Statement of Work.pdf

Statement of Work

2025 – Kayenta Health Center Proficiency Testing, Main Lab

Winkelman, Kyle P. (IHS/NAV)

BACKGROUND

Kayenta Service Unit Laboratories at Kayenta Health Center function to provide and perform Laboratory testing as requested by the healthcare providers. CLIA requires that clinical laboratories participate in a Proficiency

Test Program to comply with TJC and CMS regulations. Proficiency testing is the testing of unknown samples sent to a laboratory by a CMS approved Proficiency Test program. Most sets of Proficiency Test samples are sent to participating laboratories three times per year (called Peer Groups). After testing the samples, the clinical laboratory reports its results back to their Proficiency Test program (i.e., API, AAB, or CAP). The PT program vendor then grades the results using the CLIA grading criteria and sends the laboratory scores reflecting how accurately it performed the testing. CMS and TJC accreditation organizations routinely monitor their laboratories’ performance for inspection requirements (TJC Standards ACC-11 & ACC-12).

The Joint Commission describes the importance of participation in a Proficiency Test Program and Peer Group

Comparison data as an essential measure of “Verification of accuracy and reliability of (clinical Lab testing).”

QSA.01.05.01, QSA12 & QSA-13. Routine reviews of PT reports by the laboratory staff and director can alert them to areas of testing that are not performing as expected, and needs corrective action. Another purpose of

Proficiency Testing is to detect shifts and trends that, over time, could affect their patient results. Under The

Joint Commission (TJC) Regulation, TJC QSA-7, we are required under law to participate in a proficiency test program for each regulated analyte listed on our CLIA certificate for all major specialties and subspecialties.

Another requirement under TJC Regulations (TJC QSA-8 & QSA-9) is for all clinical laboratories to show satisfactory performance with no more than 2 consecutive failed events or failure to participate in a Proficiency

Test Program. The Joint Commission regulations, QSA.01.02.01, QSA-10 & QSA-11, also state that Clinical laboratories must show ongoing participation in a Proficiency Test Program through retention of 2 years of records for every regulated analyte included on the CLIA certificate. If we do not have a PT program in place, we will be non-compliant with CMS and TJC regulations. Proficiency testing is required for only the limited number of tests found in Subpart I, Proficiency Testing Programs for Non-Waived Testing, of the CLIA regulations.

SCOPE

CMS (Center for Medicare & Medicaid Services formerly the Health Care Financing Administration or HCFA) is the federal agency primarily responsible for implementing CLIA 88. Under the law, degree of difficulty to achieve final results are used to categorize all tests, or "analytes," as either waived, moderate- or high-complexity.

Varying quality assurance (QA) and quality control (QC) standards apply to tests based on these complexities.

Facilities that perform non-waived tests are subject to announced inspections biennially and must participate in a

CMS-approved proficiency testing program (e.g., Proficiency Test enrollment is mandatory).

DRAFT

Winkelman, Kyle P. (IHS/NAV)

OBJECTIVES

The PT vendor will mail samples as described above (under Task) to the KHC laboratory three times per year in sets of five samples or "challenges" for each of the regulated tests (fewer samples may be sent for tests not listed on the CLIA subpart I listing for each mailing). Missing samples, or compromised samples will be replaced and shipped at no charge to the government.

TASK

Most Proficiency Test samples are sent to participating laboratories three times per year (called Peer Groups) in sets of five samples or "challenges" for each of the regulated tests (fewer samples may be sent for tests not listed on the CLIA subpart I listing for each mailing). After testing the samples, the clinical laboratory reports its results back to their Proficiency Test program (i.e., API, AAB, or CAP). The PT program vendor then grades the results using the CLIA grading criteria, peer group comparison, summary data for 2 years of scores, and sends the laboratory scores reflecting how accurately it performed the testing.

The PT provider will provide a contact representative to handle problems with acquisition of replacement samples for samples damaged in transport, questionable integrity, and when the sample matrix repeatedly gives an error code on the analyzer. Missing samples, or compromised samples will be replaced and shipped at no charge to the government. The representative will be available to assist with result entry problems, submission of requests for new test additions, new quotes, and processing of billing.

The College of American Pathologists, will provide testing materials, result entry forms, result analysis, and support services for the 55 SURVEYS and additional materials requested.

DELIVERY

The College of American Pathologist will send us testing materials, in a timely manner, before each survey is due. The vendor will be contacted be a telephone call requesting assistance when there is a problem with delivery of testing materials.

GOVERNMENT-FURNISHED PROPERTY/EQUIPMENT

The KSU Laboratory maintains the surveys, survey resulting, and post survey analysis.

Winkelman, Kyle P. (IHS/NAV)

SECURITY REQUIREMENTS

No special security is required at this time. All work is performed by Laboratory staff.

PLACE OF PERFORMANCE

The CAP survey kit testing and evaluation will take place at the KSU laboratory site for all testing services that are provided there.

PERIOD OF PERFORMANCE

The Period of Performance shall be for 01/01/2025 – 12/31/2025. This will be renewed annually per CMS, CLIA, and TJC requirements.