womack army medical center, fort bragg, nc
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Womack Army Medical Center, Fort Bragg, NC. “Committed to Those We Serve”. Quality System Essentials. Quality Control – provides feedback to operational staff about the state of the process that is in progress. Acceptable – continue with process - PowerPoint PPT PresentationTRANSCRIPT
Womack Army Medical Center, Fort Bragg, NC
“Committed to Those We Serve”
Quality System Essentials
• Quality Control – provides feedback to operational staff about the state of the process that is in progress.– Acceptable – continue with process– Unacceptable – stop until a problem is resolved
• Quality Assurance – activities that are not tied to the actual performance of the process.– Retrospective review and evaluation of operational
performance
• Quality Management – interrelated processes in the context of the organization– Leadership role in commitment to quality– Encompasses the quality systems approach
Quality System Essentials
• Documents and Records• Organization• Personnel• Equipment• Purchasing and Inventory• Process Control• Information Management• Occurrence Management• Internal and External Assessment• Process Improvement• Customer Service• Facilities and Safety
Quality System Essentials
• Quality Management as an Evolving Science– The principles and tools in use today will
change as research provides new knowledge of organizational behavior, as technology provides new solutions, and as the field of laboratory medicine presents new challenges
» AABB Technical Manual – 15th ed
Quality System Essentials
• Submitted monthly by section supervisors• Summary of their QA activities
– QC/QC reviews– Preventive Maintenance– Timed activities
• Weekly, monthly, quarterly, semi-annual, annual
– Corrective actions taken
• Reviewed by Quality Manager• Reviewed by section’s Medical Director• Which QSE does this address??
QSE ToolsMonthly QA Checklists
QUALITY ASSURANCE CHECKLIST
MONTH:___________ YEAR:_______ QA Coordinator:_________________
Weekly Review By/Date
Weekly Review By/Date
Weekly Review By/Date
Weekly Review By/Date
Monthly Review By/Date
Review of Hematology Quality Control Charts
Spun Hematocrit Sickle-Chex 15 Minute ESR 60 Minute ESR Retic QC Chart Fertility QC Chart FDP QC Chart Atlas Level 1 Atlas Level 2 Kova-Trol Level 1 Kova-Trol Level 3 Corrective Action Control Logs Parrallel Testing Logs Review of Hematology Maintenance Charts Microscopre Maintenance Refrig/Freezer Temperature STA-1 Daily STA-1 Weekly STA-2 Daily STA-2 Weekly Centrifuge Maintenance LH 750-1 LH 750-2 Clinitek Maintenance Nikon Maintenance Eye Wash Check Microhematocrit MIdasII Maintenance-Stainer ESR Maintenance Log
Quality System Essentials
Document Control
• Document Control Standard Operating Procedure (SOP)– Standard format for SOPs and Forms– Matches up with items on the control logs– Only the current version in use
• Document Control Logs– Location, version, reviews
• Forms Control Logs
• What QSE does this represent?
WOMACK ARMY MEDICAL CENTER DEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310
Copy MCXC-PA-QM 14 January 2008
STANDARD OPERATING PROCEDURE
DOCUMENT CONTROL I. PURPOSE: To establish a uniform system of document control throughout the
Department of Pathology and Outlying Clinics. This system will provide a more organized tracer system for location of policies and procedures. This will ensure the most up to date version is in place at all locations.
II. PRINCIPLE: The laboratory document management system has been implemented to
ensure that all documents in use are written in the approved formats, reflect the current version, and are reviewed and approved by the appropriate individuals in a timely manner. Generally, procedures are reviewed by the Quality Manager and forwarded to the laboratory manager and the responsible pathologist for signature.
III. APPLICABILITY: This procedure is applicable to all Department of Pathology and
Outlying Clinic personnel who read, write, or review standard operating procedures (SOP) and policies for their respective laboratories.
IV. PROCEDURE: A. Procedures/Policies Control
1. Prior to implementation, all policies and procedures require approval by the medical director of the respective section and the laboratory manager.
2. Personnel affected by the policy/procedure and any revisions thereafter will read and acknowledge their understanding by signature and date. Procedure version or revision will be designated by the date in the header.
3. Policies and procedures will be managed and distributed to the appropriate locations by the proponent. The proponent will be designated in the header of the SOP following the department designation –PA.
4. The proponent (section supervisor) of the SOP will maintain a control log of all procedures and policies that they are responsible for. When more than one copy of the SOP is required, the first copy will remain with the proponent.
Copy Number Location SOP Name
Last Revision Review Review Review Review
1Safety SOP
Manual General Laboratory Safety 25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 08 2 Hematology3 STAT4 Histology5 Clark HC6 Joel HC7 Robinson HC8 BDC
9Laboratory
(Phlebotomy)
1Safety SOP
Manual Chemical Hygiene Plan 25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 082 Hematology3 STAT4 Histology5 Clark HC6 Joel HC7 Robinson HC8 BDC
9Laboratory
(Phlebotomy)
Updated: 19 Jul 20042-Jul-07CPT Tonia Urick, 71A, MS
Section: Safety (Admin.)
Updated: 22 Jan 2008Joanna Horne, MT, ASCP
WOMACK ARMY MEDICAL CENTERDEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310Hematology Section
QUALITY ASSURANCE CHECKLIST
HEM FORM 39December 12, 2007
Body of Form
LIS Form # Form Date Form Name Associated SOP(s)
1 May 9, 2006 Computer/Printer Maintenance Computer/Printer Maintenance2 May 9, 2006 Specimen Master Log Review Checksheet Result Review and Error Procedure3 May 10, 2006 Corrective Action Report Result Review and Error Procedure4 May 25, 2006 Action Needed Form Result Review and Error Procedure5 May 11, 2006 Automated Patient Result Verification Result Review and Error Procedure
7 May 27, 2006 CHCS Training Checklist CHCS Training SOP
Quality System Essentials
Forms Control Log
Quality System Essentials
Audit Tool
• Audit schedule – annual– Cross reference monthly QA Checklist to make sure
original documents reflect the items listed on the QA Checklist
– Spot check document control accuracy– Annual/Semi annual Competency audit– Quality Control records and corrective action
documentation– Phlebotomy Area – Patient identifiers, safety, HIPAA
• Unannounced audits – based on observation• Which QSE does this address?
Quality System EssentialsQuality Management Audits
YEARLY AUDIT SCHEDULE
JANUARY
Chemistry – QC Audit 1st shift
SOP updates
FEBRUARY
Hematology – QC Audit 1st shift SOP updates
MARCH
Stat Lab – QC Audits
APRIL Microbiology –
QC & QM (weekly) Audits
MAY
Outlying Clinics – QC & QM (weekly) Audits, Document Control Forms
JUNE
Hematology – QM (weekly) Review, Document Control Forms
JULY
Chemistry – QA (weekly) Review Document Control Forms
AUGUST
Stat Lab –
QA (weekly) Review Safety SOP Review
SEPTEMBER SOP / Action Comparison
(SOP matches practice)
OCTOBER Bi-Annual Review of QM
Yearly Planning Calendar – (proficiency testing not on survey)
NOVEMBER
Phlebotomy Room Observation / Audit
DECEMBER CAF Review –
All departments
Quality System Essentials
Occurrence Management
• DA4106 (Incident report)– Log item and resolution– Interdepartmental
• Lab generated• Generated Outside Dept of Pathology
• Quality Management report– Internal to Department of Pathology– Errors caught prior to release of results
• What QSE does this represent?
Quality Monitoring Report
Location
Date
- Patient Safety or Quality Issue/Concern
Description of Occurrence (Include person identifying error): ____More on Back Specimen Saved for further investigation? __Yes __No Specimen Recollected? __Yes __No Amended Report? (If so, must be attached)__Yes __No POC for amended report ______________ This Form Completed By:
Corrective Action and Suggestions for Improvement (Include steps taken):
____More on Back
TYPE OF ERROR (Check all that apply) Pre-Analytic Errors Analytic Errors
Order Error Method/assay error
Order missed Instrument problem
Wrong test ordered Faulty reagent/standard/etc
Test ordered on wrong patient Incorrect/expired calibration
Cancellation error Technical Error
Other order error Misinterpretation/misidentifcation
Specimen collection Error Dilution/pipetting error
Specimen mislabeled/unlabeled Calculation error
Wrong container or tube Run accepted-QC out of range
Wrong patient drawn Result accepted-outside linear limits
Delay in collection Sample mix-up
No initials/date/time for collection Transcription/Entry Error
Specimen not received in lab Other
Specimen contaminated with fluids Post-Analytic Errors
Processing Error Delay in reporting
Delay in testing/sending to other site STAT/Critical not called/documented
Specimen lost Other
Courier delay
Other BB entry/issue/processing Error
Quality System Essentials
BB Errors
Transcription Entry errors
Quality Monitoring Report Log
Specimen Collection Errors
Pre-Analytic Errors
Technical Errors
Post-Analytic ErrorsAnalytic Errors
Post-Analytic Errors
Method/ Assay Errors
Order ErrorsProcessing
Errors
Date Section Description of error
Quality System Essentials
Proficiency Testing
• Is your testing process in control?– Measuring system– Technical competence– Clerical
• Investigation of failed proficiency testing– Use a comprehensive form– Determine root cause– Prove you can obtain the correct result
• What QSE does this address?
D e pa rtm en t o f P a th o lo gy1 D ec 07
Laboratory ManagerLTC Linda Guthrie
Decentralized LaboratoriesVera Claude
Accreditation oversight
Laboratory NCOICMSG Larry Reyes
SecretaryLynn Salley
Point of Care CoordinatorJackie Vennero
Quality AssuranceJoanna Horne
QI CoordinatorRobin Wein
SupplyMary Martin-Mitchell
SGT Carpenter Anthony
Office of the Chief
Laboratory ManagerLTC Linda Guthrie
ChiefMAJ Branch
Transcription
Civilian SupervisorWalter Thornton
NCOIC CytologySGT Delena Roper
CytologyMedical Director
CPT Foster
HistologyCivilian Supervisor
Mona Wheat
AutopsyMedical Director
MAJ Branch
Anatomic Pathology
Laboratory ManagerLTC Linda Guthrie
ChiefMAJ Charles Scott
Laboratory NCOICMSG Larry Reyes
OIC Clinical PathologyVACAN T
NCOIC Clinical PathologySFC Cassandra Maxw ell
MicrobiologyVacant
HematologyRhonda Tucker
ChemistryBonnie McGrady
STAT LabLinda Thompson
Shipping, Receiving, HIVShanika, Reeves
Outpatient CollectionsShanika Reeves
Pathology Support
Clinical Pathology
BSL SupervisorPatricia Dempsey
OIC BSLCPT Krishnasw amy
Laboratory ManagerLTC Linda Guthrie
BioSafety Laboratory
Laboratory ManagerLTC Linda Guthrie
OIC Blood Donor CenterMAJ Jason Corley
Medical DirectorMAJ John Schaber
Quality AssuranceTransfusion Medicine
Karen Royster
Civilian SupervisorVacant
NCOIC Blood Donor CenterSGT Isom, Cherise
Blood Donor Center
Laboratory ManagerLTC Linda Guthrie
Medical DirectorMAJ John Schaber
OIC Blood Donor CenterCPT Jason Corley
Quality AssuranceTransfusion Medicine
Karen Royster
Civilian SupervisorShannon Grovenger
Transfusion Services
Transfusion Medicine
ChiefDepartment of Pathology
COL Bradley Harper
Which QSE is addressed?
Quality System Essentials
Personnel
• Gains and Losses• New Employee Orientation
– Learning methods• AV- Audiovisual• V- Verbal• R-Review of Documents• I-In service
• Training• Competency assessment
– 6 month– Annual
ACTIONS
Leadership Introductions
Tour & Staff Introductions Lockers
Supply Room
Admin/Reception
Break Room
Location of SOP’s/Policies & Regulations.
Safety Manual
QA Manual
CHCS Manual
MSDS/ Hazardous Material Storage Location
DEPARTMENT POLICIES Hours
Leave
Personal Items/GOVT property Security
Essential Employees/ Inclement weather
Telecommunication/ Internet usage:
Directories/Paging/Roster sites
Hospital Parking Policy
Location & use of Emergency Red Power Outlets
PERFORMANCE Job Description
Performance standards
Personal conduct
Rating Scheme
Initiate Competency Assess. File -6pt folder
CHCS ACCESS
System Administrator (Laboratory)
Register for AKO Account
Register for WAMC Badge and Network access (WAMC form 25-1U)
SAFETY Fire Alarm Code (Bldg B. zone 06-07)
RACE/PASS
Evacuation rally point -(Back loading dock)
Fire alarm/ extinguisher locations
Emergency eye wash/showers
MSDS/HAZMAT storage
Code Responses (Yel, Blue, Orange, Purple, Silver, Pink, Red, Gold, Green)
Personal Protective Equipment usage
Needle Stick Procedures-Packets
Safety Accident Procedures- Packets
Use of ABC cart system
Isolation Techniques/ Ward rounds
TRAINING HIPAA online training
Anti-terrorism training
Hospital Orientation Scheduled
COMPETENCY METHOD LEVEL VERIFICATION
10. Observance of Lab Safety policies.
11. Oversees MLT training and ensures students meet accreditation standards.
12. Ensures staff is trained in all areas of the Chemical Hygiene Plan and EPP.
Verification Method Codes: Competency Level:C-Course/Class Presentation O-Observe Daily Workflow M-Mock Survey/Drill E-Exceeds ExpectationsD-Demonstration S-Self Assessment W-Written Example S-SatisfactoryG-Group Discussion/Case Study V-Verbalizes Knowledge Q-QI Monitor N-Needs ImprovementNA-Not Applicable I-In-service R-Review of Paperwork/QC/SOP
The above named employee is competent to perform the assessed skills on the Competency Assessment – Section Supervisor without/with listed exceptions. If any exceptions are listed, attach a separate sheet of paper listing the exceptions and plans for remediation.____________________________________ __________________________________________Signature Date Lab Manager Signature Date
Quality System Essentials
QI MonitorLOG #7
SUBJECT POC OPENED FREQUENCY CLOSED
Microbiology Blood Culture Contamination Rate
Ms. Dempsey Jan 07 Monthly
ESTABLISHED THRESHOLD <3%
2007JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
Total # of Sticks
320
338 338
331 305 303 314 303 282 273
#Contaminates
12 6 13 5 9 5 16 11 10 9
% Cont 3.8% 1.8% 3.8% 1.6% 3.0% 1.7% 5.1% 3.6% 3.5% 3.3%
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%
JAN FEB MARCH APRIL MAY JUNE JULY AUG SEPT OCT NOV DEC
% Cont
Which QSE is addressed?
Quality System Essentials
Integration into QI Program/Minutes
• QI Worksheet– Broken down by QSE– Submitted monthly
• By section supervisors• One week prior to QI meeting• Collated by Quality Manager
– Presented at QI meeting– Submitted as the QSE attachment to the minutes
WOMACK ARMY MEDICAL CENTER DEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310
Quality Improvement Report Form
I. The report below is submitted by the _____________________ section for inclusion in the minutes for the (month) __________________QI meeting. II. Old Business QI Monitors/Issues:
TITLE: QA LOG #: (Circle one) Sentinel Indicator New Issue Old Issue
FINDINGS: CONCLUSION: RECOMMENDATION: ACTION: EVALUATION:
III. New Business A. Personnel 1. Gain/Losses:
2. Training Completions:
Individual ___________________ Completely Trained for __________________ 3. Competency Assessments:
Individual _____________________ Assessed for __________________ 4. Continuing Education Report (see attached attendance roster)
Class _________________________ Instructor______________________
B. Equipment 1. Demonstrations 2. Validations 3. Issues C. Purchasing and Inventory 1. Supply Issues 2. Contracts D. Process Control 1. Proficiency Testing Survey ____________# Responses____________#Acceptable______________ 2. Monthly QAP QA report form submitted Y N 3. SOP Updates E. Documents and Records -archived/updated/document control F. Information Management -Upgrades/downtime/issues G. Occurrence Management - DA4106 H. Assessments 1. Point of Care Testing report 2. Internal/External I. Process Improvement 1. Utilization Review item(s) a. TAT reports, etc b. Workload 2. New Tests in evaluation 3. Teams/Committee activity J. Customer Service and Satisfaction 1. Complaints – physicians, patients, staff 2. Satisfaction Surveys K. Facilities and Safety 1. Infection Control report 2. Safety Report Comments: ________________________________________________________ _________________________________ Section Supervisor
Quality System Essentials
The Final Product
• QSE attachment to Department of Pathology monthly QI minutes
• All 12 QSEs addressed during QI meeting• Opportunity for discussions
– Add/correct items
• Laboratory Director and Laboratory manager as well as staff are aware of all quality activities at that snapshot in time