SOW_for_RFP0406NB140021__2.pdf

FEDERAL BUREAU OF PRISONS

Statement of Work

Supplemental Laboratory Testing

FCC Florence Health Services Unit

Federal Bureau of Prisons

5880 State Highway 67 South

Florence, CO 81226

10/1/2013

STATEMENT OF WORK

Table of Contents

SECTION

Description of Services

Service Delivery System

Government Furnished Property and Services

General Information

Health Insurance Portability and Accountability Act (HIPAA) of 1996

Specifications

PAGE

1. Description of Services. The Contractor shall provide all management, tools, supplies, equipment, and labor necessary to perform supplemental laboratory testing services.

1.1 Basic Services. The Contractor shall provide test results on 100% STAT specimen(s) within 6 hours f r o m the request f o r pick up . The Contractor shal l p r o v i d e t e s t results on routine specimen(s) within 4 calendar days from pick up.

1.2 Records. The Contractor shall provide a printed report for specimen(s) test result(s) to FCC

Florence within 48 hours from pickup, even when test results have been previously reported by telephone.

1.3 Special Requirements.

1.3.1 The Contractor shall preserve all specimens during transportation to include dry ice storage whenever it is necessary to keep the temperature below -30 Centigrade.

1.3.2 The Contractor shall retain the remainder of each specimen for seven calendar days in case the test has to be re-accomplished. Tests shall be repeated when requested by the initial requesting physician, FCC Florence Health Services Unit, or the Contractor at no additional cost to the government.

1.3.3 The Contractor shall provide a reference manual to the Contracting Officer and the

Health Services Administrator. This manual shall include test procedures, interpretation of the test, and cost of the test. Each test shall have a separate reference number assigned. Updates to the Contractor's reference manual shall be provided as changes occur. Updates shall be provided at no additional cost to the government.

1.3.4 The Contractor shall provide a consultation service staffed with qualified personnel such as a pathologist, or technical representative. These consultants shall be available Monday through Friday (0730-1800 hours), to discuss special problems or answer questions via telephone or in person at no additional cost to the government.

2. Service Delivery System.

Performance Objective SOW Para Performance Threshold

Specimen Preservation 1.3.1 100% of the time

Specimen Retain-ability 1.3.2 Contractor shall retain the remainder of each specimen for seven days. 100% of the time.

3. Government Furnished Property and Services. There are no government furnished property or services provided by the government.

4. General Information.

4.1 Security Requirements. The contract administrator shall complete a Form BP-A0660

Authorization for Release of Information (NCIC) Check for any Contractor requiring access to

FCC Florence. The requests shall be submitted to the Health Services Unit Credentialing Officer.

4.2 Quality Control. The Contractor shall perform Quality Control in compliance with accrediting agencies such as the College of American Pathologists (CAP); or Joint Commission; or be under the Clinical Laboratory Improvement Act of 1988, and shall continue to maintain accreditation/licensure for the period of the contract

4.3 Quality Assurance. The government will periodically evaluate the Contractor's performance by appointing a representative(s) to monitor performance to ensure services are received. The government representative will evaluate the Contractor's performance through intermittent on-site inspections of the Contractor's quality control program and receipt of complaints from base personnel. The government may inspect each task as completed or increase the number of quality control inspections if deemed appropriate because of repeated complaints. Likewise, the government may decrease the number of quality control inspections if merited by performance.

The government will also investigate complaints received from various customers located on the installation. The Contractor shall be responsible for initially validating customer complaints.

However, the government representative shall make final determination of the validity of customer complaints in cases of disagreement with customer(s).

4.3.1 Quality Assurance Personnel (QAP): The Quality Assurance Personnel (QAP) is authorized government representative(s) who perform assessments of the contractor's performance. Subsequent to contract award, the identity of the QAP, with letter defining their duties and authority will be promptly furnished to the successful bidder/offeror.

4.3.2 The QAP(s) or alternate(s) ill inform the contract manager in person when discrepancies occur and will request corrective action. The QAP(s) or alternate(s) will make notation of the discrepancy on their tally/surveillance checklist with the date and time the discrepancy was noted and will request the contract manager (or authorized representative to initial the entry on the checklist.

4.3.3 Any matter concerning a change to the scope, prices, terms or conditions of this contract shall be referred to the Contracting Officer and not to the QAP(s).

4.3.4 The services to be performed by the Contractor during the period of this contract shall at all times and places are subject for review by the Contracting Officer or authorized representative(s).

4.3.5 Normal Hours of Operation. The Contractor shall provide specimen pick-up once a day

Monday through Friday, between the 1400 and 1600 hours as agreed upon. Specimen(s) shall be picked up at the FCC Florence front gate entry and transported by the Contractor to the Contractor's facility for processing. The Contractor shall provide pick-up for emergency (STAT) specimen(s) anytime, including weekends and holidays. Specimen(s) shall be picked up at the FCC Florence front g'"ate to be transported to the Contractor's facility for processing.

4.3.6 Recognized Holidays. The Contractor is not required to provide routine service on observed federal government holidays; to include, New Year's Day, Martin Luther King

Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

4.3.7 Emergency Services. On occasion, services may be required to support an activation or exercise of contingency plans outside of normal duty hours described above. The

Contractor's responsibilities for emergency support are the same as non-emergency service phases except for extended hours.

5. Health Insurance Portability and Accountability Act (HIPAA) of 1996. Based on the

I

Department of Health and Human Services HIPAA regulations contained in Title 45 of the Code of Federal Regulations, the Contractor may disclose protected health information when the disclosure is permitted by and in compliance with 45 C.F.R. '164.512. See 45 C.F.R.'

164.502(a)(1)(vi), Uses and disclosures of protected health information: general rules.

Title 45 C.F.R. I 164.512, Uses and disclosures for which an authorization or opportunity to agree or object is not required, permits your facility to disclose protected health information without the written authorization of the individual when the disclosure is for a specialized government function. See 45 C.F.R. • 164.512(k). One government function enumerated in this section is "Correctional Institutions and other law enforcement custodial situations." See 45

C.F.R. 1 164.512(k)(5). Section 164.512(k)(5) specifically provides, "A covered entity may disclose to a correctional institution or a law enforcement official having lawful custody of an inmate or other individual protected health information about such inmate or individual, if the correctional institution or such law enforcement official represents that such protected health information is necessary for (A) The provision of health care to such individuals." See 45 C.F.R.

I 164.512(k)(5)(A). All medical record requests made by FCC Florence will meet

1 164.512(k)(5)(A), as the records are needed for the provision of health care to the inmates.

The contractor will abide by the provisions of the Privacy Act of 1974 with respect to records maintained in the Inmate Physical and Mental Health System Record System, JUSTICE/BOP-

007" (see 67 Federal Register 11712-14).

STATEMENT OF WORK/SPECIFICATIONS

1. SUBJECT:

The Contractor shall provide services including all management, tools, supplies, equipment, and labor necessary to perform supplemental laboratory testing services. The Contractor shall provide test results on 100% STAT specimen(s) within 4 hours from the request for pick up. The Contractor shall provide test results on routine specimen(s) within 4 calendar days from pick up.

The Contractor shall provide a printed report for specimen(s) test result(s) to FCC Florence within 48 hours from pickup, even when test results have been previously reported by telephone.

2.SCOPE OF SERVICES:

The Contractor is responsible for provision of the services outlined in the contract. The Contractor must provide interpretation for the following laboratory tests(* refers to STAT):

Test List Pricing Aceteminophen Alcohol

ALT

AST

Ammonia Amvlase (blood, urine, and body fluid) Antistreptolysin 0 Screen B-HCG Qualitative B-HCG auantitative Basic Metabolic Panel Bilirubin Calcium Carbamazepine Hemogram (CBC) with differential Carboxhemoglobin

CD/4

CD/8

CEA Ccarcinoembryonic antigen) Cell Count (body fluid) CPK, Total

CPK-MB

Comprehensive Metabolic Panel Creatinine Clearance Creatinine (random and 24-hour urine) Crvstal ID (body fluid) D-Dimer Digoxin Dilantin Drug Screen (serum and urine) ElectrolYte Panel Estradiol Eosinophil Smear Ferritin

Fibrinogen

FSH

Gentamicin

GGT

HBV Viral Load

HCGA1C

HCV Viral Load

HCV Genotype

HDL Cholesterol

Helicobacter Pylori AB

HIV Viral Load

HIV Phenosense

HIV Resistance Mutation

Infectious Mono

Iron

Lactic Acid

LDH

LH

Lipase

Lipid Profile

Lithium

Magnesium

Microalbumin (urine)

Partial Thromboplastin Time

Phenobarbital

Phenytoin, total

Potassium {urine)

Prolactin

Protein (serum, body fluid, urine)

Prothrombin Time

PSA, Total

Salicylate

ESR

Semen Analysis, complete

Sodium {urine)

T4, Free

Theophylline

TSH

Troponin I

Uric Acid (blood and urine)

Valproic Acid

Aerobic Culture

Anaerobic Culture

Gram Stain

Aerobic and Anaerobic ID and Sensitivity

Blood Culture

Clostridium Difficil Toxin

Ova and Parasite Examination

Sputum Culture

Urine Culture

Influenza AlB Antigen screen

RSV Antigen Detection

Rotavirus Antigen Tissue Homogenization Antibody Screen

ABO/RH

Direct Antihuman Globulin Test

3. SCHEDULE:

These services are a contractual agreement. The services will be provided on an as needed basis with the contractor. The Contractor shall provide a consultation service staffed with qualified personnel such as a pathologist, or technical representative. These consultants shall be available

Monday through Friday (0730-1800 hours), to discuss special problems or answer questions via telephone or in person at no additional cost to the government. Service will not be required to take place on holidays.

4.PLACE OF PERFORMANCE:

The place of performance will be provided by the Contractor.

5. METHOD OF PERFORMANCE:

All duties will be performed in accordance with standards and methods generally accepted within the Contractor's field of expertise. The Contractor shall provide a reference manual to the

Contracting Officer and the Health Services Administrator. This manual shall include test procedures, interpretation of the test, and cost of the test. Each test shall have a separate reference number assigned. Updates to the Contractor's reference manual shall be provided as changes occur. Updates shall be provided at no additional cost to the government.

6. MINIMUM QUALIFICATIONS:

The Contractor must be properly licensed to perform these services in the state of Colorado. The

Contractor must agree that the quality of all materials and services furnished will not be inferior to the specifications.

7.SUPPLIES:

All supplies will be provided by the Contractor.

B.INMATE MANAGEMENT:

Not Applicable

9.INSTITUTION SECURITY:

The Contractor's designee assigned for specimen pick-up at FCC Florence Monday through

Friday, between the 1400 and 1600 hours, must be approved in accordance to entry procedures outlined by FCC Florence. Additionally, the pick-up designee must be cleared through the

National Crime Information Center in order to access FCC Florence.

10.CONTRACTUAL INFORMATION:

FCC Florence will be responsible for the following vouchering and law enforcement checks, as well as ensuring that fingerprinting and urinalysis testing is completed in accordance with the

Human Resource Manual to include the following:

1. National Crime Information Center (NCIC) check;

The Contractor must submit perspective pick-up designee persons for security background checks prior to any pick-up performed at FCC Florence.

11. PAYMENT TERMS:

Payment is based on the provision of an end product or the accomplishment of a specific result

12. PERIOD OF PERFORMANCE:

The anticipated period of performance includes December 1, 2013, through September 30,2014.

The anticipated periods of performance are based on the assumption that the Government will make award. In accordance with terms of the resulting contract. the Government has the unilateralright to award the additional Option Years periods. but is not obligated to do so.

13. RELEASE OF INFORMAnON

Based on the Department of Health and Human Services HIPAA regulations contained in Title 45 of the Code of Federal Regulations, the Contractor may disclose protected health information when the disclosure is permitted by and in compliance with 45 C.F.R. '164.512, See 45 C.F.R. •

164.502(a)(1)(vi), Uses and disclosures of protected health information: general rules.

Date c

Signature€ost Center Manager