SOW - OCAO Laboratory and Pathology Testing Services.docx

STATEMENT OF WORK

REFERENCE LABORATORY AND ANATOMICAL PATHOLOGY TESTING

SERVICES FOR OKLAHOMA CITY AREA INDIAN HEALTH SERVICES

PURPOSE: This Statement of Work describes the requirements to provide reference laboratory and anatomical pathology testing services for Oklahoma City Area Indian Health Service facilities.

Background: The Indian Health Service (IHS) is an agency within the US Dept of Health and Human Services, and is responsible for providing federal health services to American Indians and Alaska Natives. The provision of health services to members of federally recognized tribes grew out of the special relationship between the federal government and Indian tribes. The IHS is the principal health care provider and health advocate for the Indian people. The IHS goal is to assure that accessible health care services are available to the American Indian and Alaska Natives. The IHS currently provides health services to approximately 1.5 million American Indians and Alaska Natives, who belong to 557 federally, recognized tribes in 34 states.

The Oklahoma City Area IHS administers health care to approximately 39 tribes with a direct site user population of approximately 170,000, through 12 health centers and hospital facilities, and outpatient/outreach programs. There is a need to supplement and augment the laboratory and anatomical pathology testing services not available in most Oklahoma City Area IHS facilities. The purpose of this request is to obtain contracted clinical and anatomical pathology, cytology, histology and laboratory services along with consultative services for patients at the two (2) PHS Indian Health Service Hospitals and eight (8) PHS Indian Health Centers within the Oklahoma City Area Indian Health Service (See attachment). The contract shall provide laboratory, pathology, cytology, and histology services for testing which cannot be accomplished at the listed facilities, as well as provide for clinical laboratory consultation and directorship services as needed. Reference laboratory and pathology services required by the Oklahoma City Area are listed in attachment D-1. This list represents an annual estimate and does not intend to be inclusive of all procedures and services. The Contractor shall be expected to cover a range of consultation, laboratory, pathology, cytology, histology, and directorship services typically provided in rural civilian practices of similar size.

Scope: The Contractor shall provide reference laboratory, cytology, histology and anatomical pathology testing services for the Oklahoma City Area IHS in accordance with this Statement of Work

The Oklahoma City Area IHS locations include: Claremore Indian Hospital, Clinton Indian Health Center, El Reno Indian Health Center, Watonga Indian Health Center, Haskell Indian Health Center, Lawton Indian Hospital, Anadarko Indian Health Center, Carnegie Indian Health Center, Pawnee Indian Health Center, and Wewoka Indian Health Center. The relative number of specimens submitted by each Oklahoma City Area IHS location is variable and dependent upon the size of each facility.

Duties and Responsibilities: These duties encompass reference laboratory and anatomical pathology, cytology, and histology testing services to include specimen collection, specimen pickup/transport, testing, and reporting.

Standards of Medical Practice: The standards of medical practice and duties of the Contractor though its physicians shall be determined pursuant to Governing Body bylaws, medical staff bylaws, rules and regulations of the appropriated HIS hospital and health center, applicable provisions of law including but not limited to Center 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 (TJC) or other CMS deemed accrediting agencies. In accordance with the Indian Health Service credentialing policy, the Contractor shall complete primary source verification for each pathologist performing services under the contract. Upon the assignment of a pathologist to an Oklahoma City Area Service Unit, the pathologist shall complete a credentials packet and be credentialed by the Service Unit Governing body. Contractor pathologists shall be board certified by the American Board of Pathology.

Contractor Qualifications/Requirements: The Contractor’s laboratory shall be under the direction supervision of a physician who is board certified in Clinical and Anatomical Pathology by the American Board of Pathology. The Contractor’s laboratory shall be licensed as a medical laboratory as specified in the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88). The laboratory must also be accredited by the College of American Pathologists. The Contractor shall have adequate professional staff to provide all requested services in the appropriate quality, quantity and in a timely and cost effective manner. The laboratory will be under the direct supervision of a Physician Director; who is certified in both Anatomical and Clinical Pathology by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOPB). The Laboratory shall maintain an internal quality Control Program and participate in proficiency testing with the college of American Pathologists (CAP) and/or the Centers for Disease Control or other CMS/HCFA approved proficiency program.

The Contractor shall provide clinical and anatomical pathology services which shall include compliance by the Contractor with applicable standards of the College of American Pathologists (CAP), the Clinical Laboratory Improvement Act of 1967, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), The Centers for Medicare and Medicaid (CMS) and The Joint Commission (TJC).

The Contractor shall perform the work described in this contract dependent of Government supervision. Professional surveillance of services under this contract will be provided by the designated Contracting Officers Representative.

Contractor Personnel Requirements

Physician Director: Director shall be in a possession of a current and valid, unrestricted license to practice medicine in both the State of Oklahoma and the state in which the laboratory is located in. Director shall be certified in both Anatomical and Clinical Pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. Director shall be a graduate from an American Board of Pathology/American Osteopathic Board of Pathology approved and recognized, four year post-graduate training program which must have included, at a minimum, two full years of training in anatomical pathology and two years of training in clinical pathology with a written and recognized Certificate of Completion of such training from the residency program. Director shall have unrestricted diagnostic Anatomical and Clinical Pathology privileges from a Joint Commission (TJC) or CMS accredited hospital.

Senior Medical Technologist: Medical Technologist shall be a graduate of an approved medical technology program and have a current valid certification/registration as a Medical Technologist by one of the follow agencies: American Society for Clinical Pathology (ASCP), American Medical Technologist (AMT) or International Society of Clinical Laboratory Scientists (ISCLS)

Place of Performance: With regard to specimen collection, pickup/transport and ordering/reporting, the service shall be performed at the various Oklahoma City Area IHS facilities. With regard to specimen testing, the service shall be performed at the Contractor’s testing locations.

Point of Contact: The Contractor shall provide a point of contact that shall be responsible for the performance of the services. This individual shall have full authority to act for the Contractor on all matters relating to the daily operation of the contract. The Contractor shall designate this individual in writing to the Contracting Officer (CO) before the contract start date. An alternate may be designated, but the Contractor shall identify those times when the alternate shall be the primary point of contact. For daily communication each facility will have a designated Contracting Official Technical Representative (COTR will be the Lab Supervisor) that will communicate directly with the Contractor for all clinical and administrative laboratory issues.

Availability: The point of contact shall be available via telephone M – F during standard business hours.

Applicable Documents:

Please refer to the following web links listed:

Centers for Medicare and Medicaid Services (CMS) http://www.cms.hhs.gov Health Insurance Portability and Accountability Act (HIPAA) of 1996 http://www.cms.hhs.gov/hipaa Computer Security Act of 1980 http://www.ihs.gov/adminmgrresources/computersecurityact IHS Computer Security Directives http://www.ihs.gov/adminmgrresources

DEFINITIONS:

Chartable Patient Report: The report includes the testing site name, address, telephone number, and Lab Director. Includes the patient name, identification number, date of birth, and gender. Includes the specimen date of collection, date of receipt, identification number and requested test. Includes the specimen result, reference range, test units, and abnormal flags.

Contracting Officer (CO): A government employee with authority to enter into, administer, terminate contracts, and make relative determinations / findings.

COR (Contracting Officer Representative) Designee: A government employee who assists the activity of the CO in the administration of contracts. The COR designee is primarily responsible for the technical assistance and day-to-day management of the contract.

Critical / Panic Results: Results that fall outside of “normal” patient reference ranges that are deemed life threatening in nature.

FAR (Federal Acquisition Regulation): The regulations in use (by law) for all government agencies in the acquisition of supplies and/or services.

LDM (Laboratory Data Manager): Computer system that manages all aspects of ordering tests, reporting results, and retrieving results.

Optimal Conditions: The shipping and storing conditions of biological specimens to preserve the integrity of the analyte.

Primary / Centralized Test Site: The test site to where all specimens are initially transported prior to sorting and analyzing.

RPMS (Resource Patient Management System): Host computer system utilized by the IHS.

Special Pickup: A pickup and transport of specimens outside of established facility pickup times.

Unacceptable Specimen: Specimens that are inadequate for testing, whether due of inadequate temperature storage, age, collection method, contamination, insufficient quantity (QNS), improper preservation, etc.

GOVERNMENT FURNISHED INFORMATION / PROPERTY:

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.

CONTRACTOR FURNISHED INFORMATION / PROPERTY:

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.

REQUIREMENTS:

The Contractor shall provide reference laboratory and anatomical pathology testing services that shall include laboratory director/consultation services to Oklahoma City Area IHS.

Specimen Collection: 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.

Specimen Transport: The Contractor shall provide all anatomical and cytological specimen shipping containers and any other reagents, preservatives, packaging materials, packaging labels, laboratory test request and report forms for specimen transport at no extra charge to the government. Materials shall be available to meet each Oklahoma City Area IHS facility pickup schedule. Method of transport of specimens shall be individually arranged by the contractor for each facility to allow for the fastest and most efficient means of arrival. Courier services will be arranged and paid for by the Contractor.

The Hospitals - The Contractor shall provide for two scheduled pick-ups per day, seven (7) days per work week, including federal holidays (10 Federal holidays per year). The Contractor shall provide any special transport containers or transport environment needed for preservation of specimens during transport. 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.

The Health Centers - The Contractor shall provide for one to two scheduled pick-ups per day, five (5) days per week, Monday through Friday, excluding federal holidays, these will be scheduled specimen pick-ups, designated by each facility unit facility laboratory supervisor. The Contractor shall provide any special transport containers or transport environment needed for preservation of specimens during transport. The contractor shall provide special pick-up courier service during laboratory operating hours when requested by the laboratory supervisor.

Contractor shall ensure the timely transport of specimens, and ensures specimen integrity. Specimens shall not be in transport more than 8 hours from the Oklahoma City Area IHS facility pickup location to the Contractor primary testing site. Specimens shall be maintained at optimal conditions for testing during the entire transport time.

Specimen Testing:

Each of the Contractor’s testing facilities shall be certified and shall maintain certification as a medical laboratory in accordance with CMS/CLIA ’88 guidelines. Contractor’s CLIA certificate(s) shall be producible and provided to each Oklahoma City Area IHS facility.

Contractor shall supply a Directory of Testing Services and Interpretive Guide. The Directory shall be an alphabetical listing of procedures with corresponding test codes. The Directory shall include profile/panel breakdowns, methodologies, reference ranges and panic/critical values. The Directory shall be distributed in sufficient quantities to meet the need of each Oklahoma City Area IHS facility. Any update to the Directory shall be communicated and distributed in a timely manner.

Specimen testing shall be performed at the Contractor’s facility. 85% of testing shall be performed at the Contractor’s primary/centralized testing site. No more than 15% of specimens are to be referenced to another location, either of a Contractor’s testing site, or “other” testing site.

Specimen testing shall be performed in a timely manner. "STAT" results- shall be provided by telephone to the IHS facility within one hour from the time the patient specimen is received in the contract laboratory unless (rare instances) test methodology requires a longer time for completion. Routine clinical laboratory testing- 85% of testing shall be completed and reported within 24 hours of receipt of the specimen. All other testing (cytology and anatomical pathology) shall be completed within 5 days of receipt.

The Contractor shall provide repeat testing when clinicians feel results do not correlate with the clinical status of the patient.

Anatomical Pathology, Cytology, Histology Testing

The below described services shall be provided all facilities upon request for the Laboratory or Clinical Director.

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 and Claremore Indian Hospitals.

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.

Surgical tissue examinations shall be made available for reference and use in consultation upon request of the Indian Health Service.

Cytology

Testing shall consist of examination, screening, and detection of malignancy of cells in PAP specimens, and other body secretions or body fluids such as urine, sputum, peritoneal and pleural fluids including procedures listed on bid schedule. The Contractor shall provide cervical/vaginal cytology services for the screening and detection of malignant cells and abnormal conditions. All cytology supplies, reagents, specimen containers, requisitions and reporting forms shall be provided at no additional cost. Cervical/vaginal screening methods should include Thin Prep PAP as well as traditional slide PAP smear. Reflex testing as ASC-US results to high risk HPV DAN 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 shall be provided to the appropriate service unit laboratory manager. This report shall be individualized for each hospital and clinic.

The pathologist shall review at least 10% of all slides classified as normoplasia by the cytotechnologist.

Necropsy

Testing shall be provided on an “as needed” basis within twenty-four (24) hours following telephone request at the location mutually agreed upon by the Contractor and the requesting IHS physician or IHS Contracting Officer or representative within the local community.

If requested by the facility, the Contractor shall provide on-site Pathologist services monthly at the two hospitals. The contractor will provide on-site pathologist services at the eight (8) health centers on a quarterly basis. The contractor shall provide Laboratory Directorship to the health centers and hospitals by a physician who is board certified in Clinical and Anatomical Pathology by the American board of Pathology or the American Osteopathic Board of Pathology.

Contractor shall notify the requesting Oklahoma City Area IHS facility when an unacceptable specimen is received. Notification shall be made within 24 hours of discovery of the unacceptable nature of the specimen. The problem shall be reported via courier and written report which specifies the problem and the reason for declaring the specimen “unsatisfactory” within forty-eight (48) hours of receipt of the specimen at the Contractor’s laboratory. The Contractor shall acquire prior approval from the ordering facility before any testing is cancelled due to an unavailable specimen. The Contractor shall not re-order any test, if a test needs to be reordered, the ordering facility shall be notified by the Contractor to re-order the test internally.

Contractor shall provide a “special pickup” and/or repeat testing resulting from Contractor negligence. Repeat testing shall be performed within 24 hours of notification and at the Contractor’s expense.

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.

Data Management/Computer Interface:

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.

The Contractor shall provide for the electronic transmittal of reports from the Contractor to the Indian Health Service facilities. Lab results shall be put in data format compatible with IHS RPMS Lab Package version 5.2 patch 1042 or later version. This includes the reference laboratory enhancement (RLE) module of the version 5.2. The reference laboratory shall send no more than 68 characters per comment line (not to exceed NTE segment). This shall prevent wrap-around text and easy to read text.

To increase the Oklahoma City Area Indian Health Services data exchange and public health surveillance capabilities and to assist in the management of clinical information and improved data standardization, the contractor shall have installed a bi-directional and unidirectional interface for the electronic communication of reportable information from the contract reference laboratory to the laboratory software application in the Resource and Patient Management system (RPMS) within the 10 Oklahoma City Area laboratories. At this time all of the facilities electronically receive and/or transmit data via the Indian Health Service Generic Interface System. The contractor shall have an immediate working HL7 interface system already established and is being utilized in other Indian Health Systems Laboratories. During the phasein period, the Contractor shall be able to provide a “live” bi-directional and uni-directional interface using standard HL7 language and the resource and Patient Management System (RPMS) Generic Laboratory Interface. All interface connectivity, implementation, communication, and setup shall be the responsibility of the Contractor. The Contractor’s responsibilities shall include all phases in editing, development troubleshooting, continuous maintenance of each facility’s RPMS laboratory test files (x6 60), load/worklist file (68.2), auto instrument (64.5); IHS CPT Code, data name file, and mapping of all internal tests to the contractors lab test database. The Contractor shall provide initial set-up for reference laboratory and continuous updates to include updated CPT codes, LOINC and troubleshooting for all non-working test in regards to reference lab tests. The unidirectional interface shall send results to the RPMS PCC package via tcp/ip connection to laboratories not running the RPMS laboratory package. Laboratories using the bidirectional interface shall send orders and receive results electronically via tcp/ip connection directly into the RPMS laboratory package for verification. There shall not be separate line item charges associated with interface activities and processes. Bi-directional communication means RPMS orders download directly to the reference lab and results return directly to RPMS with no manual manipulation necessary. This interface shall require the contractors’ tech review of orders and results before release to the IHS Laboratory sites where IHS techs will release to the patients Electronic Health Record. This interface shall include all blood and body fluid reports, cytology reports, tissue reports, and microbiology reports. The contractor shall provide a means of electronic back-up and retransmission readily available and easily accessible for retransmission of results. All equipment, software, and /or hardware required to implement/maintain the bi-directional interface shall be provided by the contractor at no charge to the government. In addition any upgrades or replacements to software or hardware, and necessary computer supplies shall be provided by the contractor at no charge to the government. Computer tech support shall be available during business hours including phone numbers and contacts.

Security Requirements: The Contractor shall obtain an annual interconnect security agreement and follow appropriate information technology security requirements. The Interconnect Security Agreement (ISA) shall be provided to the awardee for completion.

Required Reports:

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.

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

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

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.

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

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.

Gross tissue examination reports shall contain the following information:

Type of specimen submitted Number of specimens submitted Size and length Any and all unusual characteristics;

Width, weight, and color

Cytology Reports

Shall contain the following information:

A histologic description of the specimen A diagnosis Recommendation for further investigation and/or therapy.

The pathologist shall telephone all abnormal and suspicious findings to the requesting physician immediately following the Pathologist’s interpretation.

Interface Reporting

The Contractor shall provide continuous bi-direction (or uni-directional when requested) interface reporting via the generic Interface System of test results performed on a continuous basis.

The Contractor shall be responsible for accuracy in reporting and shall provide report documents that are legible on both original and copy/s.

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.

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.

Contractor shall provide a monthly provider usage report, unique to each Oklahoma City Area IHS facility. The provider usage report shall include the provider name, test procedures performed with accompanying procedure code, and tallied by MTD & YTD cumulative costs.

The Contractor shall provide a semi-annual and an annual report to the Area Laboratory Consultant and to each facility Laboratory Supervisor identifying the lab test name, lab test ID #, the total number of tests resulted, cost of each test, and total cost during that time frame. Report shall be sent via an electronic “EXCEL” or related format.

The contracting laboratory will notify the Sate 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.

Laboratory Directorship/Consultation Services:

The Contractor(s) shall provide Laboratory Directorship services at each IHS facility as directed by the Laboratory Supervisor and insure that each IHS facility is in compliance with College of American Pathologists (CAP), The Joint Commission (JC), and Clinical Laboratory Improvement Amendments Act of 1988 (CLIA/1988) requirements. Each Laboratory Director must be credentialed through the Indian Health Service.

The Contractor shall provide onsite pathologist services to each hospital (accredited by CAP) depending on clinical need but not less than on a monthly basis and onsite pathologist services to each health center (accredited by Joint Commission) depending on clinical needs but not less than a quarterly basis. On a quarterly basis for hospitals and a semi annual basis for health centers, a medical technologist shall accompany the pathologist on each facility visit. The assigned pathologist shall perform the function of the Laboratory Director for sites that request such service.

The Contractor shall provide professional consultation to the various hospital committees, as may be requested by the respective Standing Hospital/Clinic Committee Chairperson in implementing compliance with the Joint Commission and College of American Pathology Accreditation Standards.

The Contractor shall provide a pathologist to review internal and external quality control, performance improvement activities and reports, laboratory procedures, and provide documentation of the review and recommendations made.

The Contractor shall provide for pathology professional consultation upon telephone request to medical staff including, but not limited to: Analysis and interpretation of pathologic findings;

Assessment and diagnosis;

Pathological interpretation of diagnosis;

Development of therapeutic plans;

Advisement of additional testing;

Research of current literature on unusual cases.

The Contractor shall provide a call-roster listing a pathologist and a consultant medical technologist to provide for consultation during other than regular hours of operation.

The pathologist, as designated Laboratory Director, shall provide consultation and technical assistance to the laboratory staff in upgrading the hospital's laboratory services and programs. This shall include a consultant medical technologist to provide "on-site" technical consultation and assure viable communications with the laboratory staff to discuss and resolve any problems that may arise on a quarterly basis at the IHS facility.

The Contractor shall provide consultation reports as listed in the Required Reports section of this contract, and any other reports required herein.

The Contractor shall provide toll-free telephone consultation on technical and medical problems. Information shall be provided on the same day it is requested

Contractor shall provide a phone directory of key laboratory personnel of all Contractor testing sites, (primary/centralized, secondary, and “outside” reference lab locations). Any updates to the phone directory shall be communicated in a timely manner. At least 2 copies of the directory shall be provided to each Oklahoma City Area IHS facility.

Contractor shall allow on-site reviews of the Contractor’s facility. On-site reviews are to be allowed prior to the award and post award of the contract. On-site reviews are to be allowed as frequently as deemed necessary by the Oklahoma City Area IHS CO or COR designee. On-site documents for review will be available upon request and at the discretion of the Oklahoma City Area IHS CO or COR designee. On-site review costs will be at the Oklahoma City Area IHS expense.

Continuing Education:

The Contractor shall provide an ongoing scheduled program of continuing education at the IHS facility for the medical and clinical laboratory staffs as a part of the IHS facility’s In-service Continuing Education Program. Services shall include:

Continuing Education sessions (one hour in length) once per year with the facility medical staff, with the date and topic to be mutually agreed upon by the pathologist and the Contracting Officer's Representative.

Continuing Education directed to the requirements of the clinical services provided and experience and education of the laboratory staff as requested by the lab manager.

The Consultant Medical Technologist shall provide education and assistance to laboratory staff “on-site” at least quarterly.

If agreed upon by the Area Lab Supervisors, the Contractor shall schedule and conduct an annual meeting for Oklahoma City Area service unit laboratory managers to provide 6-8 CEU’s for licensure requirements.

A summary of all Continuing Education sessions shall be a part of the Monthly Narrative Reports when accomplished.

Review and Inspection

The Oklahoma Area IHS Chief Medical Officer, Area Laboratory Consultant, Area Technical Consultant and designated representatives of the Contracting Officer shall have the right to review and inspect the Contractor’s facility and operations prior to award of contract. This shall be performed to determine capability of the Contractor to provide professional services required by the contract including but not limited to facilities, equipment, professional staff, range of services, hours of operation, reporting and pick-up and delivery capabilities.

Authorized representatives of the Government shall have the right at all times to make on-site reviews of the Contractor’s facilities and services to 1) examine records of services performed and 2) make any other analysis required to determine the quality of service provided and the accuracy of reports submitted to the Indian Health Service.

In preparation of offer, the Contractor may review the Contracting IHS facility laboratory upon request; not less than three working days prior telephone request to the Laboratory Supervisor as identified in Section G-2 and not less than three working days after notice

Quarterly Performance reviews

Quarterly review of services provided shall be performed by the Contracting Officer’s Representative and/or the Medical Director of the IHS facility with the Contractor’s Senior Technologists or Pathologist

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.

Schedule of Work

Services shall be provided in accordance with the following schedule of work.

The Contractor shall provide services within the time periods as designed the Statement of Work and shall provide technical staff to receive and process specimens at all times.

The Contractor shall provide for the following a minimum of regular hours for laboratory operation: Monday thru Friday 0700 to 0100 and Saturday, Sunday and Federal Holidays 0800 to 1800 for health clinics. Laboratory Service to the Claremore and Lawton Indian Hospitals shall be available 24 hours a day and 7 days per week.

The Contractor shall provide a call roster listing a Pathologist and a Senior Medical Technologist to provide for consultation during other than regular hours of operation and to arrange for receipt of specimens and performance of emergency procedures during other than regular hours of operation.

The Contractor shall provide toll-free telephone consultation on technical and medical problems on the same day it is requested.

Emergent Services:

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.