schuyler House - SchuyLab

Shipping Information (If shipping by department, please use additional copies)

Shipping Contact

Facility Name

Department

Street Address (No P.O. Boxes)

Address 2

City State Zip Code

Phone (required) Fax

Contact Email Address

Billing Information

Billing Contact

Facility Name

Mailing Address

Address 2

City State Zip Code

Phone (required) Fax

Billing Email Address

2020 Order Form Innovative Solutions. Technical Excellence.

800.333.0958 | www.api-pt.com 2/2

Additional Report Copies (To an additional person at a different location than the shipping address)

Current Consultant/Management IDs to Receive Report Copies

Please set up a new consultant/management account for the following person. They will be overseeing multiple API accounts.

Contact Name

Facility Name

Mailing Address

Address 2

City State Zip Code

Phone Fax

Email Address

Order Information

Catalog # Program Description Quantity * Unit Price Total

Purchase Order #: Sub-Total $

Authorized Signature: Shipping & Processing $ $103.00 Date: Additional Shipping Charges ** $

Please complete the following Credit Card Payment Form to pay by credit card. Order Total $

* Quantity refers to the number of sets of samples, not the number of events being ordered. Due to CLIA regulations, quantity should be 1 for PT programs. Ordering multiple Verificationprograms is allowed. For questions, please contact API.

** Contact API at [email protected] for International requests or Additional Shipping Charges for Alaska and Puerto Rico.

API Use Only

Kelly

Rectangle

Inno

vativ

e S

olut

ions

. Te

chni

cal E

xcel

lenc

e.

800.

3 33.

0958

|

ww

w.a

pi-p

t.com

2020

AP

I PT

Sch

edul

e

Pro

gra

m

Tes

t E

ven

t S

hip

Dat

es

Rep

lace

men

t D

ead

line

PT

Res

ult

s

Du

e D

ate

Ver

ific

atio

n

Du

e D

ate

Eva

luat

ion

s A

vaila

ble

On

line

Che

mis

try

- C

ore

1st

Janu

ary

13, 1

4 Ja

nuar

y 20

Ja

nuar

y 31

Fe

brua

ry 1

4 Fe

brua

ry 2

0

2nd

May

18,

19

May

26

June

5

June

19

June

25

3rd

Aug

ust 2

4, 2

5 A

ugus

t 31

Sep

tem

ber

11

Sep

tem

ber

25

Oct

ober

1

Der

mat

ophy

te,

Myc

olog

y

1st

Janu

ary

13

Janu

ary

20

Febr

uary

28

- M

arch

19

2nd

May

18

May

26

July

6

- Ju

ly 2

4

3rd

Aug

ust 2

4 A

ugus

t 31

Oct

ober

9

- O

ctob

er 2

9

Mic

rob

iolo

gy

1st

Febr

uary

10,

11

Febr

uary

18

Febr

uary

28

Mar

ch 6

M

arch

19

2nd

June

15,

16

June

22

July

6

July

13

July

24

3rd

Sep

tem

ber

21, 2

2 S

epte

mbe

r 28

O

ctob

er 9

O

ctob

er 1

6 O

ctob

er 2

9

Myc

obac

terio

logy

1s

t M

arch

2

Mar

ch 9

M

ay 1

-

May

11

2nd

Aug

ust 1

7 A

ugus

t 24

Oct

ober

16

- O

ctob

er 2

6

Hem

atol

ogy,

C

oagu

latio

n,

Urin

alys

is

1st

Mar

ch 9

, 10

Mar

ch 1

6 M

arch

27

Apr

il 3

Apr

il 16

2nd

July

6, 7

Ju

ly 1

3 Ju

ly 2

4 Ju

ly 3

1 A

ugus

t 13

3rd

Nov

embe

r 2,

3

Nov

embe

r 9

Nov

embe

r 20

N

ovem

ber

30

Dec

embe

r 10

Imm

unol

ogy

/ Im

mun

ohem

atol

ogy

1st

Mar

ch 3

0 A

pril

6 A

pril

13

Apr

il 20

M

ay 1

2nd

Aug

ust 3

A

ugus

t 10

Aug

ust 1

4 A

ugus

t 21

Sep

tem

ber

3

3rd

Nov

embe

r 30

D

ecem

ber

7 D

ecem

ber

11

Dec

embe

r 18

D

ecem

ber

31

Che

mis

try

- M

isc.

1st

Apr

il 20

, 21

Apr

il 27

M

ay 8

M

ay 1

5 M

ay 2

8

2nd

Oct

ober

12,

13

Oct

ober

19

Oct

ober

30

Nov

embe

r 6

Nov

embe

r 19


Treatment of Proficiency Testing Samples

Proficiency testing samples should be treated in the same manner as patient samples. According to CMS, “this means testing the PT [proficiency testing] samples the same number of times you would patient specimens, by the same personnel that routinely test the patient specimens, and using the same test system, including analyzer and reagents, that is routinely used for the patient specimens. PT samples should be rotated among the testing personnel in your laboratory.”1

Please note: For CMS/CLIA-regulated laboratories, do not refer any of your proficiency testing samples to another laboratory, even in cases where you would normally do so with a patient specimen.

Confidentiality Provisions

Confidentiality

Information on the identity, enrollment, and performance of individual participants is considered confidential by API and is not disclosed to third parties without explicit authorization from the customer. Once issued, reports become the property of the laboratory and may be distributed as needed. API will, however, vigorously defend our copyright on the layout and terminology of our evaluation reports and the content of our data summaries. Reports are to be used for the purpose of laboratory improvement and/or by persons providing similar services. Any use outside of those listed is considered unauthorized and is prohibited. In addition, microorganisms used in API PT programs are licensed for our use; retention or further subculturing of these organisms is unauthorized.

It is mandatory for U.S. PT providers to provide reports on U.S. laboratories to the Centers for Medicare and Medicaid Services (CMS), as well as some state Department of Health offices. A list of agencies and/or persons receiving reports, including those requested by the participant, appears on every evaluation’s report cover and on order confirmations for individual participants. Contact API Customer Service to request changes to agencies and/or persons receiving copies of your evaluation reports.

Policy for Use of Reports by Individuals and Organizations

Results from a single event of proficiency testing or results from a single analyte should not be used as the only method of judging laboratory or analyst performance. Proficiency testing is best regarded as one component of a laboratory’s efforts to ensure quality. All proficiency testing failures should be thoroughly investigated and a course of corrective action pursued. However, individual proficiency results may be affected by variables not involved in the laboratory’s routine testing, such as pre-analytical preparation of the proficiency sample and the matrix of the sample itself. These deviations from a laboratory’s normal procedures, required by the nature of proficiency testing, rarely affect long-term proficiency performance but may occasionally affect individual proficiency results.

Eurachem published a document on this topic in 2011, titled Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories. It is applicable to many types of laboratories and was developed for use with ISO standards.

1 Additional information can be obtained from the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. The CMS brochure regarding proficiency testing and PT referrals can be downloaded at https://www.cms.gov/Regulations-and-guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf.


http://www.eurachem.org/images/stories/Guides/pdf/Eurachem_PT_Guide_2011.pdf

http://www.eurachem.org/images/stories/Guides/pdf/Eurachem_PT_Guide_2011.pdf

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

https://www.cms.gov/Regulations-and-guidance/Legislation/CLIA/downloads/CLIAbrochure8.pdf


Activities Subcontracted by API

API subcontracts the manufacture of all physical samples as well as sample homogeneity and stability testing. All other activities related to this PT program are performed by API staff.

Sample Homogeneity and Stability

Homogeneity Testing

The homogeneity testing that is performed on the proficiency testing samples is based on recommendations found in ISO/IEC 17043:2010, ISO 13528:2015, and referenced documents. These techniques have been developed and refined by scientific and statistical experts and are designed for samples used in proficiency testing programs.

Quantitative Analytes

Homogeneity testing is performed on each new material proposed for use in accredited PT programs. The type of homogeneity study varies depending on the sample manufacturer, the number of samples being produced, and any anticipated source of inhomogeneity in the type of material being used. Testing is performed either on analytes which may be more likely to exhibit inhomogeneity or on analytes representative of the quality of the entire sample. Multiple levels of these analytes are tested to ensure that the material performs well regardless of the level of various analytes in the sample.

After samples have reached their final packaged form, a set quantity of samples is chosen randomly from the samples produced. Where possible, each sample is tested twice. Analysis of variance is used to measure the difference between the samples and between the replicate tests. The difference attributed only to the samples is compared to the difference typically seen in participant testing, and must meet statistical tests described in ISO 13528:2015 and referenced documents for the material to be approved.

Once a material is approved, overall participant statistics for each sample are monitored against statistics for previous samples to ensure that the material continues to perform well and the original homogeneity comparison remains valid. Participant results are evaluated using robust participant statistics rather than a reference value, so any occasional inhomogeneity between PT items is included in the evaluation criteria for each sample.

Qualitative Analytes

Homogeneity testing is performed on each new sample type proposed for use in accredited PT programs. After samples have reached their final packaged form, two or more samples are chosen randomly from the samples produced. Where possible, positive samples are tested twice; negative samples are tested only once. All results must match the targeted absence, presence, and/or identification for that sample type to be approved. Stability Testing

Stability testing is based on recommendations found in ISO/IEC 17043:2010, ISO 13528:2015, and referenced documents. It generally consists of repeating the homogeneity analyses on a smaller number of samples and verifying that there will be no significant change in samples during distribution and testing, as long as recommended storage temperatures are maintained once samples are received. When samples are stable for only a portion of the proficiency testing period, this is printed on sample packaging.



Grading Standards

CLIA ’88 and Grading

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) were established by the U.S. federal government and administered by the Centers for Medicare & Medicaid Services (CMS) to regulate U.S. clinical laboratories and proficiency test providers like API.

One of the subjects regulated by CLIA '88 is the way proficiency test results are graded. The method by which an analyte is graded depends on whether the test is quantitative (e.g., the amount of Cholesterol in a blood sample) or qualitative (e.g., a blood sample Positive/Negative for Infectious Mononucleosis). The range of results considered acceptable and the way that range is calculated is also specified by CLIA ’88 for “regulated” analytes (listed in CLIA regulations). See the Program Analysis section of this user guide or the API Grading Criteria webpage for individual analyte details.

Evaluation Reports

Evaluation reports consist of four parts: a Report Cover, Performance Summary, Comparative Evaluation, and Participant Data Summary. Full reports and individual components can be viewed, downloaded, or printed by logging into the API website and selecting “Evaluation Reports.”

Report Cover The report cover lists overall information about the evaluation report, such as other entities receiving copies of the report. It also includes the contact information for the program coordinators, the correction policy, and the details of any corrections that may have been made to a report.

Performance Summary This part of your report is a summary of your performance on individual analytes for a period of time up to the three most recent test events. It is divided into sections according to specialty/sub-specialty.

For each test event, the scores for individual analytes are calculated as the ratio of acceptable responses to the total number of samples tested, expressed as a percentage.

Analyte score = Acceptable responses

Total number of samples tested

Unsatisfactory performance (denoted by a red checkmark) is indicated for any analyte with less than 80% (100% for ABO Group, D (Rh), Typing, and Compatibility Testing). Analytes that are regulated under CLIA and will have scores sent to CMS are designated by (**).

Microbiology scores are regulated and reported to CMS by sub-specialty, not by individual analyte. Microbiology scores are grouped by sub-specialty (Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology) on your report. In the heading for each sub-specialty section is a combined score for the regulated challenges (indicated by **) in that section. This is the score that is reported to CMS. It is the ratio of acceptable responses for all regulated challenges in the sub-specialty to the total number of regulated responses, expressed as a percentage. Additional scores without double asterisks (**) may appear in each section and were not used in the calculation of the regulated sub-specialty score.


https://www.api-pt.com/Reference/Resources/GradingCriteria.pdf

https://www.api-pt.com/Reference/Resources/GradingCriteria.pdf


Sub-specialty score = Acceptable responses

Total number of responses

Unsuccessful long-term performance, where indicated, is based on unsatisfactory scores (less than 80%) for two of three test events.

Comparative Evaluation This part of your report shows a detailed breakdown of your performance and statistics for each test performed, including:

Analyte Tested Test Method Used Samples Tested (Sample IDs) Reported Result: The result that your facility reported to API. Expected Result Mean Standard Deviation (SD) Standard Deviation Interval (SDI) Performance: Your performance on the individual sample for the given test, shown as either “Acceptable”

or “Unacceptable.”

Qualitative Tests

The Expected Result is often “Positive” or “Negative,” a category or interpretation such as “Moderate,” or an identification of a bacteria, cell, or other element. It is normally determined by consensus of participating laboratories and supported by an independent reference value. Consensus is defined as at least 80% of participating laboratories agreeing on one answer or a small group of clinically correct answers. Immunohematology analytes, as defined by the CLIA regulations, require 95% consensus. If consensus is not achieved between participating laboratories, the expected result is based on the results of a small group of expert laboratories (“referees”) with successful PT performance for the past three events.

The Performance is determined by comparing the reported result to this expected result and is generally listed as “Acceptable” or “Unacceptable.” If “Not Graded” appears in the Performance column, please refer to the Participant Data Summary section of the website for technical commentary.

Quantitative Tests

The Expected Result for a quantitative test is a range of results based on a target value (mean) ± a fixed amount. This fixed amount is determined by CLIA '88 for each analyte and is expressed as a percentage, a specific quantity, or a number of standard deviations. The grading criteria are listed in the Program Analysis section of this manual.

The target value is the Mean (average) of the results for your comparison group. A comparison group, also known as a peer group, may consist of laboratories that use the same instrument or reagent as you or it may consist of laboratories that use the same method principle. A comparison group of "All Participants" (all facilities performing that test) may also be used, as well as a group of referee laboratories. The comparison group must contain at least 10 laboratories. In cases where an appropriate comparison group cannot be found, no grading criteria is applied. In addition, only samples with a minimum of 80% consensus are graded.



The Standard Deviation (SD) is calculated from the results for your comparison group. Both the mean and SD are robust statistics, calculated in such a way as to reduce the effect of any outlying results. The SD is listed for all quantitative analytes, whether or not it is the basis for the grading criteria for that analyte. It is also used to calculate the Standard Deviation Interval (SDI) described below. The SDI is not used to determine performance.

Performance is determined by comparing the reported result to the range of expected results calculated above. It is generally listed as “Acceptable” or “Unacceptable.” If “Not Graded” appears in the Performance column, please refer to the Participant Data Summary section of the website for technical commentary.

Participant Data Summary This part of your report is the statistical summaries and graphical representation of participant data, available on the API website.

The Participant Data Summary is a summary of the collected results of all laboratories that participated in each proficiency testing event. The information shown for qualitative tests includes the number of laboratories reporting each response, organized by the methods used. The information shown for quantitative tests includes the number of laboratories reporting, the mean, SD, range of acceptable results, and uncertainty for each comparison group, so long as it consists of 5 or more participants. In addition, "All Participant" statistics are shown for both qualitative and quantitative tests.

Metrological Traceability and Measurement Uncertainty of Assigned Values

Consensus values derived from participant results are not metrologically traceable to a single reference value or standard. They are traceable only to the laboratories submitting results for analysis. However, using a robust mean of participant results as an estimate of the true value of a test material is a reliable and accepted practice which has many benefits, including allowing for peer group comparisons among laboratories using similar or equivalent methods. The measurement uncertainty of consensus values used for grading is reviewed to ensure that it is reasonable in comparison to the grading intervals used. It is also reported along with each consensus value in the participant data summary.

The qualitative statistics are based on the results reported by participants but are compared to the known or reference results established by the sample manufacturer before being used for grading. Qualitative result s of this type do not require a calculated estimate of measurement uncertainty.

Advice on Interpretation of Statistics

The SDI is determined using the following calculation:

Your Result - Comparison Group Mean Comparison Group Standard Deviation

The SDI describes how far a proficiency result is from the comparison group mean. The closer the SDI is to “0”, the closer the result is to the group mean. For example, an SDI of -1.0 means that your laboratory's reported result is one standard deviation below the mean of the group and an SDI of +2.0 means that your reported result is two standard deviations above the mean.

A review of SDIs can assist with detection of random or systemic errors before they are large enough to be detected by quality control results. Random errors are caused by unknown and unpredictable events and occur



without any real pattern. Systemic errors are continuous and affect all results equally. Systemic errors are indicated by a trend or shift, and are commonly due to mis-calibration.

In a broad sense, when looking at the SDIs for a group of five proficiency samples the numbers should be both positive and negative. Systematic errors are indicated by trends in the data. If the SDIs are all positive numbers (e.g. your proficiency results are all above the group mean) your instrument's calibration could be drifting to the high side. Conversely, if your SDIs are all negative numbers your calibration could be drifting to the low side. Significant systematic error must also be considered if two or more SDIs exceed the same limit and the average of the five SDIs exceeds +1.5 or -1.5.

“Results Not Graded” – What’s Next?

Whenever a result is not graded, you should perform a self-evaluation. To do this, you would compare your result to the expected result(s). If your result falls within the expected range, you may conclude that your lab obtained the correct response. If your result does not fall within the expected range, you may want to troubleshoot to determine the cause.

In most cases, the expected result is printed on your evaluation next to your reported result for each sample. If the expected result is not printed on your evaluation, to find the result or range of results that is the most appropriate for you to use for comparison:

On the API website, click "Participant Data Summaries," located on the left-hand side of the screen. Choose the appropriate test event. You will see three drop-down menus, which will allow you to select the analyte, the peer group, and

sample number.

The Participant Data Summary includes descriptions of qualitative analytes (such as blood cell identification or organisms contained in culture samples) and other information that may help you with your documentation.


PROGRAM ANALYSIS – CHEMISTRY

► Analyte is not CAP accepted. 19 | Program is included in our A2LA scope of accreditation.

All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.

800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com

Basic ChemistryProgram Description

5.0 mL – Serum – Cholestech users see Catalog #176/976 – Lipid Plus on page 38. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.

Program Information

121 – Basic Chemistry 141 – Additional Sample Volume A21 – Basic Chemistry – Verification Program

Analytes Standard Units Conventional Units AV from Consensus

Mean ALT (SGPT) U/L U/L ± 20% AST (SGOT) U/L U/L ± 20%

Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL,

whichever is greater

Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%, whichever is greater

Calcium mmol/L mg/dL ± 1 mg/dL Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD

Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater

Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater

HDL Cholesterol mmol/L mg/dL ± 30% LDL, calculated & measured

mmol/L mg/dL ± 2 SD

Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L Triglycerides mmol/L mg/dL ± 25%

Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater

Uric Acid µmol/L mg/dL ± 17%

Format Shipping Dates

5 samples x 3 shipments January 14th, May 20th, August 26th






Chemistry – EndocrinologyProgram Description

5.0 mL – Serum – OCD Vitros labs performing thyroid tests, see Catalog #175 –Thyroid Special on page 42. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.

Program Information

125 – Chemistry – Endocrinology

Analytes Standard Units Conventional Units AV from Consensus Mean

Alpha-fetoprotein IU/mL ng/mL ± 3 SD Cortisol nmol/L µg/dL ± 25% Free T3 pmol/L pg/mL ± 2 SD Free T4 pmol/L ng/dL ± 3 SD

T Uptake N/A %

± 3 SD Uptakeunit

Thyroxine (T4) nmol/L µg/dL ± 1 µg/dL or ± 20%, whichever is greater

Triiodothyronine nmol/L ng/mL ± 3 SD TSH mIU/L uU/mL ± 3 SD



Comprehensive ChemistryProgram Description

5.0 mL – Serum – OCD Vitros labs performing thyroid tests, see Catalog #175 –Thyroid Special on page 42. Cholestech users see Catalog #176/976 – Lipid Plus on page 38. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.

Program Information

122 – Comprehensive Chemistry 141 – Additional Sample Volume A22 – Comprehensive Chemistry – Verification Program


Mean Albumin g/L g/dL ± 10% Alkaline Phosphatase U/L U/L ± 30%






Comprehensive Chemistry continued…


Mean

Alpha-fetoprotein IU/mL ng/mL ± 3 SD ALT (SGPT) U/L U/L ± 20% Amylase U/L U/L ± 30% AST (SGOT) U/L U/L ± 20%




Calcium mmol/L mg/dL ± 1 mg/dL

Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05

mmol/L, whichever is greater

Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD Cortisol nmol/L µg/dL ± 25% Creatine Kinase (CK) U/L U/L ± 30%


GGT U/L U/L ± 20%


HDL Cholesterol mmol/L mg/dL ± 30% Iron µmol/L µg/dL ± 20%

Lactic Acid mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L,

whichever is greater LDH U/L U/L ± 20% LDL, calculated and measured


Lipase U/L U/L ± 2 SD or ± 30 U/L, whichever is greater

Magnesium mmol/L mg/dL

± 25% mEq/L

Osmolality mOsm/kg mOSm/kg ± 3 SD Phosphorus mmol/L mg/dL ± 2 SD Potassium mmol/L mmol/L ± 0.5 mmol/L






Comprehensive Chemistry continued…


Mean

Sodium mmol/L mmol/L ± 4 mmol/L

T Uptake N/A %

± 3 SD Uptakeunit


TIBC (iron based

calculation)♦µmol/L µg/dL ± 20%

TIBC, measured µmol/L µg/dL ± 2 SD Free T3 pmol/L pg/mL ± 2 SD Free T4 pmol/L ng/dL ± 3 SD Total Protein g/L g/dL ± 10% Triglycerides mmol/L mg/dL ± 25% Triiodothyronine nmol/L ng/mL ± 3 SD TSH mIU/L uU/mL ± 3 SD UIBC, measured µmol/L µg/dL ± 2 SD




5 samples x 3 shipments January 14th, May 20th, August 26th ♦ See Catalog #133/180 – Immunoassay for TIBC (transferrin based calculation) on page 34.

Chemistry – WaivedProgram Description

5.0 mL – Serum – For waived methods, Cholestech users see Catalog #976 – Lipid Plus – 2 samples on page 38.

Program Information

144 – Chemistry – Waived A44 – Chemistry – Waived – Verification Program

Analytes Standard Units Conventional

Units AV from Consensus

Mean Albumin g/L g/dL ± 10%






Chemistry - Waived continued…

Analytes Standard Units Conventional

Units

AV from Consensus Mean

Alkaline Phosphatase U/L U/L ± 30% ALT (SGPT) U/L U/L ± 20% Amylase U/L U/L ± 30% AST (SGOT) U/L U/L ± 20%



Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%,

whichever is greater Calcium mmol/L mg/dL ± 1 mg/dL Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD Creatine Kinase (CK) U/L U/L ± 30%


GGT U/L U/L ± 20%


HDL Cholesterol mmol/L mg/dL ± 30% LDL, calculated & measured


Phosphorus mmol/L mg/dL ± 2 SD Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L Total Protein g/L g/dL ± 10% Triglycerides mmol/L mg/dL ± 25%










Alcohol Program Description 2.0 mL – Serum – For quantitative alcohol and qualitative acetone (ketone) testing, such as Bayer Acetest. For quantitative Beta-hydroxybutyrate testing, see Catalog #174 – B-Ketone on page 26.

Program Information

137 – Alcohol A37 – Alcohol – Verification Program


Mean

Acetone (qualitative) - - -

Alcohol mmol/L mg/dL ± 10 mg/dL or ± 25%, whichever is greater



Ammonia

Program Description 2.0 mL – Serum

Program Information

138 – Ammonia A38 – Ammonia – Verification Program

Analytes Standard Units Conventional Units AV from

Consensus Mean

Ammonia µmol/L µmol/L ± 2 SD or ± 10 µmol/L,



3 samples x 2 shipments April 22nd and October 14th






Amniotic Fluid pH

Program Description 0.5 mL – Simulated Amniotic Fluid – For Nitrazine methods.

Program Information

166 – Amniotic Fluid pH

Analytes pH (nitrazine) pH (interpretation)



Apolipoproteins

Program Description 3.0 mL – Lyophilized Serum

Program Information

130 – Apolipoproteins


Mean

Apolipoprotein A1 g/L mg/dL ± 2 SD Apolipoprotein B g/L mg/dL ± 2 SD Lipoprotein (a) nmol/L mg/dL ± 2 SD








B-Ketone

Program Description 1.0 mL – Serum – For quantitative Beta-hydroxybutyrate testing performed on chemistry analyzers or whole blood glucometers. For qualitative testing using Bayer Acetest, see Catalog #137 – Alcohol on page 24.

Program Information

174 – B-Ketone


Mean

Beta-hydroxybutyrate mmol/L mmol/L ± 3 SD or ± 0.2 mmol/L,




Blood Gas

Program Description 3.0 mL ampule – For blood gas testing on i-Stat analyzers, see Catalog #145 – i-Stat Chemistry on pages 36-37.

Program Information

111 – Blood Gas A11 – Blood Gas – Verification Program


Mean

pCO2 mmHg mmHg ± 5 mmHg or ± 8%, whichever is greater

pH - - ± 0.04 pO2 mmHg mmHg ± 3 SD








Blood Gas Plus

Program Description 3.0 mL ampule – For combination blood gas/electrolyte analyzers with or without hematocrit option. For blood gas testing on i-Stat analyzers, see Catalog #145 – i-Stat Chemistry on pages 36-37.

Program Information

112 – Blood Gas Plus A12 – Blood Gas Plus – Verification Program


Mean


pH - - ± 0.04 pO2 mmHg mmHg ± 3 SD


Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05

mmol/L, whichever is greater

Chloride mmol/L mmol/L ± 5%



Hematocrit Fraction % ± 6% Hemoglobin, calculated g/L g/dL ± 7%

Lactate mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L, whichever is greater

►Magnesium, ionized mmol/L mmol/L ± 3 SD or ± 0.1 mmol/L, whichever is greater

Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L tCO2 mmol/L mmol/L ± 3 SD








Blood Lead – 5 Samples

Program Description 1.0 mL – Hemolysate – Designed for LeadCare I, Plus, and Ultra.

Program Information

172 – Blood Lead – 5 Samples


Mean

Lead µmol/L µg/dL ± 4 µg/dL or ± 10%, whichever is greater


5 Samples x 3 shipments January 14th, May 20th, August 26th

Blood Lead - Waived

Program Description 1.0 mL – Hemolysate – Designed for LeadCare II.

Program Information

173 – Blood Lead – Waived


Mean

Lead µmol/L µg/dL ± 4 µg/dL or ± 10%, whichever is greater








Blood Oximetry

Program Description 2.0 mL ampule – Hemoglobin source is bovine.

Program Information

114 – Blood Oximetry A14 – Blood Oximetry – Verification Program


Mean

Carboxyhemoglobin Fraction % ± 3 SD or ± 3, whichever is greater

Hematocrit, calculated Fraction % ± 6% Hemoglobin, total g/L g/dL ± 7% Methemoglobin Fraction % ± 2

Oxyhemoglobin Fraction % ± 3 SD or ± 3, whichever is greater



Cardiac Markers – 5 Samples

Program Description 1.5 mL – Liquid – CAP accredited labs must test 5 samples for all Cardiac Markers, except D-dimer, Myoglobin, and waived BNP.

Program Information

140 – Cardiac Markers – 5 Samples 165 – Additional Sample Volume A40 – Cardiac Markers – 5 Samples – Verification Program


Consensus Mean

BNP pmol/L pg/mL ± 3 SD or ± 10 pg/mL,


CK-MB ng/mL ng/mL ± 3 SD or ± 3,

whichever is greater U/L U/L CK, total U/L U/L ± 30%






Cardiac Markers continued…


Consensus Mean

D-dimer ugFEU/mL ugFEU/mL

± 3 SD µg/L µg/L

Myoglobin ng/mL ng/mL ± 2 SD or ± 15 ng/mL,


NT pro-BNP pmol/L pg/mL ± 2 SD or ± 10 pg/mL,


Troponin I ng/mL ng/mL ± 3 SD or ± 0.3 ng/mL, whichever is greater

Troponin T (►qualitative)

ng/mL ng/mL ± 2 SD or ± 0.1 ng/mL, whichever is greater



Cardiac Markers – 2 Samples

Program Description 1.5 mL – Liquid – CAP accredited labs must test 5 samples for all Cardiac Markers, except D-dimer, Myoglobin, and waived BNP.

Program Information

920 – Cardiac Markers – 2 Samples J20 – Cardiac Markers – 2 Samples – Verification Program


Mean

►BNP pmol/L pg/mL ± 3 SD or ± 10 pg/mL,


D-dimer ugFEU/mL ugFEU/mL

± 3 SD µg/L µg/L

Myoglobin ng/mL ng/mL ± 2 SD or ± 15 ng/mL,


►NT pro-BNP pmol/L pg/mL ± 2 SD or ± 10 pg/mL,


►Troponin I ng/mL ng/mL ± 3 SD or ± 0.3 ng/mL, whichever is greater






Cardiac Markers continued…


Mean

►Troponin T ng/mL ng/mL ± 2 SD or ± 0.1 ng/mL, whichever is greater



Cystatin C


Program Information

170 – Cystatin C


Mean

Cystatin C mg/L mg/L ± 3 SD



Fetal Fibronectin

Program Description 1.0 mL – Liquid

Program Information

142 – Fetal Fibronectin

Analytes

Fetal Fibronectin








Fetal ROMProgram Description

0.5 mL – Simulated Amniotic Fluid – Compatible with Actim Prom, AmniSure ROM, and Clinical Innovations ROM Plus.

Program Information

131 – Fetal ROM

Analytes

Fetal Membranes Rupture Test



FructosamineProgram Description

1.0 mL – Serum

Program Information

135 - Fructosamine


Mean

Fructosamine µmol/L µmol/L ± 2 SD

mmol/L ± 2 SD or ± 0.2 mmol/L,









Glycohemoglobin

Program Description 0.7 mL – Hemolysate – CAP accredited labs using a non-waived method must test 5 samples for Glycohemoglobin. For Afinion analyzers, see Catalog #134 – Glycohemoglobin – Whole Blood.

Program Information

126 – Glycohemoglobin – 5 Samples 179 – Additional Sample Volume – 5 Samples 127 – Glycohemoglobin – 2 Samples 167 – Additional Sample Volume – 2 Samples A27 – Glycohemoglobin – 2 Samples – Verification Program


Mean

Glycohemoglobin (as HbA1c)

% % ± 3 SD or ± 20%, whichever is greater


3 shipments January 14th, May 20th, August 26th

Glycohemoglobin – Whole Blood

Program Description 0.5 mL – Liquid – For laboratories using Afinion analyzers for HbA1c testing.

Program Information

134 – Glycohemoglobin – Whole Blood


Mean

Glycohemoglobin (as HbA1c)

% % ± 3 SD or ± 20%, whichever is greater








HemoCue

Program Description 2.5 mL – Whole Blood

Program Information

128 – HemoCue – 5 Samples 928 – HemoCue – 2 Samples J28 – HemoCue – 2 Samples – Verification Program


Mean

Glucose mmol/L mg/dL ± 10 mg/dL or ± 20% whichever is greater

Hemoglobin g/L g/dL ± 7%


3 Shipments January 14th, May 20th, August 26th

Immunoassay


Program Information

180 – Immunoassay – 5 133 – Immunoassay – 3 A33 – Immunoassay – 3 – Verification Program


Mean

CEA ng/mL ng/mL ± 3 SD DHEA-S µmol/L µg/dL ± 2 SD Estradiol pmol/L pg/mL ± 2 SD

►Estriol nmol/L ng/mL ± 2 SD or ± 0.5 ng/mL,

whichever is greater FSH IU/L mIU/mL ± 3 SD Ferritin ng/mL ng/mL ± 3 SD Folate nmol/L ng/mL ± 3 SD






Immunoassay continued…


Mean

Homocysteine µmol/L µmol/L ± 3 SD LH U/L mIU/mL ± 3 SD

PAP ng/mL ng/mL ± 2 SD or ± 30%,


PSA, total ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL,

whichever is greater Prolactin ng/mL ng/mL ± 3 SD

Prealbumin g/L mg/dL ± 5 mg/dL or ± 25%, whichever is greater

Progesterone nmol/L ng/mL ± 3 SD Testosterone nmol/L ng/mL ± 3 SD TIBC (transferrin based

calc)♦ µmol/L µg/dL ± 20%

Transferrin g/L mg/dL ± 20% Vitamin B12 pmol/L pg/mL ± 3 SD


2 shipments April 22nd and October 14th ♦ See Catalog #122 - Comprehensive Chemistry for TIBC (iron based calculation) on pages 20-22.

Immunoassay – Special Program Description 2.0 mL – Lyophilized

Program Information

160 – Immunoassay – Special A60 – Immunoassay – Special – Verification Program


Mean C-peptide nmol/L ng/mL ± 2 SD Insulin uU/mL uIU/mL ± 3 SD

►Gastrin ng/L

pg/mL ± 2 SD pmol/L






Immunoassay – Special continued…


Mean

PTH pmol/L pg/mL ± 2 SD 25-OH Vitamin D nmol/L ng/mL ± 2 SD



i-Stat Chemistry

Program Description 3.0 mL ampule – For ACT testing, see Catalog #215 – i-Stat ACT on page 76. For BNP, CK-MB, and Troponin I testing, see Catalog #140/920 - Cardiac Markers on page 29-31. For quantitative HCG testing, see Catalog #409 – Serum HCG on page 40.

Program Information

145 – i-Stat Chemistry A45 – i-Stat Chemistry – Verification Program


Mean

pH - - ± 0.04


pO2 mmHg mmHg ± 3 SD

Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05 mmol/L, whichever is greater




Hematocrit Fraction % ± 6% Hemoglobin g/L g/dL ± 7%








i-Stat Chemistry continued…


Mean




i-Stat Chemistry – Waived

Program Description 3.0 mL ampule – For non-scored analytes or waived testing on i-Stat analyzers.

Program Information

945 - i-STAT Chemistry – Waived J45 - i-STAT Chemistry – Waived – Verification Program


Mean

Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05 mmol/L, whichever is greater




Hematocrit Fraction % ± 6% Hemoglobin g/L g/dL ± 7%











Lamellar Body CountProgram Description

3.0 mL – Liquid – For lamellar body counts performed on Hematology analyzers.

Program Information

208 – Lamellar Body Count


Mean

Lamellar Body Count x103/uL x103/uL ± 25%



Lipid PlusProgram Description

1.0 mL – Serum – For laboratories using the Cholestech analyzer for lipid testing.

Program Information

176 – Lipid Plus – 5 Samples 976 – Lipid Plus – 2 Samples


Mean

Cholesterol mmol/L mg/dL ± 10%


HDL Cholesterol mmol/L mg/dL ± 30% LDL Cholesterol, calculated


Triglycerides mmol/L mg/dL ± 25%








Neonatal Bilirubin

Program Description 1.0 mL – Serum – Bilirubin levels targeted to be representative of those seen in newborns.

Program Information

147 – Neonatal Bilirubin – 5 Samples 129 – Neonatal Bilirubin – 2 Samples A29 – Neonatal Bilirubin – 2 Samples – Verification Program


Mean

Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL, whichever is greater




Procalcitonin


Program Information

169 – Procalcitonin


Mean

Procalcitonin ug/L ng/mL ± 3 SD








Serum HCG

Program Description 1.0 mL – Serum – For quantitative and qualitative serum HCG methods. Laboratories testing quantitative and qualitative Serum HCG should order Catalog #409 and #D09 in order to report results for both.

Program Information

409 – Serum HCG D09 – Serum HCG – Verification Program


Mean

HCG IU/L mIU/mL ± 3 SD or ± 10 mIU/mL,




SHBG and Testosterone


Program Information

171 – SHBG and Testosterone


Mean Sex Hormone Binding Globulin

nmol/L nmol/L ± 3 SD

Testosterone, Bioavailable

nmol/L ng/dL ± 3 SD

Testosterone, Total♦ nmol/L ng/mL ± 3 SD

Testosterone, Free (►measured)

pmol/L pg/mL ± 3 SD


3 samples x 2 shipments April 22nd and October 14th ♦ If testing Total Testosterone only, see Catalog #133/180 – Immunoassay on pages 34-35.






Therapeutic Drugs


Program Information

132 – Therapeutic Drugs 136 – Therapeutic Drugs – Add-on option to Catalog #121 or #122 A36 – Therapeutic Drugs – Verification Program – Add-on option to Catalog #A22


Mean

Acetaminophen µmol/L µg/mL ± 3 SD or ± 2.5 µg/mL,

whichever is greater Amikacin µmol/L µg/mL ± 2 SD Carbamazepine µmol/L µg/mL ± 25%

Digoxin nmol/L ng/mL ± 0.2 ng/mL or ± 20%,

whichever is greater ►Ethosuximide µmol/L µg/mL ± 20% Gentamicin µmol/L µg/mL ± 25%

►Lidocaine µmol/L µg/mL ± 3 SD or ± 10%, whichever is greater

Lithium mmol/L mmol/L ± 0.3 mmol/L or ± 20%, whichever is greater

N-acetylprocainamide µmol/L µg/mL ± 25% Phenobarbital µmol/L µg/mL ± 20% Phenytoin µmol/L µg/mL ± 25% ►Primidone µmol/L µg/mL ± 25% Procainamide µmol/L µg/mL ± 25% Quinidine µmol/L µg/mL ± 25%

Salicylates mmol/L mg/dL ± 3 SD or ± 2.8 mg/dL, whichever is greater

Theophylline µmol/L µg/mL ± 25% Tobramycin µmol/L µg/mL ± 25% Valproic Acid µmol/L µg/mL ± 25%

Vancomycin µmol/L µg/mL ± 2 µg/mL or ± 20%, whichever is greater








Thyroid Special Program Description 5.0 mL – Serum – Designed for the Ortho Clinical Diagnostics Vitros analyzers.

Program Information

175 – Thyroid Special


Mean

Free T3 pmol/L pg/mL ± 2 SD


Triiodothyronine nmol/L ng/mL ± 3 SD Free T4 pmol/L ng/dL ± 3 SD TSH mIU/L uU/mL ± 3 SD

T Uptake N/A %

± 3 SD Uptakeunit



Tumor Markers


Program Information

150 – Tumor Markers


Mean

Beta-2 Microglobulin mg/L mg/L ± 2 SD CA 27.29 U/mL IU/L ± 2 SD CA 125 U/mL IU/mL ± 2 SD CA 15-3 U/mL IU/mL ± 2 SD CA 19-9 U/mL IU/mL ± 2 SD CEA ng/mL ng/mL ± 3 SD






Tumor Markers continued…


Mean

PSA, total♦ ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL, whichever is greater

PSA, free ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL,

whichever is greater ►PSA, complexed ng/mL ng/mL ± 2 SD Thyroglobulin ng/mL ng/mL ± 2 SD


3 samples x 2 shipments April 22nd and October 14th ♦ If testing Total PSA only, see Catalog #133/180 – Immunoassay on pages 34-35.

Whole Blood Glucose

Program Description 2mL – Whole Blood – For waived blood glucose meters. Per CMS, only one set of proficiency results may be reported during the regular testing period. Facilities using more than one meter should also enroll in Catalog #X23, #A23, #X18, or #J18.

Program Information

123 – Whole Blood Glucose – 5 Samples X23 – Extra Results for WBG – Verification Program – Report up to 20 additional meters using samples from #123. A23 – Whole Blood Glucose – 5 Samples – Verification Program 918 – Whole Blood Glucose – 3 Samples X18 – Extra Results for WBG – Verification Program – Report up to 20 additional meters using samples from #918. J18 – Whole Blood Glucose – 3 Samples – Verification Program


Mean



2 shipments April 22nd and October 14th


PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS




CSF & Body Fluid Chemistry

Program Description For manual cell count and body fluid crystals, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.

Program Information

177 – CSF & Body Fluid Chemistry


Mean

CSF Chemistry – 2.0 mL – Simulated CSF ►Albumin g/L mg/dL ± 2 SD Chloride mmol/L mmol/L ± 2 SD


►IgG g/L mg/dL ± 2 SD

Lactic Acid mmol/L mmol/L 3 SD or ± 0.4 mmol/L, whichever is greater

LDH U/L U/L ± 2 SD Sodium mmol/L mmol/L ± 2 SD

Total Protein g/L mg/dL ± 3 SD or ± 20%,

whichever is greater Body Fluid Chemistry – 3.0 mL – Simulated Body Fluid

Albumin g/L g/dL ± 3 SD or ± 10%,

whichever is greater Alkaline Phosphatase U/L U/L ± 30% Amylase U/L U/L ± 30%


Calcium mmol/L mg/dL ± 1 mg/dL

Chloride mmol/L mmol/L ± 2 SD or ± 5%, whichever is greater

Cholesterol mmol/L mg/dL ± 3 SD

Creatinine µmol/L mg/dL ± 0.3 mg/dL or ± 15%, whichever is greater


LDH U/L U/L ± 20%

Lipase U/L U/L ± 2 SD or ± 30 U/L, whichever is greater






CSF & Body Fluid Analysis continued…


Mean pH - - ± 2 SD Potassium mmol/L mmol/L ± 0.5% Sodium mmol/L mmol/L ± 4%

Total Protein g/L g/dL ± 3 SD or ± 10%, whichever is greater

Triglycerides mmol/L mg/dL ± 3 SD or ± 10 mg/dL, whichever is greater

Urea Nitrogen mmol/L mg/dL ± 2 mg/dL or ± 9%, whichever is greater

Uric Acid mmol/L mg/dL ± 0.17%



Ethyl Glucuronide

Program Description 5.0 mL – Urine – For qualitative testing.

Program Information

148 – Ethyl Glucuronide

Analytes

Ethyl glucuronide (EtG)



Microalbumin

Program Description 3.0 mL – Urine – For semi-quantitative dipstick testing or quantitative analysis. Recommended for Afinion users. For facilities performing other urine chemistry testing, see Catalog #143 – Urine Chemistry on pages 47-48.

Program Information

236 – Microalbumin






Microalbumin continued…


Mean

Microalbumin mg/L mg/L ± 3 SD or ± 30%,

whichever is greater Urine Creatinine mmol/L mg/dL ± 20%



Sweat Analysis

Program Description 5.0 mL – Liquid

Program Information

163 – Sweat Analysis


Mean

Chloride (qualitative) - - - ►Chloride (quantitative) mmol/L mmol/L ± 2 SD Conductivity mmol/L mmol/L ± 3 SD Osmolality mOSm/kg mOSm/kg ± 2 SD Sodium mmol/L mmol/L ± 2 SD



Urine Adulteration

Program Description 10.0 mL – Urine – For urine drug screen (toxicology) testing, see Catalog #139 – Urine Drug Screen on page 48-49.

Program Information

146 – Urine Adulteration






Urine Adulteration continued…


Mean

Creatinine mg/dL mg/dL ± 2 SD or ± 20%,


Oxidants µg/mL µg/mL ± 2 SD or ± 30 µg/mL,

whichever is greater pH - - ± 2 SD

Nitrite µg/mL µg/mL ± 2 SD or ± 30 µg/mL,

whichever is greater Specific Gravity - - ± 2 SD



Urine Chemistry

Program Description 10.0 mL – Urine – If testing urine creatinine and/or microalbumin only or for facilities using the Afinion, see Catalog #236 – Microalbumin on pages 45-46.

Program Information

143 – Urine Chemistry


Mean

Amylase U/l U/L ± 3 SD Calcium mmol/L mg/dL ± 3 SD Chloride mmol/L mmol/L ± 3 SD Creatinine mmol/L mg/dL ± 20% Glucose mmol/L mg/dL ± 3 SD Magnesium mmol/L mg/dL ± 25%

Microalbumin mg/L mg/L ± 3 SD or ± 30%,

whichever is greater Osmolality mOsm/kg mOSm/kg ± 3 SD Phosphorus mmol/L mg/dL ± 3 SD Potassium mmol/L mmol/L ± 3 SD Sodium mmol/L mmol/L ± 3 SD Total Protein g/L mg/dL ± 3 SD






Urine Chemistry continued…


Mean Urea mmol/L mg/dL ± 3 SD Uric Acid mmol/L mg/dL ± 3 SD



Urine Drug Screen

Program Description 10.0 mL – Urine – Qualitative or quantitative testing for urine drug screen.

Program Information

139 – Urine Drug Screen ( qualitative only) A39 – Urine Drug Screen – Verification Program


Mean

Acetaminophen µg/mL µg/mL ± 2 SD 6-Acetylmorphine ng/mL ng/mL ± 2 SD Alcohol mg/dL mg/dL ± 2 SD Amphetamines ng/mL ng/mL ± 2 SD Barbiturates ng/mL ng/mL ± 2 SD Benzodiazepines ng/mL ng/mL ± 2 SD Buprenorphine ng/mL ng/mL ± 2 SD Cannabinoids ng/mL ng/mL ± 2 SD Carisoprodol ng/mL ng/mL ± 2 SD Cocaine Metabolites ng/mL ng/mL ± 2 SD Cotinine ng/mL ng/mL ± 2 SD EDDP ng/mL ng/mL ± 2 SD Fentanyl ng/mL ng/mL ± 2 SD Hydrocodone ng/mL ng/mL ± 2 SD LSD ng/mL ng/mL ± 2 SD MDMA ng/mL ng/mL ± 2 SD Meperidine ng/mL ng/mL ± 2 SD Methadone ng/mL ng/mL ± 2 SD Methamphetamines ng/mL ng/mL ± 2 SD






Urine Drug Screen continued…


Mean

Methaqualone ng/mL ng/mL ± 2 SD Opiates ng/mL ng/mL ± 2 SD Oxycodone ng/mL ng/mL ± 2 SD Phencyclidine ng/mL ng/mL ± 2 SD Propoxyphene ng/mL ng/mL ± 2 SD Tramadol ng/mL ng/mL ± 2 SD Tricyclic Antidepressants ng/mL ng/mL ± 2 SD Zolpidem ng/mL ng/mL ± 2 SD


3 samples – 2 shipments April 22rd and October 14th


PROGRAM ANALYSIS – HEMATOLOGY




Hematology 3

Program Description 2.0 mL – Simulated Whole Blood – For automated techniques, including 2 and 3-part differentials or manual techniques for hematocrit, WBC (ammonium oxalate only), and platelet count.

Program Information

221 – Hematology 3 B21 – Hematology 3 – Verification Program


Mean

Automated Differential x109/L % ± 3 SD or ± 1, whichever

is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW % % ± 3 SD WBC 109 /L x109/L ± 15%


5 samples x 3 shipments March 11th, July 8th, November 11th

Hematology – 3S

Program Description 2.0 mL – Simulated Whole Blood – For the CDS Medonic M Series, Sysmex KX Series, pocH-100i, and XP-300.

Program Information

227 – Hematology – 3S B27 – Hematology – 3S – Verification Program






Hematology – 3S continued…


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD WBC x109/L x109/L ± 15%



QBC HematologyProgram Description

1.4 mL – Simulated Whole Blood – For use with QBC analyzers.

Program Information

222 – QBC Hematology


Mean

Granulocytes x109/L % ± 3 SD or ± 1, whichever

is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7%

Lymph/Mono x109/L % ± 3 SD or ± 1, whichever

is greater Platelet Count x109/L x109/L ± 25% WBC x109/L x109/L ± 15%






QBC Hematology continued…



Hematology – 5A

Program Description 2.5 mL – Simulated Whole Blood – For the Horiba Pentra 60, 60+, 80, 120 and the Coulter AcT 5-Diff.

Program Information

231 – Hematology – 5A B31 – Hematology – 5A – Verification Program


Mean










Hematology – 5B

Program Description 4.0 mL – Simulated Whole Blood – For the Siemens Advia 120, 2120, and 2120i.

Program Information

240 – Hematology – 5B B40 – Hematology – 5B – Verification Program


Mean





Hematology – 5C

Program Description 2.0 mL – Simulated Whole Blood – For the Coulter UniCel DxH600, DxH800, and LH750, LH755, LH780, LH785.

Program Information

230 – Hematology – 5C B30 – Hematology – 5C – Verification Program






Hematology – 5C continued…


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IRF % % ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD

nRBC x103/µL % ± 3 SD or ± 1, whichever

is greater Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%



Hematology – 5C2

Program Description 2.0 mL – Simulated Whole Blood – For the Coulter LH500, HmX, MAXM, and STKS.

Program Information

220 – Hematology – 5C2 B20 – Hematology – 5C2 – Verification Program


Mean


is greater Hematocrit L/L % ± 6%






Hematology – 5C2 continued…


Mean Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD WBC x109/L x109/L ± 15%



Hematology – 5D

Program Description 3.0 mL – Simulated Whole Blood – For the Abbot Cell-Dyn 3000-3700, 4000, Ruby, and Sapphire.

Program Information

242 – Hematology – 5D B42 – Hematology – 5D – Verification Program


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IRF - - ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD nRBC x109/L ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6%






Hematology – 5D continued…


Mean

RDW % % ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%



Hematology – 5H

Program Description 2.5 mL – Simulated Whole Blood – For the Beckman Coulter DXH500.

Program Information

279 – Hematology – 5H


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW TBD TBD TBD WBC x109/L x109/L ± 15%








Hematology – 5M

Program Description 3.0 mL – Simulated Whole Blood – For the Mindray 5000 series analyzers.

Program Information

226 – Hematology – 5M


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD WBC x109/L x109/L ± 15%



Hematology – 5S

Program Description 2.0 mL – Simulated Whole Blood – For all Sysmex XE, XN, XS, and XT analyzers.

Program Information

238 – Hematology – 5S B38 – Hematology – 5S – Verification Program






Hematology – 5S continued…


Mean


is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IG Absolute (#) x109/L x109/L ± 3 SD IG Percent (%) % % ± 3 SD IPF % % ± 3 SD IRF % % ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD

nRBC x103/µL x109/L ± 3 SD or ± 0.01 x

10E9/L, whichever is greater

Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD RET-He pg pg ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%



Blood Cell Identification

For laboratories that perform both Blood Cell Identification and Automated Differentials:

CMS allows for the transmission of only one of these scores each test event. Results from both tests are graded and will appear on your evaluation but only one score is sent to CMS.

If you would like your score for Blood Cell ID to be sent to CMS, enroll in Catalog #224 – Blood Cell ID – CMS Scored.

If you would like your score for your automated differential to be sent to CMS, enroll in Catalog #225 – Blood Cell ID – Not CMS Scored.

Detailed program information is located on the following page…







Program Description Virtual Images – Two virtual Wright stained peripheral blood smears for blood cell identification. One case study will include five annotated cells/objects for identification and will be graded. The second case study is educational and will include five annotated cell/objects for identification and a manual 100 WBC differential. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #286 – Add-on Blood Cell ID Photographs.

Program Information

224 – Blood Cell ID – CMS Scored 225 – Blood Cell ID – Not CMS Scored 286 – Add-on Blood Cell ID Photographs

Analytes



10 images x 3 shipments March 11th, July 8th, November 11th

Advanced Blood Cell ID Program Description Virtual Images – A virtual Wright stained peripheral blood smears for blood cell identification. The case study will include seven cells/objects chosen for ID and an educational commentary. This option is designed to offer cases studies that are more challenging and complex.

Program Information

259 – Advanced Blood Cell ID

Analytes





PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY




Body Fluid Cell Count – C Program Description 3.0 mL – Liquid – For Abbott, Coulter, Sysmex, and Advia analyzers. For manual cell counts, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.

Program Information

206 – Body Fluid Cell Count – C


Mean

RBC x1012/L x1012/L

± 3 SD cells/uL cells/uL

WBC x109/L x109/L



1 sample x 3 shipments March 11th, July 8th, November 11th

Body Fluid Cell Count – I Program Description 4.0 mL – Liquid – For Iris IQ®. For manual cell counts, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.

Program Information

207 – Body Fluid Cell Count – I


Mean

RBC cells/uL cells/uL ± 3 SD Nucleated Cells cells/uL cells/uL ± 3 SD








Body Fluid Microscopy Program Description Virtual Images – Three online images for the identification of crystals and other formed elements/cells in various body fluids. This program includes 2 shipments per year. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #181 – Add-on Body Fluid Microscopy Photographs.

Program Information

168 – Body Fluid Microscopy 181 – Add-on Body Fluid Microscopy Photographs

Analytes

Identification of formed elements


3 images x 2 shipments March 11th and November 11th

Cell Count and Body Fluid Crystals

Program Description Number of challenges per event, sample volume and sample type are shown in the table below. For CSF and Body Fluid Chemistry, see Catalog #177 – CSF & Body Fluid Chemistry on pages 44-45.

Program Information

277 – Cell Count and Body Fluid Crystals


Mean

Cell Count (2) – 2mL – Liquid RBC cells/uL cells/uL ± 3 SD WBC cells/uL cells/uL ± 3 SD WBC Differential % % ± 3 SD

Body Fluid Crystals (2) – 1.5 mL – Body Fluid Crystals - - -


4 samples x 2 shipments March 11th and November 11th






Fetal Hemoglobin

Program Description 1.2 mL – Simulated Gastric Fluid – For qualitative fetal hemoglobin. For Whole Blood Fetal Screen, see Catalog #515 – Fetal RBC on pages 131-132.

Program Information

210 – Fetal Hemoglobin

Analytes

Fetal Hemoglobin (gastric fluid)



Flow Cytometry Program Description 2.5 mL – Simulated Whole Blood – Lymphocyte phenotyping.

Program Information

229 – Flow Cytometry


Mean

►CD3 (T Cells) % Positive % Positive


►CD4 (T Helper) % Positive % Positive


►CD8 (T Cytotoxic) % Positive % Positive


►CD19 (B Cells) % Positive % Positive


►CD45 (Leukocytes) % Positive % Positive


►CD56/CD16+56 (NK Cells)

% Positive % Positive ± 2 SD

cells/uL cells/uL








HemoCue White Blood Cell Count Program Description 2.0 mL – Simulated Whole Blood – For HemoCue WBC System.

Program Information

209 – HemoCue White Blood Cell Count


Mean

WBC x109/L x109/L ± 15%



Reticulocyte Count

Program Description 1.0 mL – Simulated Whole Blood – Manual (new methylene blue stain only) and automated reticulocyte techniques. An automated reticulocyte count can be reported in Catalog #230, #238, and #242.

Program Information

223 – Reticulocyte Count


Mean Reticulocyte Count x106/uL or X103/uL % ± 3 SD



Sedimentation Rate – A

Program Description 5.0 mL – Simulated Whole Blood – For manual methods and most automated methods.

Program Information

228 – Sedimentation Rate – A






Sedimentation Rate - A continued…


Mean

Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater



Sedimentation Rate – B

Program Description 6.0 mL – Simulated Whole Blood – For Polymedco Sedimat 15 and 15 Plus.

Program Information

201 – Sedimentation Rate – B


Mean




Sedimentation Rate – C

Program Description 6.0 mL – Simulated Whole Blood – For HemaTechnologies ESR Stat Plus and ESR Stat 180.

Program Information

202 – Sedimentation Rate – C


Mean







Sedimentation Rate - C continued…



Sedimentation Rate – D

Program Description 4.5 mL – Simulated Whole Blood – For Alcor i-SED.

Program Information

203 – Sedimentation Rate – D


Mean




Sedimentation Rate – E

Program Description 3.0 mL – Simulated Whole Blood – For Alifax ESR analyzers.

Program Information

280 – Sedimentation Rate – E


Mean









Sickle Cell Screen

Program Description 2.5 mL – Simulated Whole Blood – For screening kits and electrophoresis screening methods.

Program Information

237 – Sickle Cell Screen

Analytes Sickle Cell Screen




PROGRAM ANALYSIS – ANDROLOGY




Antisperm Antibody

Program Description 500 uL – Serum – For screening kits and electrophoresis screening methods.

Program Information

154 – Antisperm Antibody

Analytes ►Antisperm Antibody



Post-Vasectomy Sperm Analysis

Program Description 0.3 mL – Stabilized Sperm Sample

Program Information

162 – Post-Vasectomy Sperm Analysis


Mean

►Sperm Count million/mL million/mL ± 3 SD Sperm, presence/absence

- - -



Sperm Count

Program Description 0.3 mL – Stabilized Sperm Sample

Program Information

151 – Sperm Count






Sperm Count continued…


Mean Sperm Count million/mL million/mL ± 3 SD



Sperm Morphology

Program Description 1 Unstained Semen Smear and 1 Virtual Image – For specific sperm morphology.

Program Information

152 – Sperm Morphology


Mean

Sperm Morphology % normal % normal ± 20% normal



Sperm Motility

Program Description Web-Based Video – For sperm motility and progressive motility.

Program Information

161 – Sperm Motility


Mean Sperm Motility % % ± 2 SD Sperm Progressive Motility

% % ± 2 SD








Sperm Viability

Program Description Glass Slides – Two Eosin-Nigrosin stained smears.

Program Information

153 – Sperm Viability


Mean

Sperm Viability % viable % viable ± 2 SD or ± 2% viable,





PROGRAM ANALYSIS – COAGULATION




Activated Clotting Time – Hemochron/Helena

Program Description 3.0 mL – Lyophilized – For the Hemochron Response, 801, Helena Laboratories Actalyke, and Cascade POC.

Program Information

211 – Activated Clotting Time – 5 Samples 916 – Activated Clotting Time – 2 Samples J16 – Activated Clotting Time – 2 Samples – Verification Program


Mean

Activated Clotting Time seconds seconds ± 3 SD


3 shipments March 11th, July 8th, November 11th

Activated Clotting Time – Medtronic

Program Description 3.0 mL – Lyophilized – For the Medtronic ACT and HMS Plus.

Program Information

212 – Activated Clotting Time – 5 Samples 917 – Activated Clotting Time – 2 Samples J17 – Activated Clotting Time – 2 Samples – Verification Program


Mean Activated Clotting Time seconds seconds ± 3 SD








Coagulation

Program Description 1.0 mL – Lyophilized Plasma – For plasma-based coagulation analyzers.

Program Information

217 – Coagulation B17 – Coagulation – Verification Program


Mean

APTT seconds seconds ± 15% Fibrinogen g/L mg/dL ± 20% INR - - ± 3 SD Prothrombin Time seconds seconds ± 15%



Coagulation, Supplemental Program Description 1.0 mL – Lyophilized Plasma – 2 samples, each in duplicate.

Program Information

281 – Coagulation, Supplemental 282 – Additional Sample Volume – Coagulation, Supplemental


Mean

Antithrombin III Activity % Activity % Activity TBD Factor II Activity % Normal % Normal TBD Factor V Activity % Normal % Normal TBD Factor VII Activity % Normal % Normal TBD ►Factor VIII Activity % % TBD Factor IX Activity TBD TBD TBD Factor X Activity % Normal % Normal TBD Factor XI Activity % Normal % Normal TBD Factor XII Activity % Normal % Normal TBD






Coagulation, Supplemental continued…


Mean Plasminogen % Normal % Normal TBD Protein C % Normal % Normal TBD Protein S % Normal % Normal TBD Thrombin Time sec sec TBD



D-dimer – Qualitative

Program Description 0.5 mL – Plasma – For qualitative D-dimer methods.

Program Information

245 – D-Dimer – Qualitative

Analytes

D-dimer



D-dimer – Quantitative

Program Description 0.5 mL – Plasma – For quantitative D-dimer methods. Quantitative D-dimer can also be reported in Catalog #140/920 – Cardiac Markers - see pages 29-30.

Program Information

246 – D-Dimer – Quantitative B46 – D-dimer – Quantitative – Verification Program


Mean

D-dimer µg/L µg/L ± 3 SD or ± 10 µg/L,

whichever is greater ugFEU/mL ugFEU/mL ± 3 SD






D-dimer - Quantitative continued…



Hemochron Jr. ACT +

Program Description 0.7 mL – Lyophilized – For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with the ACT-LR cuvette.

Program Information

248 – Hemochron Jr. ACT + B48 – Hemochron Jr. ACT + – Verification Program


Mean




Hemochron Jr. ACT – LR

Program Description 0.7 mL – Lyophilized – For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with the ACT-LR cuvette.

Program Information

247 – Hemochron Jr. ACT – LR B47 – Hemochron Jr. ACT – LR – Verification Program


Mean









Hemochron Jr. Citrate APTT

Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, and Signature Elite. For use with the Citrate cuvette.

Program Information

252 – Hemochron Jr. Citrate APTT


Mean ►APTT seconds seconds ± 3 SD



Hemochron Jr. Citrate PT

Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, and Signature Elite. For use with the Citrate cuvette.

Program Information

249 – Hemochron Jr. Citrate PT


Mean

INR - - ± 3 SD Prothrombin Time seconds seconds 15%








Hemochron Jr. PT

Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, Signature Elite, IL Gem PCL, and Gem PCL Plus. For use with whole blood.

Program Information

250 – Hemochron Jr. PT


Mean

INR - - ± 3 SD Prothrombin Time seconds seconds 15%



Heparin Assay

Program Description 1.0 mL – Lyophilized – For testing Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) levels. Not CMS scored or reported to CAP.

Program Information

278 – Heparin Assay


Mean

Anti-Xa U/mL U/mL ± 3 SD APTT seconds seconds ± 15% INR - - ± 3 SD Prothrombin Time seconds seconds ± 15% Thrombin Time seconds seconds ± 3 SD








i-Stat ACT

Program Description 1.0 mL – Lyophilized – For the i-Stat analyzer.

Program Information

215 – i-STAT ACT B15 – i-STAT ACT – Verification Program


Mean




Platelet Function – Aspirin Test

Program Description Pellet – For aspirin-induced inhibition. Designed for use with the Accumetrics VerifyNow System.

Program Information

255 – Platelet Function – Aspirin Test


Mean

Aspirin induced inhibition ARU ARU ± 3 SD or ± 50 ARU, whichever is greater



Platelet Function – PRU Test

Program Description Pellet – For P2Y12 inhibition (Plavix® and Effient®). Designed for use with the Accumetrics VerifyNow System.

Program Information

256 – Platelet Function – PRU Test






Platelet Function – PRU Test continued…


Mean

P2Y12 inhibition PRU PRU ± 3 SD or ± 30 PRU, whichever is greater



POC Coagulation A

Program Description Lyophilized Plasma – Point of Care Coagulation for CoaguChek XS, XS Plus, and XS Pro.

Program Information

214 – POC Coagulation A – 5 Samples B14 – POC Coagulation A – 5 Samples – Verification Program 914 – POC Coagulation A – 2 Samples J14 – POC Coagulation A – 2 Samples – Verification Program


Mean INR - - ± 3 SD Prothrombin Time seconds seconds ± 15%



POC Coagulation B

Program Description 1.0 mL – Lyophilized – For the i-STAT PCA, i-STAT I, and CoaguSense.

Program Information

216 – POC Coagulation B B16 – POC Coagulation B – Verification Program






POC Coagulation B continued…


Mean INR - - ± 3 SD Prothrombin Time seconds seconds 15%



Thromboelastogram

Program Description 1.0 mL – Lyophilized – For the Haemonetics Thromboelastograph® and TEM International ROTEM® analyzers.

Program Information

244 - Thromboelastogram


Mean

TEG® 5000 R-Time (R) minutes minutes ± 3 SD

K-Time (K) minutes minutes ± 3 SD or ± 0.1 minutes,

whichever is greater Max Amplitude (MA) mm mm ± 3 SD Angle degrees degrees ± 3 SD

ROTEM® CT seconds seconds ± 3 SD CFT seconds seconds ± 3 SD MCF mm mm ± 3 SD Alpha angles degrees degrees ± 3 SD

TEG 6s CK R-Time (R) minutes minutes ± 3 SD CK K-Time (K) minutes minutes ± 3 SD CK Max Amplitude (MA)

mm mm ± 3 SD

CK Alpha (a) angles degrees degrees ± 3 SD CRT Max Amplitude (MA)

mm mm ± 3 SD

CKH R-Time (R) minutes minutes ± 3 SD






Thromboelastogram continued…


Mean

CFF Max Amplitude (MA)

mm mm ± 3 SD

CFF FLEV mg/dL mg/dL ± 3 SD




PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS




Automated Urine Microscopy – I Program Description 10.0 mL – Urine – Designed for IRIS instruments.

Program Information

270 – Automated Urine Microscopy – I


Mean

Crystals - - ± 10 Non-Squamous Epithelial Cells

- - ± 10

RBC - - ± 3 SD WBC - - ± 3 SD



Automated Urine Microscopy – S

Program Description 10.0 mL – Urine – Designed for Sysmex and the Arkray Aution AU-4050.

Program Information

271 – Automated Urine Microscopy – S


Mean

Bacteria cells/uL cells/uL ± 3 SD or ± 5 cells/uL, whichever is greater

Casts casts/uL casts/uL ± 3 SD or ± 1 /uL, whichever is greater

Crystals - - -

Epithelial Cells cells/uL cells/uL ± 3 SD or ± 1 cell/uL, whichever is greater

RBC cells/uL cells/uL ± 3 SD or ± 2 cells/uL, whichever is greater

WBC cells/uL cells/uL ± 3 SD or ± 3 cells/uL, whichever is greater






Automated Urine Microscopy - S continued…



Fecal Lactoferrin

Program Description 0.5 mL – Simulated Stool Samples – For qualitative detection of fecal lactoferrin.

Program Information

261 – Fecal Lactoferrin

Analytes

Fecal Lactoferrin



Fecal Occult Blood

Program Description 1.5 mL – Simulated Stool Samples – For Guaiac or Immunoassay methods.

Program Information

284 – Fecal Occult Blood B84 – Fecal Occult Blood – Verification Program 285 – Fecal Occult Blood – Add-on to Catalog #232 or #272

Analytes

Fecal Occult Blood








Gastric Occult Blood

Program Description 2.0 mL – Simulated Gastric Samples – For gastric occult blood and pH.

Program Information

239 – Gastric Occult Blood B39 – Gastric Occult Blood – Verification Program

Analytes

Gastric Occult Blood

pH


2 samples x 3 shipments March 12th, July 8th, and November 12th

Provider-Performed Microscopy

Program Description Virtual Images – Online images for provider-performed microscopy. For KOH preparations of skin, hair, or nails, see Catalog #333 – KOH Slides on pages 104-105. This program includes two challenges for urine sediment and one challenge for all others. This is a virtual program only and does not include printed photographs. If facilities would like to receive printed photographs, add on Catalog #287 – Add-on PPM Photographs.

Program Information

233 – Provider-Performed Microscopy B33 – Provider-Performed Microscopy – Verification Program 287 – Add-on PPM Photographs

Analytes

Fecal WBC (1)

Fern Test (1)

Nasal Smear (1)

Pinworm Preparation (1)

Sperm, presence/absence (1)

Urine Sediment (2)

Vaginal Wet Prep (1)

Vaginal Wet Prep-KOH (1)






Provider-Performed Microscopy continued…



Rapid Urease

Program Description 0.5 mL – Simulated gastric biopsy samples for CLOtest, PyloriTek, or similar methods.

Program Information

260 – Rapid Urease

Analytes

Urease


3 samples x 2 shipments February 11th and September 23rd

Urinalysis and HCG

Program Description 10.0 mL – Urine – HCG is intended for waived methods. For automated urine microscopy, see Catalog #271 – Automated Urine Microscopy – S on pages 80-81. For urine testing using Iris iChem, Velocity, and vChem, see Catalog #272 – Urinalysis & HCG – I on pages 84-85 and Catalog #270 – Automated Urine Microscopy – I on page 80. For Fecal Occult Blood testing, see Catalog #285 – Fecal Occult Blood on page 81.

Program Information

232 – Urinalysis and HCG B32 – Urinalysis and HCG – Verification Program


Mean Bilirubin - - - Bilirubin, confirmatory - - - Blood/Hemoglobin - Ery/mL - Creatinine - mg/dL - Glucose - mg/dL - HCG - - - Ketones - mg/dL -






Urinalysis and HCG continued…


Mean

Leukocyte Esterase - - - Nitrite - - - pH - - - Protein - mg/dL - Protein, confirmatory - - - Reducing Substance - - - Specific Gravity - - ± 0.01 Urobilinogen - mg/dL -



Urinalysis and HCG - I Program Description 10.0 mL – Urine – HCG is intended for waived methods. For use with Iris iChem, Velocity, and vChem. For automated urine microscopy, see Catalog #270 – Automated Urine Microscopy – I on page 80. For urine testing on non-Iris methods, see Catalog #232 – Urinalysis, HCG, and FOB on pages 83-84 and Catalog #271 – Automated Urine Microscopy – S on pages 80-81. For Fecal Occult Blood testing, see Catalog #285 – Fecal Occult Blood on page 81.

Program Information

272 – Urinalysis, HCG – I


Mean

Bilirubin - - - Bilirubin, confirmatory - - - Blood/Hemoglobin - Ery/uL - Glucose - - - HCG - - - Ketones - mg/dL - Leukocyte Esterase - WBC/uL - Nitrite - - - pH - - - Protein - mg/dL -






Urinalysis and HCG – I continued…


Mean

Protein, confirmatory - mg/dL - Reducing Substance - - - Specific Gravity - - ± 0.01 Urobilinogen - mg/dL -



Urine Crystals

Program Description 1.5 mL – Urine – For identification of urine crystals.

Program Information

273 – Urine Crystals

Analytes

Urine Crystal Identification



Urine Eosinophils

Program Description Virtual Images – An online image for the presence or absence of urine eosinophils. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #289 – Add-on Urine Eosinophils Photographs.

Program Information

258 – Urine Eosinophils 289 – Add-on Urine Eosinophils Photographs

Analytes

Urine Eosinophils






Urine Eosinophils continued…


1 image x 3 shipments March 11th, July 8th, November 11th

Urine HCG – Qualitative

Program Description 1.0 mL – Urine – For non-waived methods such as latex agglutination or FIA. Also may be ordered by laboratories with waived methods who wish to test 5 samples.

Program Information

235 – Urine HCG – Qualitative B35 – Urine HCG – Qualitative – Verification Program

Analytes

HCG



Urine Sediment

Program Description Virtual Images – Two online images for identification of formed elements in urine sediment. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #288 – Add-on Urine Sediment Photographs.

Program Information

234 – Urine Sediment 288 – Add-on Urine Sediment Photographs

Analytes

Formed elements such as RBC, WBC, bacteria, casts, crystals, epithelial cells, etc.








Waived & PPM Package

Program Description Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For waived methods and procedures commonly performed in a physician’s office.

Program Information

251 – Waived and PPM Package B51 – Waived and PPM Package – Verification Program X51 – Extra Results for WBG in the Waived and PPM Package – 2 Samples


Mean Fecal Occult Blood (1) – 1.5 mL – Simulated Stool Sample

- - -

Group A Strep Antigen (2)♦ – Swab

- - -

Hematocrit & Hemoglobin (2) – 1.5 mL – Whole Blood

Hematocrit L/L % ± 6%

Hemoglobin g/L g/dL ± 7% Urinalysis (1) – 10.0 mL – Urine♦♦

- - -

Urine Sediment (2) – Photograph - - -

Vaginal Wet Prep (1) – Photograph

- - -

Vaginal Wet Prep–KOH (1) – Photograph - - -

Whole Blood Glucose (2) – 2.0 mL – Whole Blood♦♦♦

Whole Blood Glucose mmol/L mg/dL ± 10 mg/dL or ± 20%, whichever is greater


12 samples x 3 shipments March 11th, July 8th, November 11th ♦ If using a molecular method for Group A Strep, see Catalog #364/964 – Strep pharyngeal (molecular) on page 99.

♦♦ See analyte breakdown for urinalysis on pages 83-84 under Catalog #232. ♦♦♦ If using HemoCue, see Catalog #128/928 – HemoCue on page 34.


PROGRAM ANALYSIS – MICROBIOLOGY




Microbiology Enrollment Requirements CLIA requires laboratories performing microbiology tests that are regulated for proficiency testing to test five regulated challenges per test event in each sub-specialty where regulated testing is performed. The five sub-specialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. All non-waived tests in a sub-specialty can be combined to meet the five-challenge requirement. For molecular testing of direct specimens, CMS considers only bacteriology, virology, and yeast in blood cultures to be regulated tests. Regulated tests are indicated in bold type.

Challenges tested with waived methods (e.g., Rapid Group A Strep) cannot be included in the five regulated challenges. Furthermore, if one of your methods becomes waived or you change to a waived method mid-year, you are responsible for ensuring you maintain five challenges per test event for the remaining non-waived tests in that sub-specialty.

Programs listed that have fewer than five samples are to be used as add-on options to other programs in the same sub-specialty.

Susceptibility testing counts as one challenge regardless of the number of drugs reported.

Urine colony count is not a regulated test and cannot be included as one of the five challenges.

BACTERIOLOGY

Affirm VP

Program Description Swab – For the BD Affirm VP III.

Program Information

324 – Affirm VP

Analytes

Candida sp.

Trichomonas vaginalis

Gardnerella vaginalis


5 samples x 3 shipments February 11th, June 17th, September 23rd






Basic Bacteriology Package

Program Description Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For laboratories performing non-waived Group A Strep Antigen testing, Throat Cultures, and Urine Cultures. For strep testing for molecular methods, see Catalog #364/#964 – Strep pharyngeal (molecular) on page 99.

Program Information

321 – Basic Bacteriology Package

Analytes

Group A Strep Antigen (2) – Swab

Throat Culture (2) – Inocu-Swab II

Urine Colony Count (1) – Quantitated Pellet + Dilution Fluid

Urine Culture (1) – Quantitated Pellet + Dilution Fluid

Susceptibility Testing (1) – Tested on Urine Sample



Bacterial Vaginosis

Program Description 1.0 mL – Liquid – For OSOM BVBlue.

Program Information

359 – Bacterial Vaginosis

Analytes

Bacterial Vaginosis Screen








Blood Culture

Program Description 12.0 mL – Pellet + Rehydration Fluid – For aerobic and anaerobic Blood Cultures. For use as an add-on to other Bacteriology programs.

Program Information

361 – Blood Culture

Analytes

Blood Culture

Susceptibility Testing



Bordetella pertussis/parapertussis (molecular) Program Description 1.0 mL – Liquid – For molecular methods for Bordetella pertussis and Bordetella parapertussis. For use as an add-on to other Bacteriology programs.

Program Information

363 – Bordetella pertussis/parapertussis

Analytes

Bordetella pertussis

Bordetella parapertussis








C. difficile Toxin/Antigen

Program Description 1.0 mL – Liquid – For C. difficile antigen and toxin test kits. Also compatible with molecular methods.

Program Information

350 – C. difficile Toxin/Antigen – 5 Samples 347 – C. difficile Toxin/Antigen – 2 Samples – Add-on Option C47 – C. difficile Toxin/Antigen – 2 Samples – Verification Program

Analytes

C. difficile Antigen

C. difficile Toxin


3 shipments February 11th, June 17th, September 23rd

Campylobacter

Program Description Inocu-Swab II – For detection of Campylobacter sp. using antigen or culture. For use as an add-on to other Bacteriology programs.

Program Information

360 – Campylobacter

Analytes

Campylobacter sp.



Chlamydia/GC (molecular) Program Description 1.0 mL – Liquid – For nucleic acid probe or amplification methods.

Program Information

311 – Chlamydia/GC (molecular)






Chlamydia/GC (molecular) continued…

Analytes

Chlamydia trachomatis

Neisseria gonorrhoeae



Chlamydia AntigenProgram Description

1.0 mL – Liquid – For Chlamydia antigen detection kits.

Program Information

316 – Chlamydia Antigen – 5 Samples 930 – Chlamydia Antigen – 2 Samples – Add-on Option

Analytes

Chlamydia Antigen



Comprehensive BacteriologyProgram Description

Number of challenges per year, sample volume, and sample type are shown in the table below, to the right of each sample name. For facilities performing a variety of bacteriology procedures. Not compatible with molecular methods.

Program Information

328 – Comprehensive Bacteriology

Analytes

Blood Culture (1) – Pellet + Rehydration Fluid

CSF Culture (1) – Pellet + Rehydration Fluid

Campy Antigen (2) – Allowed on Stool Culture Samples

Ear/Eye Culture (1) – Inocu-Swab II






Comprehensive Bacteriology continued…

Analytes

Gram Stain (15) – Glass Slides

Group A Strep Antigen (3) – Swab

GC/Group B Strep Culture (2) – Inocu-Swab II

Educational Culture and Susceptibility (3) – Inocu-Swab II

Sputum Culture (2) – Inocu-Swab II

Stool Culture (2) – Inocu-Swab II

Urine Culture and Susceptibility Testing (3) – Quantitated Pellet + Dilution Fluid

Throat Culture (1) – Inocu-Swab II

Urine Colony Count (3) – Quantitated Pellet + Dilution Fluid

Wound Culture – Aerobic and Anaerobic (2) – Inocu-Swab II



Gram Stain

Program Description Glass Slide – Fixed unstained glass slides for Gram stain and morphology.

Program Information

320 – Gram Stain 330 – Additional Gram Stain Slides

Analytes

Gram Stain

Gram Stain Morphology








Gram Stain – Direct Smears

Program Description Virtual Images – Gram stained direct smears from various sources including blood, sputum, CSF, and wound. Not CMS Scored or reported to CAP.

Program Information

329 – Gram Stain – Direct Smears

Analytes

Gram Stain

Leukocytes

Sputum Quality

Stain Quality



Gram Stain – Vaginitis

Program Description Virtual Images – Gram stained vaginal smears for the detection of bacterial vaginosis. Not CMS Scored or reported to CAP.

Program Information

319 – Gram Stain – Vaginitis

Analytes

Bacterial Vaginosis (Gram Stain)

Nugent Score








Group A Strep Antigen

Program Description Swab – For rapid Group A Strep antigen detection.

Program Information

312 – Group A Strep Antigen – 5 Samples 912 – Group A Strep Antigen – 3 Samples – Add-on Option 912 – Group A Strep Antigen – 2 Samples – Add-on Option or for Waived Methods J12 – Group A Strep Antigen – 2 Samples – Verification Program

Analytes

Group A Strep Antigen



Group B Strep (molecular) Program Description Swab – For molecular Group B Strep testing.

Program Information

365 – Group B Strep (molecular) – 5 Samples 965 – Group B Strep (molecular) – 2 Samples – Add-on Option

Analytes

Group B Strep








GC/Group B Strep Culture

Program Description Inocu-Swab II – Culture for N. gonorrhoeae and Group B Strep. For molecular methods, see Catalog #365/#965 – Group B Strep (molecular).

Program Information

315 – GC/Group B Strep Culture – 5 Samples 929 – GC/Group B Strep Culture – 2 Samples – Add-on Option

Analytes

Neisseria gonorrhoeae Culture

Group B Strep Culture



H. pylori Antigen, Stool Program Description 0.5 mL – Fecal Suspension – For detection of H. pylori antigen. For use as an add-on to other Bacteriology programs.

Program Information

351 – H. pylori Antigen, Stool

Analytes

Helicobacter pylori Antigen








Legionella AntigenProgram Description

0.5 mL – Liquid – For Legionella antigen detection methods in urine. For use as an add-on to other Bacteriology programs.

Program Information

340 – Legionella Antigen

Analytes

Legionella Antigen



MRSA CultureProgram Description

Inocu-Swab II – For laboratories using culture methods for MRSA. For use as an add-on to other Bacteriology programs.

Program Information

356 – MRSA Culture

Analytes

Methicillin Resistant Staphylococcus aureus



MRSA/Staph aureus (molecular)Program Description

Swab – For molecular methods that detect MRSA and Staph aureus. For use as an add-on to other Bacteriology programs.

Program Information

366 – MRSA/Staph aureus (molecular)






MRSA/Staph aureus (molecular) continued…

Analytes

Methicillin Resistant Staphylococcus aureus

Staphylococcus aureus



Mycoplasma pneumoniae (molecular) Program Description 1.0 mL – Liquid – For molecular methods that detect Mycoplasma pneumoniae. For use as an add-on to other Bacteriology programs.

Program Information

374 – Mycoplasma pneumonia (molecular)

Analytes

Mycoplasma pneumoniae



Shiga Toxin

Program Description 1.0 mL – Liquid – For methods that detect Shiga Toxins 1 and 2.

Program Information

343 – Shiga Toxin

Analytes

Shiga Toxin 1

Shiga Toxin 2

Shiga Toxin 1 and 2








S. pneumoniae Antigen

Program Description 0.5 mL – Liquid – For antigen detection methods in urine. For use as an add-on to other Bacteriology programs.

Program Information

341 – S. pneumoniae Antigen

Analytes

S. pneumoniae Antigen



Strep Pharyngeal (molecular) Program Description Swab – For detection of Group A and Group C/G Strep by molecular methods

Program Information

364 – Strep Pharyngeal (molecular) – 5 Samples 964 – Strep Pharyngeal (molecular) – 2 Samples – Add-on Option

Analytes

Group A Strep

Group C/G Strep








Throat Culture

Program Description Inocu-Swab II – For culture methods detecting Group A Strep only. For molecular testing, see Catalog #364/#964 – Strep pharyngeal (molecular) on page 99.

Program Information

313 – Throat Culture – 5 Samples 953 – Throat Culture – 3 Samples – Add-on Option 952 – Throat Culture – 2 Samples – Add-on Option

Analytes

Throat Culture



Urine Culture

Program Description Quantitated Pellet + Dilution Fluid – Culture (including screening tubes, paddles, and agar plates) for bacterial colony count and/or identification. One sample per event for susceptibility testing.

Program Information

314 – Urine Culture – 5 Samples 924 – Urine Culture – 2 Samples – Add-on Option

Analytes

Susceptibility Testing

Urine Colony Count

Urine Culture








VRE Culture

Program Description Inocu-Swab II – For culture methods. For use as an add-on to other Bacteriology programs. For molecular methods, see Catalog #367 – VRE (molecular).

Program Information

357 – VRE Culture

Analytes

Vancomycin Resistant Enterococci



VRE (molecular) Program Description Swab – For molecular methods. For use as an add-on to other Bacteriology programs. For culture methods, see Catalog #357 – VRE Culture.

Program Information

367 – VRE (molecular)

Analytes

Vancomycin Resistant Enterococci








MYCOBACTERIOLOGY

Acid Fast Smears

Program Description Glass Slide – Fixed unstained glass slides.

Program Information

335 – Acid Fast Smears

Analytes

Acid Fast Smears


5 samples x 2 shipments March 4th and August 19th

M. tuberculosis (molecular) Program Description 1.0 mL – Liquid – For detection of M. tuberculosis and rifampin resistance using molecular methods.

Program Information

372 – M. tuberculosis (molecular)

Analytes

M. tuberculosis

Rifampin resistance screen



Mycobacteriology Culture

Program Description Liquid and Lyophilized – For culture and identification of mycobacteria.

Program Information

344 – Mycobacteriology Culture






Mycobacteriology Culture continued…

Analytes

Mycobacteriology Identification

►Mycobacterial Susceptibility Testing


5 samples x 2 shipments March 4th and August 19th

MYCOLOGY

Candida Culture

Program Description Inocu-Swab II – For Candida culture.

Program Information

317 – Candida Culture

Analytes

Candida Culture



Cryptococcal Antigen

Program Description 1.0 mL – Liquid – For Cryptococcal antigen detection.

Program Information

345 – Cryptococcal Antigen

Analytes

Cryptococcal Antigen








Dermatophyte Culture

Program Description Inocu-Swab II – For culture methods for dermatophytes.

Program Information

332 – Dermatophyte Culture

Analytes

Dermatophyte Culture



India Ink

Program Description 1.0 mL – Liquid – For presence or absence of encapsulated yeast using India Ink methods.

Program Information

339 – India Ink

Analytes

India Ink



KOH Slides

Program Description Glass Slides – For KOH examination of skin, hair, or nails.

Program Information

333 – KOH Slides

Analytes

KOH Preparation






KOH Slides continued…



Mycology Culture

Program Description Inocu-Swab II – For culture and identification of yeasts, molds, and aerobic actinomycetes.

Program Information

331 – Mycology Culture

Analytes

Mycology Culture



PARASITOLOGY

Blood Parasites

Program Description Two virtual blood smears and three Giemsa-stained thick and/or thin blood smears for the detection and identification of blood parasites.

Program Information

336 – Blood Parasites

Analytes

Blood Parasite Identification


5 samples – 3 times per year February 11th, June 17th, September 23rd






Giardia & Cryptosporidium AntigenProgram Description

1.0 mL – Liquid – For EIA & DFA test methods.

Program Information

342 – Giardia & Cryptosporidium Antigens – 5 Samples 932 – Giardia & Cryptosporidium Antigens – 2 Samples – Add-on Option

Analytes

Cryptosporidium Antigen

Giardia Antigen



ParasitologyProgram Description

Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For Cryptosporidium antigen, see Catalog #342/#932 – Giardia and Cryptosporidium Antigens. For Blood Parasites, see Catalog #336 – Blood Parasites on page 105.

Program Information

334 – Parasitology

Analytes

Blood Smear (1) – Photo

Formalin Concentrates (2) – 0.5 mL – Fecal Suspension

Modified Acid-fast Stain (2)

PVA (1) – Glass Slide

Stool Prep (1) – Photo








Trichomonas

Program Description 2.0 mL – Liquid – For molecular methods and for Sekisui OSOM Rapid Trichomonas test.

Program Information

362 – Trichomonas

Analytes




VIROLOGY

HPV (molecular) - 5

Program Description 1.0 mL – Liquid – For detection of High-Risk HPV using molecular methods.

Program Information

375 – HPV (molecular) – 5 Samples

Analytes

HPV

HPV genotyping (16, 18, and 18/45)








HPV (molecular) - 2Program Description

1.0 mL – Liquid – For detection of High-Risk HPV using molecular methods. For use as an add-on option to other Virology programs.

Program Information

975 – HPV (molecular) – 2 Samples

Analytes

HPV

HPV genotyping (16, 18, and 18/45)



HSV 1 & 2 (molecular)Program Description

1.0 mL – Liquid – For detection of HSV 1 & 2 using molecular methods.

Program Information

373 – HSV 1 & 2 (molecular)

Analytes

Herpes Simplex Virus Type 1

Herpes Simplex Virus Type 2



Influenza A & B (Silaris) - 5Program Description

Swab – For Silaris Influenza A & B Test kits. For other methods, see Catalog #322/942 – Virology Package on page 110.

Program Information

377 – Influenza A & B (Silaris) – 5 Samples






Influenza A & B (Silaris) continued…

Analytes

► Influenza A

► Influenza B



Influenza A & B (Silaris) - 3

Program Description Swab – For Silaris Influenza A & B Test kits. For other methods, see Catalog #933 – Virology Package – waived on pages 110-111.

Program Information

977 – Influenza A & B (Silaris) – 3 Samples

Analytes

► Influenza A

► Influenza B



Rotavirus

Program Description 1.0 mL – Liquid – For the detection of rotavirus antigen.

Program Information

348 – Rotavirus – 5 Samples 349 – Rotavirus – 3 Samples – Add-on Option

Analytes

Rotavirus Antigen








Virology Package

Program Description 1.0 mL – Liquid – For Influenza A, Influenza B, RSV, and Adenovirus. Compatible with antigen detection kits and molecular methods. For Influenza testing on Silaris, see Catalog #377/977 – Influenza A & B (Silaris) on pages 108-109.

Program Information

322 – Virology Package – 5 Samples C22 – Virology Package – 5 Samples – Verification Program 942 – Virology Package – 2 Samples – Add-on Option

Analytes

Adenovirus

Influenza A

Influenza B

Influenza A or B

RSV



Virology Package - Waived

Program Description 1.0 mL – Liquid – For Influenza A, Influenza B, RSV, and Adenovirus. Compatible with antigen detection kits and molecular methods. For Influenza testing on Silaris, see Catalog #377/977 – Influenza A & B (Silaris) on pages 108-109.

Program Information

933 – Virology Package – Waived J33 – Virology Package – Waived – Verification Program

Analytes

Adenovirus

Influenza A

Influenza B

Influenza A or B

RSV






Virology Package - Waived continued…


2 shipments February 11th and September 23rd

Molecular Multiplex Programs

For molecular testing of direct specimens, CMS considers bacteriology, virology, and yeast in blood cultures to be regulated tests. If the only regulated bacteriology, virology, or mycology testing you perform is using a multiplex analyzer, you are required to participate in five challenges, three times a year for compliance with CLIA.

Blood Pathogen Panel Program Description 1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 166.

Program Information

368 – Blood Pathogen Panel

Analytes

Identification of Bacteria

Identification of Yeasts

Resistance Genes



GI Panel Program Description 1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 167.

Program Information

369 – GI Panel

Analytes







GI Panel continued…

Analytes

Identification of Parasites

Identification of Viruses



Meningitis PanelProgram Description

1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on pages 168.

Program Information

371 – Meningitis Panel

Analytes



Identification of Yeasts



Pneumonia PanelProgram Description

0.5 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 168.

Program Information

378 – Pneumonia Panel

Analytes








Pneumonia Panel continued…

Analytes

Resistance Genes


2 samples x 3 shipments June 17th and September 23rd

Respiratory PanelProgram Description

1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 167.

Program Information

370 – Respiratory Panel

Analytes





Vaginal PanelProgram Description

0.5 mL – Liquid – For the detection of vaginitis/vaginosis using molecular multiplex panels. For use as an add-on to other Bacteriology programs. For a full list of reportable analytes, see table on page 168.

Program Information

376 – Vaginal Panel

Analytes


Identification of Candida

Identification of Trichomonas




PROGRAM ANALYSIS – IMMUNOLOGY




ANA

Program Description 0.6 mL – Serum – Qualitative reporting only. Not compatible with latex agglutination methods. See Catalog #429 – ANA (Latex Kits) for latex agglutination methods.

Program Information

421 – ANA

Analytes ANA Anti-DNA (ds, ss) Anti-Sm Anti-RNP Anti-SSA Anti-SSB


5 samples x 3 shipments April 1st, August 5th, December 2nd

ANA (Latex Kits) Program Description 0.6 mL – Serum – Qualitative reporting only. Designed for latex agglutination methods only.

Program Information

429 – ANA (Latex Kits)

Analytes ANA








Anti-CCPProgram Description

1.0 mL – Serum – May be reported as qualitative, quantitative, or semi-quantitative.

Program Information

423 – Anti-CCP


Mean

Anti-Cyclic Citrullinated Peptide

U/mL U/mL ± 3 SD or ± 5 U/mL, whichever is greater



ASOProgram Description

1.0 mL – Serum – May be reported as qualitative, quantitative, or as a titer.

Program Information

424 – ASO


Mean

Anti-Streptolysin O IU/mL IU/mL ± 2 SD or ± 25 IU/mL, whichever is greater



BRCA1/2 SequencingProgram Description

10-µg – Extracted DNA specimens

Program Information

441 – BRCA1/2 Sequencing






BRCA1/2 Sequencing continued…

Analytes ►BRCA1/2 DNA sequencing and variant interpretation BRCA1/2 duplication/deletion analysis



C-Reactive Protein

Program Description 0.5 mL – Serum – For qualitative and quantitative CRP procedures that measure levels >1.0 mg/dL.

Program Information

431 – C-Reactive Protein


Mean

C-Reactive Protein mg/L mg/dL ± 2 SD



Diagnostic Allergy

Program Description 2.0 mL – Serum – For quantitative IgE. Specific allergens may be reported qualitatively or quantitatively.

Program Information

419 – Diagnostic Allergy 437 – Additional Sample Volume


Mean Total IgE IU/mL IU/mL ± 3 SD Specific Allergens kUA/L kUA/L ± 3 SD








H. pylori Antibody

Program Description 0.5 mL – Serum – For kits that detect the Helicobacter pylori antibody. For antigen testing, see Catalog #351 – H. pylori – Antigen, Stool on page 96.

Program Information

420 – H. pylori Antibody

Analytes

H. pylori Antibody



HBV Viral Load

Program Description 1.5 mL – Plasma – For molecular quantification of HBV DNA.

Program Information

442 – HBV Viral Load


Mean

►HBV Viral Load IU/mL (log10 transformed)

IU/mL ± 3 SD



HCV Viral Load

Program Description 1.5 mL – Plasma

Program Information

439 – HCV Viral Load






HCV Viral Load continued…


Mean

►HCV Viral Load IU/mL (log10 transformed)

IU/mL ± 3 SD

►HCV, qualitative - - - ►HCV genotyping - - -



High Sensitivity CRP

Program Description 0.5 mL – Serum – For high sensitivity CRP procedures that measure levels between 0-1.5 mg/dL

Program Information

425 – High Sensitivity CRP


Mean

C-Reactive Protein (hs) mg/L mg/dL ± 2 SD



HIV Viral Load

Program Description 1.5 mL – Plasma

Program Information

440 – HIV Viral Load


Mean

►HIV-1 RNA Viral Load IU/mL (log10 transformed)

IU/mL ± 3 SD






HIV Viral Load continued…



HSV-2 Antibody

Program Description 0.5 mL – Serum – For the Biokit HSV-2 rapid test.

Program Information

430 – HSV-2 Antibody

Analytes

HSV-2 Antibody



Immunology Package

Program Description Serum – Number of challenges per event and sample volume are shown in the table below, to the right of each sample name. Cost savings package for facilities that perform all of the included tests. ASO, Rubella, and Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer.

Program Information

407 – Immunology Package


Mean Anti-Streptolysin O (5) – 1.0 mL

IU/mL IU/mL ± 2 SD or ± 25 IU/mL, whichever is greater

Infectious Mononucleosis (5) – 0.65 mL

- - -

Rheumatoid Factor (5) – 1.0 mL


Rubella (5) – 1.0 mL IU/mL IU/mL ± 3 SD or ± 10 IU/mL, whichever is greater






Immunology Package continued…


3 shipments April 1st, August 5th, December 2nd

Immunoproteins/C3 & C4


Program Information

436 – Immunoproteins/C3 & C4


Mean Alpha-1-Antitrypsin g/L mg/dL ± 3 SD Complement C3 g/L mg/dL ± 3 SD

Complement C4 g/L mg/dL ± 3 SD Haptoglobin g/L mg/dL ± 3 SD

IgA g/L mg/dL ± 3 SD

IgE IU/mL IU/mL ± 3 SD IgG g/L mg/dL ± 25%

IgM g/L mg/dL ± 3 SD



Infectious Disease Serology

Program Description 0.5 mL – Lyophilized defibrinated plasma – 1 sample provided for each analyte (CMV IgG and IgM are included in the same sample - Toxoplasma gondii IgG and IgM are included in the same sample).

Program Information

438 – Infectious Disease Serology

Analytes

►CMV (IgG & IgM) Mumps Virus IgG






Infectious Disease Serology continued…

Analytes ►Rubella IgG ►Rubeola Virus IgG ►Toxoplasma gondii (IgG & IgM) ►Varicella Zoster Virus (VZV) IgG


6 samples x 2 shipments April 1st and December 2nd

Infectious Mononucleosis


Program Information

410 – Infectious Mononucleosis – 5 Samples 910 – Infectious Mononucleosis – 2 Samples – For waived methods

Analytes Infectious Mononucleosis



Infectious Mononucleosis & Rheumatoid Factor

Program Description Serum – Number of challenges per event and sample volume are shown in the table below, to the right of each sample name. Cost savings package for laboratories that perform both tests. Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer.

Program Information

411 – Infectious Mononucleosis & Rheumatoid Factor


Mean

Infectious Mononucleosis (5) – 0.65 mL

- - -






Infectious Mononucleosis & Rheumatoid Factor continued…


Mean

Rheumatoid Factor (5) – 1.0 mL




Lyme Disease

Program Description 0.6 mL – Serum – For IgG and IgM antibody detection to Borrelia burgdorferi.

Program Information

418 – Lyme Disease

Analytes

Lyme Disease Antibody



Mycoplasma Antibody

Program Description 0.5 mL – Serum – For kits that detect Mycoplasma pneumoniae antibody.

Program Information

428 – Mycoplasma Antibody

Analytes

Mycoplasma Antibody








Rapid HIV

Program Description 1.0 mL – Serum – For laboratories using a rapid method for anti-HIV and/or HIV-1 p24 antigen. For other antigen and antibody methods, see Catalog #417 – Viral Markers on page 125.

Program Information

432 – Rapid HIV – 5 Samples 433 – Rapid HIV – 2 Samples D33 – Rapid HIV – 2 Samples – Verification Program

Analytes

Anti-HIV-1/2

HIV-1 p24 Antigen



Rheumatoid Factor

Program Description 1.0 mL – Serum – For qualitative, quantitative, and semi-quantitative (titer) methods.

Program Information

408 – Rheumatoid Factor


Mean

Rheumatoid Factor IU/mL IU/mL ± 3 SD or ± 20 IU/mL, whichever is greater








Rubella

Program Description 1.0 mL – Serum – For qualitative, quantitative, and semi-quantitative (titer) methods.

Program Information

415 – Rubella


Mean

Rubella IU/mL IU/mL ± 3 SD or ± 10 IU/mL, whichever is greater



Syphilis Serology

Program Description 1.0 mL – Serum – For qualitative and semi-quantitative (titer) methods for serum and CSF. Designed for RPR, VDRL, FTA, and Treponemal Antibody methods.

Program Information

416 – Syphilis Serology


Mean Syphilis IU/mL IU/mL -



Thyroid Antibodies


Program Information

164 – Thyroid Antibodies






Thyroid Antibodies continued…


Mean Thyroglobulin antibody (Anti-TG)

kU/L IU/mL ± 2 SD or ± 20 IU/mL, whichever is greater

Thyroid microsomal antibody (Anti-TPO)

kU/L IU/mL ± 2 SD or ± 20 IU/mL, whichever is greater



Viral Markers

Program Description 3.0 mL – Plasma – For Anti-HIV, HIV antigen, and/or Hepatitis testing. Anti-HIV and HIV-1 p24 antigen is for standard or confirmatory methods only. For rapid HIV antibody and antigen methods, see Catalog #432/#433 – Rapid HIV on page 123.

Program Information

417 – Viral Markers

Analytes

Anti-HAV (total and IgM) ►Anti-HAV (IgG) Anti-HBc (total and IgM) Anti-HBs, qualitative and quantitative Anti-HCV Anti-HIV-1 Anti-HIV-2 Anti-HIV-1/2 Anti-HIV-1/2 Confirmatory Anti-HIV-1/2, p24 Antigen HBsAg HBsAg Confirmatory




PROGRAM ANALYSIS – IMMUNOHEMATOLOGY




ABO/Rh

Program Description 3.0 mL – 4% Cell Suspension – For ABO/Rh testing.

Program Information

511 – ABO/Rh

Analytes

ABO Group D (Rho) Type



Antibody Elution

Program Description 2.0 mL – 50% Cell Suspension – For antibody elution testing on non-ABO antibodies.

Program Information

516 – Antibody Elution

Analytes

Antibody Elution



Antibody Titer – A

Program Description 2.0 mL – Serum – One serum sample for anti-A titer and one red cell sample (4% suspension) to be used as titer cell.

Program Information

519 – Antibody Titer – A






Antibody Titer - A continued…


Mean Anti-A (IgM and IgG) titer - - -


1 sample x 2 shipments April 1st and December 2nd

Antibody Titer – D

Program Description 2.0 mL – Serum – One serum sample for anti-D titer and one red cell sample (4% suspension) to be used as titer cell.

Program Information

520 – Antibody Titer – D


Mean

Anti-D titer - - -


1 sample x 2 shipments April 1st and December 2nd

Antibody Titer – AD

Program Description 2.0 mL – Serum – One serum sample for anti-A titer, one serum sample for anti-D titer, and one red cell sample (4% suspension) to be used as titer cell.

Program Information

521 – Antibody Titer – AD


Mean Anti-A (IgM and IgG) titer - - - Anti-D titer - - -






Antibody Titer - AD continued…



Automated Blood Bank

Program Description Includes five samples of CPD anticoagulated whole blood (4.0 mL each) and one donor red cell suspension (2.0 mL) for compatibility testing and antigen typing. Compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. For manual methods, see Catalog #512 – Blood Bank on page 129.

Program Information

517 – Automated Blood Bank E17 – Automated Blood Bank – Verification Program

Analytes ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing D (Rho) Type



Automated Blood Bank with Electronic Crossmatch

Program Description Includes five samples of CPD anticoagulated whole blood (4.0 mL each) and one donor red cell suspension (2.0 mL) for compatibility testing and antigen typing. Two donor red cell suspensions (2.0 mL each) with corresponding simulated ISBT donor unit labels are included for electronic crossmatch. Compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. For manual methods, see Catalog #532 – Blood Bank with Electronic Crossmatch on page 130.

Program Information

537 – Automated Blood Bank with Electronic Crossmatch






Automated Blood Bank with Electronic Crossmatch continued…

Analytes

ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing Electronic Crossmatch D (Rho) Type



Blood Bank

Program Description Includes five samples (2.0 mL each) of a 4% red cell suspension and five samples of corresponding serum (3.0 mL each). One donor red cell suspension (2.0 mL) is also included for compatibility testing and antigen typing. For automated blood bank methods, see Catalog #517 – Automated Blood Bank on page 128.

Program Information

512 – Blood Bank E12 – Blood Bank – Verification Program

Analytes

ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing D (Rho) Type








Blood Bank with Electronic Crossmatch

Program Description Includes five samples (2.0 mL each) of a 4% red cell suspension and five samples of corresponding serum (3.0 mL each). One donor red cell suspension (2.0 mL) is also included for compatibility testing and antigen typing. Two donor red cell suspensions (2.0 mL each) with corresponding simulated ISBT donor unit labels are also included for electronic crossmatch. For automated blood bank methods, with electronic crossmatch, see Catalog #537 – Automated Blood Bank with Electronic Crossmatch on pages 128-129.

Program Information

532 – Blood Bank with Electronic Crossmatch

Analytes

ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing Electronic Crossmatch D (Rho) Type



DAT

Program Description 1.0 mL – 4% Cell Suspension – For DAT testing.

Program Information

514 – DAT E14 – DAT – Verification Program

Analytes Direct Antiglobulin Testing








DAT – Automated

Program Description 4.0 mL – 15% Cell Suspension – For automated DAT testing methods.

Program Information

534 – DAT – Automated

Analytes Direct Antiglobulin Testing



Educational Blood Bank

Program Description Sample volume varies by event. 1-2 serum samples and/or 1-2 red cell samples for special challenges in antibody detection and identification.

Program Information

518 – Educational Blood Bank

Analytes

Antibody Identification



Fetal RBC

Program Description 2.0 mL – Whole Blood – For fetal screen, Kleihauer-Betke, and flow cytometry.

Program Information

515 – Fetal RBC






Fetal RBC continued…


Mean ►F Cell Value (by flow cytometry)

- - -

Fetal Screen - - - Hemoglobin F, quantitative

% % ± 2 SD or ± 0.6,




Rh Slide Test

Program Description 0.5 mL – 35-45% Cell Suspension – For laboratories using slide methodology or Eldoncards for Rh typing.

Program Information

513 – Rh Slide Test

Analytes

D (Rho) Type




800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 133 |

Paperless Proficiency Testing Entering Results Online

1) Log in to Paperless Proficiency Testing.

a. When you open your browser window, type the web address into the address bar [www.api-pt.com]. A link, bookmark, or search engine may not load the most recent version of the website.

b. Once on the API homepage, click the “Login” button in the teal section, directly underneath “Paperless Proficiency Testing.”

c. Enter your User ID in the designated field. When entering the password, turn the Caps Lock button off and use the Shift key for any capital letters.

d. If you need to reset your password, click “Lost your password?” and follow the instructions on the screen.

1

1d



2) Once you are logged in, move the cursor over “Enter Results” in the teal section, located on the left-hand side of the screen.

3) Click on “Current Events.”

4) Click on the current event (i.e. “Hematology – 1st Event (Kit 1)”).

a. Current events are events that have kits shipping out that day or kits that have already shipped.

b. Upcoming events are events that will be shipping out within the next two weeks. Early method entry is available by clicking the icon to the right of the event name.

c. If you need to print copies of worksheets and/or instructions, click on “Instructions & Worksheets” in the “View” column and select the desired option.

2 3

4a

4b

4c



5) On the “Enter or Review Test Results” page, you should see a list of the tests that your facility is enrolled in for the current event, as well as the corresponding sample IDs for each test.

6) Click on the test name (i.e. “Hematology – 5S”).

New Test Enrollment: If your facility does not have a history of reporting for this test, you will see a list of all available analytes, with no method identified. If you enter results for an analyte, you must select a method or the system will not allow you to transmit results to API.

5

6



Continued Test Enrollment: If your facility has a history of reporting for this test, you will see a list of the analytes that your facility reported during the previous test event. Beneath each analyte, the last reported method will also be listed.

a. Any additional, reportable, analytes can be selected from the “Additional Analytes” section at the bottom of the screen.

7) Input your results.

a. Depending on the nature of the test, you may need to enter numerical values, select a result from a drop-down menu, or click-to-highlight an option from a list.

8) Once you are finished entering your results, click “Save Results” at the bottom of the screen.

6a

7 7

8



9) When you have finished entering results for a test, a will appear to the left of the test name. If you have not selected a test method for all analytes where results have been entered or, if you have not entered all expected results, an will appear to the left of the test name.

a. There may be situations where a test name will not have a or an after you have entered results. For example, if a facility is enrolled in the 277-Cell Count and Body Fluid Crystals program and only performs a manual cell count, the “Manual Cell Count” test name will have a but it will remain blank next to the Body Fluid Crystal test name.

In cases like this one, you will be able to submit without the green check mark. Please be sure that your lab does not perform the test before you submit. If you have questions about this type of situation, please contact API Customer Service.

10) Once you have entered all results for the event (and verified that they have been transcribed correctly), click “Results Complete, Go to Next Step,” located beneath the Samples section.

9

10



11) On the “Attestation Statement” page, you have the ability to enter and/or update the “Lab Director (or Designee),” as well as the “Person or persons performing the test.”

12) When everything is complete, click “Transmit to API.”

a. After you transmit your results to API, you have two hours during which you are able to unsubmit the results and make corrections. After that two hour window, you will need to contact API Customer Service to discuss whether or not a correction can be made. The two hour window is only in effect if it is still prior to the deadline time on the due date.

11

12



Paperless Proficiency Testing Sub-User Accounts

Because there can only be one primary accountholder, API offers the Sub-User Account feature, which allows you to create sub-accounts with special permissions for other lab personnel. There are two types of Sub-User Accounts that can be created: a Sub-User with Supervisory Rights and a non-supervisory Sub-User.

• Sub‐Users with Supervisory Rights have the ability to review and submit results for all sample sets. They will receive the same reminder emails as the primary accountholder, excluding tracking number emails. They will receive due date reminders if that option is selected during account creation. They are also able to create other Sub-User accounts, as well as delete and edit non-supervisory Sub‐User accounts.

• Non-Supervisory Sub‐Users are only able to enter and save results for sample sets that have been assigned to them by the primary accountholder or a Sub-User with Supervisory Rights. Once a Non-Supervisory Sub-User enters and saves results, they are considered “locked” and can only be unlocked by the primary user or a Sub-User with Supervisory Rights. They will receive limited email notifications regarding the account and will only receive due date reminders if that option was selected during the account set‐up. They cannot edit their own accounts or any other Sub‐User accounts. Non-Supervisory Sub-Users cannot submit any results, even if the test is assigned to them.

Creating a Sub-User with Supervisory Rights:


a. See login tips on page 133.

1



2) Once you are logged in, move the cursor to “My Account” in the teal section, located on the left-hand side of the screen.

3) Click on “Manage Sub-Users.”

4) On the “My Account – Manage Sub-Users” page, click on “click to Add User.”

5) On the “Account Settings – Advanced Options – Add User” page:

2

3

4



a. Enter the name of the new Sub-User in the “Name” field.

b. Enter the Sub-User’s email address in the “Email field.

c. Under “Options,” check the box next to “Check to allow this person to review all results and to submit results to API (‘Supervisory Rights’).”

i. Please note: The list of tests in the “Sample Sets Available to Assign” section will become disabled and analytes cannot be selected because a Sub-User with Supervisory Rights has access to all tests.

d. Under “Options,” check the box next to “Check if this person should receive due date reminder emails,” if desired.

6) When all information is complete, click “Save and email password link to new user.”

a b

c

d

6

5



7) The new sub-user will receive an email with his/her newly created User ID and a link to set up a password. They will be able to log in to the API website immediately after the account has been created and the password has been set up.

Creating a Non-Supervisory Sub-User:

• Follow Steps 1-4 from “Creating a Supervisory Sub-User.”

5) On the “Account Settings – Advanced Options – Add User” page:

a. Enter the name of the new Sub-User in the “Name” field.

b. Enter the Sub-User’s email address in the “Email field.

c. Do not check the box under “Options” next to “Check to allow this person to review all results and to submit results to API (‘Supervisory Rights’).

d. Under “Options,” check the box next to “Check if this person should receive due date reminder emails,” if desired.

a b

c

d

8

5

6 a x

7



6) Under “Sample Sets Available to Assign,” select the tests that should be assigned to this sub-user. To select more than one sample set at a time, hold the CTRL button down while clicking on the name of the test.

a. Please note: You may assign the same sample set to multiple users. To do this, check the box next to “Show All” under “Sample Sets Available to Assign.” Once that has been done, you will see the entire list of sample sets ordered for your facility and you may assign them as you usually would.

7) Once the tests are selected, click the arrow button that points toward the “Sample Sets Assigned to This Person” section on the right-hand side. The selected tests should move to the “Sample Sets Assigned to This Person” section.

8) When the selected tests show in the “Sample Sets Assigned to This Person” section and all other information is complete, click “Save and email password link to new user.”

9) The new sub-user will receive an email with his/her newly created User ID and a link to create his/her password. They will be able to log in to the API website immediately after the account has been created.

10) Once a Non-Supervisory Sub-User enters results and saves them, only the primary accountholder or a Sub-User with Supervisory Rights can “unlock” the results for editing by double-clicking on the padlock next to the locked sample set.

Editing a Sub-User:

• Only the primary user on an account may edit a sub-user account. A supervisory sub-user can create another sub-user account but cannot edit or delete any type of sub-user account.

• Follow Steps 1-3 from “Creating a Supervisory Sub-User.”

4) Locate the Sub-User account that you wish to edit and the click “Edit” button, located at the right end of the row.

5) On the “Account Settings – Advanced Options – Edit User” page, all of the current information for the selected sub-user will appear.

6) Make the necessary changes.

7) Click “Save” at the bottom of the page.

a. Please note: If you are changing the email address for an existing Sub-User, an email with the User ID and a link to reset the password will not be sent. If you need to have the password reset, click the “Login” button underneath “Paperless Proficiency Testing,” then click “Lost your password?” Enter the User ID and the new email address and click “Send Reset Instructions.”



Deleting a Sub-User:

• Repeat Steps 1-3 from “Creating a Supervisory Sub-User.”

4) Locate the Sub-User account that you wish to delete and click the “Edit” button, located on the right side of the row.

5) On the “Account Settings – Advanced Options – Edit User” page, all of the current information for the selected sub-user will appear.

6) Click the “Delete User” button, located to the right of the displayed User ID.

4

6



7) Click “Confirm Delete” at the bottom of the page.

8) On the “My Account – Manage Sub-Users” page, you should see that the sub-user is no longer listed.

7



Paperless Proficiency Testing Viewing Evaluation Reports

1) Log in to Paperless Proficiency Testing

2) Once you are logged in, select “Evaluation Reports” in the teal section, on the left-hand side of the screen.

3) Each Evaluation Report consists of four components:

a. Cover Page: This is the cover sheet for your proficiency testing evaluation. It contains information about the laboratory, including the shipping contact information, the API#, CLIA#, which agencies and/or managers receive report copies, shipping reminders, and a section for Performance Review and Corrective Action. This can be accessed by downloading a PDF of the full evaluation.

b. Performance Summary: This is a summary of your proficiency testing performance for the last three test events. It is divided into sections according to specialty/sub-specialty. The scores for individual analytes are expressed as a percentage (ratio of acceptable responses to the number of samples tested).

c. Comparative Evaluation: This report shows the analyte tested, test method used, samples tested (Sample IDs), reported result, expected result, mean, Standard Deviation (SD), Standard Deviation Interval (SDI), and Performance.

d. Participant Data Summary (PDS): This is a summary of all of the proficiency testing data for the given event. It contains drop-down menus that allow you to select a specific analyte, peer group, and sample number, for which you can then view statistical information including the number of labs reporting, the mean, the Standard Deviation, the Range (for quantitative analytes) or the correct response, the reported responses, and the number of labs reporting for each response (qualitative analytes). The PDS can be accessed by clicking on “Participant Data Summaries” on the left-hand side of the screen.

b c

d

a



4) On the “Evaluation Reports” page, there are a few options for how to view and print your Evaluation Reports.

To View or Print a PDF - Full Evaluation:

a. Locate the year, program, and event number you wish to view.

b. Under the “Full Eval” column, click on the PDF icon for the selected event.

c. Follow the prompts generated by your Internet Browser (i.e. Explorer, Chrome, Firefox) to open the PDF.

d. View or print, as desired.

To View or Print Performance Summary Only:


b. Under the “Test Event Performance” column, click “Review” or “Failures,” as shown.

b

b



c. You may print using “Print This Screen” or “Print Report (PDF),” as desired.

To View or Print Comparative Evaluation Only:


b. Under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.

c

b



c. You may print using two options: Print This Screen or Print Report (PDF), as desired.

Viewing Grading Criteria

1) On the “Evaluation Reports” page, under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.

2) Click “View Grading Criteria”

3) A new window will open with a complete list of the grading criteria.

c

2



Viewing Statistics

1) On the “Evaluation Reports” page, under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.

2) Locate the analyte and sample number for which you wish to view statistics.

3) Click “View” in the “Statistics” column, located on the right side of the screen.

4) A new internet window will open. If desired, you may print the statistics information by clicking “Print” in the top, right-hand corner.

3

4



Corrective Action

In the event of failures, API offers blank forms that can be used for documentation of Corrective Action. The two different forms available are listed below, followed by instructions on how to access them.

• Checklist for Corrective Action: This form is designed to offer assistance to laboratories with investigating and troubleshooting proficiency testing failures.

• Corrective Action Form: This form allows laboratory personnel to document the corrective action taken for each failed analyte. The form can then be printed and retained for the laboratory’s records, along with the evaluation report.


2) Once you are logged in, select “Evaluation Reports” in the teal section, on the left-hand side of the screen.

For the “Checklist for Corrective Action”:

a. On the “Evaluation Reports” page, click on “Checklist for Corrective Action.” This will allow you to open the form and view or print it, as desired.

For the Corrective Action Form:

b. On the “Evaluation Reports” page, locate the year, program, and event number for which you want a Corrective Action Form.

c. Under the “Corrective Action” column, click on the PDF icon for the selected event.

d. Follow the prompts generated by your Internet Browser (i.e. Explorer, Chrome, Firefox) to open the fillable PDF.

e. View or print, as necessary.

i. Please note: It is possible to generate a Corrective Action Form for all events, regardless of whether or not failures occurred.

a

c



Paperless Proficiency Testing DataDashboard Information and Instructions

With DataDashboard you can quickly and easily view proficiency performance over the most recent six test events, including:

• Trending data by analyte • Percentage of acceptable results compared to all API labs • Failure count by test event • Analytes with unsatisfactory, unsuccessful, and repeat unsuccessful performance

How to Access the API DataDashboard:


2) Select “API DataDashboard” on the left-hand side of the page.

3) From the drop down menu, select the Discipline you wish to view (e.g. “Chemistry”).

a. Please note: Chemistry Core and Chemistry Miscellaneous are included in “Chemistry.” Mycobacteriology, Mycology, and Dermatophyte are included in “Microbiology.”

The Basics:

• For each graph, you have the ability to “Reset” the view, click the “Help” button for more information, or “Collapse” the window.

• For each performance panel, you have the ability to “Expand” the group, click the “Help” button for more information or “Collapse” the window

• If you would like to customize your view, you can move the windows by clicking on the heading and dragging it to the desired area (see example on the following page).

Collapse

Help Reset

Collapse

Help

Expand



o Please note: If you move a graph to the right-hand side of the page, it will automatically resize.

• Zoom In/Zoom Out: It is possible to zoom in and out on the graphs using the scroll wheel on your mouse or a trackpad.

• Print: You may print your screen by clicking the “Print” button, located at the top right hand corner of the page.

How to Navigate the Performance Dashboard:

• Once you have selected a Discipline, seven panels will appear on the screen.

• On the left-hand side, there are two graphs:

1) Failure Count by Event

o This graph shows the total number of failures over the past six events, for the selected Discipline.

o If you click on a data point, it will open the Failures Summary for that test event.

o Please note: For the Chemistry and Microbiology Disciplines, you may see a bar chart when you click on a data point. This will show you the number of failures in each category (e.g. Chemistry Core and Chemistry Miscellaneous).

o If you click on the column, it will open your lab’s Failures Summary for the selected test event.



2) Acceptable % by Event

o This graph shows the percentage of your results that were acceptable over the past six events compared to the average of all API labs, for the selected Discipline.

o If you click on a data point, it will open your lab’s Comparative Evaluation.

o Please note: For the Chemistry and Microbiology Disciplines, you may see a bar chart when you click on a data point. If you click on the column, it will open your lab’s Comparative Evaluation for the selected test event.



• On the right-hand side, there are five expandable sections that will show:

1) Analytes with unsatisfactory performance

o Analytes listed as Unsatisfactory have had only one test event with a score below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility). If another failure for this analyte occurs in either of the next two consecutive events, this analyte will transition to the unsuccessful performance section.

o If you wish to see more information on the “unsatisfactory” analyte, you can expand the panel to view the analyte name, the reported method, and the specific event.

o If you click on the Analyte Name, it will open your Failures Summary for that test event.

2) Analytes with unsuccessful performance

o Analytes listed as Unsuccessful have had two or more test events with scores below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility), in the last three events.

Collapse

Expand

Analyte Name Reported Method Specific Event



o If you wish to see more information on the “unsuccessful” analyte, you can expand the panel to view the analyte name, the reported method, and the most recent event with a failure (see example on following page).


3) Analytes with repeat unsuccessful performance

o Analytes listed as Repeat Unsuccessful have had scores below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility) for two test events, twice in the last six test events.

o If you wish to see more information on the “repeat unsuccessful” analyte, you can expand the panel to view the analyte name, the reported method, and the most recent event with a failure.


Analyte Name Reported Method Most Recent Event with a Failure

Collapse

Expand

Analyte Name Reported Method Most Recent Event with a Failure

Collapse

Expand



4) SDI Performance and Trending Analysis

o The graphs represent lab performance on quantitative tests for the most recent three test events. The dots represent the SDI of results (number of Standard Deviations from the Comparison Group Mean) on each sample tested. Please note that grading for many analytes is not based on SD so these graphs do not represent grading of results. Instead they show results in relation to other labs in the peer group.

o To view the trending data, click the “Load Graphs” button.

o Once the line graphs have loaded, click on any data point to view the statistics for the peer group.

5) Export Evaluation Data

o This export feature allows you to download your evaluation data for the selected Discipline in a CSV file format.

o The Analyte Detail option exports individual result data, including mean and SDI.

When you select the Year and Event from the drop-down menus, click “Export Data” and the file will download.



o The Performance Summary option exports performance and score information.

When you select the Year, Event, Scored for CMS, and Performance that you wish to view, click “Export Data” and the file will download.



Continuing Education

Physicians, Medical Laboratory Scientists (MLS), and Medical Laboratory Technicians (MLT) can earn up to 18 free CME or CMLE credits per year through an arrangement between API and the American Society for Clinical Pathology (ASCP). Multiple credits are offered each year in Chemistry, Microbiology, Hematology, and Immunology. Credits are also occasionally offered in Blood Banking, Coagulation, Microscopy, and Laboratory Management. Each educational exercise is available for between three and four months. The number of exercises available at any one time will vary and the number of earned credits depends on individual participation.

The acceptability of the credits provided by API is up to the organization requiring you to earn continuing education credits. Please check with the organization setting your requirements to determine if these credits will be accepted.

To Enroll in a Free Continuing Education Account:

1) Log in to Paperless Proficiency Testing (like you would if you were going to enter PT results).

2) Once you are logged in, click “Enroll” in the blue section, under “Continuing Education,” on the left-hand side of the screen.

3) Complete the fields with the requested information then click “Enroll.”

2 3


http://www.ascp.org/


4) If the enrollment is successful, the information in the fields will disappear and you will receive a message that says, “The enrollment is complete and an email has been sent to the designated person.”

5) Additional staff members can be signed up at any time.

To Log in to a Continuing Education Account – Already Enrolled:

1) When the account is created, the User ID and a link to set up a password will be sent to the email address on the account.

a. If the user has forgotten his/her User ID and password, click on “Login” under

“Continuing Education.” Then click “Lost Your Password?” and enter the correct email address. An email with the login information will be resent.

2) Click the link and follow the instructions to set up your password.

3) Once the password has been created, click the “Login” button in the blue section, directly underneath “Continuing Education.”

4) Enter your User ID in the appropriate field. When entering the password, turn the Caps Lock button off and use the Shift key for all capital letters.

5) Once logged in, you will be prompted to enter additional information. Read the paragraph on Identifying Information and then either fill out the section with your birthdate and ASCP BOC Certification Category & Number or check the box that says “I decline to have my transcripts sent electronically to any organization.”

6) If the account is activated successfully, you will now see a button that will allow you to change your password, if you choose. Account settings can be updated at any time, when logged in, by clicking on “My Account.”

How to Earn CE Credits:

1) Log in to Continuing Education.



2) Select “Earn CE Credits” in the blue section. Available exercises will be listed under their respective categories.

3) Click on the name of the exercise.

a. “Step 1” provides a link to the ASCP educational commentary that is related to the questions. The commentary is in a PDF format and should open when you follow your browser’s prompts.

b. “Step 2” provides instructions to answer the multiple-choice questions shown on the screen and an option to print the questions. Please note: If you print the questions, the answers still need to be submitted on the website to earn credit.

4) Once you’ve answered all of the questions, click “Submit for Credit” at the bottom of the screen.

2

3



5) Correct answers will be highlighted in green. Incorrect answers will be highlighted in red. All answers must be correct for credit to be awarded.

6) Once all answers are correct, you will be able to continue to the next screen and you will be asked to participate in an optional survey that will allow you to provide feedback on the exercise.

7) Repeat Steps 2-6 to earn additional credits for other available exercises.

To View Credits

1) Log in to Continuing Education

2) Select “Credits Awarded” in the blue section, under the “Continuing Education” heading.

3) Click on the name of the exercise. Follow your browser’s prompts to open the certificate as a PDF.

4) Repeat Steps 2-3 for different activities to print additional certificates.

2

3



Please note: New courses are posted around the same time that evaluations are available online (or approximately one week after another exercise’s posted expiration date). Credits are transmitted to ASCP electronically two times per month.

These instructions may not cover all of the issues and/or questions that you may encounter. If, at any time, you have a question about Continuing Education accounts, please contact API Customer Service. We will be happy to answer your questions or help walk you through any of these process!



Appendix A

Cell Count/Hematology/Sedimentation Rate Instrument List

Body Fluid Cell Count Methods and Programs

Instrument/Method Program Abbott Cell-Dyn (all models) 206 Coulter (all models) 206 Iris iQ®200 207 Siemens Advia 120/2120 206 Sysmex (all models) 206 Manual Count 277

Hematology Analyzers and Programs

Instrument/Method Program Abbott Cell-Dyn (1400 thru 1800) 221 Abbott Cell-Dyn (3000 thru 5000) 242 Abbott Cell-Dyn Emerald 221 Abbott Cell-Dyn Emerald 22 242 Abbott Cell-Dyn Ruby, Sapphire 242 CDS Medonic CA 221 CDS Medonic M-Series 227 Coulter AcT-5 231 Coulter Ac-T (all 3-part differential models) 221 Coulter HmX 220 Coulter LH500, MAXM, STKS 220 Coulter LH 750, 755, 780, 785 230 Coulter Micro Diff (all models) 221 Coulter UniCel DxH 300 221 Coulter UniCel DxH 500 279 Coulter UniCel DxH 600, 800, 900 230 Diatron Abacus 3CP 221 Diatron Abacus 5 242 Drew (Danam) Excell 16 221 Drew D3, Evolution 221 HemoCue - for WBC only (all models) 209 Horiba ABX Micros (all models) 221 Horiba ABX Pentra (all models) 231 Mindray 5000 Series 226 Mindray BC (all models) 221 QBC Autoread, Autoread Plus 222 QBC Manual Reader 222 Siemens Advia 120, 2120 240



Siemens Advia 60 221 Siemens Advia 560 242 Sysmex KX Series, pocH-100i, and XP-300 227 Sysmex XW-100 Not available Sysmex XE, XN, XN-L, XS, XT (all models) 238

Sedimentation Rate Methods and Programs

Instrument/Method Program Alcor i-Sed 203 Alifax ESR 280 Chase Westergren 830 SO 228 Diesse Mini-Cube 228 Dispette, Dispette 2 228 Globe Scientific (all methods) 228 HemaTech ESR STAT PLUS, STAT 180 202 MiniVes 228 Polymedco Sedimat 15, 15 Plus 201 Polymedco Sedimat/Sediplast 228 Sedifast, Sediplast, Sediten, Seditube 228 Streck/Analys ESR, Auto ESR Plus (all methods) 228 Ves Matic (all models) 228 Vital Diagnostic Excyte (all models) 228 Winpette 228



Appendix B

Analytes Included in Molecular Multiplex Panels

368 - Blood Pathogen Panel Molecular Bacti – Blood

Acinetobacter sp. Listeria monocytogenes Acinetobacter baumannii Neisseria meningitidis Citrobacter sp. Proteus sp. Enterobacteriaceae Pseudomonas aeruginosa Enterobacter sp. Serratia marcescens Enterobacter cloacae complex Staphylococcus sp. Enterococcus sp. Staphylococcus aureus Enterococcus faecalis Staphylococcus epidermidis Enterococcus faecium Staphylococcus lugdunensis Escherichia coli Streptococcus sp. Haemophilus influenzae Streptococcus agalactiae Klebsiella oxytoca Streptococcus anginosus group Klebsiella pneumoniae Streptococcus pneumoniae Listeria sp. Streptococcus pyogenes

Molecular Mycology – Blood Candida albicans Candida parapsilosis Candida glabrata Candida tropicalis Candida krusei

Molecular Resistance Genes - Blood Resistance Gene: mecA Resistance Gene: CTX-M Resistance Gene: vanA/B Resistance Gene: IMP Resistance Gene: vanA Resistance Gene: NDM Resistance Gene: vanB Resistance Gene: OXA Resistance Gene: KPC Resistance Gene: VIM

369 – GI Panel Molecular Bacti – GI

Campylobacter sp. Shigella EAEC Shigella / EIEC EPEC Vibrio E. coli O157 Vibrio cholerae Plesiomonas shigelloides Yersinia enterocolitica Salmonella

Molecular Parasite – GI Cryptosporidium Entamoeba histolytica Cyclospora cayetanensis Giardia lamblia

Molecular Toxin - GI C. difficile Toxin A/B Shiga Toxin 1 ETEC lt/st Shiga Toxin 2 STEC stx1/stx2



369 – GI Panel continued… Molecular Virology - GI

Adenovirus F 40/41 Rotavirus A Astrovirus Sapovirus Norovirus GI/GII

370 – Respiratory Panel Molecular Bacti – Respiratory

Bordetella holmesii B. parapertussis/bronchiseptica Bordetella pertussis Chlamydophila pneumoniae Bordetella parapertussis Mycoplasma pneumoniae

Molecular Virology – Respiratory Adenovirus Influenza A / H1-2009 Coronavirus 229E Influenza B Coronavirus Parainfluenza 1 Coronavirus HKU1 Parainfluenza 2 Coronavirus NL63 Parainfluenza 3 Coronavirus OC43 Parainfluenza 4 Human Metapneumovirus (hMPV) Respiratory Syncytial Virus Human Rhinovirus / Enterovirus RSV A Influenza A RSV B Influenza A H1 Rhinovirus Influenza A H3

371 – Meningitis Panel Molecular Bacti – Meningitis

Escherichia coli K1 Neisseria meningitidis Haemophilus influenzae Streptococcus agalactiae Listeria monocytogenes Streptococcus pneumoniae

Molecular Virology – Meningitis Cytomegalovirus Human herpesvirus 6 Enterovirus Human parechovirus Herpes simplex virus 1 Varicella zoster virus Herpes simplex virus 2

Molecular Mycology - Meningitis Cryptococcus neoformans/gatti

376 – Vaginal Panel Molecular Bacti – Vaginitis

Bacterial Vaginosis Molecular Parasite – Vaginitis




369 – Vaginal Panel continued… Molecular Mycology – Vaginitis

Candida Group Candida krusei Candida glabrata

378 – Pneumonia Panel Molecular Bacti – Pneumonia

Acinetobacter calcoaceticus- baumannii (ACB) complex

Moraxella catarrhalis Mycoplasma pneumonia

Chlamydia pneumoniae Proteus sp. Enterobacter cloacae Pseudomonas aeruginosa Escherichia coli Serratia marcescens Haemophilus influenza Staphylococcus aureus Klebsiella aerogenes Streptococcus agalactiae Klebsiella oxytoca Streptococcus pneumoniae Klebsiella pneumonia group Streptococcus pyogenes Legionella pneumophila

Molecular Resistance Genes – Pneumonia Resistance Gene: CTX-M Resistance Gene: NDM Resistance Gene: IMP Resistance Gene: OXA-48-like Resistance Gene: KPC Resistance Gene: VIM Resistance Gene: mecA/C & MREJ

Molecular Virology – Pneumonia Adenovirus Influenza A Coronavirus Influenza B Human Metapneumovirus Parainfluenza virus Human Rhinovirus/Enterovirus Respiratory Syncytial Virus



Glossary of Terms and Abbreviations

A2LA: American Association for Laboratory Accreditation

AOA: American Osteopathic Association

API DataDashboard: Performance analysis dashboard that allows API customers to view trend data by analyte, percentage of acceptable results compared to all API labs, failure count by test event, and analytes with unsatisfactory performance.

API DataDirect: Feature that allows API customers to use their LIS or middleware to upload proficiency testing results directly to the API website.

API ImageViewer: Feature that allows API customers to view virtual images while logged into their Paperless Proficiency Testing account. While using the ImageViewer, customers are able to scan the slide to view other cells (in addition to the cells selected for identification) and can utilize other features like measurement and magnification tools.

CMS: Centers for Medicare and Medicaid Services

CLIA ’88: Clinical Laboratory Improvement Amendments of 1988

CAP: College of American Pathologists

CE/CME: Continuing Education/Continuing Medical Education

Corrective Action: Action taken by the testing facility to identify and correct any deficiency resulting in a proficiency testing failure.

Evaluation Report: Detailed report indicating a testing facility’s performance during an event. Includes Performance Summary Report and Comparative Evaluation.

HFAP: Healthcare Facilities Accreditation Program

Homogeneity: In the context of proficiency testing, homogeneity refers to the extent that all PT samples of the same sample ID (e.g. CH-01) are of the same state and quality, meaning the expectation is that they will return the same results.

LAP: CAP’s Laboratory Accreditation Program

Paperless Proficiency Testing (PPT): Feature that allows API customers to manually enter, review, and submit their PT results on the API website. PPT also allows API customers to review evaluation reports, utilize the API ImageViewer and API DataDashboard, and customize several aspects of their API account.



Participant Data Summary (PDS): Section of the API website that contains the quantitative and qualitative statistical data from participant and referee test results, along with selected interpretive information.

PT: Proficiency Testing

Qualitative: Describing the quality of something in size, appearance, value etc. In the context of PT, qualitative testing refers to testing where the result is either “positive” or “negative” or where it is a categorization, interpretation, or identification (e.g. “moderate,” “yeast seen,” or “monocyte”).

Quantitative: Measuring or relating to something in regards to quantity, rather than quality. In the context of PT, quantitative testing refers to a test where the result is a number, usually with a specific unit of measure attached.

Standard Deviation (SD): A calculation used to indicate the extent of deviation for a group of data.

Standard Deviation Interval (SDI): Describes how far a PT result is from the comparison group mean. Determined by the following calculation:

Your Result - Comparison Group Mean Comparison Group Standard Deviation

TJC: The Joint Commission



O CAP Accepted ◊ CAP – Accepted PT not required ► Not CAP Accepted

This list is not intended to replace CAP guidelines on required analytes. See the current, online API catalog index for the most up-to-date information on CAP accepted analytes.

Index

Analyte Page

#O 25-OH Vitamin D 36 O 6-Acetylmorphine 48

AO ABO Group 126, 128-130 ◊ ABO Subgroup 128-130O Acetaminophen (TDM) 41O Acetaminophen (UDS) 48◊ Acetone 24O Acid Fast Smears 102O Activated Clotting Time (ACT) 70, 73, 76O Adenovirus 110O Albumin (◊ body fluid, ►CSF Chemistry) 20, 22, 44-47O Alcohol 24, 26O Alcohol (UDS) 48O Alkaline Phosphatase (◊ body fluid) 20, 23, 44O Alpha-1-Antitrypsin 120O Alpha-fetoprotein 20-21O ALT (SGPT) 19, 21, 23 O Amikacin 41 ◊ Ammonia 24 ◊ Amniotic Fluid pH 25 O Amphetamines 48 O Amylase (◊ body fluid) 21, 23, 44, 47 O ANA 141 ◊ Antibody Elution 126 O Antibody Identification and Screen 128-131◊ Antibody Titer – A 126-128◊ Antibody Titer – D 126-128◊ Anti-CCP 115O Anti-DNA (ds, ss) 114◊ Antigen Typing 128-130O Anti-HAV (◊ total) 125► Anti-HAV, IgG 125O Anti-HBc (total and IgM) 125O Anti-HBs 125O Anti-HCV 125O Anti-HIV Confirmatory 125O Anti-HIV-1 and 2 125O Anti-HIV-1/2 123O Anti-RNP 114O Anti-Sm 114► Antisperm Antibody 67O Anti-SSA and SSB 114O Anti-Streptolysin O (◊ titer) 115, 11◊ Anti-TG 125◊ Antithrombin III Activity 71◊ Anti-TPO 125◊ Anti-Xa 75O Apolipoprotein A1, B 25O APTT (►Hemochron Jr. Citrate) 71, 74◊ APTT (Heparin Assay) 75O AST (SGOT) 19, 21, 23O Automated Differential (CBC) 50-58

B◊ Bacterial Vaginosis 89 O Barbiturates 48 O Benzodiazepines 48 O Beta-2 Microglobulin 42 O Beta-hydroxybutyrate (B-Ketone) 26

Analyte Page ◊ Bilirubin, body fluid 44 O Bilirubin, direct and total, serum 19, 21, 23, 39 O Bilirubin, urine (◊ confirmatory) 83-84O Blood Cell Identification 58-59O Blood Culture 90, 92O Blood Parasite 105O Blood/hemoglobin (urine) 83-84

O BNP (► Cat. #920 – only accepted for wvd. methods)

29-30

◊ Body Fluid Cell Count 60 ◊ Body Fluid Chemistry 44 ◊ Body Fluid Crystals 61 ◊ Body Fluid Differential 61 ◊ Body Fluid Microscopy 61 O Bordetella pertussis/parapertussis 90 ► BRCA1/2 DNA Sequencing 115-116O Buprenorphine 48

CO C. difficile Antigen (◊ toxin) 91 O CA 125 42 O CA 15-3 42 O CA 19-9 42 O CA 27.29 42 O Calcium (◊ body fluid) 19, 21, 23, 44, 47 O Calcium, ionized 21, 27, 36-37 O Campylobacter sp. 91-92O Candida (◊ Cat. #376 – Vaginal Panel) 103-116O Cannabinoids 48O Carbamazepine 41O Carboxyhemoglobin 29◊ Carisoprodol 48► CD19 (B Cells) 62► CD3 (T Cells) 62► CD4 (T Helper) 62► CD45 (Leukocytes) 62► CD56/CD16+56 (NK Cells) 62► CD8 (T Cytotoxic) 62O CEA 34, 42O Chlamydia Antigen 92O Chlamydia trachomatis 91-92

O Chloride (◊ CSF, body fluid) 19, 21, 23, 27, 36-37, 44, 47

O Chloride, sweat (►quantitative) 46O Cholesterol (◊ body fluid) 19, 21, 23, 38, 44O CK-MB 29► CMV IgG 120► CMV IgM 120

O CO2 19, 21, 23, 26-27, 36-37

O Cocaine Metabolites 48

O Compatibility Testing (◊ Electronic Crossmatch)

128-130

O Complement C3 & C4 120 O Conductivity, sweat 46 O Cortisol 20-21O Cotinine 48O C-peptide 35O C-Reactive Protein (hs) 118O C-Reactive Protein (quant., qual.) 116O Creatine Kinase (CK) 21, 23, 29O Creatinine (◊ body fluid, urine adult.) 36-37, 44, 46-47, 83





Analyte Page O Cryptococcal Antigen 103 O Cryptosporidium 106 O CSF Culture 92 ◊ Cystatin C 31

D

O D (Rho) Type 126, 128-130, 132 O D-dimer (◊ qualitative) 29-30, 72-73 O Dermatophyte Culture 104 O DHEA-S 34 O Digoxin 41 O Direct Antiglobulin Testing (◊ automated) 130-131

E

O Ear/Eye Culture 92 O EDDP 48 ◊ Electronic Crossmatch 128-130 O Estradiol 34 ► Estriol 34 ► Ethosuximide 41 ◊ Ethyl glucuronide (EtG) 45

F ► F Cell Value (by flow cytometry) 132 ◊ Factor Activity (► Factor VIII) 71-72 ◊ Fecal Lactoferrin 81 ◊ Fecal Occult Blood 81 O Fecal WBC 82 O Fentanyl 48 O Fern Test 82 O Ferritin 34 O Fetal Fibronectin 31 ◊ Fetal Hemoglobin (gastric fluid) 62 ◊ Fetal Membranes Rupture Test 32 O Fetal Screen 515 O Fibrinogen 71 O Folate 34 O Free T3 20, 22, 42 O Free T4 20, 22, 42 ◊ Fructosamine 32 O FSH 34

G

◊ Gastric Occult Blood 82 ► Gastrin 35 O GC Culture 93, 96 O Gentamicin 41 O GGT 21, 23 O Giardia 106

O Glucose (◊ body fluid) 19, 21, 23, 27, 36-38, 44, 47, 83-84

◊ Glucose, Whole Blood (O HemoCue) 34, 43 O Glycohemoglobin (as HbA1c) 33 O Gram Stain (◊ morphology) 92-93 ◊ Gram Stain, Direct 94 ◊ Gram Stain, Vaginitis 94 O Granulocytes (◊ IG#, IG%) 51 O Group A Strep Antigen 87, 89, 93, 95 O Group A Strep (molecular) 99 O Group B Strep (molecular) 95 O Group B Strep Culture 93, 96 O Group C/G Strep (molecular) 99

H

O H. pylori Antibody 117 O H. pylori Antigen, Stool 96 O Haptoglobin 120 O HBsAg & HBsAg Confirmatory 125

Analyte Page ► HBV Viral Load 117 O HCG, serum 40 O HCG, urine (qual.) 83-86 ► HCV genotyping 117-118 ► HCV Viral Load 117-118 ► HCV, qualitative 117-118 O HDL Cholesterol 19, 21, 23, 38

O Hematocrit 27, 29, 36-37, 50-58, 87

O Hemoglobin 27, 29, 34, 36-37, 50-58, 87

O Hemoglobin F, quantitative 132 ◊ Heparin Assay 75 ► HIV-1 RNA Viral Load 118 O Homocysteine 34 O HPV (◊ genotyping) 107-108 O HSV 1 & 2 108 O HSV-2 Antibody 119 ◊ Hydrocodone 48

I O IgA 120 O IgE 116, 120 O IgG (►CSF Chemistry) 44, 120 O IgM, total 120 ◊ India Ink 104 O Infectious Mononucleosis 191, 121-122 O Influenza A (►Silaris) 108-110 O Influenza B (►Silaris) 108-110

O INR (◊ waived, Cat. #278 – Heparin Assay)

71, 74-75, 77-78

O Insulin 35 ◊ IRF 54-55, 58 O Iron 21-22, 35

K

O Ketones (◊ serum qual.) 24 O KOH Preparation 104

L

O Lactate 27, 36-37 O Lactic Acid 21, 44 ◊ Lamellar Body Count 38 O LDH (◊ body fluid) 21, 44 O LDL (◊ calculated) 19, 21, 23, 38 O Lead 28 O Legionella Antigen 97 O Leukocyte Esterase 83-84 O LH 34-35 ► Lidocaine 41 O Lipase (◊ body fluid) 21, 44 O Lipoprotein (a) 25 O Lithium 41 ◊ LSD 48 ◊ Lyme Disease Antibody 122 O Lymph/Mono 51

M

O Magnesium 21, 47 ► Magnesium, ionized (blood gas) 27 ◊ MCH, MCHC, MCV, MPV 50-58 O MDMA 48 O Meningitis Panel (◊ yeast) 112 ◊ Meperidine 48 O Methadone 48 O Methamphetamines 48 O Methaqualone 48 O Methemoglobin 29





Analyte Page O Microalbumin (urine) 45-46

O Molecular Multiplex Panels (bacteria, ◊ parasites, ◊ resistance genes, viruses, ◊ yeast)

111-113

Blood Pathogen Panel 111 GI Panel 111-112 Meningitis Panel 112 ◊ Pneumonia Panel 112-113 Respiratory Panel 113 ◊ Vaginal Panel 113 O MRSA 97-98 ◊ Mumps Virus IgG 120-121 O Mycobacteriology Identification 102-103 ► Mycobacteriology Susceptibility Testing 102-103 ◊ Mycobacterium tuberculosis (molecular) 102 O Mycology Culture 105 ◊ Mycoplasma Antibody 122 O Mycoplasma pneumoniae 98 O Myoglobin (quant., qual.) 29-30

N

O N. gonorrhoeae 92, 93, 96 O N-acetylprocainamide 41 O Nasal Smear 82 O Nitrite (◊ urine adulteration) 47, 84 ◊ nRBC 54-55, 58

O NT pro-BNP (►Cat. #920 – CAP requires 5 sample program)

29-30

O

O Opiates 48 O Osmolality (◊ sweat) 21, 46-47 ◊ Oxidants 47 O Oxycodone 48 O Oxyhemoglobin 29

P

O p24 antigen 123, 125 O PAP 34-35 O Parasitology 106 O Parathyroid Hormone (PTH) 36 O pCO2 26-27, 26

O pH (◊ gastric, body, amniotic fluid, urine adulteration)

26-27, 36-37, 44-45, 47, 82

O Phencyclidine 49 O Phenobarbital 41 O Phenytoin 41 O Phosphorus 21, 23, 47 O Pinworm Preparation 82 ◊ Plasminogen 72 O Platelet Count (◊ IPF) 50-58 ◊ Platelet Function 76-77 O pO2 26-27, 36 O Potassium (◊ body fluid) 27, 36-37, 45, 47 O Prealbumin 35 ► Primidone 41 O Procainamide 41 O Procalcitonin 39 O Progesterone 35 O Prolactin 35 O Propoxyphene 49 ◊ Protein C 71-72 ◊ Protein S 71-72 O Protein, urine (◊ confirmatory) 47, 83-84

O Prothrombin Time (◊ waived, Cat. #278 – Heparin Assay)

71, 74-75, 77-78

O PSA (total, free) 35, 43

Analyte Page ► PSA, complexed 43

Q

O Quinidine 41

R

O RBC (◊ automated body fluid and urine) 50-58, 60-62, 80, 86, 131-132

◊ RDW 50-58 O Reducing Substance 84-85 O Reticulocyte Count (◊ RET He, IRF) 54, 56, 58, 63 O Rheumatoid Factor (◊ titer) 119, 121-123 O Rotavirus Antigen 109 O RSV 110 O Rubella Antigen (◊ titer) 119, 124 ► Rubella IgG 120-121 ► Rubeola Virus IgG 120-121

S

O S. pneumoniae Antigen 99 O Salicylates 41 ◊ Sedimentation Rate 63-65 O Sex Hormone Binding Globulin (SHBG) 40 ◊ Shiga Toxin 98 O Sickle Cell Screen 66

O Sodium (◊ CSF, body fluid, sweat) 19, 22-23, 27, 36-37, 44-47

◊ Specific Allergens 116 O Specific Gravity (◊ urine adulteration) 47, 84-85 O Sperm Count (► post-vasectomy) 67-68 ◊ Sperm Morphology 68 ◊ Sperm Motility 68 ◊ Sperm, presence/absence 67, 82 O Sperm Viability 69 O Sputum Culture 93 O Stool Culture 93 O Susceptibility Testing (►TB) 88-90, 93, 100-103

O Sweat Analysis (► chloride, quant.; ◊ osmolality, sodium)

46

O Syphilis Serology (◊ CSF titer) 124

T

O T Uptake 20, 22, 42 ◊ tCO2 27, 36, 37 ◊ Testosterone, Bioavailable 40 ◊ Testosterone, Free (►directly measured) 40 O Testosterone, Total 35, 40 O Theophylline 41 O Throat Culture 89, 93, 100 ◊ Thrombin Time 71-72, 75 ◊ Thromboelastogram 78-79 O Thyroglobulin 48 O Thyroxine (T4) 20, 22, 42 O TIBC (◊ calculated) 22, 35 O Tobramycin 41 O Total Protein (◊ body fluid) 22-23, 44-45, 47 ► Toxoplasma gondii IgG 120-121 ► Toxoplasma gondii IgM 120-121 O Tramadol 49 O Transferrin 35

O Trichomonas (◊ Cat. #376 – Vaginal Panel)

88, 107, 113

O Tricyclic Antidepressants 49 O Triglycerides (◊ body fluid) 19, 22-23, 38, 45 O Triiodothyronine 20, 22, 42

O Troponin I (►Cat. #920 – CAP requires 5 sample program)

29-31

► Troponin T, qual. 29-31





Analyte Page

O Troponin T, quant (►Cat. #920 – CAP requires 5 sample program)

29-31

O TSH 20, 22, 42

U

O UIBC, measured 22 O Urea 48 O Urea Nitrogen (BUN) (◊ body fluid) 19, 22-23, 27, 37, 45 O Urease 83 O Uric Acid (◊ body fluid) 19, 22-23, 45, 48 O Urinalysis 83-85 ◊ Urine Adulteration 46-47 O Urine Chemistry 47-48 O Urine Colony Count 89, 93, 100 ◊ Urine Crystals 85 O Urine Culture 89, 93, 100 ◊ Urine Eosinophils 85-86 ◊ Urine Microscopy, automated 80-81 O Urine Sediment 82, 86-87 O Urobilinogen 84-85

V

◊ Vaginal Panel 113 O Vaginal Wet Preparation 82-83 O Valproic Acid 41 O Vancomycin 41 ► Varicella Zoster Virus (VZV) IgG 121 O Vitamin B12 35 O VRE 101

W

◊ WBC (auto CSF/BF, body fluid diff., urine)

60, 80

O WBC Count (blood, manual CSF/BF) 61 O Wound Culture 93

Z

◊ Zolpidem 49


AmericanProficiencyInstitute

800.333.0958

www.api-pt.com

200S 2020

american proﬁciency innovative solutions. - api-pt.com

Documents