36C26118Q0353-005.docx

36C26118Q0353

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

662-18-1-146-0003 36C26118Q0353 05-03-2018 Jon Ursino 916-923-4920 05-17-2018

612MCP

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan

CA

95652-2609 X X 621511 $32.5 Million N/A X VA Northern California Healthcare System 5342 Dudley Blvd., Bldg. 209 McClellan

CA

95652

612MCP

Department of Veterans Affairs Department of Veterans Affairs VA Northern California HealthCare System 3230 Peacekeeper Way, Bldg. 209 McClellan

CA

95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin

TX

78714-9971 877–353–9791 See CONTINUATION Page Anatomic pathology Services for the San Francisco VA Medical Center.

Ordering information:

Maximum Single Order Limit is $439,838.93.

Maximum Contract Limit is $2,056,097.82 See CONTINUATION Page To be identified X Amanda J. Simmons Contracting Officer Table of Contents

A.2 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Order Year 1 - 6/1/2018 to 5/31/2019 Contract Period: Base POP Begin:

POP End:

Contract Period: Base POP Begin:

POP End:

Order Year 2 - 6/1/2019 to 5/31/2020

Contract Period: Base POP Begin:

POP End:

Order Year 3 - 6/1/2020 to 5/31/2021

Order Year 4 - 6/1/2021 to 5/31/2022

Order Year 5 - 6/1/2022 to 5/31/2023

B.2 DELIVERY SCHEDULE

0.00

0001AA

562.00

0001AB

5,179.00

0001AC

21,907.00

0001AD

359.00

0001AE

3,145.00

0001AF

1,672.00

0.00

0002AA

562.00

0002AB

5,179.00

0002AC

21,907.00

0002AD

359.00

0002AE

3,145.00

0002AF

1,672.00

0.00

0003AA

562.00

0003AB

5,179.00

0003AC

21,907.00

0003AD

359.00

0003AE

3,145.00

0003AF

1,672.00

0.00

0004AA

562.00

0004AB

5,179.00

0004AC

21,907.00

0004AD

359.00

0004AE

3,145.00

0004AF

1,672.00

0.00

0005AA

562.00

0005AB

5,179.00

0005AC

21,907.00

0005AD

359.00

0005AE

3,145.00

0005AF

1,672.00

PERFORMANCE WORK STATEMENT

FOR

ANATOMIC PATHOLOGY SERVICE (113B) LAB TESTING

1. SCOPE OF WORK

1.1. Contractor shall provide laboratory services to include pickup and transport of specimens to its laboratory; preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation as requested by the Anatomic Pathology Service, San Francisco VA Medical Center, hereinafter referred to as the SFVAMC.

1.1.1. Location of service destination is:

San Francisco VA Medical Center 4150 Clement St. Anatomic Pathology Lab San Francisco, CA 94121-1545

1.1.2. Work shall be performed at the Contractor’s facility.

1.1.3. HAZARDOUS WASTE: Formaldehyde shall be used in the specimen containers.

1.1.4. The services shall include the following:

1.1.4.1. Tissue procession and sectioning

1.1.4.2. Hematoxylin and eosin (H&E) staining

1.1.4.3. Histochemical stains and Immunohistochemistry

1.1.4.4. A statement of the total number of cassettes received, blocks made and total number of slides sent

1.1.4.5. Check the daily sheet for accuracy in case of discrepancy

1.1.4.6. Specimen carriers

1.1.4.7. Notify the SFVAMC Pathology Service of any missing or mislabeled cassettes

1.1.4.8. All supplies for special tests (e.g., but not limited to, viral studies)

1.1.5. Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the SFVAMC COR but not less than once each day. The SFVAMC COR or designee shall notify the Contractor during weekends and federal holidays, via telephone, when a pick-up courier is required.

1.1.6. Transport samples in such a manner as to ensure the integrity of the specimen. If the results are unsatisfactory, the block will be reprocessed and additional stained slides will be reproduced at no additional charge to the Government. Each incident shall be reported monthly at the pathology QA meeting.

1.1.7. Contractor shall supply any special preservatives required for specimen preservation.

1.1.8. Analyze samples and provide accurate test results on the correct patients.

1.1.9. Routine test results shall be reported within 2 to 21 days of specimen testing by fax to the department of Anatomic Pathology Service, SFVAMC depending on the TAT specified for that particular test.

1.1.10. Consult with Laboratory on test results by telephone as needed.

1.1.11. Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

1.1.12. Billing and test report summaries shall begin the first day of the month and include the last day of the month.

1.2. Types and Estimated Quantities Per Year

2. GENERAL DEFINITIONS

2.1. 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 because of a critical value might cause harm or undue suffering for a patient.

2.2. 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.

2.3. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.

2.4. Reference or Referral Laboratory. All work shall be performed at the Contractor’s facility. The services shall include: (a) tissue processing and sectioning, (b) hematoxylin and esosin (H&E) staining, (c) histochemical stains, (d) immunohistochemistry.

2.5. Reference Value. A range of test values expected for a designated population of individuals.

2.6. Slides. Glass surface containing biological material to be analyzed.

2.7. Fresh specimen. A body fluid or tissue sample removed for medical examination and analytical testing.

2.8. Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing.

2.9. Tests. Diagnostic assays to evaluate a patient's physiological condition.

2.10. 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. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost-effected.

2.11. TAT - The delivery and pickup times will be monitored by the Pathology Service Staff of the SFVAMC. The number of cassettes sent, blocks made and slides received shall be monitored as per the contract. It is the responsibility of the Contractor to check the daily sheet for accuracy on the day of pick up. In case of a discrepancy, the Contractor shall notify the Pathology Service at the SFVAMC by faxing (415-379-5643) detailed description of the missing or mislabeled cassettes before 9:00 am on the day following the pick-up date. The SFVAMC Staff will check the submitted slides against a copy of the submitted sheet to ensure that all requested procedures have been performed.

2.12. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

2.13. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by 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.

3. LICENSING AND ACCREDITATION

3.1. Staff/Laboratory Licenses/Certifications

3.1.1. Laboratory License: The Contractor shall make sure the laboratory has all licenses, permits; accreditation and certificates required by law and specifically maintain current certifications/accreditation through:

3.1.1.1. CAP (College of American Pathologists)

3.1.1.2. CLIA (Clinical Laboratory Improvement Act)

3.1.1.3. All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP). Contractor is to provide evidence of such accreditation to COR within 30 days of contract start date. Any recertification updates will be given to the COR within 30 days of receiving them.

3.1.1.4 Staff License: The Contractor shall, without expenses to the Government, be responsible for obtaining the necessary licenses, including current California Medical License and Permits for complying with any applicable Federal, State, and Local Laws, Codes and Regulations in connection to the performance of the type of services required and make sure testing staff have current and valid professional state and or federal certifications. Technologists, medical technicians, and cytotechnologists shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology, be Clinical or Anatomic Pathology board certified and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction. The laboratory Director shall be a licensed American Board of Pathology certified pathologist.

3.1.1.5 Anatomic Pathology & Clinical Laboratories testing staff will work under the general direction of a qualified clinical or anatomic pathologist who specializes in the requested testing discipline and the supervisory technologist.

4. CONTRACTOR RESPONSIBILITIES

4.1.1. The Contractor shall perform pathology procedures compatible with the participating VA operating capacity and equipment. The Contractor shall not introduce new medical procedures and services for specimens provided by VAs without prior recommendation to, and approval of, the COR, or authorized laboratory representative.

4.1.2. 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. The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer’s technical representative.

4.1.3. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion, fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered.

4.1.4. The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested.

4.1.5. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

4.1.6. Contractor shall fill out and maintain for specimens the VA provided test request form necessary to meet clinical and administrative requirements of VA at no additional expense to the government.

4.1.7. The Contractor shall contact the VA COR to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The Contractor shall provide to the VA the supplies and equipment within two (2) work days after receipt of the delivery order. The VA COR will request replenishment of supplies from the Contractor on an as needed basis.

5. COURIER SPECIMEN PICK-UP AND DROP OFF TIMES

5.1. Routine. The Contractor shall provide routine courier scheduled specimen pickup and drop off not less than once each day. The specimens will be picked up between 5:00 pm to 5:30 pm Monday to Friday. Contractor must be located within a geographical area which enables sufficient courier transportation and processing time for slides to be delivered by 9:00 am the following day except on Saturday and Sunday. The VA COR or designee shall notify the Contractor during weekends and federal holidays, via telephone, in case a pick-up or drop off by courier if required.

5.2. Contractor and SFVAMC shall have an agreement to non-pick up holidays which are the National Holidays when a courier pick up and drop off may not be necessary.

6. TEST RESULTS

6.1. Routine. The Contractor shall provide routine test results to the ordering SFVAMC, Anatomic Pathology Service (113B) facility within twenty-four (24) hours following test completion, 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. Reference values will be provided for all tests conducted, as appropriate.

6.2. Telephone Consultation. The Contractor shall consult with the VA COR, requesting Clinician or designee at the VAMC by telephone as needed.

6.3. The Contractor shall immediately telephone the respective VA COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition.

6.4. Reporting of Results: Quality Assessment of histology slide staining and correct labeling of the slides 98% of the time will be the level of acceptance.

7. SLIDES

7.1. The Contractor shall return representative slides, paraffin blocks, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the participating VAMC or clinics at the same time the contractor submits the final reports.

7.2. The Contractor shall prepare additional blocks and slides, in quantities specified by the participating VAMC for review by pathologists.

7.3. For malignant cases, the Contractor shall call results to the submitting VAMC, and prepare paraffin blocks and slides review by the Armed Forces Institute of Pathology (AFIP) or other Government Pathology Organization (GPO).

7.4. For benign cases, the Contractor shall prepare slides for review by participating VA.

8. STORAGE OF SPECIMENS

8.1. The Contractor shall store all specimens as required by regulatory agencies (RA).

8.2. Upon request by the VAMC COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA.

8.3. In the absence of RA requirements, the Contractor shall store 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.

9. TEST SAMPLES

9.1. Upon provision of sample slides by the government, the Contractor shall provide interpretation of sample slides. The sample may include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

10. DOCUMENTATION

10.1. The Contractor shall ensure all required documentation shall include, at a minimum, timeliness, legibility, accuracy, content, and signature. Contract personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the contract personnel’s own signature to the documents and validating their contents.

11. MONTHLY TESTS SUMMARY

11.1. The Contractor shall provide to each VA a cumulative (year-to-date) monthly report of all tests received during the month and for all outstanding results. The report shall identify the tests that were received to include 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, tests, TAT for each test, corresponding cost per test.

12. SERVICE

12.1. The contractor shall provide telephone number(s) fax numbers and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times excluding weekends and holidays.

12.2. The contractor shall include names and telephone numbers of technical Directors available for consultation.

12.3. Contractor shall submit with this proposal a percentage discount off the specified published price list for all tests other than those detailed in the Schedule. Any new tests or tests sent to a subcontractor should be covered under the discounts.

12.4. Contractor shall assign a specific local account representative to each VA facility.

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

12.6. In the event that the contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the VA COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. 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/COR.

13. TELECOMMUNICATIONS

13.1. Telecommunications Linkage. Each VAMC shall receive transmission of the results to a teleprinter (fax) located at the hospital site or thru an electronic interface. Contractors shall provide personal computers (PC) or faxes at no charge for this service. Any necessary "hooks-ups" shall be the responsibility of the contractor (including one commercial phone line for terminal/datafax connection if required). The transmission of all the completed and/or partial test results shall arrive at the hospital within published TAT except where specified. The contractor is responsible for all supplies required for transmission of test results.

13.2. The teleprinter/fax system (all elements of the transmission path including the transmitter and associated receivers) must be able to:

13.2.1. The contractor shall be responsible for preventive and as-needed maintenance on the teleprinter/fax, PC and all associated devices;

13.3. The referring VAMC will construct shipping lists on VISTA listing specimens, tests, and other information to openly identify the shipment. The referring VAMC will also transmit electronic messages containing those tests being transported to the receiving Contractor facility.

13.4. The electronic transmission of orders will include shipping information to enable the VA receiving facility and the Contractor to have shipping information prior to arrival. These orders will be stored in a “pending orders” file, pending specimen/shipping list arrival.

13.5. Shipping list will have complete information to allow manual order entry at the referral site, if required. Required information will include:

13.5.1. Name of shipping facility.

13.5.2. Shipping List ID.

13.5.3. Shipping date/time.

13.5.4. Referring point of contract.

13.5.5. Method of shipment –carrier, bill no., estimated time of arrival, etc. (if other than the reference lab courier).

13.5.6. List of tests with patient demographics similar to VISTA load/worklist.

13.5.7. Bar code site and specimen ID on shipping list and specimen ID labels.

13.5.8. Automated order entry will also be possible with the use of a bar code scanner that reads patient demographics in a universal ID number format. The receiving facility (Contractor) shall:

13.5.8.1. Process shipments upon arrival using shipping list.

13.5.8.2. Accession specimens into computer from “pending orders” file.

13.5.8.3. Update electronic shipping lists with status of specimens, i.e., received, missing, insufficient quantity, incorrect shipping conditions, improper specimen, etc.

13.5.8.4. Store links to referring site/accession for acknowledge of shipment.

13.5.8.5. Receipt, status of testing and results transmission to referring VA and update workload, as appropriate.

13.5.8.6. Construct electronic messages containing test results and return to VA site.

13.6. Upon receipt of tests, the VA will update the order/accession with test results and allow either automatic release or provide for review before release as well as update workload.

13.7. Emergencies due to computer malfunction, the Contractor will provide a contingency system to provide a hard copy to each VA. The hardware will be placed in a location designated by each VAMC and maintained according to the criteria specified in paragraph 13. TELECOMMUNICATONS with the following additions:

13.7.1. Contractor will provide telephone service in the event of transmission or printer degradation.

13.7.2. Contractor will be responsible for the installation and, if and when necessary, the removal of all telecommunication equipment. This will take place a mutually agreed upon time between the VAMC and the Contractor.

14. TESTING METHODOLOGY & REFERENCE

14.1. Testing methodology and reference ranges for a test must be defined in the laboratory user manual.

15. FAILURE OF AUTOMATED SYSTEM

15.1. In case of failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, fax, or courier service) to the participating VAMC or clinic, and shall maintains same time frames as the automated system.

16. MAINTENANCE OF AUTOMATED SYSTEM

16.1. The Contractor shall provide preventive and as-needed maintenance on the 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 VA COR or designee.

17. CONTRACTOR TESTIMONY

17.1. Medical-legal specimens used for evidence in legal proceedings shall comply with the guidelines set forth:

17.1.1. The VA COR shall provide the form for the chain of custody in the event, that specimens are anticipated for legal proceedings. This form shall be used to record the name and position of every person who handles the specimen and report.

17.1.2. The Contractor shall run the ordered test procedure the same day of specimen receipt. The Contractor shall telephone results to the participating VAMC or clinic upon completion of testing with a written report delivered with the next scheduled pick-up time.

17.1.3. At the request of the contracting officer, laboratory personnel shall be available for testimony and preparation of court appearances if required to explain the methodology of determining results. Cost for court appearance shall include negotiated hour rates for the professional required, economy class airline rates or allowable government rate for privately owned vehicle mileage, and the current joint travel regulation rates for meals and lodging.

18. GOVERNMENT RESPONSIBILITIES

18.1. Specimen Preparation and Packaging:

18.1.1. Each VA facility will provide laboratory specimens prepared accordingly to the contractor's laboratory user’s manual, identified, and labeled for testing. The contractor shall provide an adequate supply of requisition forms, specimen containers, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements.

18.1.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

18.1.2.1. Contract Specialist – To Be Determined at time of Award.

18.2. Contracting Officer Responsibilities:

18.2.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

18.2.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

18.2.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

19. COR RESPONSIBILITIES.

19.1. The COR for this contract is: To Be Determined at Time of Award.

19.2. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

19.3. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

19.4. The COR will maintain a record-keeping system of services by keeping and maintaining monthly a Running Balance Excel spreadsheet of services rendered and invoices paid. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

19.5. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference. The Government’s failure to enforce this does not constitute a waiver.

20. CONTRACTOR PERSONNEL

20.1. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

20.2. The Contractor shall provide evidence of reapplication to the VA COR of any state license, CLIA certification, or clinical pathology certification 60 days before expiration license. The Contractor shall provide a copy of the renewed licenses/certificates to the VA COR before expiration.

20.3. The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Federal Government, either military or civilian, unless such -person seeks and receives approval accordingly to DOD 5500.7-R, the Joint Ethics Regulation (JER). This policy is available to the Contractor upon request.

21. PERFORMANCE STANDARDS QUALITY ASSUARANCE (QA) AND QUALITY IMPROVEMENT (QI)

21.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, timely reporting of test results, and maintaining required certifications. Methods of Surveillance: Periodic inspection and monitoring of customer comments/complaints. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

21.2. Laboratory Manager Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The COR will assist with communication between CO and Contractor. The CO is final authority on validating complaints.

21.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

22. HOURS OF OPERATION

22.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract 24 hours a day, 7 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR.

22.2. This includes weekends and federal holidays.

23. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (JCAHO)

23.1. All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the Joint commission and the College of American Pathologists (CAP). Offeror is to provide evidence of such accreditation.

24. MALPRACTICE LIABILITY INSURANCE

24.1. Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.

25. MALPRACTICE CLAIMS

25.1. 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.

26. END OF CONTRACT PERFORMANCE

26.1. At the end of the period of contract performance, the participating medical treatment facility (VAMC) will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractors provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days.

36C26118Q0353

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Contract Number: Task Order:

Contractor’s name:

1. PURPOSE

a. This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored

· How monitoring will take place

· Who will conduct the monitoring

· How monitoring efforts and results will be documented.

b. This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

c. This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CS: TBD

b. Contracting Officer’s Technical Representative (COTR) - The COTR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COTR shall keep a quality assurance file. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: TBD

c. Other Key Government Personnel: TBD

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager – TBD

b. Other Contractor Personnel - TBD

4. PERFORMANCE STANDARDS

a. The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined.

b. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

c. The Performance Requirements are listed below in. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

QUALITY ASSURANCE SURVEILLENCE PLAN (QASP)

Contractor must handle the specimens properly during the tests processing.

Excellent lab. work services within the scope of practice 100% of the time.

Accurate diagnosis and turnaround time within 1 -3 days

Proficiency Testing Data The proficiency testing (PT) is necessary to verify the accuracy and reliability of its testing.

The PT test will improve the quality of testing for VA patients.

Licensing, registrations and certifications must be kept current

5. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. There will be quarterly meetings held with the Contractor to discuss any issues. In addition, the COR shall use the following surveillance methods in the administration of this QASP.

a. PERIODIC INSPECTION. The COR will perform periodic inspection of test results received, encounters and other standard communications, procedures and follow up to ensure both completion of the documentation and completion to the established standards.

b. CUSTOMER COMPLAINTS. The COR will review and investigate as necessary laboratory managers’ complaints, with results to be discussed with vendor as required.

6. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral or negative outcome.

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also there should have been NO significant weaknesses identified.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also there should have been NO significant weaknesses identified.

Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also there should have been NO significant weaknesses identified.

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating.