Herpes Simplex Virus (HSV) Testing SOW.docx

STATEMENT OF WORK

NAVAL Medical Hospital San Diego, California

Laboratory Mail-Out Services: Expedited Viral Identification by Polymerase Chain Reaction Procedures and Pathology Studies and Ancillary Tests (delineated in Table 1). This is a base year plus four option years requirement.

1.0 INTRODUCTION

1.1 Organization

The Naval Medical Hospital (NMC) located in San Diego, California is responsible for providing the U.S. Navy, other military branches, and their military families with reliable quality health care. In addition to maintaining status as one of the nation’s premier care providers, NMC is responsible for preparing for deployable support of operational forces, as well as shaping the future of military medicine through education, training and research.

1.2 Background and Objective

In order to properly diagnose patients, NMC often requires expedited laboratory mail out testing in addition to the standard lab mail outs currently on contract. Polymerase Chain Reaction (PCR) is a highly technical laboratory methodology used to amplify as little as a single strand of DNA or RNA in order to create a larger working sample for the detection and diagnosis of infectious disease s using conventional testing technologies. NMC requires expedited PCR in support of clinical patient care. Conventional viral growth and identification can take several weeks and entails special viral media, living cell lines and incubators. Critically ill patients requiring an expedited diagnosis cannot wait for two or three weeks for a viral diagnosis. PCR technology can provide an answer anywhere between 6 hours to 48 hours. The impact of untreated kidney disease can mean long term dialysis or loss of life. Electron microscopy analysis is STAT in nature and expedited results are required in order to facilitate immediate patient intervention.

Due to the highly specialized nature of the technology and the lack of required resources, it is not cost effective for testing to be performed in house. Professional resources, financial resources and space requirements necessary prevent NMC from offering this particular test located on site.

The objective of this contract is to provide PCR services and highly specialized, expedited electron microscopy services in accordance with the requirements as stated herein.

2.0 REQUIREMENT

2.1 Task Description and Deliverables

The purpose of PCR is to diagnose the presence of the following viruses or bacteria within an expedited manner: Herpes Simplex Virus Types 1 and 2. Expedited diagnosis facilitates faster supportive therapies for patients. PCR testing is used when an expedited viral or bacterial identification instance exists. Patients requiring PCR are potentially critically ill and the existing mail out reference laboratory offering viral or bacterial testing is not efficient. Without the availability of an expedited PCR service, disease diagnosis will be delayed requiring the patient to potentially be exposed to more tests, medications and hospitalization time than necessary until identification of the virus or bacterial infection is made. The purpose of the pathology specimen electron microscopy processing is to assess non-neoplastic kidney disease in an expedited manner as an adjunctive study to support light and immunofluorescent microscopy.

Courier service for all PCR to be tested will be provided by Naval Medical Center. NMC requires the following tests:

Table 1

2.2 Task Personnel Requirements

2.2.1 US Citizenship: US citizenship is required.

2.2.2 Technical and Personal Skills

Laboratory professionals who perform PCR and electron microscopy techniques must possess the technical skills associated with those specialized laboratory disciplines. The laboratory will provide a copy of their CAP accreditation certificate as required by CAP as well as their Clinical Laboratory Improvement Amendments (CLIA) certificate. The reference laboratory must act in accordance with commercial laboratory practices.

Laboratory Reports must comply with the Health Insurance Portability and Accountability Act (HIPAA) regulations with necessary HIPAA clauses included. Per HIPAA Part II CFR 164.501, 164.502, 164.506, laboratory services are considered indirect physician providers. Reports will include medical liability clauses for non-personal medical services. Information provided in the reports must comply with the College of American Pathologists (CAP) standards. The vendor will provide a copy of their CAP accreditation certificate as required by CAP as well as their Clinical Laboratory Improvement Amendments (CLIA) certificate. The reference laboratory must act in accordance with commercial laboratory practices. All subcontracted referral laboratories used by the vendor must also meet the above requirements.