Proficiency Testing Statement of Work.pdf

Whiteriver Service Unit Laboratory Department

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

A. Introduction

A new requirement with 4 option years for proficiency samples is needed for the Whiteriver Service Unit & Cibecue Health Center, Laboratory Department to maintain accreditation with Joint Commission.

B. Background

The College of American Pathologist provides proficiency testing and calibration verification samples to meet Joint Commission’s Quality Standards 01.01.01 through 01.03.01.

In order to maintain accreditation with Joint Commission (TJC) and Center for Medicare & Medicaid Services (CMS), the Whiteriver Indian Hospital and Cibecue Health Center Laboratory departments must be enrolled in a proficiency testing program according to CLIA’88 regulations.

Proficiency testing determines how well a laboratory’s results compare with those of other laboratories that use the same methodologies (Joint Commission QSA.01.01.01). Such testing can identify patterns of performance problems that may not be otherwise recognized by internal mechanisms. Those internal mechanisms are quality control, preventative maintenance, and competency evaluations.

Proficiency testing also provides a good indication about the quality of a laboratory program.

Without proficiency testing, patient testing cannot be performed.

The WRSU Laboratory has been utilizing the College of American Pathologist (CAP) for over 17 years.

The laboratory personnel are familiar with the handling, testing, and reporting criteria of this proficiency testing provider. CAP is the largest laboratory peer comparison program in the world. CAP’s program allows laboratories, such as ours, to regularly evaluate our performance and improve accuracy the patient results. CAP adheres strictly to its product shipping calendar and provides important updates as needed. The reporting method is simple to use as all results are submitted via on-line. Results are sent back within a month of testing..

C. Statement of Work

1. The Contractor must be able to provide proficiency test samples and calibration/linearity samples for Whiteriver and Cibecue laboratories.

2. The Contractor is responsible for providing the following proficiency samples and calibration/linearity kits for the Whiteriver Laboratory throughout the calendar year:

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Serum Alcohol

Aqueous Blood Gas: pH, PO2, PCO2, sO2, Ionized Calcium, Methemoglobin, Carboxyhemoglobin

B-Type Natriuretic Peptide

Cardiac Markers: Troponin

Wide range C-reactive protein

Routine Chemistry: ALT, Albumin, Alkaline Phosphatase, Ammonia, Amylase, AST, Total Bilirubin, Conjugated and Unconjugated Bilirubin, Calcium, Chloride, CO2, Total Cholesterol, Iron, Ferritin, TIBC, GGT, HDL, Creatinine Kinase, Creatinine, Glucose, Lactate, Lactate Dehydrogenase, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid;

Acetaminophen, Gentamicin, Salicylates, Valproic Acid, Vancomycin

Ligand Assays: Vitamin B12, Folate, Free T4, TSH, and Quantitative beta-HCG

Betahydroxybutyrate

Chemistry/Lipid/Enzyme Linearity

Therapeutic Drug Monitoring Linearity

Ligand Linearity

Treponema Antibody

Urine Chemistry Linearity

Serum Ethanol Linearity

C-reactive Protein Linearity

Hemoglobin A1c Linearity

Troponin Linearity

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Ammonia Linearity

Brain Natriuretic Peptide Linearity

Cerebrospinal Fluid Chemistry

Blood Oximetry

Urine Chemistry: Potassium, Sodium, Creatinine, Protein, Microalbumin

Two (2) Urine Drug Testing: Buprenorphine, Barbiturate, Benzodiazepine, Cocaine, THC, Opiate, Phencyclidine, Fentanyl, Oxycodone, Methamphetamines, Amphetamines

Viral Markers: HIV

Hemocytometer Fluid Count

Automated Body Fluid Cell Count

Coagulation: Prothrombin, INR, Partial Thromboplastin Time, D- Dimer

Hematology (CBC) with Auto Differential and Cell Identification

Reticulocyte

Glycohemoglobin (A1c)

Hematology Calibration Verification/Linearity

Semen Analysis

Reticulocyte Calibration Verification/Linearity

D-Dimer Calibration Verification/Linearity

Serum Osmolality

Urine Osmolality

Direct Antibody Testing

Transfusion: ABO group, Rh typing, unexpected antibody, and compatibility testing

Bacteriology: Bacterial Identification, gram stain, and Antimicrobial susceptibility testing

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Virology Molecular: Flu A/B, RSV, COVID

Molecular: C. diff, MRSA SSTI, GBS, CT/NG, TV, HSV, VZV, HMPV, Bordetella, Parainfluenza, Adenovirus, Legionella

Rapid Strep Molecular

Clinical Microscopy, Urinalysis, Pregnancy testing, and Fecal Occult testing

Rapid Urease

Syphilis Serology

3. The Contractor is responsible for providing the following proficiency samples and calibration/linearity kits for the Cibecue Laboratory throughout the calendar year:

Cardiac Markers

Routine Chemistry: ALT, Albumin, Alkaline Phosphatase, Amylase, AST, Total Bilirubin, Calcium, Chloride, Total Cholesterol, HDL, Creatinine Kinase, Creatinine, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid

Ketones

Chemistry/Lipid/Enzyme Linearity

Urine Chemistry

Urine Drug Testing: Buprenorphine, Barbiturate, Benzodiazepine, Cocaine, THC, Opiate, Phencyclidine

Hematology (CBC) with Auto Differential and Cell Identification

Hematology Calibration Verification/Linearity

Virology Molecular: Flu A/B, RSV, COVID

Rapid Strep Molecular

Clinical Microscopy

Whole Blood Glucose

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Whole Blood Coagulation-INR Testing

4. The Contractor shall provide 5 samples 3 times a year for regulated analytes and 5 samples 2 times a year for non-regulated analytes.

5. The Contractor shall provide calibration/linearity samples twice (2) a year for Whiteriver and Cibecue laboratories.

6. The Contractor is responsible for the packaging and shipping proficiency samples according to the temperature storage conditions.

7. The Contractor is responsible for notifying the hospital laboratory supervisor when changes with shipment dates have been made to the proficiency samples.

8. The Contractor is responsible for notifying the hospital laboratory supervisor when changes in reporting criteria have been made.

9. The Contractor shall make sure that the hospital laboratory and clinic has the most current contact information that includes key personnel, departments, etc. of telephone numbers and e-mail addresses for immediate communication.

10. The Contractor must be on the approved CMS proficiency testing provider list.

D. Estimated annual quantities:

The contractor will abide by the CLIA regulations as to the quantities shipped per year.

E. Shipment

1. Contractor shall identify the IHS purchase order on all packing slips for tracking and payment purposes. Failure to list the IHS purchase order number may cause payment delays.

2. The Contractor shall provide proficiency samples as required to the following facilities:

Whiteriver PHS Indian Hospital

Laboratory Department P. O. Box 860 400 West Apache Drive Whiteriver, Arizona 85941 Phone No. 928-338-3761

Cibecue Health Center

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Laboratory Department 2 West 3rd Street Cibecue, AZ 85911 Phone No. 928-332-2560, ext. 3841

F. Designated Contracting Officers Representative (COR)

1. The Contracting Officer shall designate the COR representing the Government for the purpose of this contract in writing. Such designation will set forth the duties specifically delegated in regard to the performance of this contract. A copy of the designation will be provided to the contractor.

2. The major responsibility of the COR is to ensure Contractor accountability, monitor contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract.

3. The COR shall be responsible for:

a) Monitoring the Contractor’s technical progress, including the surveillance and assignment of performance and recommending to the contracting Officer changes in requirements;

b) Interpreting Statement of Work;

c) Performing technical evaluation as required;

d) Performing technical inspection and acceptance required by the contract;

e) Assisting the contractor in the resolution of technical problems encountered during performance.

The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The COR does not have the authority to change or alter the order amount, terms and conditions.

G. WRSU Point of Contact:

Eddie Gloshay Laboratory Supervisor Telephone: 928-338-3761 Email: Eddie.Gloshay@ihs.gov WRSU Laboratory Department 200 West Hospital Drive Whiteriver, AZ 85941

200 W. Hospital Dr. / PO Box 860 Whiteriver, Arizona 85941 Phone (928)338-4911 Fax: (928)338-3760

Heather Layton Hematology Lead CLS Telephone: 928-338-3764 Email: Heather.Layton@ihs.gov WRSU Laboratory Department 200 West Hospital Drive Whiteriver, AZ 85941