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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 15, 2014 FBO #4647
DOCUMENT

Q -- STAT Lab Services - Attachment

Notice Date

8/13/2014
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Wilkes Barre VAMC;Acquisitions (049E);1111 E End Blvd;Wilkes Barre PA 18711-0030
 

ZIP Code

18711-0030
 

Solicitation Number

VA24414Q1427
 

Response Due

8/20/2014
 

Archive Date

9/19/2014
 

Point of Contact

Kevin Balser
 

E-Mail Address

Barre
 

Small Business Set-Aside

Total Small Business
 

Description

- Wilkes Barre VA Medical Center is looking for small businesses that can meet the following requirements (This is not a solicitation for a quote, but sources sought only): It is the intent of the Department of Veterans Affairs Medical Center, Wilkes-Barre, (WBVAMC) to establish a contract for testing required as STAT but not performed at the WBVAMC. This is limited testing. 1.Contractor shall provide all employees, supervision, supplies and equipment necessary to perform the required testing, including transportation of specimens on an as needed basis. The Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) located at 1111 East End Boulevard, Wilkes-Barre, PA 18711 via telephone when services are required will notify the contracting laboratory. If services are to be provided, notification can be at any time during the day. 2.The contractor must meet the standards and requirements of all licensing and accreditation agencies to include the following: Joint Commission on Accreditation of Healthcare Organizations (JCAHO), College of American Pathologists (CAP), Occupational Safety and Health Administration (OSHA), American Association of Blood Banks (AABB), Food & Drug Administration (FDA), and Nuclear Regulatory Commission (NRC). 3.Copies of all relevant permits/ licenses and certification inclusive of any sanctions current or pending throughout the United States must be supplied to the WBVAMC. These documents must be updated immediately by providing current certificates, as they become available. These documents include the CLIA license and Laboratory Accreditation (either by College of American Pathologist or Joint Commission) 4.Contractor shall ensure specimens are shipped following the guidance provided in 49 CFR. 5. Contractor shall: a.Have in place a system, for all FDA-approved analytical systems and test methods, including waived tests, to ensure all test methods are validated prior to the implementation of all test methods. The validation protocol, at a minimum, must meet the manufacturers' recommendations, any accreditation requirements, and be consistent with the requirements outlined in 42 CFR 493.1253 - Standard: Establishment and Verification of Performance Specifications, as applicable. b.Perform correlation studies between new tests or methods and current instruments or methods providing results for the same analyte. c.Must perform, or have already performed a study for non-FDA-approved, laboratory modified FDA-approved methods, or tests developed in-house, to establish and document the method's performance specifications. Protocols using Clinical Laboratory Standards Institute (CLSI) guidelines are recommended. For in-house developed methods or systems, the frequency of calibration depends on the scientific data to ensure reliable testing is provided by the laboratory. d.Have clearly written manuals available in each testing area for all test methods and instruments to substantially comply with current laboratory accreditation requirements. e.As a minimum, follow the manufacturer's recommendations for performing the testing including, but not limited to: quality control, reagent storage, maintenance, function checks, etc. f.Have new lots of reagents validated for all tests including waived testing. g.Assure that all analytes measured from commercial test-kit procedures are FDA-approved and meet the same general guidelines and standards of the analytical system. h.Assure that tests performed using different methodologies, instruments, or at other testing sites, have correlation studies between the main laboratory and these other test sites performed at least twice yearly. i.Have standards, procedures, and policies developed for reporting of timely, accurate, reliable and clear test results. j.Have established policies for detection of potential errors or differences in test results for the same analyte between the clinical laboratory and all ancillary testing sites. k.Ensure that all laboratory test results are carefully reviewed for accuracy of reporting by the testing personnel performing the test before the data is released. l.Have written policies which ensure the positive identification of the VA specimen from the time the specimen is received until testing has been completed and the results reported. m.Ensure optimum integrity of the specimens from the time of collection until testing has been completed, and the results reported. n.Perform preventive maintenance on each type of equipment used based on the manufacturer's recommendations, regulatory requirements, accreditation standards, and internal requirements. o.Perform preventive maintenance on a schedule which meets manufacturer recommendations, all applicable regulatory requirements, and accreditation standards. p.Ensure that preventive maintenance documentation is maintained, including equipment ID, preventive maintenance results, actions taken (i.e., equipment disposition), and follow-up. q.Perform quality control on each type of equipment used based on manufacturer's recommendations, regulatory requirements, accreditation standards, and internal requirements. r.Ensure that quality control documentation is maintained, including equipment ID, quality control results, actions taken, and equipment disposition. 6. The contractor shall hold liability insurance in the amounts specified by Pennsylvania state law. 7.The contractor will supply test requisition forms to the WBVAMC which will have a pre-printed Account Number on them and the WBVAMC name and location. These requisitions will be used to check off what tests are required to be performed. 8.Services for tests that are needed as STAT but are not available at WBVAMC laboratory are requested on an as needed basis. The WBVAMC will notify the contractor as soon as they are aware the services will be necessary. 9.Services may also be needed in cases where instrumentation at Wilkes-Barre VA Medical Center laboratory is not operational. In these cases, testing may not be required as STAT, but will need to be done within 3 hours of receipt of the specimens. 10.The WBVAMC laboratory will package specimens according to the guidelines required by Federal and State laws. The specimens will be labeled with the labels from the WBVAMC computer system. The labels will contain the patient's full name, patient's full social security number, the accession number generated from the WBVAMC computer system, and the test required. 11.The WBVAMC will fill out a Test Requisition Form with all the pertinent information required to include the patient's full name, patient's full social security number, the patient's date of birth, patient's gender, the date and time of collection of the specimen, the type of specimen and the test required. Additionally, the WBVAMC will ensure that the billing information is correct on the form to ensure that the patient will not be billed for the test. 12.The contractor will pick up the specimens within one hour of the call as tests being sent will be STAT. The specimens will be picked up at the following location. Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre, PA 18711 Room A3-38 13.The most common Stat tests that will be required with the anticipated volumes are as follows: TestCPT CodeQty/ year Semen Analysis89300& 8932110 Serum Osmolality8393070 Urine Osmolality83935140 Toxicology Screen overdose (Serum)80100 - 8010380 Acetaminophen (urine)8200320 Salicylates8019620 Factor X Assay852605 Drug Confirmation8010235 (Tacrolimus) FK50680197 Stat tests may not be limited to the tests listed above. 14. For Semen Analysis, the WBVAMC will actually send the patient with a test Requisition form. The patient will give the specimen at the contracting laboratory. 15. Results of tests will be available within 1 hour of receipt to the testing laboratory. Results will be faxed. Results deemed as critical will be called in.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/WBVAMC693/WBVAMC693/VA24414Q1427/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-14-Q-1427 VA244-14-Q-1427.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1570228&FileName=VA244-14-Q-1427-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1570228&FileName=VA244-14-Q-1427-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Wilkes Barre VAMC;1111 E End Blvd;Wilkes Barre PA 18711-0030

Zip Code: 18711
 

Record

SN03464404-W 20140815/140814000718-a502f19d6face229c0af87054a30367d (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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