Walk the Walk and Talk the Talk:

Meeting the Inspector with Confidence!

Sharon S. Ehrmeyer, Ph.D.UNIVERSITY OF WISCONSIN MEDICAL SCHOOL

MADISON, WI

Successful Strategy#1

Know your inspection agency’s requirements!

CLIA regulations must be met through accreditation with:

CLIA,JCAHO, orCAP

Regulatory reality

General Regulatory Requirements

Follow manufacturer’s protocols Validate method before routine use

Accuracy, precision, reportable range, etc. Have authorized operators

Initial (documented) training and on-going competency assessment

Include patient and operator identification Monitor instrument functions

General Regulatory Requirements

Perform required maintenance Perform and evaluate QC at appropriate

intervals Perform corrective actions

Provide an audit trail From testing to patient record

Participate in regulatory proficiency testing Document all information

QC, QA checks, PT results, maintenance, etc.

Who’s on first?

What regulations to follow; who inspects depends on CLIA certificate arrangement: JCAHO accreditation

– Accepts CAP and COLA inspections– Reinspects waived POCT every 3 years

CAP accreditation– CAP must inspect

CMS for CLIA compliance– Sites not seeking specific accreditation

CLIA’03 Final QC Regulations

Good news!! Allows one survey cycle (2 years) to:

– Permit labs to comply– CMS to develop revised surveyor/lab guidelines

Bad news!! No comments solicited Regulation is final Still not complete; other subparts will follow

Judy Yost, CMS 2003

JCAHO Comprehensive Accreditation

Manual (Pathology and Clinical Laboratory Services)

Beyond 2003

JCAHO – 2004 and beyond

Draft of proposed standards at www.jcaho.org

Goal with revisions: Eliminate redundancies Reduce documentation and paperwork Focus survey process on patient safety and

health care quality

JCAHO – 2004 and beyondJCAHO’s new accreditation model:

More data drivenLess predictableMore customized to individual organizationFewer standards, but not reduced requirementsStandards’ wording revised to be better understandChange in basic format

– Intent statement replaced with rationale and measurable characteristic (element of performance, e.g., there is a written policy that defines QC)

Some standards are now “elements of performance”– WT.1.4.1 (2002-2003) At a minimum, manufacturer’s instructions are

followed.

JCAHO – 2004 and beyond

JCAHO’s new survey process – Shared Visions-New Pathways: Scoring changed from a 5 to a 3-point process No percentage score Focus on lab functions – pre- through post-

analytical

Waived Testing (2002-2003)WT.1 Organization defines use of waived test results in patient care (definitively

or only as a screen).WT.1.1 Organization identifies personnel responsible for performing and

supervising waived testing.WT.1.2 Personnel performing tests have adequate, specific training and

orientation to perform the tests, and demonstrate satisfactory levels of competence.

WT.1.3 Policies and procedures governing specific testing-related processes are current and readily available.

WT.1.4 QC checks, as defined by organization, are conducted on each procedure.WT.1.4.1 At minimum, manufacturer’s instructions are followed. WT.1.5 Appropriate QC and test records are maintained.

Waived Testing (2004-2005)

WT.1.10 -- Organization defines use of waived test results in patient care (definitively or only as a screen).

WT.1.20 -- Organization identifies staff responsible for performing and supervising waived testing.

WT.1.30 -- Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence.

WT.1.40 -- Approved policies and procedures governing testing processes are current and readily available.

WT.1.50 -- QC checks, as defined by the organization, are conducted on each procedure.

WT.1.60 -- Appropriate QC and test records are maintained.

WT -- Elements of performance (2004-2005)

WT.1.10 -- Organization defines use of waived test results in patient care (definitively or only as a screen). If test is used for screening, then confirmatory test is

specified in procedure, if required WT.1.20 -- Organization identifies staff responsible for performing and supervising waived testing.

Each identified may be employees of the organization, contracted staff, or employees of a contracted service.

WT -- Elements of performance (2004-2005)

WT.1.30 -- Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence. Competency assessments are based on frequency of staff performance

of testing, technical background and skills, complexity of method and consequence of inaccurate results

Assessment of skills include at least one of following– Performing test on unknown sample

– Supervisory or qualified person observe routine work

– Monitor QC performance

WT -- Elements of performance (2004-2005)

WT.1.40 -- Approved policies and procedures governing testing processes are current and readily available. Specimen collection, ID, and appropriate required labeling Specimen preservation, as appropriate Instrument calibration QC and remedial actions Equipment performance evaluation Test performance

WT -- Elements of performance (2004-2005)WT.1.50 -- QC checks, as defined by the organization, are

conducted on each procedure. Written QC plan that specifies how procedures will be controlled for

quality, establishes timetables, and explains rationale QC checks conducted as specified in plan

– For glucose, 2 levels of QC are run each day of patient testing

– For other methods, QC is based on how test is used, reagent stability, manufacturer’s recommendations, organizations experience with test, currently accepted guidelines

– At minimum, manufacturers’ instructions are followed

WT -- Elements of performance (2004-2005)

WT.1.60 -- Appropriate QC and test records are maintained. All QC results documented All test results are documented QC records, instrument problems, and patient results

correlated Functional audit trail maintained

QC – JCAHO (2002-2003)

(QC.1) Documented QC program(QC.1.2) Validation of methods(QC.1.3) Daily surveillance of results (QC.1.4) Perform / document corrective actions (QC.1.5) Review QC results before reporting

results(QC.1.6) Follow manufacturer’s reagent

guidelines

2004 QC Standards (pre-publication)Proficiency Testing

QC.1.10 -- Each specialty and subspecialty has a documented QC program.

QC.1.20 -- PT services used for specialty and subspecialty equal or exceed CLIA regulatory requirements

QC.1.30 -- Lab maintains a cumulative record of PT participation and includes documented review and evaluation of each unsatisfactory PT result

QC.1.40 -- Lab ensures PT testing is performed in the same manner as patient sample testing.

QC.1.50 -- PT performance is maintained at an acceptable level.

2004 QC Standards (pre-publication)

Quality Monitoring and Control Systems

QC.1.60 --Lab uses system for verifying accuracy and reliability of test results for tests not in regulatory PT.

QC.1.70 -- Lab’s QC system validates methods used.

QC.1.80 -- Lab uses system to evaluate and correlate relationship between results for same test performed with different methodologies/instruments or at different sites.

QC.1.90 -- Lab’s QC system includes daily and periodic result surveillance by appropriate staff.

QC.1.100 -- Lab takes remedial action for deficiencies identified by QC measures or authorized inspections and documents such actions.

2004 QC Standards (pre-publication)Quality Monitoring and Control Systems, cont.

QC.1.110 -- Lab ensures QC results meet criteria for acceptability before reporting patient test results.

QC.1.120 -- QC specimens are tested in same manner as patient samples.

QC.1.130 -- Lab follows written guidelines for properly preparing, storing, dispensing, and periodically evaluating all reagents, including water, to ensure accurate, precise results.

QC.1.140 -- Lab ensures reagents and solutions are completely and accurately labeled according to written guidelines.

QC.1.150 -- Laboratory retains QC records as required by law.

JCAHO – QC standards (2004 and beyond)

Like for WT, each standard has elements of performance for guidance in meeting the standard

Specialty and subspecialty sections to follow (depends on testing performed) Clinical chemistry Hematology and coagulation Clinical microscopy (urinalysis)

JCAHO – 2004 and Beyond

Checkout proposed standards at:www.jcaho.org

Also think about 100% compliance 100% of time

for patient safety

Successful Strategy#2

Apply the Regulations

Identify Problems (Concerns) in YOUR laboratory

How? Be objective Do periodic mock reviews

CAP Interim Self Survey JCAHO’s Preparation Guidelines COLAs inspection checklist Inspection Checklist Consultants

Use tracker tools

Mock Inspection – Gen. Information Is testing performed under an appropriate CLIA

certificate? Central Laboratory or other (specify)____________ Type of certificate - waived, mod. or high complexity Expiration date ________________ Director named on certificate _________________ Which agency inspects?

– JCAHO – CAP – COLA – CMS (CLIA) – Other (specify)_________

Mock Inspection -- QA

QA Plan implemented and available to view? Director and supervisor signed off / approved? Monitors assure total quality care? Documentation of problems/resolutions?

Accuracy verified for all analytes? Results correlated?

with other methods / instruments Complaints and deficiencies logged and corrected? QA activities / reports show quality is built in?

Mock Inspection -- Personnel Director/supervisor meet CLIA qualifications

and applicable state/local laws? Testing personnel authorized for specific

testing? Received adequate training? Assessed, on a defined interval, for continued

competency? Records, including training and competency

assessment, maintained?

Mock Inspection -- Procedure manual

The most current PM is available to staff? Dated when put in place? Updated with the latest product inserts? Reviewed and signed by the Director or designee

initially (and every 2 years)? Old PMs for discontinued methods retained for at

least 2 years? Testing personnel are familiar with its

content?

Mock Inspection -- QC

Established QC program that describes: frequency of QC and number of controls analyzed? acceptable limits? documentation of QC results? corrective action for values outside acceptable limits? corrective action for unacceptable controls and

documentation? review of QC data including review of any corrective

action reports?

Mock Inspection -- PT

Enrolled in regulatory PT for the regulated tests? PT results reviewed and review documented

(signed and dated)? Each failure investigated and corrective actions

documented? Records maintained for appropriate time?

Mock Inspection -- Reagents

Kept in original container? Stored as directed by manufacturer?

– If a specific temperature range is required, temperature must be monitored.

Not used beyond indicated expiration dates?

Mock Inspection -- Lab safety

Safety manual available to staff? Does it contain:

– general institutional requirements?– instructions to minimize the risk of exposure to HIV,

hepatitis, etc.?– fire prevention and control?– electrical safety?– hazardous waste disposal including sharp/needle

disposal?– internal and external disaster plans?

Tracker Tools* to ID Problems

System to evaluate Pre-analytic processes Analytic processes Post-analytic

*Anne Belanger, MA, MT(ASCP)Consultant, Laboratory Accreditation

Tracker Tools*

Ordering Specimen collection Specimen processing Sample testing Resulting

*Tools apply to all testing

Tracker Tools Ordering

Right test ordered on right patient?How does the order get to the laboratory?Order is clear and legible?Polices and procedures for specimen collection?

Specimen collectionSterile technique used to draw blood?Blood preserved properly in appropriate

container?Blood collected at correct time?Specimen labeled adequately?

Tracker ToolsSample testing

Adequate technical procedures available?Analysts attested to their familiarity with these?Specimen integrity and identification maintained?Specimen tested in a timely manner?Equipment maintained per manufacturer's

instructions?QC performed and within acceptable limits?Corrective action taken for unacceptable QC results?Sample rerun as necessary?Results verified?

Tracker Tools

ResultingCorrect result noted in report?Result legible?Appropriate reference intervals included?Pertinent comments noted (e.g., hemolysis)?Result reported to doctor in a timely fashion?

Fix Problems Identified

PrioritizeAssignCorrect

Successful Strategy#3

Keep it simple; Work Smarter

Don’t forget everything you learned by just focusing on the

rules!

Don’t get caught in the trap!Avoid common citations

Don’t get caught in the trap!

Common citations Following manufacturer’s directions QC

– Perform at appropriate frequency– Corrective actions for out-of-control situations

QA– Have a plan– Monitor for effectiveness

2X / year, comparisons and accuracy assessments Personnel competency Proficiency testing

– Participation– Review of results– Corrective actions

Documentation

Fail-safe Inspection Tips

Things that should never occur: Dirty laboratory Messy storage areas Unsafe practices

– Pre through post-analytical Uncorrected old citations

– Always have a plan! Staff who are not in the loop

ADVICE FROM INSPECTED LABS

Know and understand inspecting agency’s regulations Follow to the “nth” degree

Have documentation for everything Have all manuals, records and files current and

understandable Have an overall plan that states the lab’s

approach to QA Educate the staff -- everyone is on the same page

ADVICE FROM INSPECTED LABS

With inspectors: Be courteous Be honest

– Don’t volunteer extra information, but don’t get “dingy” Be ready to explain the why and how

– Don’t argue, explain in writing – With areas of concern, ask for suggestions

Be professional Be confident; act confident

INSPECTION DOs AND DON’T

Don’t procrastinate Paperwork, personnel reviews, records, etc.

Do maintain an up-to-date QA program Do come to the table prepared

Prepare everyone Don’t operate a “sloppy ship”

Follow all rules – always Make compliance a requirement for continued

employment

INSPECTION DOs AND DON’T Don’t delegate inspection duties to unprepared

staff Unknowledgeable staff communicating with the

inspector is a disaster Do have an alternative plan if the assigned staff

member (to be with inspector) becomes unavailable

Do present an organized front Have “private space” for inspector to review materials

and documentation

Organized documentation

Document, Document, Document

Inspectors don’t want to see that you have the ability to produce quality results, they want:

PROOF OF A QUALITY OPERATION

Documentation must be organized and easy to understand

Documentation -- PersonnelJob descriptionsPersonnel records (including licenses as applicable)

OSHA bloodborne pathogen testing Hepatitis B vaccination record or declination form Immunization/health/accident/incident records

Orientation/in-service/cont. education recordsPerformance evaluationsOrientation and competence assessment

Documentation- policies/procedures

Administrative Technical Safety

General Fire Disaster Chemical hygiene Infection control

Documentation- policies/procedures

Specimen collection Computer (including backup), as

applicable Procedure manuals Inpatient and outpatient records CQI activities

Documentation- records

Test validation protocols and records Proficiency testing results (2 years) Accuracy data, if not in PT Quality control results Method correlation records

Documentation- records

Function checks and calibration, maintenance, and repair records for all equipment

Temperature records only when relevant

– regents must be stored at specified temperature Corrective action records for PT, QC

After the inspection

Final decision usually up to regulator's oversight function, e.g., its board

Review all citations Perform follow up per regulator's guidelines

Prepare plan of correction Implement needed corrections Provide evidence to regulator per guidelines

Keep inspection ready