ATTACHMENT A - STATEMENT OF WORK - LAB PROFICIENCY TESTING.docx

STATEMENT OF WORK

Laboratory Proficiency 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 Proficiency Testing (PT) 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. After evaluation of solicitation (RFI) responses have option years may be considered.

3) ACRONYMS

a) Proficiency Testing – PT

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 PT programs that allow the laboratory to compare its performance with peer groups.

c) The vendor’s peer group must have a minimum of 460 participating laboratories.

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

e) The vendor must ship the PT surveys on time according to the schedule.

f) The vendor must provide technical support when needed.

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

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, PT 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) SERVICE:

a) The contractor will provide analysis of samples results 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 PT 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 Proficiency Testing, Quality Management in accordance with VA Handbook 1106.01 PATHOLOGY AND LABORATORY MEDICINE SERVICE (P&LMS) PROCEDURES.

b) The vendor must provide PT, individual evaluations and participant summary reports for each LOT of PT samples. PT samples are to be sent twice per calendar year.

8) REPORTS

a) Reports must be sent to VA National Enforcement Office. Vendors who are not under a VA contract must have shall authorize the Proficiency Testing Program to release copies of all PT 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.

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