B.01_Combined_Synopsis_and_Solicitation_W81K00-19-T-M022_Amendment_0001.pdf

W81K00-19-T-M022 Amendment 0001

Combined Synopsis/Solicitation

The purpose of Amendment 0001 to the Combined Synopsis/Solicitation is as follows:

1. Provide answers to questions submitted.

2. Revise the last sentence in Paragraph 2 as follows: “This procurement is being conducted in a total small business set-aside.”

3. Revise the PWS

Proposals are due by 19 Aug 2019, at 10:00 AM, MT. Offers shall be submitted via e-mail.

Questions shall be submitted via e-mail not later than 1 Aug 2019, 10:00 AM, MT. No questions will be entertained after this date.

The point of contact is Ms. LaKeshia Cooper at lakeshia.s.cooper.civ@mail.mil.

Amendment 0001 Acknowledgement:

Print Name Date: _________________

Signature Cage code: _________________

Questions & Answers

Question 1: Please confirm the combined synopsis/solicitation is a small business set-aside.

Answer 1: The combined synopsis/solicitation is a small business set-aside. The second paragraph of the first page has been revised from “full & open” to “small business set-aside.”

Question 2: Please confirm applicability of DFARS Clause 252.211-7003, Item Unique Identification and Valuation (MAR 2016), and inclusion in subsequent contract award?

Answer 2: Clause 252.211-7003 is required in supply and service contract valued at $5,000 or more.

Question 3: PWS, Paragraph 3.b. please clarify “BACH” as it applies to this requirement for

WBAMC.

Answer 3: BACH does not apply to this requirement. Paragraph 3.b. of the PWS is revised from “Contractor will notify BACH” to “Contractor will notify WBAMC.”

Question 4: Please clarify/confirm if the resulting contract is an Indefinite Delivery Indefinite Quantity (IDIQ) with task/delivery orders?

Answer 4: The resulting contract will not be an IDIQ.

Question 5: PWS, Paragraph 7 Please clarify if contractor will store all specimens with the exception of tissue blocks and slides. If contractor is to return all tissue blocks and slides, please identify date, time, location, and POC for return of tissue blocks and slides.

Answer 5: All tissue blocks and slides do need to be returned. The materials need to be returned ideally within two weeks of being signed out.

POC: WBAMC

5005 N. Piedras Dept of Pathology- Histology RM 3164 El Paso, TX 79920

Phone: 915.742.6440 AP Supr

We do send "fresh" tissue in formalin or other fixatives (flow samples, kidneys, Chromosome samples, etc.) and these have particular shipping and storage requirements for testing.

Question 6: PWS, Paragraph 11, please clarify sentence regarding “ARUP.

Answer 6: ARUP is accompany that provides many laboratory reference tests. Many of our consults are sent out with the option for the consult facility to perform additional testing that is needed to determine the diagnosis. For billing purposes, it is helpful to have an itemized list of tests performed/billed.

Question 7: PWS Paragraph 12.c Please clarify/confirm if there are STAT requirements and if so, please provide which tests are STAT TATs?

Answer 7: Stat requirements are cases in which we require a 48 hour turn-around time to ensure providers can determine treatment modalities and if the patient will need to be sent to another facility for treatments not available at WBAMC. In addition, In-patient kidney cases require results in 24-48 hours (Immunofluoresence, Electron Microscopy, and tissue biopsy results).

Question 8: Shall the offeror complete the applicable provisions and submit with the quote?

Answer 8: Yes complete applicable provisions and submit with quote.

PERFORMANCE WORK STATEMENT (PWS)

1. Contractor shall provide laboratory services to include pickup and transport of specimens to its laboratory; preanalytlc processing as defined in its laboratory users manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result Interpretation. The contractor shall provide the following services:

a. Provide all necessary supplies, not limited to the following:

• Requisition forms

• All supplies for special tests

• Special instructions

• Current list of tests with reference ranges and specimen requirements

• Specimen carriers

• All forms (Contractor does not provide chain-of-custody testing).

b. Provide specimen pick up services as defined in the contract. Transport samples in such a manner as to ensure the integrity of the specimen.

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

d. Analyze samples.

e. Testing will be performed and reported within the turnaround times published In Contractor's directory of services or User's Guide, as modified from time to time by written notification provided 30 days In advance of the effective date. Critical Value test results shall be reported immediately.

f. Provide monthly invoices by the 3rd workday of each month following the month in which service was delivered. Billing and test report summaries shall begin the first day of the month and include the last day of the month.

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

h. Provide Anatomic Pathology with a means of communication to permit immediate inquiry regarding the status of pending tests.

2. LICENSING AND ACCREDITATION

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

i. Contractor shall be accredited by the College of American Pathologists (CAP).

ii. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) if contractor is engaged in interstate commerce.

iii. Laboratory director shall be a licensed physician or a licensed bioanalyst (meet CFR

493 requirements)

3. CHANGES.

a. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the contracting officer (CO) or MTF contracting officer representative (COR). Contractor shall be responsible for assuring all subcontractors have appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the CO and MTF COR of any change of subcontract laboratory. Any charges shall be submitted to the MTF COR for review and approval. Notwithstanding the foregoing, Contractor cannot provide advance notice to changes in subcontract laboratories for review and approval in every case.

b. Due to fluctuating market conditions, Contractor makes annual price adjustments (increases and decreases) to the fees for testing sent to its established referral testing vendors.

Contractor will notify WBAMC of referral testing pricing changes approximately 30 days prior to the effective date of July 1 of each calendar year.

4. PROCEDURE GUIDANCE

a. The Contractor shall perform pathology procedures compatible with the participating MTF operating capacity and equipment. The Contractor shall not introduce new medical procedures and services for specimens provided by MTF's without prior recommendation to, and approval of, the COR MTF commander or authorized representative,

i. The Contractor shall ensure that all procedures performed have acceptable daily controls conducted to determine procedure accuracy. The dally control records are to be available for review upon request by the contracting officer (CO) or contracting officer's representative (COR).

ii. 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.

If the government requests a repeat test for any other reason, the government may be charged for the additional testing performed by Contractor as determined by the supervisor of the laboratory section that performed the original test, based on the nature of the request at the time of request. If such repeat testing is necessitated as a result of the fault of the government, the government will be charged for both the original test and the repeated test.

iii. The Contractor shall notify the MTF 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.

iv. The Contractor shall not refer tests to another laboratory without advance permission of the MTF COR or designee. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

If WBAMC requests that a test not performed by Contractor be performed by a laboratory other than Contractor's designated laboratory, Contractor will accommodate the request. However, due to the special handling issues associated with such requests, WBAMC will be BILEDed the cost of the test charged by the performing laboratory, a handling fee, and a service fee.

v. The Contractor shall contact the MTF COR within five (5) calendar days after award 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 MTF the supplies and equipment within four (4) to six (6) work days after receipt of the delivery order. The MTF COR will request replenishment of supplies from the Contractor on an as needed basis.

5. SPECIMEN PICK-UP TIMES

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

6. TEST RESULTS

a. The Contractor shall report all abnormal test results MTF upon completion of testing. The

Contractor shall confirm all abnormal results by subsequent repeat testing, upon request by the MTF COR, as required by Contractor's current laboratory procedures and/or protocols at no additional charge to the government.

b. Routine. The Contractor shall provide routine test results to the ordering MTF within the turnaround times published in Contractor's directory of services or User's Guide, as modified from time to time by written notification provided 30 days in advance of the effective date.

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.

c. Telephone Consultation. The Contractor shall consult with the MTF COR, requesting

Clinician or designee at the MTF by telephone as needed.

d. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. 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)

• Facility Name

• Patient's location (clinical/ward), (if supplied)

• Date/time speclmep received in Reference Lab

• Test ordered

• Date/time of specimen collection (when available)

• Date test completed

• Test result

• Reference range

• Toxic and/or therapeutic range where applicable

• Testing laboratory specimen number

• Name of testing laboratory (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,

7. SLIDES

The Contractor shall return all tissue blocks and slides that are submitted to Contractor.

8. STORAGE OF SPECIMENS

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

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

2. In the absence of RA requirements, the Contractor shall store specimens after all testing has been completed in accordance with the College of American Pathologists regulatory requirements for specimen retention.

9. TEST SAMPLES

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

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 TEST SUMMARY

Contractor will provide utilization reports that contain monthly and year-to-date volumes and revenues. Utilization reports are generated around the fifteenth day of each month and will be mailed to key contacts at WBAMC. Upon request, an electronic version of the report in Microsoft® Excel format can be e-mailed to the WBAMC representative each month. Contractor shall also provide a monthly invoice that will include accession number, patient's name, Social Security Number (or other medical record number, if provided), and specimen collection dates required by accreditation agencies. Contractor will also provide, upon request, a detailed monthly, client-specific, turnaround time report. ARUP's utilization reports and invoices do not include the ordering physician's name. Contractor has both the capability and expertise necessary to develop customized reports for WBAMC; however, WBAMC may be charged a fee for the development and production of customized utilization reports depending on the nature and frequency of the request.

12. SERVICE

a. The contractor shall provide telephone number(s) and contact person to be used 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.

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 MTF 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. New tests sent to a subcontractor, or tests classified by Contractor as non-discountable will not be eligible discount. In the event multiple awards are made, the participating MTF will select a primary contractor based on the contractor's capability of meeting the MTFs requirements (i.e. tests required and· overall price of providing the service based on estimated quantities, logistic capability of meeting STAT/TAT requirements, best value for the MTF).

d. Contractor shall assign a specific local account representative to each MTF.

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

f. 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 CO/MTF COR 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 CO/COR.

13. TELECOMMUNICATIONS

a. Telecommunications Linkage. Each MTF shall receive, where applicable, transmission of the results to a printer located at the hospital site. The transmission of all the completed and/or partial test results shall arrive at the hospital within published TAT except where specified. The printer system (all elements of the transmission path including the transmitter and associated receivers) must be able to:

i. Provide format of the copies equal to the current facilities format or acceptable to the Laboratory Advisory Committee

ii. Operate in a "normal" medical center operating environment without additional expense for air conditioning, humidity control, or noise suppression.

14. TESTING METHODOLOGY

Testing methodology for a test must be defined in the laboratory user manual.

15. FAILURE OF AUTOMATED SYSTEM

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

16. CONTRACTOR TESTIMONY

Contractor does not perform testing on chain of custody specimens to be used for evidence in legal proceedings and does not provide expert witnesses for such legal proceedings.

17. CONTRACTOR PERSONNEL

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.

2. The Contractor shall provide evidence of reapplication to the MTF 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 MTF COR before expiration.

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 according to DOD 5500.7-R, the Joint Ethics Regulation (JER). This policy is available to the Contractor upon request.

4. The Contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment.

Military Reservists and National Guard members may be subject to recall to active duty.

The abrupt absence of these personnel could adversely affect the Contractor's ability to perform; however, their absence at any lime shall not constitute an excuse for nonperformance under this contract.

PICKUP / DROP OFF LOCATION

WILLIAM BEAUMONT ARMY MEDICAL CENTER

5005 NORTH PIEDRAS

EL PASO, TX 79920

FOB: Destination

18. ACCOUNTING FOR CONTRACT SERVICES/CONTRACTOR MANPOWER

REPORTING

The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL Contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address https://www.ecmra.mil/Default.aspx. The required information includes: (1) Contracting Office, Contracting Officer, COR; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data;

(5) Estimated direct labor hours (including subcontractor); (6) Estimated direct labor dollars paid this reporting period (including subcontractor); (7) Total payments (including subcontractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each subcontractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (10) Locations where Contractor and subcontractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website);

(11) Presence of deployment or contingency contract language, and, (12) Number of contractor and subcontractor employees deployed in theater this reporting period (by country). (13) As https://www.ecmra.mil/Default.aspx part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each Government fiscal year and must be reported by 31 October of each calendar year. The Contractor shall notify the COR by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the Contractor will notify the KO. Report Schedules are based on the Government’s Fiscal Year cycle, regardless of the contract period of performance cycle. If this order requires a final CMR report which does NOT align to the Fiscal Year; the final CMR report shall be due NLT 30 days after the performance period ends.

END PERFORMANCE WORK STATEMENT