Reference Lab SOW updated4.9.25.docx

Statement of Work (SOW) Reference Laboratory and Anatomical Pathology Testing Services

1. PURPOSE OF THE PROJECT

The Oklahoma City Area Office (OCAO), Indian Health Services (IHS) has a requirement for Reference Laboratory Services to provide laboratory testing procedures for the Oklahoma City Area Office clinics and hospitals providing laboratory services to the following nine (9) sites.

Department of Health and Human Services Indian Health Service

ANADARKO INDIAN HEALTH CENTER

201 EAST PARKER MCKENZIE DRIVE

ANADARKO, OK 73005

CARNEGIE INDIAN HEALTH CENTER

212 E 4TH ST.

CARNEGIE, OK 73015

WEWOKA INDIAN HEALTH CENTER

CLINICAL LAB

SH 56 & 270

PO BOX 1475

WEWOKA, OK 74884

CLINTON INDIAN HEAL TH CENTER

10321 N 2274 ROAD

CLINTON, OK 73601-9303

El RENO INDIAN HEALTH CENTER

1801 PARKVIEW DRIVE

EL RENO, OK 73036

HASKELL HEAL TH CENTER

2415 MASSACHUSETTS

LAWRENCE, KS 66046-4827

PHS LAWTON INDIAN HOSPITAL

1515 LAWRIE TATUM ROAD

LAWTON, OK 73501

PAWNEE INDIAN HEAL TH CENTER

1201 HERITAGE CIRCLE

PAWNEE, OK 74058

WATONGA INDIAN HEALTH CENTER

1305 S CLARENCE NASH BLVD

WATONGA, OK 73772

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

1. The Contractor is to perform laboratory testing procedures listed on the attached schedule, and any other laboratory testing as required, when ordered by one of the listed facilities. Each facility shall have the prerogative to direct emergency testing (as defined by the clinician) to any laboratory of its choice for expedient results reporting.

2. The Contractor shall perform in-house, the majority (90% or more) of testing received from the Oklahoma City Area IHS Service Units the Contractor shall include with the bid and after award of contract will provide to the Oklahoma City Area IHS Service Units:

a) A list/catalog of tests/procedures performed in the Contractor’s laboratory where specimens are sent, to include instructions for specimen requirements and handling;

b) A list/catalog of tests/procedures performed in another laboratory but with the Contractor’s laboratory network of regional and satellite laboratories, to include instructions for specimen requirements and handling and the name and address of the laboratory where sent;

c) A list/catalog of tests/procedures performed in another laboratory outside the Contractor laboratory’s network of regional and satellite laboratories, to include instructions for specimen requirements and handling and the name and address of the laboratory where sent; and

d) A Contractor’s laboratory testing frequency with a turnaround time schedule listing the expected time interval from receipt of specimen to reporting of test results, which will be met ninety percent (90%) of the time.

3. There shall not be a separate charge for specimen handling/processing by the Contractor’s laboratory for those tests sent to a second laboratory, or be invoiced as “miscellaneous tests”.

4. Until such time that test requisitioning is electronic or in the event the electronic test requisitioning is inoperable, the Contractor shall provide at no additional cost, to each requesting laboratory, Contractor’s test requisition forms which shall:

a) Be pre-printed;

b) Include the name of the facility from which specimens are sent;

c) Include the address of the facility from which specimens are sent;

d) Include a unique identification number of the facility from which specimens are sent;

e) Be in duplicate or more, which will provide the requesting facility with a copy of the requisition; and

f) Be designed with a check-off system listing the commonly ordered tests on one page. Please include a sample requisition(s) with the bid.

Electronic test requisitioning shall include items b, c, d, and f.

5. The Contractor shall arrange and provide at a minimum Monday through Friday (excluding Federal Holidays) specimen pick-up from each facility and transport specimens to the Contractor's laboratory using the most efficient means available. The pick-up times shall be established by mutual agreement between the respective facility laboratory and the Contractor with the exception of Lawton Indian Hospital facility that will require two courier pick-ups on a daily basis. Laboratory specimens shall be in transit between the facility and the Contractor’s laboratory no more than eight (8) hours ninety percent (90%) of the time. The sender shall be notified as soon as reasonably possible or within the twenty-four (24) hour period following specimen pickup of any specimen received in an unsatisfactory condition, is not received, or is not appropriate for the test requested. Specimen collection and transport materials, including packaging and cold packs and/or dry ice for frozen specimens will be supplied by the Contractor at no additional cost to the facility. Shipping containers color coded for frozen/refrigerated/ambient temperatures are required. Specimen integrity during transport shall not be compromised. The contractor shall provide continuous (24-hour, 7 day a week) emergency and stat courier service, utilizing contractors STAT testing menu to include PT/INR and Carboxyhemoglobin.

6. Until such time that electronically ordering/reporting interfacing capabilities are functioning, the ordering facility laboratory shall receive at a minimum duplicate hard copy of each test result from the Contractor’s laboratory using the most expeditious and cost-effective manner, and this is to be established by mutual agreement between the respective Laboratory and the Contractor before contract award. If an electronic receiver-printer is to be used for this purpose, following each transmission batch should be a transmission summary, which includes the number of patients where abnormal results were reported. The electronic receiver-printer shall be installed within 10 working days of contract award. Reports for commonly ordered tests that are run daily shall be received by the following business day not later than 12:00 p.m. The contractor shall make available an online tests results review for the ordering facilities medical providers and health information management staff. In addition to the test results, the reports shall be chart-ready and include the following:

a) Name and address of the Contractor’s laboratory;

b) Name of the laboratory performing the test if other than the Contractor’s laboratory;

c) Patient name;

d) Patient complete identification number;

e) Patient date of birth and gender if known;

f) Ordering clinician name;

g) Date specimen collected, if known;

h) Date specimen received by contract laboratory;

i) Date results reported;

j) Contractor’s laboratory assigned accession number;

k) Test reference (normal) ranges; and

l) Test interpretation when indicated.

“Critical values,” or significantly abnormal test results, which may indicate a life threatening condition, will be immediately communicated to the client laboratory and the contractor will follow the client facility’s critical value reporting policy, followed by the faxed report. Include with the bid a listing of test values where other than routine reporting action is taken. It is expected that for specimens where degradation is not a problem, they will be retained for a minimum of one week. If, in the opinion of the requesting physician, a test result is not compatible with the patient’s clinical condition, and provided there is adequate specimen remaining, a repeat test may be requested at no additional charge.

7. Beginning twelve (12) months after start of contract, the Contractor shall provide an Antibiogram report to the COR and Laboratory Supervisors. This report shall be inclusive for the previous 12 months and for each organism, for which sensitivities have been performed, list the total number times tested and the percent sensitive to each antibiotic tested. Accompanying the report, for the same time period, shall be a listing of all sites from which organisms were tested, and the frequency each organism was tested from each site.

8. The Contractor shall provide cytology services for the screening and detection of malignant cells and abnormal conditions in PAP and other body secretions or body fluids such as urine, sputum, peritoneal and pleural fluids including procedures listed on bid schedule. All cytology supplies (including those for PAP Thin Prep preparations), reagents, specimen containers, requisition and reporting forms shall be provided at no additional costs.

9. The quality of the cytology service shall be assured through direct supervision by a Pathologist certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. Each Cytotechnologist or person examining liquid-based cytology/thin prep preparations must meet the requirements as specified in the Clinical Laboratory Improvement Amendments of 1988.

10. The Contractor shall provide, within the day of specimen receipt, urgently needed cytology reports on specimens collected in cases with a life-threatening clinical presentation. Special or urgent handling will be noted on the request form.

11. Results of cytology studies shall be returned to the ordering facility within seven (7) to ten (10) working days from date of receipt at the Contractor’s facility ninety percent (90%) of the time. In the absence of an electronic bi-directional interface, the report shall be typed in duplicate and the original shall be chart ready.

12. The Contractor shall provide gross and microscopic examinations of organs, tissues, and other biopsy specimens removed during surgical procedures, or postmortem examination. The Contractor shall provide the appropriate equipment and supplies for the above processes. The contractor shall provide surgical pathology services at the Lawton Indian Hospitals

13. Oklahoma City Area IHS Service Units are prepared to electronically receive and/or transmit data. Within six (6) months of contract award, the Contractor shall be able to provide a bi-directional interface using standard HL7 language to the facility’s Resource and Patient Management System (RPMS). The bi-directional interface will send orders and receive results electronically via TCP/IP connection (Virtual Private Network). The Contractor will provide an electronic copy of their test file with order codes, result codes, CPT codes and LOINC codes. The Contractor will work with the Oklahoma City Area Informatics team to develop, enter all available reference laboratory tests into the Service Unit RPMS lab package and test the interface. There shall not be a separate line item charge associated with interface completion.

The Contractor shall provide a bi-directional HL7 interface to the RPMS lab package that has been developed in conjunction with and tested by the Indian Health Service’s Office of Information Technology and is in use at other IHS facilities.

Within 1 month of the award of the contract, the Contractor shall assign a project manager/specialist and dedicate system resources to the set up and testing of the Contractor laboratory interface at each facility. The Contractor will submit a project plan with weekly updates to the COR of the project timeline. The Contractor shall perform updates to the test database in a timely manner, either through email or regular paper mail.

14. The contracting laboratory will notify the State Surveillance Officers of all required reportable diseases within the state of the facility. The Contractor shall make arrangements for reporting formats with the State Surveillance Departments. Reportable diseases for Oklahoma and Kansas will be identified by the Contractor and reported as described.

15. The Contractor shall provide a monthly report summary to the Laboratory Supervisor a listing of positive laboratory findings for all reportable diseases.

16. Contractor shall provide all tubes, containers, media, reagents, and any other supplies necessary for specimen collection. Materials shall be supplied within 72 hours of request.

17. The Contractor shall bill all anatomical pathology specimens (cytology, tissue, organs, and/or biopsy specimens) at the Medicare/Medicaid prevailing rate with documentation of the ICD10 code/s.

18. Contractor shall repeat testing upon request. When Oklahoma City Area IHS providers feel that reported results do not correlate with the clinical status of the patient, the Contractor shall repeat the specimen testing within 24 hours of request. If repeat testing does not resolve the conflict, the Contractor shall submit the specimen to an “outside” facility, (mutually agreed upon), at the Contractor’s expense.

19. Contractor shall provide, install, and maintain a Laboratory Data Manager (LDM) at each Oklahoma City Area IHS facility. The LDM is to include a color monitor (13” min) stand-alone PC capable of generating requisitions, receiving patient reports, (partial and complete), dual tray laser printer capable of printing min 8 pgs/min with a min 600 DPI resolution. LDM is capable of password protected. LDM shall be installed and operational prior to the contract award. Prior to activation, the Contractor shall train the lab staff at each Oklahoma City Area IHS facility on the LDM. The Contractor shall be responsible to provide toner cartridges, paper, and any other necessary supplies relative to the maintenance and operation of the LDM.

The LDM shall not be inoperable for more than twenty-four (24) hours at any time. In case of printer failure, a copy of all results not transmitted shall be delivered by courier with then next scheduled laboratory specimen pick-up or by fax.

20. Contractor shall provide a monthly workload report, unique to each Oklahoma City Area IHS facility. The workload report shall include the test procedures performed with accompanying procedure code in MTD & YTD tallies.

21. The Contractor shall provide a quarterly written quality management report regarding lost or rejected specimens. If needed the Contractor will perform a root cause analysis on each instance.

3. PERIOD OF PERFORMANCE

The base year Period of Performance will be 12 months from date of award with 4 option years.

4. LEVEL OF EFFORT

4.1. The Contractor shall arrange and provide at a minimum Monday through Friday (excluding Federal Holidays) specimen pick-up from each facility and transport specimens to the Contractor's laboratory using the most efficient means available.

4.2. the ordering facility laboratory shall receive at a minimum duplicate hard copy of each test result from the Contractor’s laboratory using the most expeditious and cost-effective manner,

4.3. Contractor credentialing must comply with the requirements specified in the CLIA and within the SOW.

4.4. Contractor must adhere to reporting requirements as directed in the SOW

4.5. Contractor shall provide, install, and maintain a Laboratory Data Manager (LDM) at each Oklahoma City Area IHS facility.

5. SPECIAL REQUIREMENTS

5.1. In accordance with HHSAR 304.1303, To ensure compliance with Homeland Security Presidential Directive-12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD-12) It is the IHS policy that all staff and contractors who require physical access to federally controlled facilities and logical access to the IHS Information Technology (IT) networks and systems must obtain an HSPD-12-compliant access card. Individuals will be issued an access card upon meeting the HSPD-12 requirements and a favorable background investigation.

5.2. The OKC Area Office is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by OKC Area Office official, presenting valid identification, smoking restriction and any safety procedures.

5.4. The contractor shall not disclose or cause to disseminate any information concerning operations of OKC Area Office. Such action(s) could result in violation of the contract.

5.5. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the Contracting Officer Representative (COR).

5.6. The offeror shall provide the following Reference Laboratory credentials with their offer:

5.6.1. The Laboratory shall be licensed as a medical laboratory as specified in the Clinical Laboratory Improvement Amendments of 1988. Proof of U.S. Department of Health and Human Services Interstate Laboratory License; and Medicare Provider Number is required.

5.7. The Contractor's laboratory shall maintain a Quality Assessment Plan with documentation of quality assurance activities for the previous year.

5.8. The laboratory shall maintain a laboratory standard internal Quality Control Program for all procedures as appropriate and participate in recognized proficiency testing program for each laboratory discipline.

5.9. The laboratory shall use testing methodologies that are clinically acceptable, or methodologies which are "state of the art" in laboratory medicine.

5.10. The laboratory shall have adequate staff and facilities to provide the required clinical laboratory tests/procedure and professional consultation to the IHS facilities.

5.11. The laboratory shall provide documents to support the qualifications and capabilities of the offeror to fulfill requirements of the contract. Special attention should be paid to related efforts to include references from both metropolitan and rural hospitals, a listing of key personnel who will be assigned for direct work to meet the terms of the contract, along with resumes that clearly present the qualifications of these personnel.

5.12. The laboratory shall include with the offer a listing of test values where other than routine reporting actions are taken.

5.13. The laboratory shall include with the offer a sample requisition form which contains the information as outlined.

5.14. The laboratory shall include, with the offer, and after award of a contract, provide to the IHS laboratory:

5.14.1. a list/catalog of tests/procedures performed in the Contractor's laboratory where specimens are sent, to include instructions for specimen requirements and handling;

5.14.2. a list/catalog of tests/procedures performed in another laboratory but within the Contractor the laboratory's network of regional and satellite laboratories, to include instructions for specimen requirements and handling and name and address of the laboratory where sent;

5.14.3. a list/catalog of tests/procedures performed in another laboratory outside the Contractor laboratory network of regional and satellite laboratories, to include instructions for specimen requirements and handling and the name and address of the laboratory where sent; and,

5.14.4. a Contractor's laboratory testing frequency with a turnaround time schedule listing the expected time interval from receipt of specimen to reporting of test results, which will be met ninety percent (90%) of the time.

5.14.5. a sample of the Offeror’s invoice.

5.15. Verification of the above shall be provided to the Contracting Officer prior to contract award, and shall be maintained for the duration of the contract.

5.16. The laboratory shall include documentation of prior past history of successful bi-directional interfaces that utilizes the HL7 RPMS Indian Health Service laboratory information system

5.17. Emergency services shall be provided as an on-call, 24 hours per day, 7 days per week basis. The Contractor shall be responsible for delivery of emergent specimens to the Contractor’s facility. Emergency pathology procedures and examination shall be available within ninety (90) minutes of telephone notification by the IHS. Results, interpretation and consultation shall be provided by either contractor to IHS immediately following completion of procedures, examinations and tests. This may be accomplished by telephone conference followed by delivery of reports/documents on the next regular scheduled pick-up visit to the hospital; or by pick-up of reports by the IHS facility, whichever is deemed appropriate by the reviewing IHS physician.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.1. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of services. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.2. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday.

6.3. The Contractor shall establish a reporting system that includes site visit reports, monthly service unit workload reports, and other appropriate ad hoc reports at no extra charge. The contractor shall respond to CMS, TJC, and other governmental and accrediting agency requests for Government Performance and Results Act (GPRA) performance measurement reports, statistical evaluation, semi-annual evaluation of calibrations an other special report requests.

6.4. Contractor shall provide a final chartable patient report. Final reports are to be computer generated print-outs and shall be provided within 1 hour of completion of test via the laboratory printer and laboratory interface, unless methodology requires longer time for completion.

6.5. Critical/Panic results are to be phoned immediately to the requesting Oklahoma City Area IHS facility.

6.6. All reports of laboratory tests performed under this contract shall include:

Patient name and IHS Chart Number Name of requesting physician Contractor’s accession number Date and time of specimen collection Date and time of specimen receipt in the Contractor’s laboratory Reference ranges of methodology Initials of technologist performing the procedure. Location of actual testing

6.7. All pathological reports provided under this contract shall include diagnostic terminology and codes of currently recognized and accepted nomenclature to ensure standard diagnoses readily understandable by the attending physician and consistency in reporting of results and file indexing for retrieval by manual and electronic means.

6.8. Anatomical Pathology Reports including surgical and necropsy shall include descriptive analysis of both gross and microscopic findings unless exempted by the IHS medical staff

6.9. The descriptive analysis shall be in sufficient details to justify the diagnosis rendered which shall be based upon such analysis. The report shall include a summary of the clinical information provided by the attending physician.

6.10. Gross tissue examination reports shall contain the following information:

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

The Government shall provide the facilities, equipment and PPE for the use by the contractor for the provision of the services required under this contract.

Information: All unique government information related to this lab testing service that is necessary for Contractor performance shall be made available to the Contractor. The Contracting Officer or COR designee shall be the point of contact for identification of any information supplied by the government.

Communication (Modem) Line: Each Oklahoma City Area IHS facility shall be responsible to provide, install, and maintain a dedicated communication (modem) line.

Communication (LDM) Space: Each Oklahoma City Area IHS facility shall provide space for the Laboratory Data Management (LDM).

Specimen Processing/Supplies Space: Each Oklahoma City Area IHS facility shall provide space for the processing of specimens and storage of collection/processing/transport supplies.

Specimen Storage: Each Oklahoma City Area IHS facility shall provide refrigerator and freezer storage space for specimens awaiting pickup and transport.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract.

Information: All unique Contractor information related to this lab testing service that is necessary for government operations shall be made available to the Contracting Officer or COR designee. The designated point of contact (as identified by Contractor) shall supply any requested information.

Specimen Collection Supplies: The Contractor shall supply each Oklahoma City Area IHS facility with specimen collection supplies.

Specimen Transport Supplies: The Contractor shall supply each Oklahoma City Area IHS facility with specimen transport supplies.

Communication (LDM): The Contractor shall supply each Oklahoma City Area IHS facility with a Laboratory Data Management (LDM) system.

Laboratory Request Forms: The Contractor shall supply each Oklahoma City Area IHS facility with Laboratory Request Forms.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

1. The Contractor shall comply with the Privacy Act and HIPAA.

2. The Contractor shall be Clinical Laboratory Improvement Amendment (CLIA) certified.

3. The Contractor shall be current and in good standing with Joint Commission, and/or College of American Pathologists (CAP) accreditation.

4. The Contractor shall provide the services described on each separate order independent of Government supervision.

5. The Contractor shall deliver to the Government such medical reports, items, and services as specified on each separate order

6. Review shall include examination of quality, quantity, and timeliness of all services provided; plus responsiveness of Contractor in meeting the minimum requirements of the contract.

Area Laboratory Supervisor Signature:_________________________

Chief Operating Officer Signature:_________________________ image1.png image10.png image2.png image20.png