SOW - Reference Lab.pdf

STATEMENT OF WORK (SOW)

as of 05/11/2021

1. Introduction: The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to VA San Diego Healthcare System

– Pathology and Laboratory Medicine Service department (PALMS)VISN 22 procurement request for Reference Laboratory testing services.

2. Background. The contracted reference laboratory (Contractor) shall process the specimens and/or perform analytical testing as defined by the Contractor's reference test manual and report analytical test results as required. All terms, conditions and requirements defined herein shall apply to any laboratory (i.e., branch, division, sub-contractor, etc.)

performing reference testing on behalf of the Contractor.

3. Scope. The contractor shall perform services for Pathology and Laboratory Medicine Services for the VA San Diego Healthcare System, San Diego, California.

Estimated Period of Performance:

06/17/2021 – 06/16/2022

The contractor will be responsible for the following:

a. The Contractor will provide shipping and transport instructions to maintain specimen integrity.

b. The Contractor shall process specimens a manner that ensures their integrity.

c. The Contractor shall provide timely and appropriate testing of patient specimens, as detailed in the Reporting Results section.

d. The Contractor shall store the specimens a minimum of seven days after the test is reported in the event that subsequent action is required (i.e., problem solving and/or repeat testing).

e. Reporting results:

A report, defined as a printed final copy of laboratory testing results, shall be transmitted by the contractor to the ordering laboratory by faxing to a secure fax machine.

Test report shall at minimum contain the following information:

• Patient's name and/or identification number

• VA accession number if provided by the laboratory

• Physician's name if supplied

• Medical record number or laboratory accession number if supplied

• Patient's location (clinic/ward) if supplied

• Test ordered

• Date/time of specimen collection when available

• Date/time test completed

• Test result

• Reference intervals

• Toxic and therapeutic ranges if applicable

• Flagged abnormal

• Critical value

• Reference laboratory specimen number

• Name and address of testing laboratory if other than Contractor

• Other information the laboratory has that may indicate questionable validity of test results

Unsatisfactory specimens shall be reported with documentation supporting unsuitability for testing.

f. Contractor shall adhere to the specified turnaround time from the receipt of specimen:

Item Test Description Required

Turnaround (Hours)

1 TACROLIMUS FK506

2 HLA Donor Specific Antibodies 24

3 Platelet Aggregation

4 PH Body Test 24

g. Performance monitoring. The contractor shall furnish a monthly exception report and turn-around-times will be monitored.

Additional Requirements:

a. Licensures - only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall be licensed/accredited by the College of American Pathologists (CAP), Medicare and other state regulatory agencies as mandated by Federal and State statutes. In addition, the laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and shall comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA).

In response to this solicitation, the Contractor shall supply copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America. In addition, as these documents are reissued or reworded, the awarded Contractor shall supply a copy to the Contracting Officer. This documentation shall also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

The Contractor shall ensure that each facility is in compliance with the College of American Pathologists (CAP) standards, Clinical Laboratory Improvement Amendments (CLIA) standards, and VHA Directive 1106 and VHA Handbook 1106.01, Attachments B and C respectively.

VASDHCS shall:

a. Transport specimens via courier. Provide specimens properly prepared, identified and labeled for testing.

b. Material Safety Data Sheets shall be provided by the VASDHCS as appropriate for supplies containing hazardous chemicals (e.g., boric acid tablets, acids).

CPTs included but not limited to:

Item Test Description

Unique Identifier

Test Code

CPT Code

1 TACROLIMUS FK506

FKTR

80197

2 HLA Donor Specific Antibodies HDSA 86832/86833

3 Platelet Aggregation

PLTAG

85576

4 PH Body Test XPH 89051

4. Hours of Operation Normal tour-of-duty hours at VASDHCS is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays” New Year’s Day January 1st Martin Luther King’s Birthday

Third Monday in January

President’s Day Last Monday in January Memorial Day Last Monday in January Independence Day July 4th

Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day November 11th Thanksgiving Day Fourth Thursday in November

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

5. Security Requirements

The Contractor shall be responsible for the security and integrity of specimens and for compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The Contractor shall also be responsible for ensuring the proper credentialing of its employees who interact with personnel.

Additionally, the Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6, Attachment D, and shall adhere to Appendix C and Appendix D and submit proper documentation as required.

The selected reference laboratory(ies) shall assume full liability for the samples and data at the time of receipt. The Contractor shall use reasonable and appropriate safeguards to prevent use or disclosure of protected health information (PHI) not provided for by this solicitation.

Within 24 hours of the Contractor becoming aware of a HIPAA violation involving electronic transactions, paper labels and code sets, privacy, security or standard identifier, or disclosure of PHI not provided for by this solicitation, the Contractor shall report violations to the proper authorities identified in VA Handbook 6500.6.

6. Invoicing.

The Contractor shall submit a monthly invoice for services rendered no later than 21 days following the close of the month in which the test result was reported. The invoice shall be checked for accuracy and shall display chronologically by date of Contractor receipt the name of the patient, the date of specimen collection by the Contractor, details of the test performed on each patient, and the unit and total testing costs. The Contractor shall not charge for repetitive testing performed on a specimen to verify questionable initial results.

5. Security Requirements