ATTACHMENT A - STATEMENT OF WORK - LINEARITY TESTING.docx

STATEMENT OF WORK

Laboratory Linearity Testing Services

1. INTRODUCTION

A. The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to Laboratory Linearity Testing (LT) for the VISN22 Pathology and Laboratory Medicine Services (P&LMS) department at:

VA Long Beach Healthcare System (VALBHS) Pathology & Laboratory Medicine Service 5901 E. 7th Street Long Beach, CA 90822

2. PERIOD OF PERFORMANCE:

A. The period of performance shall be for a one (1) year base period.

3. ACRONYMS

A. Linearity Testing – LT B. Clinical Laboratory Improvement Amendments – CLIA C. Centers for Medicare and Medicaid Services – CMS

4. BRAND NAME OR EQUAL

5. MINIMUM TECHNICAL CAPABILITIES/REQUIREMENTS:

A. The vendor must be Centers for Medicare and Medicaid Services (CMS)-approved provider that conforms to Clinical Laboratory Improvement Amendments (CLIA) and cover all areas in Clinical Pathology and Anatomic Pathology.

B. The vendor must offer Linearity Test (LT) programs that allow the laboratory to compare its performance with peer groups.

C. The vendor must ensure the laboratory receives the LT surveys in good condition (package is intact and was transported in the proper temperature).

D. The vendor must ship the LT surveys on time according to the schedule.

E. The vendor must provide technical support as needed.

F. The vendor must offer a competency assessment hub for managing the competency of laboratory testing personnel.

G. The competency program must be comprehensive and customizable to the needs of the VA Long Beach laboratory. It must offer a library with CE courses that covers all the VA Long Beach laboratory disciplines.

H. The vendor must provide access to a CLIA approved software or program that can be used for competency training, with exams, and monitoring and assessing training for approximately 50-75 users.

I. The competency assessment must offer a library with continuing education (CE) courses that cover the following VALB laboratory disciplines, Microbiology, Molecular biology, Chemistry, Immunology, Serology, Hematology, Coagulation, Transfusion medicine, Uranalysis, Quality management.

J. The competency assessment must cover the six CLIA elements of competency assessment,

1. Direct observations of routine patient test performance;

2. Monitoring the recording and reporting of test results including critical results;

3. Review of intermediate test results or worksheets, LT results, quality control records, and preventive maintenance records;

4. Direct observation of performance of instrument maintenance and function checks;

5. Proficiency or blind sample test results; and

6. Evaluation of problem-solving skills including written tests, instrument troubleshooting, or sample handling issues.

K. The software or program must have a checklist for monitoring competency assessments that is customizable to its specific instruments.

6. PRODUCT/SERVICE:

A. The contractor will provide analysis of samples with unknown values to be compared with results from peer laboratories and reported to the participating laboratory and the VA National Enforcement Program Long Beach VA Health Care System (LBVAHCS).

B. The contractor must ensure that LT are performed in a way that are trackable and reportable.

C. The contractor’s services must adhere to policy and guidance from regulatory bodies not limited to the, CDC, HHS, CLIA and VA National Enforcement Program.

7. DELIVERABLES:

A. The contractor is responsible for providing reports that relate to Linearity Testing, Quality Management in accordance with VA Handbook 1106.01 PATHOLOGY AND LABORATORY MEDICINE SERVICE (P&LMS) PROCEDURES.

B. The vendor must provide linearity testing, individual evaluations and participant summary reports for each LOT of LT samples. LT samples are to be sent twice per calendar year.

C. REPORTS

A. Reports must be sent to VA National Enforcement Office. Vendors who are not under a VA contract must have shall authorize the Linearity Testing Program to release copies of all LT evaluation reports to the VA National Enforcement Program.

B. Reports must show both qualitative and quantitative assessments not limited to the data listed below.

i. Qualitative Assessments: positive or negative results.

i. Quantitative Assessments: Mean, Standard Deviation, Number of labs, Standard Deviation Index, Limits of Lower, Acceptability Upper, Grade.