A05- SOW- CSU Lab Compliance Testing.pdf
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- CSU Laboratory Compliance Testing Services
- Solicitation number
- SS-IHS1519247-BI
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This Statement of Work (SOW) details Lab Proficiency Testing Services for the Crow Service Unit (CSU), an Indian Health Center with three clinical laboratories located in Crow Agency, Pryor, and Lodge Grass, Montana. The objective is to obtain College of American Pathology (CAP) proficiency tests and CMS regulatory updates for these laboratories, which are required to maintain CLIA (Clinical Laboratory Improvements Amendments) certification. The comprehensive testing scope includes 62 different testing categories ranging from alcohol/volatiles and blood cultures to viral markers and STI detection, covering critical areas like hematology, microbiology, chemistry, and specialized diagnostic testing.
The contract requires the contractor to provide proficiency test products, technical telephone consulting during business hours, participant test summaries, CMS result notifications, and access to a competency program. The testing will be performed within a 12-month period, with the contractor expected to have expertise in proficiency testing services and meet all CLIA standards mandated by the Department of Health and Human Services. The primary point of contact is Danielle Tofte, Laboratory Manager, who can be reached at (406) 638-3384 or Danielle.Tofte@ihs.gov. The three specific laboratory sites have unique CLIA numbers: Crow/Northern Cheyenne Hospital Laboratory (27D0409364), Pryor Clinic Health Station Laboratory (27D0959321), and IHS Clinic Laboratory in Lodge Grass (27D0665246).
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Other files
| File | Type | Posted |
|---|---|---|
| 04. IEE Representation Form.pdf | ||
| CSU Lab Compliance Testing 03. BIA Sources Sought v.2.docx | DOCX document |
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STATEMENT OF WORK
Lab Proficiency Testing Services
Crow Service Unit, Crow Agency, MT, Pryor, MT, & Lodge Grass, MT
A. BACKGROUND:
Crow Service Unit (CSU) is a PHS Indian Health Center that provides healthcare service to the Crow Indian Reservation, located in southeastern Montana. CSU consists of three (3) clinics, one in Crow Agency, MT, one in Pryor, MT, and one in Lodge Grass, MT. Each clinic has a clinical laboratory. The laboratories perform diagnostic testing of patient specimens as part of an overall assessment of patient health and affects clinical decisions for patient care. The laboratories require accreditation by the Center for Medicare and Medicaid Services (CMS) as it demonstrates compliance with CLIA (Clinical Laboratory Improvements Amendments) regulatory standards. This is required so the laboratories can accept human samples for diagnostic testing. Proficiency testing is needed to monitor the quality and accuracy of diagnostic testing at each site. The College of American Pathology (CAP) provides the proficiency testing services to evaluate and benchmark CSU laboratory performance. CAP also provides resources to keep the laboratories updated with the latest CMS regulatory requirements.
B. OBJECTIVE / DELIVERABLES:
The objective is to obtain College of American Pathology (CAP) proficiency tests and CMS regulatory updates for CSU’s three (3) laboratories located in Crow Agency, MT, Lodge Grass, MT, and Pryor, MT.
The deliverables are the results of proficiency tests, recommendations for continued quality improvements, and information regarding the latest CMS regulatory requirements.
1. CAP/ADLM SERUM
2. ALCOHOL/VOLATILES
3. CRITICAL CARE BLOOD GAS
4. BLOOD CELL ID, PHOTOGRAPHS
5. BLOOD CULTURE
6. B-TYPE NATRIURETIC PEPTIDES, 5
7. CHALLENGE
8. COAGULATION-LIMITED
9. CLINICAL MICROSCOPY MISC
10. PHOTOPAGE
11. URINALYSIS W/BODY FLD & URINE SED
12. PHOTOS
13. SARS-COV-2 MOLECULAR
14. CARDIAC MARKERS
15. CHEMISTRY/THERAPEUTIC DRUG
16. MONITORING
17. BACTERIOLOGY
18. GROUP B STREP DETECTION
19. DIRECT ANTIGLOBULIN TEST
20. ERYTHROCYTE SEDIMENTATION RATE
21. HEMATOLOGY AUTOMATED
22. DIFFERENTIAL SERIES
23. FUNGAL SMEAR
24. SYPHILIS SEROLOGY
25. HEMOGLOBIN A1C, WAIVED
26. HCG, SERUM
27. HIGH SENSITIVITY C-REACTIVE
28. NUCLEIC ACID AMPLIFICATION
29. RESPIRATORY LIMITED
30. INFECTIOUS MONONUCLEOSIS
31. TRANSFUSION
32. MEDICINE-COMPREHENSIVE
33. LIGAND ASSAY-GENERAL
34. KETONES
35. SERUM ETHANOL CVL
36. CHEMISTRY/LIPID/ENZYME CVL
37. URINE CHEMISTRY CVL
38. HEMATOLOGY CVL
39. MICRO BENCH TOOLS COMPETENCY
40. METHICILLIN RESISTANT S AUREUS, 5
41. CHAL
42. OCCULT BLOOD
43. POINT-OF-CARE CARDIAC MARKERS
44. PROCALCITONIN
45. FETAL MEMBRANE/PRETERM LABOR
46. IMMUNOLOGY-SPECIAL, H PYLORI IGG
47. URINE CHEMISTRY-GENERAL
48. CAP/ADLM URINE DRUG TESTING,
49. SCREENING
50. VIRTUAL GRAM STAIN BASIC
51. COMPETENCY
52. 25-OH VITAMIN D, TOTAL
53. VIRAL MARKERS-SERIES 1
54. VIRAL MARKERS-SERIES 6
55. QUALITY CROSS CHECK-WHOLE
56. BLOOD GLUCOSE
57. WHOLE BLOOD PT/INR, I-STAT
58. CAP GENERIC SURVEY BINDER
59. COMPETENCY ASSESSMENT HUB UP
60. TO 50 USERS
61. COMP ASMT HUB-COMPLIANCE CSE UP
62. TO 50
63. STI DETECTION, MOLECULAR
C. SCOPE OF WORK:
Provide proficiency tests, continuing education, and competency assessment. The Contractor shall furnish all the necessary services and material required to provide the proficiency tests.
The Contractor shall provide services for the following:
A. Crow / Northern Cheyenne Hospital Laboratory, Crow Agency, MT
CLIA # 27D0409364
B. Pryor Clinic Health Station Laboratory, Pryor, MT
CLIA # 27D0959321
C. IHS Clinic Laboratory, Lodge Grass, MT
CLIA # 27D0665246
Requirements include:
• Products for Proficiency Tests
• Technical telephone consulting available to Crow Service Unit Laboratory staff during normal business hours;
• Provide CSU Staff with participant summaries, notification of proficiency tests results to
CMS.
• Access to competency program.
D. PERIOD OF PERFORMANCE:
Proficiency Testing shall be scheduled and performed within the 12-month period established at time of the award.
E. STANDARD REQUIREMENTS:
Service must result in CSU laboratories meeting CLIA standards as mandated by Department of Health and Human Services.
F. WORKFORCE REQUIREMENTS:
Contractor must have the required expertise to provide proficiency testing services.
G. ASSUMPTIONS:
1. Access to Buildings:
If required, it shall be the Contractor's responsibility, through the Contracting Officer’s Representative (COR) or their designee, to obtain access to buildings and facilities and arrange for them to be opened and closed.
Crow Service Unit Contact Information:
Danielle Tofte, Laboratory Manager
(406) 638-3384 Danielle.Tofte@ihs.gov
2. Permits:
The Contractor shall, without additional expense to the Government, obtain all appointments, licenses, and permits required to perform the work. The Contractor shall comply with all applicable federal, state, and local laws. If required, evidence of permits and licenses shall be provided to the Contracting Officer or the COR before work commences.
3. Contractor Furnished Items:
The Contractor shall provide all the labor and necessary resources to perform the requirements of this contract.
H. GENERAL QUALITY ASSURANCE:
Contractor shall provide service that meets or exceeds CMS requirements, and coordinate service with Danielle Tofte, Laboratory TPOC.
mailto:Danielle.Tofte@ihs.gov
| STATEMENT OF WORK |
| Lab Proficiency Testing Services |
| F. WORKFORCE REQUIREMENTS: |
| G. ASSUMPTIONS: |
| 1. Access to Buildings: |
| If required, it shall be the Contractor's responsibility, through the Contracting Officer’s Representative (COR) or their designee, to obtain access to buildings and facilities and arrange for them to be opened and closed. |
| The Contractor shall, without additional expense to the Government, obtain all appointments, licenses, and permits required to perform the work. The Contractor shall comply with all applicable federal, state, and local laws. If required, evidence of p... |
| H. GENERAL QUALITY ASSURANCE: |
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