36C26224Q0976_ Attachment B SOW.doc

REFERENCE LABORATORY

STATEMENT OF WORK

The Phoenix Veterans Affairs Heath Care System (hereafter Phoenix VAHCS) requires clinical and anatomic pathology diagnostic testing services from a qualified Reference Laboratory for the on an as-needed basis, for laboratory testing protocols not performed by the in-house laboratory.

Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide reference laboratory services to the Phoenix VAHCS described herein. Reference laboratory services include but are not limited to; specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; and consultative services. The Contractor shall be CLIA certified.

I.

Specimen Preparation and Storage for Reference Testing Specimens

A. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

B. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory.

C. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

II. Transportation Services for Reference Testing Specimens A. Contractor shall provide and is responsible for transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in accordance with 49 CFR Part 173.199 to ensure the safety and integrity of the biomedical material is maintained.

B. Routine transportation services shall occur once per day from the Phoenix VAHCS, Main Inpatient Laboratory. Specimen pick-up times will be negotiated after contract award.

C. Stat transportation services shall occur upon request 24 hours 7 days a week from the Phoenix VAHCS, Main Inpatient Laboratory within 2 hours of request. The Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1) Shipping and packaging containers. Packing material shall be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3) Test request forms for specialized testing (i.e. Immunohistochemical (IHC)/

In Situ Hybridization (ISH) Stains Request).

D. Contractor or designee shall be responsible for reconciliation of transportation fees.

III. Specimen Testing

A. The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required testing. Contractor shall make available the following test information:

1) Access to reference laboratory portal or manual requisition forms

2) Alphabetized test name list

3) Test order code

4) Specimen collection and preservation requirements

5) Test method employed (indicate if testing performed in duplicate) and interpretations.

6) Test reference intervals adjusted for age, sex or race, when required.

7) Test specific sensitivity, specificity and interferences, when required.

8) Result code

9) Test critical values if any

10) Policy for critical value notification

11) CPT coding

12) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a government facility.

13) Schedule of test performance (specific days of week indicated)

14) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory shall be cited)

Contractor shall notify the Contracting Officer and the Phoenix VAHCS Pathology and Laboratory Medicine Service of any test information modifications no later than two weeks prior to the implementation date of the test change.

Any new test(s) shall be added to the contract through modification by the Contracting Officer (VA POCs and Government facility representatives do not have this authority) prior to specimen being tested.

B. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the VA POC or designee.

C. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

IV. Specimen Retention

A. Clinical specimens, such as serum, whole blood and raw bone marrow, will be retained by the Sonora Reference Lab for a period that they deem necessary.

B. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported.

V. Reporting of Results

A. The results of routine testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information.

B. The results of stat testing shall be reported within 4 hours of receipt at the reference lab.

C. A report of laboratory testing results shall be issued either as a printed final copy or through electronic delivery by contractor secure date management system (website). However, in unusual circumstances where electronic delivery by contractor secure website is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited.

D. Each test report shall, at minimum, include the following information:

1) Patient's full name

2) Patient’s identification number, e.g., social security number (SSN)

3) Physician’s name (if supplied)

4) Government laboratory accession number (if supplied)

5) Submitting facility name

6) Submitting facility account number

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

8) Test(s) ordered.

9) Date/time of specimen collection (when available)

10) Date/time test completed.

11) Test result

12) Reference intervals (adjusted for age, sex or race, when appropriate)

13) Toxic and therapeutic ranges, if applicable

14) Flagged abnormal results.

15) Reference laboratory accession number

16) Name and address of testing laboratory

17) Any other information the laboratory has that may indicate a questionable validity of test results.

18) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

E. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

VI. Customer Service

A. Contractor shall provide customer service that is accessible by telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

B. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

1.

Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

a. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

2. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within 2 hours of the initial call.

b. Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

2. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

c.

Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

2. Result interpretation inquiries shall be addressed within four business hours of initial call.

3. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

C. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, lack of electronic order etc.

VII. Consultative Services/Utilization Reports A. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

B. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

C. Contractor shall provide a cumulative workload summary report of tests performed. The summary shall include the test name/description, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures.

1. A copy of the report shall be delivered electronically to the Contracting Officer, Lead VA POC, and each Government facility VA POC by the 10th of the month following the close of the reporting month.

2. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by three (3) different methods:

a. Test names listed alphabetically.

b. Test names listed in order of year-to-date test frequency (highest to lowest)

c. Test names listed in order of year-to-date total test cost (highest to lowest) VIII. Data Management System

A.

Contractor shall provide to the Phoenix VAHCS all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Phoenix VAHCS and the Contractor’s database. Required test parameters include:

1) Ordering code

2) LOINC code

3) CPT code

4) Interface code

5) Test cost

6) Reference ranges

7) Units of measurement

8) Test result interpretation or interpretive remarks, if appropriate

9) Testing site (if not performed at the vendor’s main laboratory facility

10) Test methodology

11) Specimen types

12) Specimen collection and handling requirements

13) Indication whether test is a panel/profile test, list of tests included.

The parameters for all tests in the Contractor’s database shall be kept current and be available to the Phoenix VAHCS throughout the performance period of the contract. Updates to the test parameter information shall be provided to the Phoenix VAHCS no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

B. The Contractor shall provide a data management system that meets the following requirements:

1) Test definition, test information and test requirements shall be complete, available and easily accessible.

2) Shipping manifest shall be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

3) The status and the results of testing shall be available within published timeframes and easily retrievable using varying options. At a minimum the options shall include Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests shall have an indication of the pending time until completion. Alert messages, or other notification, shall be generated when testing is delayed beyond published timeframes.

4) Reports of test results shall be immediately available upon verification of the test result. Contractor’s computer located at the Phoenix VAHCS shall be able to print test results upon request and reprint retrospective test results.

Special Contract Requirements I. Services

A. The Phoenix VAHCS may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

B. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance shall cover the provider(s) for services in all states where services are rendered by the provider. Contractor shall indemnify the Phoenix VAHCS for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

C. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

II. Federal Holidays Contractor is not required to provide transportation of specimens on federal holidays, except in STAT situations. The 11 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Juneteenth (June 19th), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

III.

Qualifications/Requirements of Laboratory & Contractor Personnel

A.

Laboratory

1. The Contractor shall continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or shall demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The Contractor shall maintain valid certifications during the entire performance period of this contract.

2. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America shall be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor shall supply a copy to the Contracting Officer’s Representative assigned to each Government facility.

3. Contractor shall notify immediately the (VA POC) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.

4. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

B.

Personnel

1. Contractor shall ensure all testing and supervisory personnel at the reference laboratory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

2. Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

3. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, shall be completed by the individual contractor employee(s) within VA established timeframes.

4. Contractor couriers entering any Government facility shall prominently display a contractor-issued identification badge.

IV.

HIPAA Compliance

Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health, and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The Contractor shall prove to the Phoenix VAHCS that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Contractor Services.

V. Contract Performance Monitoring

A.

Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. VA POC will be responsible for verifying contract compliance. (VA POC) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2. Documentation of services performed will be reviewed prior to certifying payment. The VA POC will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3. Departments being served, through the VA POC(s), will provide a written statement annually to the to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).