PWS.pdf

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PERFORMANCE WORK STATEMENT REFERENCE LABORATORY TESTING SEVICES, LABORATORY DIRECTORSHIPS, TECHNICAL SUPERVISOR, CONSULTIVE SERVICES, AND EQUIPMENT TECHNICIAN CHECKS.

GREAT PLAINS AREA INDIAN HEALTH SERVICES CLINIC AND HOSPITAL SYSTEMS

1. GENENERAL INFORMATION

General: This requirement is for non-personal services to provide reference laboratory and pathology services, directorship (including CLIA required technical positions, if needed) and equipment tech for checks for all Great Plains Area service units in compliance with the manufacturer, Joint Commission, CAP, CMS, CLIA, COLA, and ETC. regulatory and accreditation standards for the health centers and hospitals in the GPAIHS, and the associated services described herein.

The government will not exercise any supervision or control over the contractor personnel providing the supplies/services described herein. This PWS is structured to support Executive Order titled ‘PROMOTING EFFICIENCY, ACCOUNTABILITY, AND PERFORMANCE IN FEDERAL CONTRACTING’ requirement for fixed‑price, performance‑based contracting by establishing measurable outcomes, defined deliverables, and performance standards that strengthen contractor accountability. There are 4 main parts to this contract: 1. CLIA required Laboratory Directorship (LD), Technical Supervisor (TS), Clinical Consultants (CC), Technical Consultant (TC), and Consulting Technologist 2. Instrument tech for calibration checks, alarm setpoints, thermometer checks etc. 3. Reference lab testing with electronic downloading of orders and results. 4. Reporting

1.1 Description of Services/Introduction: The contractor shall provide all personnel, transportation, equipment, supplies, facilities, supervision, other items and non-personal services necessary to provide/perform the supplies/services defined in this Performance Work Statement. The contractor assumes all liability risks for the work performed under the contract/order. The contractor must assume total liability for all contractor employees.

1.2 Place of Performance: Patient specimens shall be picked up at the following locations, directorships (including CLIA required technical positions) shall be provided at each site, and an equipment tech shall provide checks equipment checks in accordance with accreditation organizations, regulatory agencies, and manufacture specs for all the following sites:

1.3.1 Clinics currently moderately complex and need specimen pickups at least 5 days a week(M-F) excluding federal holidays that they are closed on:

Fort Thompson IHS Kyle IHS Lower Brule 1323 BIA route 4 1000 Health Ctr Rd 601 Gall St Fort Thompson, SD 57339 Kyle, SD 57752 Lower Brule, SD 57548

WWKMHCC (Sisseton SD) Wanblee IHS Wagner IHS 100 Lake Traverse Drive 210 1st St 111 Washington Ave NW Sisseton, SD 57262 Wanblee, SD 57577 Wagner, SD 57380

McLaughlin IHS 701 East 6th St McLaughlin, SD 57642

1.3.2 Hospitals that are currently moderately complex but may change to high complex if the staffing and need arises.

These locations require pickup at least 6 days per week as long as they do not perform microbiology identification and sensitivity testing on one or more of the following culture types: body fluids, wound, or blood cultures.

Eagle Butte IHS Fort Yates IHS 24276 166th Street, Airport Rd. 10 Standing Rock Ave Eagle Butte, SD 57625 Fort Yates, ND 58538

1.3.3 Hospitals that are currently High complex and require at least 6 days per week as long as they do not perform microbiology identification and sensitivity testing on one or more of the following culture types: body fluids, wound, or blood cultures.

Pine Ridge IHS Rosebud IHS 607 Indian Health Road 400 Soldier Creek Dr

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Pine Ridge, SD 57770 Rosebud, SD 57570

1.3.4 Hospitals that are currently High complex and do not require at least 6 days per week as long as they perform microbiology identification and sensitivity testing on all the following culture types: body fluids, wounds, or blood cultures. This may change during the contract period and will then require at least 6 days per week to pick up specimens.

Quentin N. Burdick Memorial Health Care facility (Belcourt IHS) 1300 Hospital Loop Belcourt, ND 58316

1.4 Physical Security: The contractor shall be responsible for safeguarding all government property, equipment and information while performing the services described herein.

1.5 Period of Performance: 5 years or 60 months from contract start date.

1.6 Recognized Holidays: The contractor is not required to perform services on holidays.

New Year’s Day, Martin Luther King Jr.’s Birthday, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

1.7 Type of Contract: This acquisition is solicited as a Firm-Fixed‑Price IDIQ contract in accordance with the Executive

Order titled ‘Promoting Efficiency, Accountability, and Performance in Federal Contracting,’ which requires fixed‑price, performance‑based contracting as the Government’s default approach. The government anticipates award of a Firm-Fixed-Price IDIQ contract with obligations to be awarded via Task Order/Delivery Order by the individual service units listed. All task orders issued under this IDIQ will be Firm-Fixed‑Price to ensure full compliance with Executive Order requirements governing the use of non‑fixed‑price contract types. The minimum guarantee in the amount of $1,000.00 is to be awarded as the first Task Order/Delivery Order concurrent with contract award. Upon issuance of a Task Order/Delivery Order, the minimum guarantee of $1,000 will be de-obligated and cannot be invoiced as the minimum guarantee was met with award of a Task Order/Delivery Order. In the event a Task Order/Delivery Order is not awarded in this contract, the contractor is entitled to invoice for the minimum guarantee of $1,000.

1.8 Contract Administration: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements in the contract/order. 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 changes that will affect price, quantity, or quality of the performance in the contract/order. In the event the contractor affects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. All changes to the contract will be issued via an amendment and/or modification in writing from the Contracting Officer to the contractor. The Contracting Officer retains final authority over all aspects of the contract/order and any resultant task orders; including, but not limited to, any technical drawings and any technical requirements and specifications.

1.9 Contracting Officer Representative (COR): The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract/order and assists in contract administration. A letter of designation issued to the COR, a copy of which will be provided to the contractor, states the responsibilities and limitations of the COR, especially with regards to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract/order.

1.10 Quality Control: The contractor shall develop and/or maintain an effective quality control program to ensure the services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent and ensure non-recurrence of defective services. The contractor’s quality control program is how they assure themself that their work complies with the requirements of the contract. The contractor’s quality

Page | 3 control program is to be delivered within 30 days after contract award. After acceptance of the quality control program, proposed changes shall be submitted to the Contracting Officer and COR within five working days of the proposed effective date.

1.11 Quality Assurance: The government shall evaluate the contractor’s performance under the contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is focused on what the government must do to ensure that the contractor has performed in accordance with the performance standards. The plan defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.12 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other government personnel, as appropriate, may meet periodically with the contractor to review the contractor’s performance. At these meetings the Contracting Officer will appraise the contractor of how the government views the contractor’s performance and the contractor will appraise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

These meetings shall be at no additional cost to the government.

1.13 Invoices: The Contractor shall establish an invoicing system compatible with the Federal Acquisition Regulation (FAR) Prompt Payment policy and submit those invoices via the E-Invoicing/IPP system; monthly, upon completion of delivery or of services that were performed. Invoices must include the obligation number that is provided on the contract/order, for the specific period of performance, to ensure timely payment. The COR or TCOR are responsible for the acceptance and/or certification of invoices for those supplies/services provided to the government.

1.14 As prescribed in FAR Subpart 42.15, the Indian Health Service (IHS) evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15 and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided with an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement IHS uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies.

1.14.1 Each contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the contracting officer contact information for the contractor’s representative with their response to the solicitation. The contractor is responsible for notifying the contracting officer of any change to the contractor’s representative during the contract performance period. Contractor’s representative contact information consists of a name and email address.

1.14.2 The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor’s designated representative for comment. The contractor’s representative will have sixty days to submit any comments and return the report to the IHS Assessing Official.

Failure by the contractor to respond within sixty days will result in the Government’s evaluation being placed on file in PPIRS without contractor’s comments.

2. Size of system and government experience

2.1. Provide how many laboratories are in your system; Provide how many independent laboratories do you provide the laboratory director and consulting technologist for in the North and South Dakota region; How many government laboratories nationwide do you provide laboratory director and consulting technologists to; Provide a point of contact for each of the government contracted facilities.

2.2 The Contractor shall establish a reporting system that includes site visit reports and other reports mentioned in the following sections.

2.3 The Contractor shall provide at least annually onsite training at the hospitals and health centers for requested or needed topics to make the lab better. These topics can be agreed upon between the contractor and lab manager.

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2.4 In accordance with Indian Health Service credentialing policy, the Contractor shall complete a primary source verification for each pathologist performing services under the contract if required by the accreditation body for that laboratory. Upon the assignment of a pathologist to a Great Plains Area service unit, the pathologist shall complete a credentials packet and be credentialed by the service unit Governing Body, if required by the accreditation body for that laboratory. Contractor pathologists shall be board certified by the American Board of Pathology.

2.5 The standards of medical practice and duties of the Contractor through its physicians shall be determined pursuant to Governing Body bylaws, medical staff bylaws, rules and regulations of the appropriated IHS hospital and health center, applicable provisions of law including but not limited to Centers for Medicare/Medicaid Services (CMS) compliance, rules and regulations of any and all governmental authorities relating to licensure and regulation of physicians and hospitals, and standards and recommendations of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), COLA, AAAHC, AABB and CAP .

2.6 The contractor shall provide clinical and administrative tech support, information, and consultation by phone, including phone numbers and contacts, and/or by web site.

3. DEFINITIONS AND ACRONYMS:

Definitions: Terms used within the PWS

3.1 Contractor. A supplier or vendor awarded a contract to provide specific supplies or services to the government.

Term refers to the prime contractor.

3.2 Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

3.3 Contracting Officer’s Representative (COR). An employee of the US 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 if 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.

3.4 Day. Unless otherwise specified in the PWS, day(s), references a calendar day(s)

3.5 Defective Service. A service output that does not meet the standard of performance associated with the

Performance Work Statement.

3.6 Physical Security. Actions that prevent the loss or damage of government property.

3.7 Quality Assurance. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

3.8 Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of the contractor’s performance.

3.9 Quality Control. All necessary measures taken by the contractor to assure that the quality of a product or service shall meet contract requirements.

3.10 Subcontractor. One that enters into a contract with the prime contractor. The government does not have privity of contract with the subcontractor.

4. Acronyms AO – Approving Official (Purchase Card)/Administration Officer/Assessing Official (CPARS) BAA – Business Associate Agreement BPG – Business Partner Gateways CAP – College of American Pathologists CLIA – Clinical Laboratory Improvement Amendments of 1988 CO – Contracting Officer COR – Contracting Officer’s Representative COTS – Commercial-Off-the-Shelf CPARS – Contractor Performance Assessment Reporting System

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GPAIHS – Great Plains Area Indian Health Service FAR – Federal Acquisition Regulation FISMA – Federal Information Security Management Act of 2002 FIPS – Federal Information Processing Standards FOIA – Freedom of Information Act GIS – Generic Interface System HIPPA – Health Insurance Portability and Accountability Act of 1996 IFCAP – Integrated Funds distribution, Control point monitoring, Accounting & Procurement IPP --- Invoice Processing Platform LEDI – Laboratory Electronic Data Interchange MOU/ISA – Memorandum of Understanding & Interconnection Security Agreement NCO – Network Contracting Office NIST – National Institute of Standards and Technology PHI – Protected Health Information POC – Point of Contact PPIRS – Past Performance Information Retrieval System PRS – Performance Requirements Summary PWS – Performance Work Statement QA – Quality Assurance QAP – Quality Assurance Program QASP – Quality Assurance Surveillance Program QC – Quality Control QCP – Quality Control Program RPMS – Resources and Patient Management System TE – Technical Exhibit HHS – Department of Health and Human Services

5. GOVERNMENT FURNISHED ITEMS AND SERVICES:

5.1 Equipment: None

5.2 Materials: None

6. CONTRACTOR QUALIFICATIONS:

Requirements of Laboratory & Contractor Personnel

6.1 Laboratory

• Contractor, including subcontractor(s), must continuously hold a Certificate of Accreditation from the Centers for

Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 and must demonstrate accreditation. The reference laboratory must maintain valid certifications during the entire performance period of this contract. As the certificates are re-issued or re-awarded, the Contractor must provide a copy to the Contracting Officer’s Representative. Certificates of accreditation must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

• Contractor must notify immediately the Contracting Officer’s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.

• 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.

• The Contractor shall provide a data management system that meets the following requirements:

o Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse, touch screen, or typed in. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test.

o Test definition, test information and test requirements must be complete, available and easily accessible.

Page | 6 o Shipping manifest must be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

o The status and the results of testing must be available within published timeframes and easily retrievable using varying options. At a minimum the options must include: Sort by patient name; Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes.

o Reports of test results must be available within an hour of verification of the test result. Contractor’s portal located on a Government supplied computer must be able to print test results upon request and reprint retrospective test results.

6.2 Personnel

6.2.1 Reference lab testing personnel

• 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, appropriate accreditation standards, or other accrediting organizations and State standards.

6.2.2 CLIA required laboratory positions (Laboratory Director, Technical Supervisor, Clinical Consultants)

• The contractor shall provide a list of personnel that are CLIA/Joint/COLA qualified to serve as laboratory directors and other CLIA required positions, such as Technical Supervisors for all IHS locations and their CV’s and other CLIA required documentation.

• A list of the proposed consulting technologists and their CV’s and CLIA required documentation.

• Details and timeframes for transition of laboratory director turnovers and how long proposed laboratory directors will be onsite for required paperwork to be filled out such as CLIA certificate, procedure manual signatures, etc.

• Provide a report format for the laboratory director’s report and the consulting technologist’s report.

• Provide a list of QAPI monitors and examples of the report that would be sent to the laboratory manager to stay in compliance with regulatory agencies.

• Provide an example of the antibiogram report that will be sent quarterly to each facility and the COR.

• Provide an example of a yearly antibiogram aggregated by the whole area and by each service unit for the GPAIHS that will be submitted to the COR.

• Provide an example of a yearly antibiogram aggregated for the whole GPAIHS for Gram-Negative Rods broken down by source that will be submitted to the COR.

• Provide an example of a yearly antibiogram aggregated for the whole GPAIHS for Gram-Positive Cocci broken down by source that will be submitted to the COR.

• Provide an example of a blood culture report for monthly reporting of organism and information to identify the specimen and submitting location, this will allow IHS to perform a chart review to track contamination rates.

• Provide how regulatory/accreditation issues will be identified, recommended fixes communicated and tracked for completion.

• How many consulting technologists will be dedicated to the IHS and call center to answer IHS problems?

• Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

• Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English

• Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within IHS established timeframes.

• Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor ‘s company.

6.2.3 Service Technician/Instrument Technician

• The contractor shall provide a list of checks to be performed on a quarterly basis for hospitals and semi-annually for all clinics. An equipment maintenance technician shall visit each facility and provide all manufacturers required calibration checks, microscope cleanings, pipette checks, timer checks, alarm checks and alerts (blood bank), tachometer checks, thermometers to NIST, include but not limited to calibration, accuracy, precision, alarms, trip

Page | 7 points, response times, and safety, clean and lubricate, and light maintenance/repairs that would be done on all common laboratory equipment, such as but not limited to centrifuges, timers, blood bank equipment, thermometers, all pipettes, all microscopes, rotators, balances, weights, mechanical diff counters, visual inspect all miscellaneous equipment, and recommendations for replacement/repair all in accordance with manufactures recommendations.

The possibility always exists of additional equipment. The contractor will need to provide any additional checks that may go along with new equipment. Provide a detailed report format as to how all of this will be reported to GPA Chief Biomedical Officer, Lab Manager, and COR. An onsite binder with this information needs to be updated before leaving the site. Contractor will be responsible for maintaining this binder for accreditation purposes. Provide a schedule as to when and who will be doing this at each location to meet regulatory requirements and their credentials, training, and

CV

7. TASK SPECIFICATIONS:

7.1 Scope of Work

• Reference Laboratory Services shall include, but are not limited to:

• Specimen Preparation and Storage.

• Transportation of Clinical Laboratory Specimens, Microbiology Cultures, and Stocks.

• Performance of Analytical Testing.

• Reporting of Analytical Test Results.

• Laboratory Directorship and technical positions such as Technical Supervisor and Clinical Consultant.

• Equipment tech to perform equipment checks per manufacturers specifications and regulation

• and Consultative Services.

7.2 Specimen Preparation and Storage for Reference Testing Specimens

7.2.1 Contractor shall supply the GPAIHS with its commercial laboratory reference test manual ensuring that the collection and storage of specimens are in accordance with Contractor’s requirements.

7.2.2 Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. Examples are:

• Special Tubes: Royal Blue, Yellow ACD, PPT, etc.

• Specimen Collection kits: Aptima Unisex collection swabs, Quantiferon Gold, UroRisk, etc.

• Transport Media: SAF Vials, etc.

• Test Kits: Traysolol, etc.

• Transfer Supplies: Amber transfer tube w/cap, Frozen Transpak Bottles, etc.

• Packaging/Mailing supplies: Foam tube rack shipping kits, Bio-hazard bags, appropriate DOT/IOTA or other regulating agency’s category shipping containers, etc.

• Any other specialty tubes and/or kits

7.2.3 Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

7.3 Transportation Services for Reference Testing Specimens

7.3.1 Contractor shall provide daily transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. Frozen specimens shall be maintained in a frozen state during transport.

7.3.2 Routine transportation shall occur once per day following the requirements in subsections of 1.3 above from the Government facilities listed herein; Specimen pick-up times will be negotiated after contract award.

7.3.3 Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

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a) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

b) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

c) Electronic ordering and results interface shall be available for a minimum of 95% of tests ordered. Interface shall be provided at the contractor’s expense and must be available within 31 days of contract award to avoid delay in patient testing or results. For tests that are not electronically ordered, the contractor shall provide:

i) Test request forms preprinted with the appropriate Shipping Section details and account information.

ii) Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

d) Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract.

7.4 Specimen Testing

7.4.1 The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Technical Exhibit 2, Attachment A (approximately 128,000 tests) and for others too numerous to mention and Technical Exhibit 2, Attachment B (definition of some panels) Contractor shall make available the following test information on a test compendium:

a) Requisition form requirements, if applicable

b) Alphabetized test name/Description list

c) Test order code

d) Specimen collection and preservation requirements

e) Test method employed (indicate if testing performed in duplicate) and interpretations

f) Test reference intervals adjusted for age, sex or race, when required

g) Test specific sensitivity, specificity and interferences, when required

h) Result code

i) Result description

j) Test critical values, if any

k) Policy for critical value notification

l) CPT coding

m) LOINC code

n) Ask at order questions and codes

o) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a government facility.

p) Schedule of test performance (specific days of week indicated)

q) Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited)

Contractor shall notify the Contracting Officer, COR and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

7.4.2 All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

•The Contractor shall ensure the accurate and timely performance (defined at 5.4.1 o) of laboratory testing services on the biomedical materials.

7.5 Specimen Retention

All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material such as autopsy specimens) generated by the IHS shall be retained by the testing facility for the timeframe required by the

Page | 9 regulatory agency or their accreditation agency, unless it is requested to be returned to the IHS by the IHS. The testing facility will be responsible for the cost of sending the specimen back.

7.6 Reporting of Results

A. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined at 5.4.1 o).

B. A report on laboratory testing results must be issued through the host-to-host electronic transmission of the test results and as a final printed copy. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, direct connected secured printer, or by telephone facsimile to a protected machine identified to the Contractor by the IHS. Delivery by electronic mail i.e., MS Outlook, etc. is prohibited. All lab results must be printed automatically in the laboratory by a printer supplied to the lab by the contractor. These printouts must contain all CLIA required and accreditation required information for a test, along with the local laboratories LIS number. The contractor must also have a label printer available to print specimen labels for specimens to be sent to them.

Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in Section Telecommunication Requirements below.

C. Each test report shall, at minimum, include the following information:

1) Patient's full name

2) Patient’s identification number, e.g., IHS chart number

3) Patients Date of Birth

4) Physician’s name (if supplied)

5) IHS laboratory accession number (if supplied)

6) Submitting facility name

7) Submitting facility account number

8) Patient's location (clinic/ward) (if supplied)

9) Test(s) ordered

10) Date/time of specimen collection (when available)

11) Date/time test completed

12) Test result

13) Reference intervals (adjusted for age, sex or race, when appropriate)

14) Toxic and therapeutic ranges, if applicable

15) Flagged abnormal results

16) Reference laboratory accession number

17) Name and address of testing laboratory

18) Any other information the laboratory has that may indicate a questionable validity of test results.

19) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

D. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated

Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

E. Contractor shall not, under any circumstances, furnish reports directly to patients.

7.7 Record Keeping

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7.7.1 The contractor must establish a record keeping system for all tests performed.

7.7.2 Clinical or other medical records (i.e., test results) of IHS patients treated by Contractor under this contract are owned by the IHS. If requested, test results will be mailed to the IHS at no additional cost. If a subpoena or court order is received to produce a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

7.8 Customer Service

A. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week, to assist Government staff in tracking and resolving related issues/problems that may arise in the performance under this contract.

B. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

Telephone Inquiries – Telephone inquiries are divided into five major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1) Specimen Collection

a) Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

b) Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

2) Testing

a) Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

b) Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

3) Technical Expertise

a) Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

b) Result interpretation inquiries shall be addressed within four business hours of initial call.

c) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

4) Account follow-up

a) Information general in nature yet specific to the account, e.g., test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

5) Directorships, Technical Consultants, and Clinical Consultants

a) Must be available and respond according to CLIA regulations and local laboratory accreditation standards. (See section 6.2.2 and CLIA regulations for additional information).

b) Must provide onsite visits per the parameters listed in section 8 below, PRS#8 in Exhibit A, and 6.2.2 above.

C. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

D. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

8. Consultative Services, Laboratory Directors, and Reports (See also section 10, technical exhibit 1, and technical exhibit 3)

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A. Contractor shall provide consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

B. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations for the facilities on mechanisms to reduce their costs.

C. On a quarterly basis for all hospitals and health centers, a medical technologist shall visit each facility to provide a consulting technologist report. This report must contain items that are needed to maintain regulatory compliance and suggested fixes to remain in regulatory compliance with the specific regulatory agency that was chosen for that facility.

The Medical Laboratory Director and Technical Supervisor of Immunohematology must provide a detailed written consultation report upon completion of the on-site visit. The report shall be based on assuring the facility passes their laboratory accrediting body survey. It shall include, but not be limited to, services performed, contacts made, problems and deficiencies identified, recommendations made, any follow-up needed and corrective action plans for addressing identified deficiencies and problems which may cause the facility to fail an accreditation survey. The reports shall be submitted to the Chief Executive Officer, Clinical Director and/or the Chief Medical Officer, Laboratory Supervisor and Contract Officer Representative.

D. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the facility name, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to-date test expenditures.

i. A copy of the report shall be delivered electronically to the COR

ii. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods:

a) Facility name

b) Test names listed alphabetically

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

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

E. Monthly an itemized electronic “transaction report” shall be exported to the IHS Area COR. Data should be exported in an “EXCEL compatible format. The monthly report must include at a minimum the name of test performed, cost per test; the number of tests performed during the month; a cumulative (“year-to-date”) number of tests performed and a cumulative (“year-to-date”) cost of tests.

F. Monthly a report which will include at a minimum account number and/or account name, test number, test name, cost of test, quantity of each test ordered, amount spent on each test for the month, a year-to-date quantity ordered for each test and year-to-date amount spent on each test. Data should be exported in an “EXCELTM” compatible format.

G. Monthly all report data exported and submitted to the facility shall be HIPAA compliant.

H. The Contractor shall provide on a quarterly basis an anti-biogram report for each organism isolated for each facility laboratory. This report should be sent to the Great Plains Area Chief Medical Officer, Contracting Officer Representative and the Laboratory Supervisor at each facility. The report should contain specimen description, number of specimens collected, culture identification, date of specimen collection, antimicrobial sensitivity, and a composite quarterly report on antimicrobial susceptibility rates.

I. Secure Data transfer a monthly blood culture report broken down by service unit, organism, patient name, patient date of birth, collection date and time and other pertinent data to allow chart review and tracking of blood culture contamination rates to the lab manager and COR.

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J. Send a yearly aggregate antibiogram report of the GPAIHS to the COR sortable by IHS location, specimen source and organism gram stain and morphology for those locations that microbiology is performed by the reference lab.

K. The Contractor shall provide surgical pathology for facilities requiring this service. The electronic and paper pathology reports are to include a gross and microscopic description of each specimen and a diagnosis. In the case of a diagnosis of a malignant tumor, the stage of the disease must be included whenever possible. Contractor will provide reports and/or slides upon request, for all patients being treated for malignant disease within the Indian Health Service or by non-IHS health providers.

L. The Contractor shall provide cervical/vaginal cytology services for the screening and detection of malignant cells and abnormal conditions consistent with current recommendations of the American Society for Colposcopy & Cervical Pathology.

All cytology collection supplies, requisitions and reporting forms shall be provided at no additional cost to the IHS facility. Cervical/vaginal screening methods should include Thin Prep PAP.

Reflex testing of ASC-US results or Co-testing to high-risk HPV-DNA testing shall be an option for each of the referring facilities.

A monthly report including the list of patients who have had cytology services performed, with the date of specimen and by degree of dysplasia by the provider will be provided to the appropriate service unit laboratory supervisor. This report should be individualized for each hospital and clinic.

The “Bethesda System 2001” (or current terminology as accepted by accrediting bodies) terminology shall be used for reporting cervical/vaginal cytological diagnoses. The quality of the cytology service shall be assured through direct supervision by a Pathologist certified in Anatomical Pathology. Each cytotechnologist shall meet the requirements as specified in the Clinical Laboratory Improvement Amendments of 1988.

A statistical report specific to their service unit must be sent to each service unit laboratory supervisor listing at least the following: all the providers, total pap’s MTD, total pap’s YTD, MTD #unsat, YTD #unsat, YTD UNSAT%, no endocervical component MTD, no endocervical component YTD, no endocervical component% YTD, and # of total cases in each of the MTD Groups.

OTHER MALIGNANT NEOPLASMS: (specify) Results of cytology studies shall be returned to the appropriate IHS facility within four (4) business days from the date of receipt at the Contractors laboratory.

The Contractor shall provide, upon written or verbal request, a copy of the original report(s) and the original slide(s) to the party designated by the attending physician.

The Contractor shall maintain a permanent cytology register, which will include patient name, IHS patient identification number and date of birth, facility location and results. A data retrieval system must be available. Thus, allowing the cytology report for a specific patient seen at a given IHS facility on a specified date is available within one

(1) day using the five (5) identification criteria listed above.

The Contractor shall provide to each facility’s designated individual, a list of all patients who have had cytology services performed the previous month, with date of specimen, and results. This list will be grouped into diagnostic categories that are consistent with the Bethesda System 2001 terminology.

M. The Contracting laboratory is subject to on-site inspections by authorized representatives of the U.S. Government prior to contract award and during the contract period to review the Contractor’s facility and services, to examine records for quality assurance practices, current licenses and accreditation and make any other analysis required to determine the adequacy of personnel, instrumentation, and the quality and accuracy of services provided to meet the terms of this contract.

N. The Great Plains Area Laboratories listed above will have the option to send communicable type disease testing to their respective State Labs if they choose. Communicable type disease tests that could and may go to the State labs include but are not limited to: GC/Chlamydia, Influenza, tick-borne diseases, TB, RSV, Pertussis, O&P, Herpes, PKU’s, West Nile virus, Hanta virus, Syphilis, Positive SARS-COV2, and certain Stool culture pathogens.

O. The GPAIHS has Five hospitals, they include Belcourt and Fort Yates in North Dakota and Eagle Butte, Pine Ridge, and Rosebud in South Dakota. The Contractor shall provide onsite Pathologist/Laboratory Director services to each hospital at least 3 times per quarter. These three events should be spaced at approximately equal intervals during the

Page | 13 quarter. Currently two of the Hospitals (Eagle Butte and Fort Yates) are moderately complex labs with emergency release blood. These two facilities, as long as they are moderately complex labs, can have Semi-annual pathologist onsite visits, if appropriate and not otherwise indicated to occur more often, in the case that they go back to high complexity, and then visits would revert to above stated high complexity and a Laboratory Director would need to be negotiated. Rarely site visits maybe canceled due to acts of God or other unforeseen circumstances if agreed to by the COR, Laboratory Manger, and Laboratory Director.

P. Pathologist services to each health center at least once per year, and be available by phone/video conference for consultation. The GPAIHS consists of seven health centers, which are Fort Thompson, Kyle, Lower Brule, McLaughlin, Sisseton, Wagner, and Wanblee all in South Dakota. All circumstances, the Laboratory Director needs to be available for required signatures to satisfy regulatory and accreditation requirements.

Q. On a quarterly basis for hospitals and health centers, a medical technologist shall visit each facility to provide a consulting technologist report. This report must contain items that are needed to maintain regulatory/accreditation compliance and suggested fixes to remain in regulatory compliance with the specific regulatory/accrediting agency that was chosen for that facility. The consulting technologist should at a minimum, meet the requirements to be able to be the laboratory director of at least a moderately complex lab.

R. The contractor shall provide an onsite equipment maintenance technician on a quarterly basis for hospitals and semi-annually for all clinics to provide all required calibration checks. They must also bring with them all required certifying equipment to perform the tasks needed at each facility. The following are some of the tasks, but not limited to, timer checks, pipette checks, scale checks, thermometer calibrations, alarm checks, response times, safety, clean and lubricate, RPMS, light maintenance, accuracy checks, precision checks, etc. on all common lab equipment, such as but not limited to centrifuges, timers, blood bank equipment, thermometers, pipettes, microscopes, rotators, balances, mechanical diff counters all in accordance with manufacturers recommendations.

S. The assigned Pathologist shall perform the function of Laboratory Director on those sites deemed highly complex.

T. The contractor shall provide and perform the function of Laboratory Director for the moderately complex sites as needed for staff vacancies and to fulfil regulatory requirements.

U. The Laboratory Director for our moderately complex clinics must, at a minimum, meet all appropriate CLIA and COLA requirements and standards for Laboratory Director for the laboratories they oversee for oversight requirements, education and experience, and onsite visit requirements, if more stringent than what is required in this document.

V. The Laboratory Director for our moderately and highly complex hospitals must, at a minimum, meet all appropriate CLIA and JOINT requirements and standards for Laboratory Director for the laboratories they oversee for oversight, education and experience, and onsite visit requirements, if more stringent than what is…