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. Holter Analysis Only
31. Holter Cardiologist Overread
32. Holter Recorder and Disposable Supplies, One-time Use and Analysis;
33. 24 Hour ABP One Time Use
34. 30 Day Transtelephonic Event Monitoring
35. 12 Lead ECG – Tracing with Computer Analysis
36. Urine Culture and Sensitivity
37. 24 Hr Urine Calcium
38. 24 Hr Urine Phosphate (Phosphorus)
39. 24 Hr Urine Uric Acid
40. 24 Hr Urine Creatine
41. Urine Culture, Routine
42. Kidney Stone, Urine/Sa
43. UA/M w/rflx Culture, R
44. Sedimentation Rate-wes
45. C-Reactive Protein, QU
46. Hepatic Function Panel
47. Hematocrit
48. hCG,Beta Subunit,Qual,Serum
49. hCG,Beta Subunit, Qnt, Serum
50. Urine HCG
51. Drug and Alcohol testing
52. Blood HCV Screening
53. Measles, Mumps, Rubella Immunity Profile
54. Polio virus antibody immune status
55. Lead, blood adult
56. Testosterone, free and total
57. Testosterone, Serum
58. Zinc, Whole blood
59. Zinc, plasma serum
60. 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.