Medical Laboratory Services

A. General. 1. This PWS supports the UTNG Individual Medical Readiness (IMR) for certain laboratory and medical surveillance and testing. 2. The Government may evaluate the quality of professional and administrative services provided, but retain no control over the medical professional aspects of services rendered such as testing procedures, etc. The Contractor will provide supervision, all labor, tools, materials, equipment, and incidentals required to conduct clinical lab services and deliver results as stated herein. 6.0 Procedures and Standards. A. General. 1. This BPA is for - Non-Personal Health Care - Services, as defined in FAR Part 37.101. In accordance with FAR Part 37.4 the Government may enter into a non-personal health care services contract with physicians, dentists and other health care providers under authority of 10 U.S.C. 2304 and 41 U.S.C. 253. The Government shall evaluate the quality of professional and administrative services provided, while the Government retains non-control over the medical, professional aspects of services rendered. The Contractor will indemnify the Government for any liability producing act or omission by the Contractor, its employees and agents occurring during contract performance. The Contractor will maintain medical liability insurance, in a coverage amount acceptable to the Contracting Officer (KO), which is not less than the amount normally prevailing within the local community for the medical specialty concerned. The Contractor is required to ensure that its subcontractors, if any, for provisions of health care services, contain the requirements of the clause at 52.237-7, Indemnification and Medical Liability Insurance, including the maintenance of medical liability insurance. B. Compliance. 1. Contractor shall ensure all procedures are conducted in accordance with applicable U.S. Department of Labor, Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and Health Insurance Portability and Accountability Act (HIPAA) of 1996(P.L.104-191) Standards. 2. Contractor shall provide documentation as evidence of compliance for each requirement set forth in the Performance Work Statement for personnel, equipment and procedures prior to initial performance after award, and documentation shall be updated prior to performance of services if changes are made to personnel, equipment, procedures. Contractor shall also provide documentation when requested by the COR. C. Licensing. 1. Contractor shall ensure all clinical laboratory services are performed by a laboratory licensed through the U.S. Department of Health and Human Services (DHHS), Health Care Financing Administration pursuant to the terms of the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 263a) and the College of American Pathologies. 2. Contractor shall ensure licensed medical technicians perform the screening/testing elements. D. Coordination / Quality Assurance Issues. 1. Contractor shall, upon request, consult with a representative of the UTNG by telephone to coordinate or resolve compliance, quality, logistical, or any other issues that might arise before, during, and after the testing period. E. Quality Assurance Surveillance Plan (QASP) 1. A Quality Assurance Surveillance Plan (QASP) listing the procedures or processes, shall be utilized to validate the terms and conditions are successfully met as discussed in the PWS. F. References. Army Regulation 40-5, Preventive Medicine Army Regulation 40-501, Standards of Medical Fitness Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) - http://wwwn.cdc.gov/clia/regs/toc.aspx Health Insurance Portability and Accountability Act (HIPAA) of 1996(P.L.104-191) Occupational Safety and Health Administration Regulations (Standards 29 CFR) G. Laboratory Test Panels The following laboratory test panels shall be administered as requested under the standards of CLIA, OSHA, HIPAA. 1. Comprehensive Metabolic Panel: comprised of glucose, calcium, pre-albumin, albumin, sodium, CO2, potassium, chloride, blood urea nitrogen (BUN), creatinine, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), and bilirubin. 2. Lipid Panel: comprised of total cholesterol, triglyceride level, HDL level, LDL level, Very low density lipoprotein (VLDL) level, ratio of total cholesterol to HDL, ratio of LDL to HDL. 3. CBC with differential comprised of White blood cell count, white blood cell types, red blood cell count, hematocrit, hemoglobin, red blood cell indices, platelet count, mean platelet volume. 4. CBC without differential and platelet 5. Prostate Specific Antigen (PSA) 6. Blood Typing 7. Hemoglobin A1C 8. Blood Glucose 9. Free thyroxine (FT1 or FT4) 10. Urine Microscope and Specific Gravity 11. Stool Guaiac (fecal occult blood test) 12. Sickle Cell Screen 13. G6PD (Glucose-6-phosphate dehydrogenase deficiency) - malaria prophylaxis screening 14. Varicella Titer 15. Thyroxine (T4) 16. Thyroxine (T4) Free, Direct 17. Hgb Solubility 18. Venipuncture 19. TSH 20. Ceruloplasmin 21. Triiodothyronine (T3) 22. PTH, Intact 23. Hepatitis Panel 24. Eosinophil Count, Nasal 25. Pap Smear 1 slide w Mat 26. Pap Smear, 1 slide 27. RPR Test 28. Uric Acid, Serum 29. Renal Panel 30. Urine Culture and Sensitivity 31. 24 Hr Urine Calcium 32. 24 Hr Urine Phosphate (Phosphorus) 33. 24 Hr Urine Uric Acid 34. 24 Hr Urine Creatine 35. Urine Culture, Routine 36. Kidney Stone, Urine/Sa 37. UA/M w/rflx Culture, R 38. Sedimentation Rate-wes 39. C-Reactive Protein, QU 40. Hepatic Function Panel 41. Hematocrit 42. hCG,Beta Subunit,Qual,Serum 43. hCG,Beta Subunit, Qnt, Serum 44. Urine HCG 45. Drug and Alcohol testing (Urinalysis) 46. Blood HCV Screening 47. Measles, Mumps, Rubella Immunity Profile 48. Polio virus antibody immune status 49. Lead, blood adult 50. Testosterone, free and total 51. Testosterone, Serum 52. Zinc, Whole blood 53. Zinc, plasma serum 54. Cholinesterase, RBC 55. Other testing or service as required and agreed upon by Contracting Officer and Contractor. H. Personal Protective Equipment (PPE) 1. Contractor shall furnish and assure healthcare workers are provided with the appropriate PPE such as, but not limited to: gloves, protective eyewear, etc., where there is a potential for exposure to blood or other potentially infectious materials. 2. Contractor shall ensure each healthcare worker complies with the requirements of 29 CFR 1910.1030 Blood borne Pathogens Standard. I. Infectious Waste Transportation and Disposal 1. Transportation and disposal of all infectious waste shall be in accordance with local, state, and federal regulation. 2. Contractor shall ensure puncture resistant sharps containers are readily accessible to healthcare workers and located in all treatment areas where sharps could potentially be used. 3. Contractor will provide all necessary supplies for blood draw or urine samples and any materials necessary for packaging and transportation of samples to their laboratory. The Contractor must demonstrate the ability to meet this firm requirement (method of transportation/ ability to preserve and protect transported samples, etc). J. Medical Reports and Recordkeeping 1. Contractor shall ensure one (1) copy of the Soldier's examination/screening/findings is furnished to the Utah Army National Guard (UTARNG) Medical Detachment within three working days via digital format and fax from the time of sample pickup. Copies provided (sent) in bulk to the COR shall be sent in appropriately secured in correctly sized individual envelops not folded. Each copy of Soldier's examination/screening/findings much include the Soldier's full name, social security number and/or date of birth, and if stapling is required; documents will be stapled in the upper left hand corner, at a minimum. Medical examination results shall include all diagnostic tests, graphs, charts, reports, questionnaires, waivers, employee consent forms, physical findings, and examination results. The Contractor shall provide the UTARNG Medical Detachment/Army Aviation Medical Section with a hard copy of these results within three working days of picking up samples. The Contractor must demonstrate the ability to meet this firm requirement for delivery of results. Results of medical surveillance testing, which are questionable and /or of critical significance shall be communicated directly and immediately to the UTARNG Medical Detachment or the Army Aviation Medical Section by telephone or fax. 2. Contractor shall identify all medical records with the Soldier's full name, social security number, date of birth, at a minimum. The Contractor shall ensure work / health history forms and medical reports are complete and legible (typed / printed). K. Examination Scheduling 1. Coordination of scheduling shall be a joint effort between the UTARNG Medical Detachment/Army Aviation Medical Section and the Contractor. Initial schedule of pick up: 1700-1800 daily Monday - Thursday, On/Call pick up Friday - Sunday, Holidays only in the event of an emergent situation or natural disasters. Scheduling may also fall under the already established standard procedures of the Contractor where these procedures may be mutually agreed upon between the COR, UTARNG Medical Detachment and Contractor. In the event of an emergency the UTARNG Medical Detachment may request an emergent pickup in addition to the regular scheduled pickup of specimens (1700-1800 Monday-Thursday). The UTARNG reserves the right to request additional pickup on non-scheduled days (Friday-Sunday within 2 hours of notice of samples needing to be picked up) in the event of weekend duty days or Holidays. Pick up from two locations: 1) Medical Detachment Camp Williams 17800 S Camp Williams Road Bldg. 9000 Bluffdale, UT 84065 2) Aviation Medical facility 7602 Airport Road, West Jordan Utah 84084. 2. In the event of a Contractor equipment failure, specific testing and / or parts of examinations that are not completed during the testing period shall be completed at a scheduled time mutually convenient for the Contractor and the UTARNG Medical Detachment. Contractor will give the UTARNG Medical Detachment notice of specimen results requiring additional time in the event of equipment or facility failure. Unfinished testing / examinations will be completed at no additional cost to the Government. 3. Contractor will provide at a minimum annual maintenance and upkeep of specimen drop box. COR reserves the right to request maintenance and upkeep of specimen drop box as needed (if applicable). L. Service Delivery Summary (SDS) 1. A Service Delivery Summary shall be completed by the COR for each BPA Call. The Service Delivery Summary shall include, but not be limited to, the following performance objectives and standards: PERFORMANCE OBJECTIVE PERFORMANCE STANDARDS Insurance & Licensed and/or certified staff All physicians and technicians have required insurance, licenses, and certifications, 100% of the time. Drop Box Maintenance (if applicable) Annual Maintenance performed or as requested by the COR Emergent Pick up Were samples picked up within two hours of request? Specimen Pick up Were specimens picked up 100% of the time? Equipment Certification Instrumentation meets or exceeds performance standards 99% of the time Medical Surveillance All FTS and/or temporary personnel have been examined 98% of the time Blood and Urine results All results will be delivered within the guidelines set forth in the PWS. Medical Reports and Recordkeeping Privacy Act Statements for each Full Time Support (FTS) and/or temporary personnel and the reports are submitted within the specified three working days 98% of the time or greater. 2. This PWS conveys the basic requirements, performance standards and assessment measures that will apply to all issued BPA Calls. Performance standards, when stated in the PWS, provide a general basis for measuring the performance of each requirement associated with the standard. 3. The Contractor shall perform in accordance with the requirements of this PWS and the requirements of each individual BPA Call. The service requirements are summarized into performance objectives. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement when applicable. Additional specifics SDS factors may be defined in the individual BPA Call. 4. Government remedies. The KO shall follow the requirements of FAR 52.246-4, Inspection of Services - Fixed Price (AUG 1996) for Contractors failure to correct non-conforming services. In the event that services fail to conform to contract requirements and cannot be remedied by reperformance, the Government reserves the right to reduce the contract price to reflect the reduced value of the non-conforming services. The Government will notify the Contractor of weaknesses or discrepancies as they become apparent. The first notification will be to attempt to obtain re-performance, if possible. Deficiencies that exceed the SDS acceptable levels will be issued on a Contract Discrepancy Report. Unsatisfactory performance may result in a cure notice or termination of a Contractors services under a BPA. M. Management Personnel 1. The KTR shall appoint one Contract Manager and a back-up manager, who will be the Contractors authorized point of contact with the COR. The appointment shall be in writing. 2. The Contract Manager shall have full authority to commit the Contractor on matters concerning the Blanket Purchase Agreement. N. Reimbursement for Travel Expenses 1. All services performed shall be either rendered on site at the designated locations in Bluffdale or West Jordan Utah or performed within Contractors facilities and no reimbursement shall be made for travel expenses. All travel costs are the sole responsibility of the Contractor. 7.0 Evaluation of Performance A. Evaluation of Contractor Performance. 1. Reference FAR Clause 52.246-4, Inspection of Services - Fixed Price. 2. The Contractors performance will be evaluated after each BPA Call. For those tasks listed in the SDS, the Quality Assurance Evaluator (QAE) shall be the COR. The COR will follow the methods of surveillance specified in the Government's QASP. Government personnel will record all surveillance observations. When an observation indicates defective performance, the COR will require the contract manager or representative to initial the observation. The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgement that they have been made aware of the defective performance. B. Quality Control 1. Reference contract clause 52.246-4, Inspection of Services - Fixed Price. The Contractor shall develop, implement, and maintain a comprehensive quality control program that assures compliance with all requirements of this BPA and its associated Calls. The Contractor shall maintain, enforce, and document a Quality Control Plan (QCP). The QCP shall ensure that the Government receives the level of quality that is consistent with the requirements specified in each BPA Call. C. Applicable Documents 1. The Contractor shall identify and comply with all applicable federal, state, and local statues for each BPA Call. 2. Publications and forms that apply will be listed in the PWS. The Contractor is obligated to follow those publications and use those forms. The Contractor shall be guided by those publications or use those forms to the extent necessary to accomplish requirements in the PWS. The Government at the start of the BPA shall provide all publications and forms listed, or will provide access to the forms and publications listed through electronic means. 3. Supplements, amendments and/or replacements to listed publication may be issued during the life of the BPA. The Contractor shall implement changes and notify the KO in writing of such changes. 8.0 Management of Deliverables and Reporting. 1. The Contractor shall be responsible for creating, maintaining, and disposing of records and reports required by this PWS. When requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such report. All documentation, records, files, continuity books, schedules, etc., which are the responsibility of the Contractor are the property of the Government and shall remain so upon termination or completion of this contract. The Contractor shall keep these items current. 2. The Contractor shall permit the COR or UTARNG Medical Detachment/AASF authorized representative access to all records, data, and facilities used in the performance of the anticipated services.