Performance Work Statement - Reference Lab Testing Services - CTX - Revised 2-9-2023.docx

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

1.1 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. There are 4 main parts to this contract: 1. CLIA required Laboratory Directorship, Technical Supervisor Clinical Consultants, and consulti 2. Instrument tech for calibration checks, alarm set points, thermometer checks and etc. 3. Reference lab testing with electronic downloading of orders and results. 4. Reports

1.2 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.

1.3 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 of 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 when they are closed:

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 identification and sensitivity testing on one or more of the following culture types: body fluids, wound, or blood cultures.

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

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

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: Twelve (12) months (1 Year), with four (4) one-year options

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: The government anticipates award of a Firm Fixed-Price, Non-Personal Healthcare Service, Indefinite Delivery/Indefinite Quantity (IDIQ) contract, subject to a single award.

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 effects 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 assures themself that their work complies with the requirements of the contract. The contractor’s quality 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 apprise the contractor of how the government views the contractor’s performance and the contractor will apprise 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 is 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 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 to notify 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’s Representative (COR) will perform a single evaluation when the contract is complete. For contracts exceeding one year, the COR 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 the sixty will result in the Government’s evaluation being placed on file in PPIRS without contractor’s comments.

1.15 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 contact for each of the government contracted facilities.

1.15.1. Size of system and government experience.

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

1.15.3. 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.

1.15.4. 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.

1.15.5. 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 .

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

2. DEFINITIONS AND ACRONYMS:

2.1 Definitions: Terms used within the PWS

Contractor. A supplier or vendor awarded a contract to provide specific supplies or services to the government. Term refers to the prime contractor.

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.

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.

Day. Unless otherwise specified in the PWS, day(s), references a calendar day(s) Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

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

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

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

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

2.2. 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 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

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1 Equipment: None

3.2 Materials: None

4. CONTRACTOR QUALIFICATIONS:

Requirements of Laboratory & Contractor Personnel

4.1 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(ies) must maintain valid certifications during the entire performance period of this contract. As the certificates reissued or re-awarded, the Contractor must provide a copy to the Contracting Officer’s Representative. Certificates of accreditation s 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:

· 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.

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

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

· 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.

· 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.

4.2 Personnel

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.

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, and etc.

· Provide a report format for the laboratory director’s report and also 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 aggregate by the GPAIHS 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.

4.3 Service 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 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

5. TASK SPECIFICATIONS:

5.1 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.

5.2 Specimen Preparation and Storage for Reference Testing Specimens

5.2.1 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.

5.2.2 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

· Test Kits: Traysolol

· Transfer Supplies: Amber transfer tube w/cap, Frozen Transpak Bottles

· Packaging/Mailing supplies: Foam tube rack shipping kits, Bio-hazard bags

· Any other specialty tubes and/or kits

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

5.3 Transportation Services for Reference Testing Specimens

5.3.1 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.

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

5.3.3 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:

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:

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

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

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

5.4 Specimen Testing

5.4.1 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/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.

5.4.2 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 l)) of laboratory testing services on the biomedical materials.

5.5 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 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.

5.6 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 l).

B. A report of laboratory testing results must be issued through the host to host electronic transmission of the test results and as a printed final 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 print automatically in the laboratory by a printer suppled 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.

5.7 Record Keeping

5.7.1 The contractor must establish a record keeping system of all tests performed.

5.7.2 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.

5.8 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 for 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 when 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 11.2 for additional information).

b) Must provide onsite visits per the parameters listed in section 13 below.

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.

5.9 Consultative Services, Laboratory Directors, and Utilization Reports (See also section 10 and technical exhibit 1)

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 to the facilities on mechanisms to reduce their costs.

C. 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)

D. 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 services to each hospital at least 2 times per quarter (the third visit can be via electronic means if agreed upon by lab manager and laboratory director), if not in person, obtain signatures via electronic method and/or telephonic/web conferencing with the site. These three events should be spaced at approximately equal intervals during the course of the 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 quarterly pathologist onsite visits, if appropriate and not otherwise indicated to occur more often. If any of the above named hospitals perform only moderate complexity testing, then the pathologist consulting visits may occur quarterly, 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.

E. 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.

F. 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.

G. 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, etc. see #2 below on page 4. The assigned Pathologist shall perform the function of Laboratory Director on those sites deemed highly complex. The contractor shall provide and perform the function of Laboratory Director for the moderately complex sites as needed for staff vacancies and to fill regulatory requirements.

5.10 Data Management System

A. Contractor shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor’s database. Required test parameters include:

i. Ordering code

ii. LOINC code

iii. CPT code

iv. Interface/result code

v. Test cost

vi. Reference ranges

vii. Units of measurement

viii. Test result interpretation or interpretive remarks, if appropriate

ix. Testing site (if not performed at the vendor’s main laboratory facility

x. Test methodology

xi. Specimen types

xii. Specimen collection and handling requirements

xiii. Indication whether test is a panel/profile test, list of tests included

The parameters for all tests in the Contractor’s database shall be kept current and be available to the Government sites throughout the performance period of the contract via a test compendium spreadsheet. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

B. Information should be encrypted or have a dedicated secure line for the integrity of patients and results and reports through a RPMS direct portal. Demonstrate that you have an HL7 interface in the RPMS system.

5.11 Telecommunication Interface Requirements

5.11.1 The contractor must possess a IHS Data Exchange Agreement (DEA), and a Business Associates Agreement (BAA) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop, program, and test an interface connection to electronically transmit orders and test results between the Contractor’s host computer system and the Government’s host computer system (RPMS). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.)

5.11.2 The RPMS host computer system supports a Universal Interface (UI) and a Generic Interface System (GIS). The contractor must establish a secure electronic connection between the Contractor’s host computer and the Government’s host computer. The contractor must have a program built into the RPSM that accepts their interface connection. The configuration must provide the required security of the Government host computer system. The actual electronic connection between the RPMS and the Contractor’s host system must be setup prior to the contract award. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract.

5.11.3 Contractor shall provide, install, and if necessary, remove, all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all sites referred to herein. This may include, but is not limited to:

a) Generic Interface System (GIS) for the interface connection

b) Shipping list printers

c) Bar-code printers

d) Back-up result printers connected directly to Contractor’s computer system

e) Any required communication lines

f) Software to receive and send orders

g) Consumable supplies to maintain the operation of the equipment listed above, e.g. toner, etc.

5.11.4 Contractor shall be responsible for all annual recurring costs associated with support and maintenance of the Generic Interface System (GIS) system including all GIS equipment, software and instrument connections. The Generic Interface System will be located in a Government secured area. The Contractor shall coordinate with the respective Government Information Technology Department to access the GIS.

5.11.5 The Contractor shall conduct preventive maintenance and repair of Contractor furnished hardware, software and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software.

5.11.6 All electronic messaging between the two (Contractor and Government) host computer systems using the GIS shall utilize RPMS Health Level Seven (HL7) V1.6 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc web-site, www.HL7.org.

5.11.7 The contractor shall provide a detailed plan (dates, names, facilities, and etc.) on how the reference interface will be switched from one electronic reporting system to another. This will need to be active within 14 days of contract start date and will need to provide minimal impact to patients and IHS laboratory staff. The contractor shall have a current HL7 interface with the IHS Resource and Patient Management System (RPMS).

5.12 RPMS Generic Interface System (GIS): Identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The GIS specification follows very closely the HL7 V2.3.1 standard. GIS identifies encoding tables and HL7 message protocol conventions.

GIS also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format in the shipment. This information will also be in electronic HL7 format.

(GIS) software will provide a HL7 acknowledgement for the receipt of tests results from the contractor. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy must contain Government’s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest.

5.12.1 The Contractor shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government’s assigned specimen identification shall be returned to the requesting medical center.

5.12.2 Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain and support the services of the host-to-host linkage between the Government and the Contractor.

5.12.3 Contractor shall provide in-service training required for the routine loading and care of printers and other hardware and will also provide at least one in-service per year on topics to help the lab become better, these need to be performed on site. The training will ensure that Government staff is capable of performing routine servicing of hardware and will increase the quality of the laboratory results.

5.12.4 Meeting the below specified deadlines are of utmost importance to the Government. As such, Contractor shall have an operational interface connection with the facilities listed herein within 14 days of contract award. The establishment of the test database will be the responsibility of the Contractor and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmissions through the interface connection will be the joint responsibility of the Government and Contractor.

Test database construction and transmission validation will occur using a phased approach that occurs over the periods of time listed in the table below. Identification of specific test names for each phase will be provided after contract award.

Names Test Transmission Validation Time Periods

The Contractor shall certify in writing successful test validation on the final day of the time periods indicated for Phase 1 and Phase 2 listed above. Written certification will not be required for Phase 3, as test establishment and validation will occur on an individual, as needed basis.

6. CONFIDENTIALITY OF PATIENT RECORDS

A. The Contractor is a IHS contractor and will assist in the provision of health care to patients seeking such care from or through IHS. As such, the Contractor is considered as being part of the Department health care activity. The contractor is considered to be a IHS contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of IHS records access and patient confidentiality, Contractor is an IHS contractor and therefore, Contractor may have access, as would other appropriate components of IHS, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of IHS records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from IHS has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as IHS.

B. The records referred to above shall be and remain the property of IHS and shall not be removed or transferred from IHS except in accordance with U.S.C.551a (Privacy Act), 5 U.S.C. 552 (FOIA), and federal laws, rules and regulations.