Combine Solicitation – Q– 610-15-1-087-0005 Local Lab Testing Marion

Notice Type: Combine Solicitation

Posted Date: 27-AUG-14

Office Address: Department of Veterans Affairs;Ann Arbor Healthcare System;Network 11 Contract Office;2215 Fuller Road;Ann Arbor MI 48105

Subject: Q-- 610-15-1-087-0005 Local Lab Testing Marion

Classification Code: Q - Medical services

Solicitation Number: VA25114Q0659

Contact: Kellie J KonopinskiContracting Officer 734-222-4330 mailto:[email protected]

Description: Department of Veterans Affairs

VA Ann Arbor Health Care System

Department of Veterans Affairs Ann Arbor Health Care System

This is a solicitation for commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation VA251-14-Q-0659 is issued as a request for quotes (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-12. The North American Industry Classification System (NAICS) number is 621511, size standard $30 million. All responsible sources may submit a proposal which shall be considered by the contracting officer.

Statement Of Work - STAT Lab Services (Marion Campus)

The clinical laboratory at the VA Northern Indiana Healthcare System (VANIHCS), Marion, Indiana campus performs routine, STAT and ASAP testing for patients at this facility during administrative hours. During non-administrative hours (4:00pm-7:00am Monday through Friday and 24 hours on Weekends and Federal Holidays) STAT testing is performed by an alternate laboratory facility. Additionally, there are situations in which the VANIHCS laboratory cannot be perform the testing, but it must be performed locally due to the time requirements. Examples include confirmatory testing for suspicious results, time sensitive tests not performed in house and quality assurance checks. Finally, the contracted laboratory will provide transfusion services to patients being transfused at the VANIHCS Marion Campus. The facility selected to perform these services must be able to provide the following:

- Contractor shall provide laboratory services for laboratory testing 24 hours/day, 7 days/week, 365 days/year.

- Contractor is to provide STAT testing which cannot be performed at the VANIHCS laboratory. STAT testing will be available 24 hours/day, 7 days/week, 365 days/year.

- Contractor shall provide a wide variety of testing sufficient to support a fully operational health care facility. Testing shall include routine analyses in Chemistry, Special Chemistry, Toxicology, Hematology, Coagulation, Urinalysis, and Microbiology.

- Contractor shall provide quality assurance testing and second opinion testing as needed 24 hours/day, 7 days/week, 365 days/year.

- Contractor is to provide transfusion service to include all pre and post transfusion testing required to insure a compatible blood product is available for transfusion at the VANIHCS facility.

- Contractor will provide appropriate follow up testing and investigation for suspected transfusion reactions associated with those blood products provided by the contractor for transfusion at the VANIHCS facility.

- Contractor shall provide a Laboratory user's manual that describes the preanalytic collection and processing requirements, reporting details, and interpretive information when appropriate.

The contractor must provide the following at no additional charge:

a. Requisition forms

b. Special instructions

c. Current list of tests with reference ranges and specimen requirements

d. Current critical value list

e. Analyze the samples.

f. Routine test results generally shall be reported within 24 hours of specimen pickup. The submitting laboratory recognizes that certain test procedures shall require a longer turnaround time (TAT) than 24 hours. The contractor is required to provide a list of those tests that routinely have a TAT in excess of 24 hours. Test results shall be received no later than 12 hours after completion of a test.

a. STAT test results shall be reported within 2 hours or less of the telephone request for STAT service unless otherwise stated by the reference lab as not available. Critical value test results shall be immediately reported to VANIHCS.

(1) Reporting of non-critical results - STAT and/or Routine test results are printed/faxed to VANIHCS Pathology and Laboratory Medicine service on a contractor provided printer or designated fax machine.

(2) Critical value test results are reported by telephone to Pathology & Laboratory Medicine Service at 765-677-3321 ext 73831 during administrative hours and to ext 73850 during non-administrative hours.

b. Consult with the VANIHCS Pathology & Laboratory Medicine Service regarding test results as needed.

c. Provide VANIHCS a means of communication to permit immediate inquiry regarding the status of pending tests.

d. Transfusion Services provided on an as needed basis.

2. Licensing and Accreditation (Mandatory Criteria).

a. Shall have all licenses, permits, accreditation and certificates required by law.

b. Shall be accredited by the College of American Pathologists (CAP), CLIA, or the Joint Commission.

c. Accreditation by the Centers for Disease Prevention and Disease Control (CDC) is required if the contractor is engaged in interstate commerce.

d. Laboratory Director is a licensed physician or a licensed bioanalyst.

3. Reporting of Results. A report is defined as a printed final copy of laboratory testing results. This report shall be received via a contractor provided printer or VANIHCS fax if a printer is not available or by request of VANIHCS. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum contain the following information:

a. Patient's full name

b. Social Security number or Date of Birth

c. Medical Record number or unique identification code

d. Physician Name

e. Patient Location

f. Date/Time specimen received by the reference lab

g. Test Ordered

h. Date/Time of specimen collection

i. Date test completed

j. Test result

k. Flag abnormals

l. Reference range

m. Toxic and/or therapeutic range when applicable

n. Testing laboratory specimen identifier

o. Name of Testing Laboratory (contractor and/or subcontractor)

p. Type of Specimen

q. Critical value test reports shall include documentation of the person notified at VANIHCS, the date and time of notification and the name of the person at the contract laboratory completing the notification.

r. Any additional comments related to test, provided by the submitting lab

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

t. Unsatisfactory specimen shall be reported with regard to its suitability for testing.

u. Documentation for all corrected reports to include the originally reported result.

5. Quality Control. To ensure proper handling and test performance, the contractor shall provide the following information upon request during the life of the contract:

a. For quality purposes, tests routinely performed in duplicate should be indicated.

b. Indication of average monthly volume of specified tests that the laboratory performs.

c. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

d. Proficiency testing data to include a list of tests outside the + 2SDI range for the past 2 years. Contractor shall notify laboratory of any tests with unsatisfactory proficiency testing during the contract period.

e. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.

f. The VANIHCS facility will maintain an Internal Quality Control program to monitor the quality of test results received from the contractor. Unidentified split specimens may be sent periodically to the contractor for testing. A split specimen may also be sent to another reference laboratory for comparison.

g. The contractor(s) facilities, methodologies (defined as the principle of the method and the references), and quality control procedures may be examined by representatives of the VANIHCS at any time during the life of the contract.

6. Service.

a. The contractor shall provide telephone number(s) and contact person(s) to be used by the VANIHCS to make specimen problem inquiries and problem solving at all times, including weekends and holidays.

NAME: _________________________________________________________________

TITLE: ____________________________ Telephone Number: ____________________

NOTE: Also, include names and telephone number(s) of Technical Director(s) and Pathologist(s) available for consultation.

NAME: _________________________________________________________________

TITLE: ____________________________ Telephone Number: ____________________

NAME: _________________________________________________________________

TITLE: ____________________________ Telephone Number: ____________________

NAME: _________________________________________________________________

TITLE: ____________________________ Telephone Number: ____________________

b. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VANIHCS upon adverse action by a regulatory agency.

c. Contractor shall submit with this proposal a percentage discount off the specified published price list for all tests as applicable. Any new tests or tests sent to a subcontractor should be covered under the discounts.

d. Contractor shall assign a specific local account representative.

NAME: _________________________________________________________________

TITLE: ____________________________ Telephone Number: ____________________

e. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced.

In the event the contractor changes the assay procedure or a critically important component of an assay (e.g. an antibody, purified antigen, etc), the contractor shall notify the contracting officer and the laboratory director prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the contracting officer. The contractor is liable for excess procurement costs.

7. Testing Methodology. Testing methodology for a new test must be defined in the laboratory users manual.

8. Sample Preparation. During administrative hours, the VANIHCS laboratory shall provide laboratory specimens processed according to the contractor's laboratory users manual, identified and labeled for testing. During non-administrative hours, specimens will be transported immediately so that processing can occur at the contractor's site. The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory users manual. Contractor shall supply any special preservatives and collection containers required for specimen collection and preservation.

10. Location. Address and telephone number for the VANIHCS Marion campus laboratory is:

1700 E. 38th Street

Marion, IN 46953

(765)677-3321 ext 73831

Offers shall be submitted to Kellie Konopinski, Contract Specialist, at [email protected] by no later than Friday, September 5, 2014 at 4:00 pm, EST. For information regarding this solicitation, please contact Kellie Konopinski at 734-222-4330.

Link/URL: https://www.fbo.gov/spg/VA/VAAAHCS506/VAAAHCS506/VA25114Q0659/listing.html