20240806 W81K00-24-Q-0143-0002.pdf

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

POC: CHRISTOPHER A. GREGORY

3610 MCINDOE RD BLDG 1103

JBSA FORT SAM HOUSTON TX 78234

0012050867

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to make the follow ing changes to the above referenced solicitation:

(a) The performance w ork statement (PWS) has been updated to specify the tests required as a part of this acquisition; reference Sections

1.1.3 and 1.1.4 of the PWS.

(b) The deadline for submission of quotes has been extended to 12 August 2024 at 11:00AM Central Time.

(c) All other terms and conditions of this solicitation remain unchanged, in full force and effect.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 15

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 06-Aug-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W81K0024Q0143

X 9B. DATED (SEE ITEM 11)

26-Jul-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

05-Aug-2024

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0024Q0143

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 09-Aug-2024 03:00 PM to 12-Aug-2024 11:00 AM.

The following have been modified:

PERFORMANCE WORK STATEMENT

1.0. GENERAL. This is a non-personal services contract to provide genetic testing for newborn patients. The Government will not exercise any supervision or control over the Contractor’s employees performing services specified herein. Such employees shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.1. SCOPE. The Contractor shall provide all required facilities, personnel, services, transportation ,materials, equipment, and supplies required to provide the newborn/patient testing services specified herein.

1.1.2 All tests shall be executed at the Contractor's facility, or within the Contractor's network of laboratories (affiliate or qualified sub-contractor). Contractor referrals to a secondary (sub-contractor) laboratory shall be done only with the express permission of the COR, the WBAMC shipping department, and the Contracting Officer.

Handling fees or additional charges for referrals to secondary laboratories shall not be allowed. Contractor shall have a plan to ensure no delay or stoppage of service in case of a national emergency (example 9/11).

1.1.3. All testing shall be in accordance with the Food and Drug Administration (FDA) regulations. The testing panel shall include those specified below in section 1.1.4. The below DNA testing shall be performed by the Contractor through PCR and allele specific hybridization.

1.1.4 The below listed tests are included in this requirement. Performed together, these tests constitute the quantity “1 Each” and are not separable. The below estimated annual quantity amounts are historical and not indicative of future requirements. Should any amount not be required by the Government, the Contractor agrees, at no cost to the Government, to reduce the quantities such that they reflect the Government’s actual usage.

Annual Test Quantity: 1,600

(a) G6PD

(b) Biotinidase deficiency

(c) Galactosemia

(d) Cysitc Fibrosis

(e) Congenital Adrenal

Hyperplasia

(f) Hemoglobinophaties

(g) SCID

(h) Amino Fatty and

Organic Disorders

(i) Congenital Hypothyroidism

(j) X-ALD

(k) SMA

(l) MPS-I

(m) Pompe

1.2. CONTRACTOR RESPONSIBILITY.

1.2.1. The Contractor shall ensure all employees under this contract who will be interacting with government personnel(i.e.,ContractorRepresentative,customer service personnel, data entry/specimen processing technician, and courier) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.2.2. The Contractor shall ensure each laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located. The Contractor shall ensure any subcontractors performing services hereunder shall meet the same requirements as the prime Contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be provided to the WBAMC, Fort Bliss, TX JAW the FDA regulations.

1.2.3. The Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. The Contractor shall ensure all laboratory testing staff complies with minimum Federal, State, and local law qualifications/requirements. The Contractor shall ensure all employees comply with applicable State regulations regarding their certification or registry, or license for the State in which the Contractor's testing facility is located.

l.2.4. The Contractor shall ensure all testing and supervisory personnel at all Contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

l.2.5. The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the Contracting Officer's Representative (COR) within 10 working days after contract award. The Contractor shall also submit copies of all certification licenses for the Technical Supervisors of the Primary Contractor's laboratory.

l.2.6. CONTRACTOR PERSONNEL.

1.2.6.l. Contractor Representative. The Contractor shall designate and submit, in writing, within 10 working days after award, the name of a full-time Contractor Representative and alternate. The written designation shall be submitted to the contracting officer and the COR as identified on contract.

1.2.6.1.1. The Contractor shall ensure the Contractor Representative is available telephonically, or in person by appointment, as needed, for troubleshooting, servicing, introducing new tests, to discuss immediate administrative, technical issues, and problem areas the customers may be experiencing in the field, etc. During non-duty hours, the Contractor Representative shall be accessible on a cell phone.

1.2.6.2. Customer Services. The Contractor shall provide customer service which shall be accessible by toll -free telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other applicable related issues/problems that may arise in the performance of work under this contract. The Contractor shall provide toll-free number(s)

1.2.6.3. TESTING, SHIPPING, REPORTING.

1.2.6.3.1. The Contractor shall provide testing service 7 days a week.

1.2.6.3.2. The Contractor shall provide all necessary supplies and instructions for shipping and supplies for biologic specimens to be transported from WBAMC to the Contractor. The contractor shall provide a courier service Monday through Friday, which is to be billed against this contract and included in the price of each individual test.

The Contractor shall retain title of the goods while they are in transit. The Contractors' courier service shall be responsible for all pick-up, delivery, insurance charges, taxes, inspection fees and other charges applicable to the transport by the Contractor hereunder, which Contractor may, at its option, prepay and include as a separate line item for reimbursement in the applicable invoice for such shipment.

1.2.6.3.3. The Contractor shall provide test results through secure FTP or e-mail to the Representatives of the Shipping Department. Results must be a protected portable document file (.pdf) or text file and available by secure FTP or emailed upon completion of the testing and verification of results for accuracy within a 72 hour period following receipt of the specimens. Test results must also be sent as a text file capable of being uploaded into our Computer Management System. The text file format will be provided as an attachment. Only complete test results shall be sent.

1.2.6.3.4. The Contractor shall inform the COR of any delay in test results within the 24-hour period via e-mail, secure fax, or via phone. Repeat results for initially positive and failed run sample shall be available within 72 hours of receipt of receiving specimens. The Contractor shall provide additional confirmatory testing for specimens that are initially positive.

1.2.6.3.5. The additional confirmatory testing results shall be available within 5 to 10 business days to WBAMC Pathology Support Supervisor via e- mail or secure fax. Confirmation test results will be available based upon the requirements established by the specific testing procedure. Facsimile will be utilized as a back-up to e-mail. A list of email addresses will be provided by the Representatives of the WBAMC Pathology Support within 10 working days after award to the Contractor to provide results electronically through email.

1.2.6.3.6. Handling of Specimen or Request Discrepancies: Specimen loss due to breakage, misplacement, mishandling, or any other Contractor-related problem will be considered unacceptable if more than two (2) specimens are lost or otherwise compromised per month. Repeated problems with specimen loss may be grounds for termination of the contract for cause. The contractor shall resolve request discrepancies (i.e. illegible request, missing donor information, or other clerical errors) via telephone or e-mail with WBAMC personnel before canceling test or discarding specimen.

1.3. PERFORMANCE QUALITY.

1.3.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall provide a copy of its existing Quality Control System within 10 working days after award ofthe contract. Any changes made after award of contract shall be submitted to the COR, the Contracting Officer and Contract Specialist for Government's review and final approval by Contracting Officer prior to implementation.

1.3.1.1. The Contractor shall maintain QC System records that are complete and reliable.

1.3.1.2. A progress meeting shall be held by telephone within 60 calendar days after contract start date between the COR and the Contractor to discuss any issues.

1.3.1.3. The Contractor shall perform external proficiency testing surveys as required by CAP/CUA for all regulated analytes. The Contractor shall provide the COR a listing of external proficiency surveys that the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request.

1.3.1.4. The Contractor shall operate a quality control program as required by FDA; Current CLIA requirements are located at the Health Care Financing Administration's website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR, the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification resultsfor assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

1.3.1.5. All test methods shall be FDA approved for testing. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation and testing methods, standard operating procedures must be validated prior to implementation and use by the Contractor providing testing in accordance with (IAW) FDA requirements.

1.3.1.6. The Contractorshall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime Contractor.

1.3.2. Government Performance Requirements Summary (PRS). The Government will monitor the Contractor's performance under this contract, in part using result tum-around times, percentage of discrepant results and by selected inspections or audits of the Contractor's own written instructions and procedures.

1.3.3 The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure.

l.4. SAFETY REQUIREMENTS. The Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1.5. SECURITY REQUIREMENTS.

l.5.l. Physical Security.

1.5.1.1. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations.

l.5.l.2. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government at each Submitting Activity to receive patient results. Results shall be handled as private medical records in accordance with DA Pam 25 -51, Privacy Act Requirements for Medical Records Systems.

1.5.1.3. All inquiries, comments or complaints pertaining to patient information or Government information, aside from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution.

2. DEFINITIONS AND ACRONYMS APPLICABLE TO THIS CONTRACT

2. l. DEFINITIONS.

2.1.1. CONTRACTOR. The term as used in this contract refers to both the “prime contractor” and “sub-contractor”.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.l.4. DEFECTIVE SERVICE. A unit of service which contains one or more defects, or noncompliance with specified requirements.

2.l.5. ETIOLOGIC AGENT. Infectious agents as defined by 42 CFR Part 72.

2.1.6. QUALITY ASSURANCE. The Government procedures used to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.7. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken by the Government to assure the quality of an end product or service shall meet contract requirements.

2.1.8. SHIPPING FORM. Form(s) used to initiate shipping actions.

2.1.9. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.10. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary Contractor.

2.1.11. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract.

2.1.12. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the PWS.

2.2. ACRONYMS

ACOR - Alternate Contracting Officer'sRepresentative AQL - Acceptable Quality Level ASCII - American Standard Code for Information Interchange ASCP - American Society ofClinical Pathologists BDC - Blood Donor Center CAP - College of American Pathologists CDC - Centers for Disease Control CFR - Code of Federal Regulations CLIA -Clinical Laborato1y Improvement Amendments of 1988 CME - Continuing Medical Education CONUS - Continental United States COR - Contracting Officer Representative CV - Curriculum Vitae

DES - Defense Encryption Standard DD250 - Department of Defense Form 250(Receiving Report) DoD - Department of Defense EIA - Enzyme Immunoassay FDA - United States Food and Drug Administration FSC - Federal Service Code HBcAb - Hepatitis B Vims CoreAntibody HBsAg - Hepatitis B Surface Antigen HBV - Hepatitis B Virus HCV - Hepatitis CVirus HHS - U.S. Department of Health and Human Services HIPAA - Health Insurance Portability & Accountability Act HIV 1&2 - Human Immunodeficiency Virus 1&2 HL7 - Health Level 7 HTLV 1&2 - Human T-Lymphotropic Viruses Types!&II IATA - International Air Transmit Association IAW - In Accordance With LAN - Local Area Network MIS - Management Information System ml - Milliliter MTF - Medical Treatment Facility NAT - Nucleic Acid Test OSHA - Occupational, Health, and Safety Administration OTSG - Office of the Surgeon General, U.S. Anny POC - Point of Contact PRS - Performance Requirements Summary QAP - Quality Assurance Plan QA - Quality Assurance QAP - Quality Assurance Program QC - Quality Control QNS - Quantity Not Sufficient PBWS - Performance Based Work Statement RIBA - Recombinant Inununoblot Assay SBU - Sensitive But Unclassified SSN - Social Security Number STS - Treponema Pallidum (Syphilis) TP-PA - Treponema pallidum particle agglutination UIC - Unit Identification Code VPN - Virtual Private Network WNV - West Nile Virus

3. GOVERNMENT INFORMATION

3.1. RESPONSIBILITIES. The Government will:

3.1.1. Perform specimen collection.

3.1.1.2. Provide biologic specimens that have been collected and processed per the Contractor's published pre• analytical requirements, and in accordance with standard quality procedures.

3.1.1.3. Label each sample with a unique number and provide the Contractor with test requests, lists, or work documents with required ordering information per the Contractor's requirements.

3.1.1.4. Provide patient notification IAW FDA requirements and established DoD policies

3.1.1.5. Ship specimens toContractor usingContractor required shipping material and Contractor-provided a courier Monday through Friday.

3.2. GOVERNMENT-FURNISHED ITEMS.

3.2.1. Specimens for testing.

4.0. CONTRACTOR-FURNISHED ITEMS

4.1. COMMERCIAL CLIENT SERVICES MANUAL. The Contractor shall provide a hard copy (electronic copy optional) of its Client Services Manual to the COR at the WBAMC BDC during the strut-up period. Examples of the information to be provided include the following:

(a) Test specific specimen collection and preservation requirements for each test or analyte.

(b) Test specific method and interpretation for each test or analyte.

(c) Test specific method reference ranges, when required.

(d) Test specific method sensitivity, specificity, and interferences, when required.

(e) Test specific schedule of performance and average turnaround time for each.

(f) Result Code

(g) Instrumentation used to test each analyte.

4.1.2. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc.): In the event of any methodology change, written information/instruction shall be provided to the Contracting Officer, Contract Specialist and COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for changes in testing algorithms-if needed. All changes to procedures with less than 15 calendar days' notice shall be provided to the COR and only implemented with concurrence by the Contracting Officer’s Representative. The COR will notify the Contracting Officer and Contract Specialist in the event of noncompliance with this requirement.

4.1.3. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to Contracting Officer, Contract Specialist and COR once test procedure validation is complete.

4.1.4. SUPPLIES. If the Contractor requires unique supplies, the Contractor shall provide an initial 6-week stock of materials or supplies to be used by WBAMC in preparation for shipment of specimens for testing requirements.

Supplies required for the initial 6-week period shall be a part of the contract stmt-up period responsibilities.

Government-held stock of Contractor-furnished items shall be routinely replenished by the Contractor to allow performance of all contract requirements without interruption. Maintenance of the stock will be by request from the COR to the Contractor. On a case-by-case basis, emergency supplies may be requested by the COR and shall be provided by the Contractor as required. The Contractor shall meet with COR within 5 working days after the award of the contract to determine the quantity required. The Contractor shall:

4.1.4.1. Furnish materials and supplies necessary to meet the requirements for the provision ofservices established under the terms of this contract.

4.1.4.2. Furnish materials/suppliesto the WBAMC to prepare specimens for shipping to the Contractor's facility for processing and testing. Some examples of supplies required may include, but are not limited to:

4.1.4.3. Shipping and packaging containers forsubmitting specimens in a manner required for efficient processing at the Contractor's facility.

4.1.4.4. As necessary, filter paper for collection required by the Contractor.

4.1.4.5. Furnish written instructions to Government personnel forsample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of filter paper.

4.1.4.6. Government facilities will utilize unique Barcode labelsfor identification on each sample. TheContractor must be capable of accepting labels in ISBT 128 technology for samples received for testing.

4.2. FACILITIES.

4.2.1. The Contractor shall maintain the necessary facilities to perform services under the terms of this contract.

4.3, LABOR: The Contractor shall maintain necessary labor to perform the services under the terms of this contract.

5.0. DESCRIPTION OF WORK.

5.1. TESTING. The Contractor shall be CAP/CLIA accredited, and FDA licensed to perform all testing required.

The Contractor shall inform of any delay in test results within the 24-hour period via telephone, e-mail or secure fax.

Repeat positive results for initially positive and failed run sample shall be available within 72 hours of receipt of the specimens. The Contractor shall provide additional repeat testing for specimens that are initially positive. The additional confirmatory testing results shall be available within 5 to 10 business days to WBAMC via e-mail or secure fax. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All laboratory testing shall be executed in accordance with standard industry practices.

5.1.1. The Contractor shall ensure the accurate and timely performance of laboratory testing services in biologic specimens provided by COR. The quality for allservices rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies. Contractor will have a plan, in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service.

5.2. CONTRACTOR LABORATORY INFORMATION SYSTEM.

5.2.1. The Contractor shall provide and maintain a computerized laboratory information and management system for rapid retrieval and printing of laboratory results including elements within the Contractor's laboratory. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines.

5.2.2. The Contractor's automation shall provide:

5.2.2.1. Test results reporting. Routine test results shall be using secure FTP or up-loadable text file and sent by portable document format (pdf) electronically transmitted to the submitting facility within 72 hoursfrom receipt of samples. Only complete test results will be included in the transmitted text file. Incomplete test results will be held until all results are available before being transmitted.

5.2.2.2. Any delaysin testing due to failed instrument malfunctions should be reported immediately if delay in testing beyond 24 hrs. will occur.

5.2.2.3. Once corrective actions have been taken or resolved and testing resumed, test results will be made available immediately upon completion of review.

5.3. HANDLING OF SPECIMEN OR REQUEST DISCREPANCIES.

5.3.1. Specimen loss due to exposure to the sun, misplacement, mishandling or any other Contractor-related problem(s) shall be reported immediately to the shipping department upon knowledge or detection of problem.

Repeated problems with compromised specimens may be grounds for termination for cause of the contract.

5.3.2. Any specimens that have been exposed to the sun, or otherwise compromised during transit shallbe immediately reported to the WBAMC Shipping Department upon unpacking at theContractor's laboratory.

5.3.3. All specimensshall be processed within 24 hours ofreceipt. Specimen discrepancies or additional specimen requirements shall be brought to the attention ofthe WBAMC Shipping Department within the 24-hour period.

5.4. SPECIMEN RETENTION.

5.4.1. Specimens shall be stored/retained by the Contractor for at least 7 days after the reporting of the results. In selected cases, and upon request by WBAMC, the Contractor shall store/retain specimens for up to 30 days at no additional cost.

5.5. REFERRALS TO ANOTHER LABORATORY OR INSTITUTION. The Contractor shall ship specimens to other laboratories as required when referral work is sent by the Government to another institution which may be conducting jointstudies or when the specimen istime sensitive. Specimen transport expense for referralsto another laboratory or institution shall be at no additional cost to the Government.

5.6. RESULTS REPORTING.

5.6.l. The Contractor shall provide reports of specimen testing to the WBAMC within a 72-hour tum-around time from receipt.

5.6.2. Specimen testing reportsmeeting CAP/CLIA requirementsshall be electronically transmitted in portable document format (pdf) to the facility for local printing. As a minimum, printable reports shall include:

(a) The name and address ofthe contract laboratory where each test was performed.

(b) The Patient name and Date of Birth.

(c) The name of the contract Laboratory Director or Medical Director.

(d) A phone number to contact the contract laboratory concerning the test results.

(e) The specimen collection date and time.

(f) The Contractor's report date and time.

(g) The test result(s)

(h) The unit of measurement for quantitative tests.

(i) The normal or expected range.

(j) The report status (i.e., final or interim).

(k) Other interpretive information appropriate for the test(s).

5.6.3. Abnormal results (results outside the reference range), or incomplete testing shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). Only complete test results (with the exception of confirmatory testing) will be released by the Contractor. Incomplete testing will be held until all results are available, with the exception of repeat testing.

5.6.4. In cases of malfunction of the Contractor-supplied electronic repo11ing method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed repm1s to the COR until the automated information system is properly functioning.

5.7. MANAGEMENT REPORTS.

5.7.1. Monthly COR Reports. The Contractor shall provide bimonthly data summary reports of tests performed to the COR under this contract. The printed reports shall be delivered to the contracting officer, Contract Specialist and COR identified by the contract, by the tenth calendar day of the month after the end of each monthly recurring period.

5.7.1.1. The reported information shall include subtotals for each test and the test name, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year to date (per test), and cost year to date (per test). The Contractor shall also provide notice of when a selected test is subject to a unit price reduction/increasebasedonthediscounttermsincorporated under contract. The test name, vendor'stest code, the revised unit cost per test, and effective date shall be annotated.

5.7.2. The reports with data required in PWS paragraph 5.7.1.1. Shall be reported using the primary method. Results may be sorted by four additional methods:

5.7.2.1 Results listed chronologically by date submitted is the primary repot1ing method.

5.7.2.2. Test names listed alphabetically.

5.7.2.3. Test names listed in order of year-to-date test frequency (highest to lowest).

5.7.2.4. Test names listed in order of year-to-date total test cost (highest to lowest).

5.8. MISCELLANEOUS CONTRACTOR RESPONSIBILITIES.

5.8.l. The Contractor shall keep the contracting officer, Contract Specialist and COR, informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide quarterly updates.

5.8.2. The Contractor shall provide through its toll-free customer service network, with minimal transfers and holding, access to knowledgeable, responsive laboratory professionals.

5.9. CONTRACT START-UP PERIOD. Immediately upon award of a contract, there will be a start-up period consisting of a maximum of 30 calendar days. The intent of this start-up period is to enhance coordination between the Government and the Contractor in order to avoid misunderstanding or mistakes on the part of both parties. The Contractor shall provide the necessary personnel required to perform training/orientation with coordination from the COR. During this period, the following shall take place:

5.9.l. The Government CORs will brief the Contractor as to where to ship their shipping/packaging/collection materials. If needed, the Contractor will make a site visit to the Shipping Department to instruct personnel on labeling, packing and shipping requirements.

5.9.2. The Contractor shall provide materials and supplies needed for shipment of filter papers from COR to Contractor to last for the initial 6-week period.

5.9.3 The Contractor shall provide COR with processing and shipping information and their commercial client services manual during the start-up period.

6. APPLICABLE REGULATIONS, MANUALS, TECHNICAL BULLETINS, PAMPHLETS, AND

SPECIFICATIONS. The following regulations are Mandatory. Electronic or scanned copies of all applicable regulations will be made available to the Contractor after award, but prior to performance of the contract.

REGULATION NAME

AR 40-3 Medical, Dental, and Veterinary Care, CH 5 Anny Blood Program (11 MAY 2009) AR 340-17 Release of information and Records (15 Dec 86).

AR 340-21 The Army Privacy Program (5 Jul 85).

AR 340-21-1 the Anny Privacy Program: System Notices and Exceptions Rules (16 Dec 85).

AR 380-19 Information System Security OPNAVINST 6530.4B Department of the Navy Blood Program (13 AUG 2007) DA PAM 25-51 Privacy Act Requirements for Medical Records Systems

MEDDAC

CUA Clinical Laboratory Improvement Amendments of 1988 DoD 5200.28-STD DoD Trusted Computer Evaluation Criteria "Orange Book".

Title 42 CFR, Part 72 Interstate Shipment of Etiologic Agents.

Title 29 CFR Occupational Safety and Health Standards(1990) Title 21 CFR, Parts 210-211, 600-680 Food and Drug Administration: Drug (210-21I), Biological Products (600-680)

7. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

7.1 The objective of the QASP is to provide a strategy for surveillance of the Contracotr’s performance of newborn genetic testing services in support of William Beaumont Army Medical Center (WBAMC), Fort Bliss, Texas. This plan will provide a basis for the government’s evaluation of the Contractor’s key areas of performance under this contract. The Contracting Officer (KO), in conjunction with input provided by the Contracting Officer’s Representative (COR), will evaluate the Contractor’s performance. Oversight of the Contractor’s performance will assure quality and consistency of contract performance.

7.2 PERFORMANCE MEASUREMENT OBJECTIVE: The key area(s) of the Contractor’s performance that will be evaluated during the term of the contract. The statement of work reference will be provided for each performance measurement objective.

7.3. ASSESSMENT METHOD: Contractor performance is inspected and evaluated on key areas of performance on a monthly basis. The method of surveillance varies by the PWS requirement being surveilled.

7.4. ACCEPTABLE QUALITY LEVEL (AQL): The degree to which the Government will allow the Contractor’s key areas of performance to vary; the variance from the standard that the Contractor is allowed and the grading/measurement associated with deviation from the specific performance standard.

7.5 KEY AREAS OF PERFORMANCE (PERFORMANCE REQUIREMENTS SUMMARY)

Item

PWS

Requirement

Standard Acceptable Quality Level

Surveillance Method (Primary)

Performance Incentive

Licensure, Certification, and Accreditation (1.1.2)

In accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located.

Subcontractors performing services shall meet the same requirements as the prime Contractor.

Not less than 100% of time during contract period of performance

COR

Inspection

Annotation on monthly reports

Failure to comply may be grounds for termination

Customer Service Availability (1.2.6.2)

Customer service accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other applicable related issues/problems that may arise in the performance of work under this contract.

of time during contract

Annotation reports

Results Collection (1.2.6.3.2)

Contractor shall provide a courier service Monday through Friday.

of time during contract

Annotation on monthly reports

Turn-Around Time (1.2.6.3.3 Through 1.2.6.3.5)

Initial tests within a 72-hour period following receipt of the specimens. Contractor shall inform the COR of any delay in test results within a 24-hour period

Repeat results for initially positive and failed run sample shall be available within 72 hours of receipt of receiving specimens. Additional confirmatory testing results shall be available within 5 to 10 business days.

Timely results for 98% or greater of all specimens submitted

COR

Inspection

Annotation on monthly reports

Specific Handling and Request Discrepancies (1.2.6.3.6.)

Specimen loss due to breakage, misplacement, mishandling, or any other Contractor-related problem will be considered unacceptable if more than two (2) specimens are lost or otherwise compromised per month

No more than two individual specimen losses per month.

Annotation reports

Repeated losses may be grounds

Quality Control (1.2.1.4)

Contractor shall operate a quality control program as required by FDA; Current CLIA requirements are located at the Health Care Financing Administration's website:

http://www.phppo.cdc.gov/CLIA. Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

Not less than 100% of time during contract period of performance

COR

Inspection

Annotation on monthly reports

Failure to comply may be grounds

7.6 REPERFORMANCE OF SERVICES. If any of the services do not conform to contract requirements, the Government will require the contractor to re-perform the services in conformity with contract requirements, at no additional cost to the Government. When the defects in services cannot be corrected, the Government may (1) require the contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed. The KO may exercise appropriate contractual remedy should the contractor fail to promptly take the necessary action to ensure future performance is in conformity with contract requirements.

7.6.1. CONTRACT DEFICIENCY REPORTING. When apparent non-satisfactory work is identified, the COR shall prepare a Contract Discrepancy Report (CDR) and submit to the KO for review, use DD Form 2772. The Contractor shall then be required to respond to the CDR. The Contractor shall explain reasons for substandard performance, how performance will be returned to acceptable levels, and how recurrence of the same or like problems will be prevented. The KO will evaluate the Contractor's explanation, assess its validity, and determine whether it is acceptable. The contractor shall be required to correct/eliminate any deficiencies in services in a timely manner. Notification begins when pertinent documents (e.g., Customer Complaint Record or CDR) are issued to the contractor. Time of notification and correction of all applicable deficiencies should be entered on all Government documents and retained in the contract file. The Government may execute a deduction in payment for noncompliance when validated by the KO

(End of Summary of Changes)