CLIA Certificate for Provider-

performed Microscopy

Provider Training

Alana McCoy, MT(ASCP)

CMS Regional Office #4, Atlanta

Leah Ferrier, MT(ASCP)CM

CMS Regional Office #9, San Francisco

June 28, 2017

Disclaimer

This presentation was current at the time it was published or

uploaded onto the web. Medicare policy changes frequently so

links to the source documents have been provided within the

document for your reference.

This presentation was prepared as a service to the public and is

not intended to grant rights or impose obligations. This

presentation may contain references or links to statutes,

regulations, or other policy materials. The information provided

is only intended to be a general summary. It is not intended to

take the place of written law including regulations. We

encourage readers to review the specific statutes, regulations,

and other interpretive materials for a full and accurate statement

of their contents.

2

Agenda

• Introduction of Speakers

• Presentation

• Question & Answer session

3

CLIA/PPM Definitions

• CLIA - Clinical Laboratory Improvement

Amendments of 1988

• CMS – Centers for Medicare & Medicaid Services

• CDC – Centers for Disease Control and

Prevention

• FDA – Food and Drug Administration

• PPM - Provider-performed microscopy

4

Learning Objectives

• Provide a general overview of the CLIA program

• Describe the history of Provider-performed

microscopy certificate

• Identify applicable CLIA regulations related to

Provider-performed Microscopy procedures

• Identify Educational Resources to assist with

meeting compliance

5

CLIA Regulation Overview

• Final CLIA regulation published in Federal Register

on February 28, 1992 and effective on September

1, 1992 as 42 CFR Part 493 Laboratory

Requirements

• Established uniform quality standards for all

laboratory testing to ensure accuracy, reliability

and timeliness of laboratory test results regardless

of where the test was performed

6

CLIA Program Responsibilities

7

The Definition of a “Laboratory”(as defined by CLIA)

Any facility that examines human specimens for the

diagnosis, prevention, or treatment of any disease

or impairment of, or the assessment of the health of,

human beings …..

8

All Clinical Laboratories…..

that perform testing on human specimens for these

purposes must:

• apply for a CLIA certificate

• pay appropriate fees and

• follow applicable CLIA requirements

9

CLIA Certificate Types

• Certificate of Waiver (CoW)

• Certificate for Provider-Performed Microscopy

(PPM) Procedures

• Certificate of Compliance (CoC)

• Certificate of Accreditation (CoA)

10

CLIA Test Complexity

• Waived testing

• Moderate complexity with subcategory of PPM

procedures

• High complexity

• Laboratories are certified at the highest level of testing

performed

• FDA determines the complexity of many tests. FDA

Complexity Search

• Non-categorized tests are high complexity.

11

PPM History: January 1993

New CLIA certificate type

(subcategory of moderate complexity testing)

Physician-performed microscopy procedures• Allowed physicians to perform certain microscopic

exams in addition to waived testing during patient’s

visit

• Microscopic examinations categorized as moderate

complexity

• Limited to bright-field or phase-contrast microscopy

• Specimens that are labile or in which testing delay

could compromise accuracy of results

12

13

PPM History (continued)

• Limited specimen handling or processing required

• Proficiency testing or control materials may not be

available to monitor the entire testing process

• Not subject to routine (biennial) inspections but a

CLIA certificate is required

• Must meet other applicable requirements,

including quality standards

14

PPM History: April 1995

• Renamed to Provider-performed microscopy (PPM) to include other practitioners, and to clarify tests that can be performed:

• Added midlevel practitioners if:• licensed by the state in which the lab is located, if required,• a nurse midwife, nurse practitioner, or physician assistant, and • under physician supervision unless independent practice is

authorized by the State.

• Added Doctors of Dental Medicine or Surgery (D.D.M./D.D.S.) who may qualify as PPM lab directors or testing personnel if:

• Licensed by the state in which laboratory is located

15

PPM Procedures

• All direct wet mount preparations for the presence

(or absence) of bacteria, fungi, parasites and

human cellular elements

• All potassium hydroxide (KOH) preparations

• Post–coital direct, qualitative

examinations for vaginal or

cervical mucous

16

PPM Procedures (continued)

• Urine sediment examinations

• Pinworm examinations

• Fern tests

• Nasal smears for granulocytes

17

More PPM Procedures

• Fecal leukocyte examinations

• Qualitative semen analysis (limited to the presence

or absence of sperm and detection of motility)

18

Educational Resources

This resource is available on the

CDC website: CDC PPMP

Booklet

19

Tips for PPM Procedures

20

Laboratory Director Qualifications

To obtain a Certificate for PPM, the laboratory

director must be qualified as a:

• M.D., D.O., or D.P.M. licensed to practice in the State in

which the laboratory is located,

• midlevel practitioner (nurse midwife, nurse practitioner,

or physician assistant) who is authorized to practice

independently in the State in which the laboratory is

located, and, if required, is also licensed to practice in

that state, or

• D.D.M./D.D.S. licensed to practice in the state in which

the laboratory is located.

21

Testing Personnel Qualifications

PPM testing personnel must qualify as a:• Physician licensed in the state in which the lab is located

(M.D., D.O., or D.P.M.),• D.D.S./D.D.M. licensed in the state in which the lab is

located, or• Midlevel practitioner (licensed if required to be so in the

state in which the laboratory is located) and they are: • under the supervision of a physician, or • practicing independently if authorized to do so by the State in

which the laboratory is located

If microscopy testing is performed by testing personnel that do NOT meet this criteria, the examinations are MODERATE COMPLEXITY and the laboratory needs a Certificate of

Compliance (CoC) or a Certificate of Accreditation (CoA).

22

Testing Personnel Requirements (continued)

Unless the Medical Technologist/Clinical Laboratory Scientist qualified in one of the categories described in the prior slides, a Medical Technologist/Clinical Laboratory Scientist Does Not qualify as testing personnel in a laboratory with a PPM certificate.

23

Laboratory Director Responsibilities

The laboratory director must:

• Direct no more than 5 laboratories.

• Ensure that the laboratory performs only the 9 types of PPM examinations and tests categorized as waived.

• Ensure that the PPM testing is performed by qualified testing personnel (i.e. qualifying M.D., D.O., D.P.M., D.D.S./D.D.M., or midlevel practitioners) during the patient’s visit.

• Comply with the applicable CLIA requirements

24

Testing Personnel Responsibilities

The testing personnel are responsible for

• Specimen processing,

• Test performance, and

• Reporting test results

• The testing personnel must perform the tests using

either bright field or phase-contrast microscopy

25

Testing Personnel Responsibilities (continued)

PPM Procedures must be performed by –

• A qualifying physician (i.e., a qualifying M.D., D.O., D.P.M.)

during the patient’s visit on a specimen obtained from his or

her own patient or a patient from a group medical practice

of which the physician is a member or employee.

• A qualifying D.D.S./D.D.M. during the patient’s visit on a

specimen obtained from his or her own patient or a patient

from a group dental practice of which the dentist is a

member or employee.

26

Midlevel Practitioner

A qualifying nurse midwife, nurse practitioner, or physician assistant may perform PPM procedures either -

• Under the supervision of a physician, or

• If in independent practice, on their own patient or the patient of a clinic, group medical practice, or other health care provider in which the midlevel practitioner is a member

27

CLIA Requirements for PPM Testing

• Competency Assessment

• Environment for testing

• Procedure Manual

• Equipment and Maintenance

• Quality Assessment

• Proficiency Testing (if available) or twice annual

verification of accuracy

28

Training and Competency Assessment

• Well-trained, skilled personnel are essential for quality testing and patient care.

• The laboratory must establish and follow written policies, and procedures to assess testing personnel competency.

• If a solo practitioner has a PPM laboratory, the solo practitioner must establish a minimal level of proficiency in order to demonstrate competency

• PT samples, if available, could be used to assess competency

• Document all training and competency assessment activities

29

Annual Competency Requirements

30

Examples of Competency Assessment

PPM competency assessment may include direct

observations that:

• The test is actually performed during the patient’s

visit

• The correct microscope type is used (i.e. bright

field or phase contrast)

• Testing personnel perform the test correctly

following established laboratory policies and

procedures and report test results according to the

laboratory’s procedure manual

31

Procedure Manual and Maintenance

• Procedure manual: written procedures for all

activities performed in the laboratory

• Retain records of testing and procedures for at

least 2 years

• Centrifuge & Microscope maintenance, including

documentation

32

Facility Requirements

• Environment:

• clean workspace

• sufficient lighting

• appropriate utilities

• sufficient supplies/reagents

• State requirements

33

Appendices and Resources

34

Quality Assessment

The laboratory should have an ongoing quality

assessment component that monitors, identifies,

evaluates, and resolves problems as appropriate for

PPM testing.

• CLIA Quality Assessment provides risk management to

practitioners for their laboratory testing.

35

Proficiency Testing (PT)

• The PPM laboratory must verify the accuracy of

their testing at least twice annually

• There are PT materials specifically for PPM

examinations that can be used to meet this

requirement

• If the labs do enroll in PT, they are subject to the

PT requirements, including PT referral

36

Additional CLIA Requirements

• Documentation for test order

• Specimen Identification

• Specimen reporting in patient medical record,

patient chart

• Proper storage and labeling of reagents

37

Inspection Requirements

Laboratories with a PPM certificate are

not subject to routine (biennial)

inspections; however…

38

Inspection Requirements (continued)

• CMS/CMS agent may inspect PPM laboratories to:

• Determine if the laboratory is operated in a manner that

does not constitute a risk to public health

• Evaluate a complaint

• Determine if the lab is testing beyond the scope of the

PPM certificate

• Collect information on the appropriateness of PPM

testing

39

Waived Testing Performed with a PPM Certificate

PPM labs may also perform waived testing

If waived testing is included –

• Follow the manufacturer’s instructions

• No personnel requirements for waived testing

40

Additional CDC Educational Materials for Waived Testing

In addition to the information found on the CLIA

website……

• CDC has published “Ready, Set, Test” booklet -

describes recommended practices for physicians,

nurses, medical assistants and others performing

patient testing under a CLIA Certificate of Waiver

• CDC also offers an on-line training course

corresponding to “Ready, Set, Test”.

41

Ready, Set, Test!

42

Summary

Certificate of Provider-performed Microscopy

procedures:

• Includes 9 specific microscopic exams

• Must use bright-field or phase-contrast microscope

• Exams are performed during patient’s visit

• Exams are performed by qualified individuals

43

Summary (continued)

• Subject to applicable CLIA requirements

• PT or twice yearly test accuracy verification

• Record retention (at least 2 years)

• Procedure Manual

• If microscopy testing is performed by an individual

NOT meeting PPM testing personnel

requirements, the exams are Moderate complexity

and the laboratory needs to obtain a CoC or CoA

44

Educational Websites

CMS CLIA website

FDA CLIA Medical Devices Database

CDC Stacks Public Health PublicationsCDC CLIA PPM ProceduresCDC Ready Set Test Booklet

45

CMS CLIA Informational Brochures

• CLIA Brochure #7 - Laboratory Director

Responsibilities

• CLIA Brochure # 8 - Proficiency Testing

• CLIA Brochure #9 - How to file a complaint

• CLIA Brochure #10 - What Do I Need to Do to

Assess Personnel Competency?

Use this link to find CLIA Brochures

46

THANK YOU

Questions concerning this presentation and topic may be sent too

LabExcellence@cms.hhs.gov

47

Question & Answer Session

48

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49

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