Q--REFERENCE LABORATORY TESTING
Department of Veterans Affairs, VA Palo Alto Health Care System | Published September 22, 2015 - Deadline September 25, 2015
The solicitation number, VA261-15-q-0998 is issued as a Request for Quotation (RFQ). This document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 effective September 3, 2015 and Veterans Affairs Acquisition Regulation Supplement (VAAR) current to September 30, 2013. The North American Industry Classification System (NAICS) Code for this acquisition is 541380, Size Standard: $15.0.
ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001 Reference Laboratory Services
Contract Period: Base
POP Begin: 10-1-2015
POP End: 09-30-2016
1 YR $0 $0
GRAND TOTAL $0
Statement of Work
Reference Laboratory Testing
GENERAL DEFINITIONS FOR LABORATORY SERVICES
1. Committee - An individual or group of laboratory directors (Chiefs), or their designees, that evaluate the medical/technical/service/quality qualifications of offeror's laboratories, and scores these factors in the solicitation. During the life of the contract, this group monitors the quality and service provided by the contractor.
2. Contracting Officer (CO) - Individual(s) at the VA National Acquisition Center (NAC) authorized to enter into, administer, and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the contracting officer acting within the limits of their authority as delegated by the contracting officer.
3. Contracting Officer's Technical Representative - A Federal employee who assists the ordering/issuing agency contracting officer in the administration of task orders issued under this contract. The COR is primarily responsible for the day-to-day program management of the ordering activity's task or task orders. Ordering agencies may have different designators for this category (e.g. GTR- Government Technical Representative, COR - Contracting Officer's Representative, etc.)
4. Critical Value - A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient.
5. Esoteric Test - A test that is similar to specialized tests, except they can only be done in a few laboratories throughout the country.
6. Frozen Section - A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery.
7. Overflow - A test usually performed in the ordering activity lab, which might be referred to the contractor's laboratory in case of instrument breakdown or other circumstances interfering with the ordering facility's ability to analyze the specimens.
8. Paraffin Block - A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.
9. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so.
10. Reference or Referral Laboratory - The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility.
11. Reference Value - A range of test values expected for a designated normal population of individuals.
12. Routine Test - A test that is usually performed at high volume in which the result is required in 24 hours generally.
13. Slides. Glass surface containing biological material to be analyzed.
14. Specimen - A body fluid or tissue sample removed for medical examination and analytical testing.
15. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence at a special time, or reported within a shorter than usual time.
16. Specialized Test - A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. The delay usually occurs to allow tests received from different centers to be batched to make the operation cost-effective.
17. STAT - A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases.
18. Surgical Specimen - A sample or part of an organ or tissue removed during Surgery for medical examination and analytical testing.
19. Tests - Diagnostic assays to evaluate a patient's physiological condition.
20. Turnaround Time (TAT) - The length of elapsed time between pick-up or dispatch of specimen from the government ordering activity's laboratory and the receipt of the completed printed report received by the government ordering activity's laboratory.. Exception: For STAT tests, the TAT shall begin at the time of notification by the ordering activity laboratory to the contractor that the specimen is ready for pick-up. These definitions apply whether the contractor or a subcontractor performs the test.
B.1.1 STATEMENT OF WORK
I. GENERAL REQUIREMENTS
The Contractor shall be responsible for performing preanalytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the VA Pacific Islands Health Care Systems, its Laboratory Services,and/or other government healthcare access points as contracted. Services shall include the transportation of clinical laboratory specimens to the contractor's laboratory(ies), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility. The Contractor shall provide varying levels of support service depending on the unique characteristics presented by each individual ordering activity.
Services to be furnished under this contract shall be ordered by issuance of a task order by the ordering activity for results to be delivered to the site designated on the task order and in accordance with standards, clauses and provisions of this document.
The Contractor shall provide an Authorized FSS Price List of all testing services available along with the price to be billed the government for each testing service. The price list, at a minimum, shall include the following data elements:
- Ordering Code (Contractor's Identification Code)
- LOINC - Logical Observation Identifier Names and Codes
- CPT Code
- Interface Code
- Test Description, including reference ranges and units of measurement
- Test methodology
- Specimen types
- Specimen collection and handling requirements
- Test result interpretation or interpretive remarks, if appropriate
- Testing site (if not performed at the Contractor's main laboratory facility)
- Maximum turn around time (TAT), excluding time required for repeat assay. For those tests offered on a STAT basis, TAT should be listed separately
- Give assay schedule - State "MWF" for a test set up Monday, Wednesday, and Friday; - "MTWTF" for Monday through Friday, "TT" for Tuesday and Thursday, and "DAILY" for every day, Monday through Sunday including Holidays
- Number of calendar days required for completing an assay and reporting a result
- State assay method
- Limit number of tests per day. Applies to overflow tests only.
- Net FSS Unit/Test Price
II. Period of Performance
10/1/2015/2015 thru 09/30/2016
III. GENERAL QUALIFICATIONS
A. Licensing and Accreditation
Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.
A. Licensing and Accreditation (CONTINUED)
The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO). Changes to the requirements will be executed by a bilateral modification to the contract.
Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA).
B. Malpractice Liability Insurance
Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage of not less than $1,000,000.00 per occurrence. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.
The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an investigation or suspension.
Any Subcontractor performing under this contract must also have malpractice liability insurance in the amount of $1,000,000.00 per occurrence and a copy of the Medical Malpractice Insurance Certificate must be provided before award/performance of the contract.
C. Contractor Laboratory and Personnel
The Contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.
D. Test Result Reporting
Contractor shall provide electronic transmission (i.e. teleprinter, fax, or computer-to-computer via modem response) of all completed and/or partial test results to the ordering activity within awarded Turnaround Time (TAT), except where specified. Contractor shall provide all required hardware, software and related consumable supplies to support the transmission of electronic data for each ordering activity at no additional charge. Any necessary "additional required connections" shall be the responsibility of the contractor. All equipment, software and hardware remain the property of the contractor. All risks of loss remains the responsibility of the contractor. The government is not responsible for loss due to negligence, fire, water or other natural disaster or damage from terrorism or war, and any other resultant damage to equipment, software, hardware and connections.
Contractor shall be responsible for preventive and as-needed maintenance on any installed teleprinter, PC and all peripheral devices; shall have the responsibility to train medical center personnel in routine operations (loading and unloading paper, ribbon changes, test and reset); and shall provide a validation service (fax or telephone) in the event of transmission or printer degradation, if requested by the ordering activity. Additionally, contractor is responsible for transmission of all data to be accomplished in a manner that protects the privacy of all personally identifiable patient information.
III. CONTRACTOR'S RESPONSIBILITIES
A. Procedure Guidance
The testing methodology and reference ranges for a test must be defined in the laboratory user manual. The Contractor shall provide change notice prior to implementation of any new medical procedures and services.
The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Contracting Officer (CO) or Contracting Officer's Representative (COR), the Contractor will make available quality assurance information on specific testing procedures for review.
Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the Government.
The contractor shall provide all necessary supplies normally provided to its commercial customers, not limited to the following:
Dry ice and appropriate container
Current list of tests with reference ranges and specimen requirements
Log books for samples sent out and results returned
All forms, including Chain of Custody forms
Special media or tubes for samples
All supplies for special tests (e.g., but not limited to, viral studies)
The Contractor shall contact the COR within a maximum of five (5) calendar days after award of task order or Blanket Purchase Agreement, to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The COR will request replenishment of supplies from the Contractor on an as needed basis.
C. Test Results
The Contractor shall provide telephonic, fax, or computer-to computer-via-modem response within the commercially published emergency Turnaround Time (TAT) of specimen pick up, unless otherwise agreed. The Contractor shall report all STAT and abnormal test results to ordering activity upon completion of testing.
The Contractor shall provide all confirmatory testing, upon request of the ordering activity, at no additional charge to the Government.
C. Test Results (CONTINUED)
The Contractor shall provide routine test results to the ordering activity in accordance with the testing specifications defined in the Contractor's commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a turnaround time longer than 24 hours (excluding the above
exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer.
The Contractor shall consult with the COR, requesting Clinician or designee at the ordering activity by telephone as needed. The Contractor shall immediately telephone the respective COR, requesting Clinician or designee to report Critical Values or test result that may indicate a life threatening condition.
Reporting of Results
A report is defined as a printed final copy of laboratory testing results. This report shall be received by remote terminal where applicable. If results are previously telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information:
-Patient's name and/or identification code (Social Security number)
-Physician's name (if supplied)
-Medical record number (if supplied)
-Patient's location (clinical/ward), (if supplied)
-Date/time specimen received in Reference Lab
-Date/time of specimen collection (when available)
-Date test completed
-Toxic and/or therapeutic range where applicable
-Testing laboratory specimen number
-Name of testing laboratory and address (contractor and/or subcontractor)
-Type of specimen
-Any additional comments related to test provided by submitting labs.
-Any other information the laboratory has that may indicate a questionable validity of test results.
-Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.
D. Retention of Specimens
Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering activity COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall retain specimens, after all testing has been completed: clinical specimens seven (7) days, surgical specimens six (6) months, cytology and histopathology slides indefinitely; and paraffin blocks for five (5) years.
The Contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the Contractor personnel's own signature to the documents and validating their contents.
F. Monthly Test Summary
The Contractor shall provide to each ordering activity at a minimum, the utilization reports customarily provided to commercial customers. The report shall identify the tests that were received to include at a minimum, accession number, patient's name, Social Security Number, and specimen collection and test report dates required by accreditation agencies. The Contractor report shall indicate the requesting physician's, tests, TAT for each test, corresponding cost per test and a STAT charge.
IV. SERVICE AND MAINTENANCE
The contractor shall provide telephone number(s) and contact person to be used by the ordering activity to make specimen problem inquiries and problem solving at all times including weekends and holidays. The contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.
The 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 ordering activity upon adverse action by a regulatory agency. Contractor shall assign a specific local account representative to each ordering activity. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced.
In the event that the contractor changes the assay procedure or a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the CO prior to the intended change. 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 CO.
The Contractor shall provide preventive and as-needed maintenance on any installed terminal or data fax system at the facility/clinic at no additional charge to the Government. The Contractor shall provide maintenance within 72 hours of notification by the COR or designee.
In case of failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) to the participating ordering facility or clinic.
V. CONTRACT QUALITY ASSURANCE/QUALITY CONTROL
The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the life of the contract.
The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.
A. Specimen Pick-up Times
STAT/Emergency: No STAT pick up required at this time.
Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the ordering activity. The ordering activity COR or designee shall notify the Contractor via telephone, when a special pick-up courier is required.
C. Sample Preparation
Each ordering activity will prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory users manual. The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user manual. The contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens.
Any security requirements of contractor personnel will be specified by ordering activities. Security requirements may apply to personnel, contractor property and/or information technology.
SOLICITATION PROVISIONS/CONTRACT CLAUSES:
FAR Number Title Date
52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (APR 2014)
52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (DEC 2014)
52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (MAY 2015)
For the purposes of this clause items (b) 4, 6, 8, 25, 27, 28, 30, 33, 40, 42, 51 are considered checked and apply.
52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)
This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):
52.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)
(a) Definitions. As used in this clause-
(1) Contract financing payment has the meaning given in FAR 32.001.
(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).
(3) Electronic form means an automated system transmitting information electronically according to the Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.
(4) Invoice payment has the meaning given in FAR 32.001.
(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.
(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.
(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:
(1) VA's Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)
(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.
(d) Invoice requirements. Invoices shall comply with FAR 32.905.
(e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for:
(1) Awards made to foreign vendors for work performed outside the United States;
(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;
(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;
(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or
(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.
(End of Clause)
VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)
The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.
(End of Clause)
VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)
The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of California. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.
Contracting Office Address:
Department of Veterans Affairs; VISN 21
3801 Miranda Avenue
Palo Alto, CA 94304
Primary Point of Contact: