INDIAN HEALTH SERVICE

Portland Area

Requirements Document

1. Title

Laboratory Support Services - Medical Laboratory Scientist and Medical Technician

(Phlebotomy)

2. Background

The Portland Area Indian Health Service, Yakama Service Unit is the principal federal health care provider and health advocate for Indian people and provides a comprehensive health service delivery system for American Indians and Alaska Natives. The Service Unit requires laboratory support services to assist in the delivery of direct patient medical care in a clinical laboratory setting.

The requirement supports the overall health care status of the eligible patient population served by the Yakama Service Unit. The work involves direct patient care, laboratory diagnostic testing, specimen collection, quality control, and coordination with health care providers. Performance must support applicable clinical laboratory, patient safety, privacy, confidentiality, credentialing, and facility requirements, including CLIA, COLA, OSHA, HIPAA, Privacy Act, and Indian Health

Service credentialing/background requirements.

3. Scope

The contractor shall provide non-personal laboratory support services consisting of one (1)

Medical Laboratory Scientist and one (1) Medical Technician (Phlebotomy) in a moderate complexity outpatient clinical laboratory setting. Services shall support diagnostic testing, phlebotomy, specimen collection and handling, quality control, documentation in the electronic health record, patient flow, and coordination with health care providers.

Services shall be provided during clinic operating hours as scheduled, not to exceed forty (40) hours per week. The intended outcome is timely, accurate, safe, and compliant laboratory support for direct patient care at the Yakama Service Unit.

4. Specific Tasks or Specifications

A. Staffing and general service requirements

• Provide no more than one (1) Medical Laboratory Scientist and one (1) Medical

Technician (Phlebotomy).

• Perform laboratory duties in a moderate complexity outpatient setting.

• Provide laboratory support during clinic operating hours as scheduled, not to exceed forty (40) hours per week.

• Perform or assist with diagnostic testing in chemistry, hematology, urinalysis, serology, and microbiology, and assist with phlebotomy as needed.

• Operate laboratory equipment and analyzers, run quality controls, perform calibration of laboratory equipment, and apply professional judgment when resulting challenging diagnostic laboratory results.

• Maintain patient safety, infection control, biosafety, quality control, and regulatory compliance in the performance of all laboratory duties.

B. Medical Laboratory Scientist duties

• Ensure accurate and timely patient testing while prioritizing patient safety, infection control, and regulatory compliance.

• Perform and interpret diagnostic tests; maintain laboratory equipment; conduct quality control procedures; and document results in the electronic health record.

• Perform phlebotomy, proper specimen collection, specimen handling, and related laboratory processes.

• Maintain a safe laboratory environment through adherence to biosafety protocols.

• Collaborate with health care providers, communicate critical test results, manage inventory, and participate in inspections, audits, and regulatory compliance activities.

• Support internal, external, and organizational customer service; attend and participate in laboratory department meetings; and complete all required training.

C. Medical Technician (Phlebotomy) duties

• Perform phlebotomy procedures and specimen collection with emphasis on patient safety and comfort.

• Support the pre-analytical phase of laboratory testing and related diagnostic processes.

• Perform CLIA-waived testing while ensuring quality control compliance.

• Manage laboratory inventory and accurately document patient information in the electronic health record.

• Perform clerical duties, including answering phones, responding to staff and patient inquiries, and maintaining organized records.

• Oversee laboratory reception functions, including patient check-in, appointment scheduling, and facilitation of laboratory services.

• Coordinate patient flow in accordance with compliance requirements to enhance efficiency and minimize wait times.

• Support internal, external, and organizational customer service; attend and participate in laboratory department meetings; and complete required training and continuing education to maintain competencies.

D. Minimum qualifications

• Medical Laboratory Scientist: current and valid Medical Laboratory

Technician/Technologist/CLS certification from a nationally recognized credentialing agency or state licensing body; current CPR certification; and at least one (1) year of experience working as a medical laboratory scientist.

• Medical Technician (Phlebotomy): at least one (1) year of experience working in phlebotomy and current CPR certification.

• All key personnel shall meet Yakama Service Unit requirements for credentialing and background. Additional information may be required by Indian Health Service.

• Personnel shall meet applicable requirements stated in the Medical Staff By-Laws, IHS manual, State scope of practice requirements, and national certifying body requirements.

• Personnel shall meet the conditions of Section 408 of the Miscellaneous Indian

Legislation, Public Law 101-630, for covered positions involving regular contact with or control over Indian children.

E. Required post-award documentation

The contractor shall complete, sign, and return the following required forms within ten (10) days after award:

• Certification of Immunization

• Declaration of Employment

• Certification of Education and Insurance

• HIPAA Agreement, Business Associate Agreement

• Addendum to Declaration for Federal Employment (OF 306) Indian Health Service Child

Care and Indian Child Care Worker Positions

5. Performance Monitoring

The Government shall monitor and evaluate the quality and appropriateness of patient care and laboratory support services. Monitoring shall include review of service delivery, compliance with applicable clinical and regulatory requirements, and identification of performance deficiencies before performance becomes unacceptable.

• The Contracting Officer Representative and on-site contact will be provided after award and will coordinate technical aspects of the service and review performance.

• The contractor shall use the Indian Health Service timekeeping sheet for recording hours of contract performance. The contractor shall sign the Record of Service

Delivered and record daily arrival, departure, lunch departure/return, and end-of-day departure times.

• The Government will review invoices and timekeeping records for accuracy. Payment will be based on services actually completed and accepted by the Government.

• Performance monitoring may include review of quality control records, laboratory documentation, patient flow, training completion, participation in meetings, and compliance with credentialing, background, privacy, and safety requirements.

6. Security Requirements

The contractor and key personnel shall comply with all applicable privacy, confidentiality, facility access, credentialing, background, and health information security requirements. Contractor personnel shall comply with HIPAA, the Privacy Act, applicable Indian Health Service confidentiality requirements, and any local facility policies governing access to protected health information and patient records.

• Protected Health Information shall be used, disclosed, and safeguarded only as authorized for performance of the services.

• Contractor personnel shall meet Yakama Service Unit credentialing and background requirements before performing services.

• Covered personnel shall satisfy Public Law 101-630 requirements for positions involving regular contact with or control over Indian children.

• Access to the Electronic Health Record, Resource Patient Management System, and other systems shall be limited to access provided by the Government for performance of required services.

• Services shall be performed in accordance with applicable Privacy Act and confidentiality clauses and agency regulations.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information

(GFI)

The Yakama Service Unit, Portland Area Indian Health Service shall provide the facility space, existing Government property, medical and non-medical equipment, supplies, and systems necessary for patient care and laboratory operations at the Service Unit.

• Government-furnished equipment and supplies include existing laboratory equipment, analyzers, supplies, medical and non-medical equipment, and patient care areas used by the Indian Health Service medical department.

• Government-furnished information includes orientation to Indian Health Service and the Indian community being served; introduction to the Electronic Health Record, Resource Patient Management System, and other programs or packages necessary to perform the work; and notice of facility closures as soon as practicable.

• The Service Unit will not provide an assistant unless necessary for patient management.

8. Other Pertinent Information or Special Considerations

• Regular clinic hours are 8:00 a.m. to 5:00 p.m., Monday through Friday. The clinic is closed on federally recognized holidays and on certain days of closure pursuant to an

Executive Order by the President of the United States.

• Inclement weather conditions or facility issues, including electrical or water issues, may hinder normal operating hours. The Service Unit will notify the contractor of facility closure as soon as practicable, using mutually agreed notification methods.

• Substitute personnel may be proposed when scheduled coverage cannot be provided because of illness or vacation. Any proposed substitute must meet the same qualification, credentialing, and privileging requirements and must be approved by the

Contracting Officer and Contracting Officer Representative before performance.

• The contractor shall provide professional liability coverage in amounts reasonable and customary for the appropriate specialty, not less than $1,000,000 per occurrence, covering liability for personal injury or property damage, including legal representation and defense expenses.

• The contractor is responsible for applicable Federal, State, and local taxes and duties associated with performance.

a. Identification of Possible Follow-on Work

The requirement includes one (1) six-month option period that may be exercised at the discretion of the Government. Additional future related work, if needed, would be subject to separate Government review, approval, and funding.

b. Inspection and Acceptance Criteria

Services are acceptable when the contractor provides qualified personnel, performs the scheduled laboratory support services, complies with required clinical, safety, privacy, credentialing, and quality control standards, and submits accurate timekeeping and invoice documentation for Government review.

• Key personnel must meet the qualifications, credentialing, background, CPR, certification, and experience requirements identified in this document.

• Laboratory services must be timely, accurate, properly documented in the electronic health record, and performed in accordance with applicable quality control, calibration, infection control, biosafety, and regulatory compliance requirements.

• Specimens must be collected, handled, and processed safely and appropriately. Critical results must be communicated in accordance with applicable procedures.

• The Contracting Officer Representative or designated Government representative will review performance, records, timekeeping, and invoices before acceptance and payment.

9. Risk Control (Contracting Officer to delete if not applicable)

• Risk - unavailability of qualified personnel: Mitigation: require key personnel to meet stated certification, experience, CPR, credentialing, privileging, and background requirements; require substitute personnel to meet the same requirements and obtain

Government approval before performance.

• Risk - inaccurate or delayed laboratory results: Mitigation: require quality control procedures, equipment calibration, use of professional judgment, regulatory compliance, and Government monitoring of quality and appropriateness of patient care.

• Risk - patient safety or infection control issue: Mitigation: require adherence to patient safety, infection control, biosafety protocols, required training, and applicable regulatory standards.

• Risk - unauthorized disclosure of protected health information: Mitigation: require

HIPAA, Privacy Act, confidentiality compliance, business associate safeguards, and access limited to Government-provided systems needed for performance.

• Risk - disruption from inclement weather or facility issues: Mitigation: require coordination with the Service Unit and prompt Government notification of facility closures using mutually agreed notification methods.

10. Place of Performance / Delivery Address / Location

Yakama Service Unit

401 Buster Road

Toppenish, WA 98948

11. Period of Performance

The period of performance shall consist of one (1) six-month base period and one (1) six-month option period. Each period shall not exceed one hundred twenty (120) workdays. Specific calendar start and end dates shall be established in the award documents.

12. Delivery Schedule

Services shall be provided eight (8) hours per day, five (5) days per week, during clinic operating hours, as scheduled by the Government, not to exceed forty (40) hours per week. Regular clinic hours are 8:00 a.m. to 5:00 p.m., Monday through Friday, excluding federally recognized holidays and authorized closures.

• Required post-award forms shall be completed, signed, and returned within ten (10) days after award.

• Invoices shall be submitted monthly for services actually completed during the applicable invoice period, and payments shall be made only after Government acceptance of services and receipt of a proper invoice.