Proficiency TestingEverything you always wanted to know

and never realized it!Barbara Burmeister MT (ASCP)Business ManagerWSLH Proficiency Testing

Michael Muth, MBA, RRT,RCPDirector of Pulmonary, Neurology and SleepGood Samaritan Hospital - Los Angeles

PLEASE STAND BY: WEBINAR WILL BEGIN AT 11:00 AM PSTFOR AUDIO CALL: 866-740-1260 / ACCESS CODE:764-4915

Objectives Quick Facts about California Thoracic Society

and WSLH Proficiency Testing as Proficiency Providers Accreditation Requirements PT Lab Responsibilities Scoring PT Failures and Forms

Quick Facts on ProficiencyProviders in the United states 14 Center for Medicaid and Medicare (CMS) approved Proficiency Organizations Many vary by Analytes offered, costs, support and regulations

Quick Facts on California ThoracicSociety as a Proficiency Provider CTS based on West Coast, San Francisco CTS offers clinical support from your peers, 2 Reference Techs Innovative Pulmonary/Critical Care support Evidence -based research Online and paper results

Quick Facts on WSLH PT as aProficiency ProviderWSLH PT based in Madison, WIPart of the University of Wisconsin and the WI State Public Health Laboratory35+ years of PT experienceResponsive customer serviceFlexible ordering and high quality samplesOnline result reporting, training and competency

Why Do PT?

Primary benefit of PT To provide laboratories with independent evaluations

of their testing capability. Strength of PT

Lies in the ability to observe simultaneous data frommany laboratories.

Right answers = Good performance Best Lab Practices and Quality Assurance In many cases PT is required

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Accreditation versus PT

A PT provider is not a lab accreditation agency

An accreditation agency grants a lab itslicense/certificate to perform patient testing andremain in business as long as its requirements aresatisfied. They perform on-site surveys (inspections)bi-annually and monitor compliance/performance in-between surveys by reviewing PT data if available.

A PT provider offers services which may (or may not)be one of the requirements of an accreditationagency.

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Accreditation versus PT

CLIA is the federal “minimum”. Other accreditation agencies (“deemed”) must ensure

CLIA regulations are enforced but can impose additionalrequirements. CAP’s LAP Joint Commission COLA Certain states (CA, MD, PA, NJ, NY)

PT IS ONLY ONE PART OF ACCREDITATION! KNOW YOUR ACCREDITATION REQUIREMENTS.

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT – Lab ResponsibilitiesCLIA Requirements (Minimum)

Authorize release of scores to CMS or other deemedaccreditation agency.

Maintain enrollment for the full calendar year beforeswitching to another PT provider.

Test PT samples in same manner as patient specimensby same personnel and using routine methods...butnever refer a PT sample even if patient samplesare referred for the same testing.

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT – Lab Responsibilities

Test PT samples the same number of times as patientspecimens.

Maintain PT documentation for at least two years: Enrollment confirmation Sample handling and storage instructions Results reported to the PT provider (including signed attestation forms) Reports received from the PT provider Troubleshooting and corrective actions

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

CLIA Requirements forPT Providers (“CMS Approved”)

Be a nonprofit organization. Assure quality of test samples. Score PT results according to CLIA regulations. Provide results to accreditation agencies in the proper

electronic format. Provide attestation statement and signature form for

customer use.

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Requirements for PT Providers

Meet specialty and subspecialty criteria. Comply with packaging, shipment and notification

requirements. Provide replacement samples if necessary. Resolve technical, administrative and scientific problems. Provide “off schedule” PT for customers who have

received a cease-testing directive. Maintain records for five years (all specialties).

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Transfer of data to accreditation agencies 3 different electronic formats

CMS CAP CA

Paper, e-mail or online access for states 50-60 days after each due date (weekly transmissions)

Requirements for PT Providers

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT Process Overview

Participants receive PT samples, analyze them andreturn results.

Results are entered into a scoring database throughonline result entry, scanning import or manual entry.

Results are evaluated using predefined scoring criteriaand event scores are assigned to each analyte.

An event score is a numeric value reportedas a percent (0 to 100%).

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Scoring Overview

Scoring Criteria Predefined criteria come directly from the CLIA ‘88

regulations for all CLIA-regulated analytes. Examples

pH + 0.04 pCO2 + 5 mm Hg or + 8 % (greater) pO2 + 3 SD Sodium + 4 mmol/L Potassium + 0.5 mmol/L Chloride + 5 % Glucose + 10 % or + 6 mg/dL (greater) Hemoglobin + 7 %

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Peer Group Scoring Consists of any of the following:• Specific instrument model• Like instruments from a single vendor• All results for an analyte

Coordinator works with instrument vendors to determine what can be scored together. Peer scoring group must contain a minimum of 10 results and cannot be used until consensus validates it.

Scoring Overview

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Consensus requirement 80% of all results within a peer scoring group must

fall within the acceptable range. If so, the group is valid for scoring purposes. If not, all results receive a score of 100% and must

be self-evaluated by participant.

Scoring Overview

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Scoring Overview

Scoring exceptions Excuse requested status – result receives 100% score

(surveyor must concur with reason) Late status (results received after the result due date)

– result receives 0% score Missing results (one or more of five results left blank

for a regulated analyte) – blank result receives 0%score (MUST make a comment if leaving blanks).

Non-consensus status – result receives 100% score(lab must do self-evaluation)

Not scored status – result receives 100% score (labmust do self-evaluation)

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT Failures

MUST investigate and document ALL PT failures even if80%

Determine and Investigate the PT event in question: Clerical error Interpretation error Analytical error Sample handling problem PT material problem (matrix effect) Random variation

Review calibration, QC and/or other PT data for sametesting

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT Failure DocumentationRequirements

Evaluate related patient results Contact PT provider for additional data/ assistance Specify corrective action taken Specify change(s) made on PT results equal to or less

than 80% Retest PT sample or request another set of the same

samples from PT provider on all samples less than 80%(if available)

To minimize or prevent future deficiencies Document review: Signature/date Verify and Review with Staff and Medical Director

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

PT Failure Consequences

One event - Unsatisfactory performance <80% for each analyte <80% for all analytes in a sub-specialty Lab must take necessary corrective action. Lab must document those actions. If accredited by CAP or Joint Commission, a letter may be received requesting proof of corrective actions. Lab must keep all corrective actions with failure results

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Multiple Events - Unsuccessful Performance <80% for same analyte in 2 consecutive or 2 of 3

events <80% for all analytes in a sub-specialty in 2

consecutive or 2 of 3 events CMS’s intent is not to revoke the CLIA certificate for

initial unsuccessful PT failure except in cases of cleardanger to the patients

Lab can voluntarily cease testing for analyte(s) inquestion

PT Failure Consequences

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

State CLIA process: Lab asked for a plan of action to correct the

problem. Lab is monitored by subsequent PT, additional PT

(e.g. “off schedule”) or special inspections todetermine progress.

Lab is billed for the cost of the process.

PT Failure Consequences

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

If this fails: Lab could be subject to on-site monitoring

(at its expense). Lab could be subject to monetary fines until

problems are corrected. As a last resort:

CMS would revoke the lab’s certificate and stop all Medicare/Medicaid payments.

PT Failure Consequences

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

All accreditation agencies must impose similar sanctions and keep CMS informed for regulated analytes. Unregulated/waived may have different consequences.

PT Failure Consequences

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

Sample Failure Forms

Sample: California Thoracic Society

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

10 Steps to Successful PT

Enroll annually. Know the shipment schedule. Prior to sample receipt, ensure conditions are good. Open package and inspect samples immediately. On the test date, ensure QC is acceptable. Test samples in same manner as patient specimens. Fill out the result form correctly. Read the

instructions. Submit the results before the result due date. Keep a

confirmation. Review the PT report immediately upon receipt. Review successful performance less than 100%.

CLIA regulations 42 CFR Ch. IV Part 493: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

QUESTIONS OR COMMENTS

Questions:Phone: 415-536-0287 / Email: info@calthoracic.org

For more information about the CTS PT Program, please click the link below:http://www.calthoracic.org/content/proficiency-testing-program