2017 Focus on Compliance - College of American Pathologists

2017 Focus on Compliance

Gregory Gagnon, MD, FCAP June 21, 2017

Dare to be Different: Avoiding the Most Common Lab Gen and All Common Deficiencies

Disclosure

Guang Fan, MD, FCAPS. Robert Freedman, MD, FCAPGregory Gagnon, MD, FCAP Kenneth Klein, MD, FCAPJacob Mayer, PhD, HCLD

© 2017 College of American Pathologists. All rights reserved.

The following authors/planners/reviewers have no financial interests/relationships to disclose:

Authors/Planners/Reviewers Commercial Interest Role Received

Andrew Goodwin, MD, FCAPHaematologicTechnologies

Medical director Monetary stipend

The following authors/planners/reviewers have financial interests/relationships to disclose:

Jill Miller, MDRitu Nayar, MD, FCAPMichael Talbert, MD, FCAPVictoria Keller, MT(ASCP)Eleanore Wojewoda, MS, MT(ASCP)

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AccreditationThe College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CE (Continuing Education for Nonphysicians)The CAP designates this educational activity for a maximum of 1 credit/hour of continuing education. Each participant should only claim those credits/hours he/she actually spent in the activity.

ASCP StatementThe American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.

California and Florida StatementThis activity is approved for continuing education credit in the states of California and Florida.

© 2017 College of American Pathologists. All rights reserved. 3

Today’s PresenterDr. Gagnon has been part of the pathology faculty for the Brody School of Medicine at East Carolina University in Greenville, North Carolina since 1989. He is board certified in anatomic and clinical pathology and hematopathology and a member of the College of American Pathologists Commission on Laboratory Accreditation since 1997. Dr. Gagnon served as the Regional Commissioner for North and South Carolina, Virginia, and West Virginia and is currently chair of the Accreditation Education Committee. He has been actively involved as a volunteer in the Laboratory Accreditation Program for over 25 years as team leader or member for numerous regional, national, and international laboratory inspections.


Gregory Gagnon, MD, FCAP

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Objectives

• List the most commonly cited deficiencies from the Laboratory General and All Common checklists.

• Implement practical processes to avoid these deficiencies.• Describe techniques for organizing documentation that

demonstrates compliance with these accreditation requirements.


Most Common Deficiencies Cited in Lab General Checklist

• GEN.55500 Competency Assessment: 29.4%• GEN.20375 Document Control: 12.1%• GEN.54400 Personnel Files: 8.6%• GEN.77400 Eyewash Requirement: 6.5%• GEN.16902 QM Plan Implementation and Annual Review: 5.3%


Most Common Deficiencies Cited in the All Common Checklist

• COM.01200 Activity Menu: 7.1%• COM.10000 Procedure Manual: 5.3%• COM.04250 Method Comparison: 4.8%• COM.30600 Maintenance and Function Checks: 4.3%• COM.10100 Procedure Manual Review: 4.2%


GEN.55500 Competency Assessment of Testing Personnel• Training (GEN.55450) versus Competency (GEN.55500)• Waived versus nonwaived testing• Define test systems • Six elements of competency• Records of assessments• Written procedure


Competency: Test Complexity

• Waived testing– Annually after training, assessor qualifications by lab director,

lab chooses elements used in assessment.• Nonwaived testing

– First year after training semiannually, then annually.– All six elements used to assess each test system (as

applicable).– Supervisory responsibilities (ongoing monthly reviews,

assessments, etc).


Assessors of Competency

The laboratory director must ensure that individuals performing competency are qualified through education and experience to meet the defined regulatory requirements associated with the complexity of testing.

Testing personnel performing high complexity testing must be assessed by an individual meeting the qualifications of a general supervisor and delegated by the medical director to assess competency.

Testing personnel performing moderately complex testing must be assessed by an individual meeting the qualifications of technical consultant and delegated by the medical director to assess competency.


General Supervisor QualificationsSupervisors/general supervisors meet defined qualifications and fulfill expected responsibilities.

Must possess one of the following: • Bachelor's degree in a chemical, physical, biological, clinical

laboratory science, or medical technology with at least one year experience with high complexity testing

• Associate degree in a laboratory science or medical technology program with at least two years experience with high complexity testing

• Have previously qualified or could have qualified as a general supervisor prior to February 28, 1992

Individuals meeting the qualifications of a general supervisor for high complexity testing may assess the competency of high complexity testing personnel, if this duty is delegated, in writing, by the medical director.

© 2017 College of American Pathologists. All rights reserved.11

Technical Consultant QualificationsThis requirement applies to laboratories performing moderate complexity testing, but not high complexity testing.

Must at a minimum possess:• Bachelor's degree in medical technology, or a bachelor’s

degree in a chemical, physical, biological, or clinical laboratory science AND

• At least two years of experience in nonwaived testingIndividuals meeting the qualifications of a technical consultant may assess the competency of personnel performing moderate complexity testing.


Competency: Test Systems

• Use activity menu to identify test systems• Includes preanalytic, analytic, and postanalytic steps in the

testing process• Multiple analytes under single test system if steps are similar

(ie, chemistry panel)• Same analyte with two test systems (ie, automated, manual

microscopic urine)• Assessments performed for each test system


Competency: Six Elements of Assessment

• Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing, and testing

• Monitoring the recording and reporting of test results, including, as applicable, reporting critical results

• Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records

• Direct observation of performance of instrument maintenance and function checks

• Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples

• Evaluation of problem-solving skills


Competency: Records of Assessments

• Create a grid • Test systems• Component steps of the test system• Element used to assess step• Date assessment performed• Person performing assessment


Example of Defined Test Systems

Employee Name: Date of Hire:

1 Direct observation of routine patient test performance including, as applicable, patient identification and preparation, handling and processing. BLIND ABSC #2 BLIND DAT #3 BLIND FMH #4 BLIND SICKLE #5 Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.6

GEL TEST DIRECT

Specify Instrument / Assay ABORH ABSC/ABID ISXM AHG XM AG TYPE DAT (IGG) DAT(C3) ABSC/ABID AHG XM DAT FMH SICKLE ELUTION

1

Specimen Processing Patient ID accuracy

1 Patient Testing

2 Result Entry

2Reporting Criticals/Delays N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

3Review Intermediate results/Worksheets N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

3 Review QC N/A

3 Review Patient Results

3 Review PM records e) b) N/A c) c) a) d) N/A N/A

4Direct Observation of Maintenance e) b) N/A c) c) N/A c) d) N/A N/A

5Proficiency Testing or Blind Samples c)

6 Problem Solving

Comments

a) daily temps; b) saline bottles; c) cell washer; d) MTS weekly, e)serofuge qcSN

Date:

Date:

ANNUAL/SEMI-ANNUAL COMPETENCY ASSESSMENT

Evaluation of problem solving skills.

Direct observation of performance of instrument maintenance and function checks.

I have read and understand the standard operation of procedures for the tests listed above, and I had an opportunity to review and ask questions about policies and procedures related to equipment and testing above.Date:

Satisfactory - Requires minimal supervision with no more than 10% prompting and minimal oversight in less than the time scheduled.Needs Improvement - Needs additional training prior to working alone.

Employee Signature: Evaluator Signature:

Date:

Period of Evaluation:

Monitoring the recording and reporting test results, including, as applicable, reporting critical results.Review of intermediate test results or worksheet, quality control records, proficiency test resulting and preventive maintenance.

TUBE TEST KITSGEL TEST INDIRECT

Blood Bank Manager Signature:Technical Coordinator Signature:Based upon successful completion of their competency assessment, the employee is deemed to be competent to perform patient testing unsupervised.

Microsoft Excel Worksheet


Competency: Written Procedure

• Detailed procedure that reflects the process• Who can perform assessment• Frequency of assessment• How six elements are utilized• How assessment is recorded/documented • How new testing is incorporated• Retraining and reassessment process when problems

identified


GEN.20375 Document Control

• Includes QM, safety, personnel, LIS, specimen collection• Date in service, date of revisions, schedule of review,

identification of reviewer(s), date of retirement• Includes forms and job aids• Written procedure that accurately describes system• Not specifically required (but helpful) - numbering system,

electronic system, master control log• Ensures only current policies in use, and that

approval/review documentation is available


COM.10000 Procedure Manual• Written procedure must match the laboratory’s practice• Electronic manuals must be available to all personnel, and

must have down time alternative• Reviews must be biennial (every two years) by medical

director or designee and must be recorded• Single signature on a manual’s table of contents is not

sufficient• Procedures must be available for inspector


COM.10100 Procedure Manual Review

• Procedure review must be delegated by laboratory director• Each procedure must have documentation of review• Biennial review for technical policies/ procedures only


GEN.54400 Personnel Files• Must include records that document technical personnel

meet qualifications for positions held• Diploma, transcript, primary source verification, equivalency

evaluation• License, certification (if state requires)• Summary of experience• Job description, list of procedures, supervision• Accidents, employment dates, continuing education• Written policy

– Primary source verification acceptance criteria– Required documents

• File for each person on roster• Audit periodically for completeness• Should support CLIA defined roles: GEN.53400, GEN.53600,

GEN.53625, GEN.53650, GEN.54750• Should reflect Personnel Evaluation Roster GEN.54025


GEN.77400 Emergency Eyewash

• 10 seconds or less from hazardous chemicals• Deliver 1.5 L/min for 15 minutes• Hands free, flow to both eyes simultaneously• Unobstructed access• Tepid temperature• Signage indicating location• Nozzles or covers to protect from contaminants• Plumbed system tested weekly• Self contained visually checked weekly and have

manufacturers specifications available


GEN.16902 QM Implementation• Written Quality Management (QM) plan GEN.13806• Evidence that QM plan is implemented as designed

– Quality monitors with thresholds and documentation of review and actions taken

• Documentation that effectiveness of QM plan is evaluated annually

– Revision of written QM plan– Annual written QM evaluation report– Meeting minutes of annual effectiveness discussion


Examples of Quality Indicators


QA MONITORING AND PERFORMANCE IMPROVEMENT _____ (Year)

Indicator Monitor Frequency

Threshold/ Goal Jan Feb Mar April May June July Aug Sep Oct Nov Dec Actions

Blood BankTransfusion documentation complete monthly 90%

Blood utilizationmonthly C/T ratio <2.0

Blood component wastagemonthly <1%

ChemistryCalling critical values within 30 minutes monthly 98%

Troponin TATmonthly

95% within 30 min

General LaboratoryUnlabeled/mislabeled specimens monthly 100%Test order accuracy monthly 100%Corrected reports monthly <0.5%Proficiency testing monthly 100%accidents / injuries monthly zeroOccurrences monthly trendsHematology

STAT TATmonthly

95% within 30 min

Specimen acceptability monthly 99%Microbiology

Blood culture contaminationmonthly <3%

Specimen acceptability monthly 99%Pathology

Frozen section TATmonthly

100% within 20 min

POCLab draw follow-up for critical WBG monthly 98%This report is completed monthly and submitted quarterly to the Quality Oversight Committee.

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COM.04250 Comparability of Instruments and Methods

• Nonwaived methods only• Methods within a single CAP/CLIA number• At least twice a year• Written procedure including acceptance criteria• Patient samples, controls• Applies to instruments/methods producing the same

reportable results (ie, manual differential versus automated differential)


COM.04250 Comparability of Instruments and Methods, cont.

• List the methods/instruments to be compared• Designate the time frame for the study• Identify who will carry out the study• Indicate specimens to be used for study• Specify the data to be collected• Specify how to analyze the data• Establish acceptability criteria (COM.04300)• Document review of data, actions taken


COM.30600 Maintenance and Function Checks• All instruments and equipment• Written procedure• Schedule specified by manufacturer• Documentation of performance and monthly review


COM.01200 Activity Menu

• Procedure manual should correspond to Activity Menu• Add to new test implementation process• Audit Activity Menu periodically, especially when doing

reapplication• Remove retired tests • Custom checklist is generated by Activity Menu selections


COM.01200 Activity Menu

• Inaccurate activity menu may result in a nonroutine inspection and added expense for the laboratory


Summary: Avoiding the Most Common Deficiencies• Written procedure for what you are doing.• Document that shows you are doing it.• Anticipate inspector requests.• Cross reference checklist item with documentation.• Think like an inspector!


Performance Analytics Dashboard

• Online reporting tool for proficiency testing and accreditation performance (new 2016)

• Access through e-LAB Solutions Suite• Includes inspection results for up to three accreditation

cycles• Laboratory Deficiency Detail is one of several reports that

can help identify if your laboratory has been cited for one of these common deficiencies

To learn more about the Performance Analytics Dashboard search “dashboard” at cap.org.


Laboratory Deficiency Detail Report


Select the cycle to review

Print or export the report for analyzing, sharing, or storing.32

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2017 Focus on Compliance - College of American Pathologists