Attachment E - PWS Clinical_Laboratory_Scientist.pdf

PERFORMANCE WORK STATEMENT

Clinical Laboratory Scientist (Ambulatory Laboratory Testing and Phlebotomy Services)

Fort Yuma Health Care Center (FYHCC)

BPA - Multi-Specialty Ambulatory Care Services

Revised Draft - 12 June 2026

1. Background and Purpose

Fort Yuma Health Care Center (FYHCC) is an Indian Health Service (IHS) facility located in Winterhaven, California, serving a primarily Native American patient population. FYHCC requires contractor-provided ambulatory clinical laboratory testing and phlebotomy services from time to time to maintain continuity of specimen collection, testing operations, diagnostic support, patient safety, and timely access to laboratory results. This Performance Work Statement

(PWS) defines the required service outcomes, performance standards, deliverables, and operating constraints for contractor-provided Clinical Laboratory Scientist (CLS) services in the FYHCC Laboratory Department and related ambulatory care settings.

This PWS is structured as a nonpersonal services requirement. It does not establish a requirement to fill Government staffing vacancies or to augment Government supervisory chains. The contractor remains responsible for managing and supervising its workforce while the Government evaluates whether BPA call services meet applicable BPA, call, and

PWS requirements.

2. Scope and Required Service Outcomes

The contractor shall provide ambulatory clinical laboratory testing and phlebotomy services at FYHCC during BPA call coverage periods through qualified, cleared, competency-validated, licensed or otherwise authorized Clinical Laboratory

Scientist personnel. Services shall be performed in accordance with applicable state licensure or other legal authorization, demonstrated competencies, the complexity of testing the individual is authorized to perform, valid test orders, FYHCC laboratory procedures provided during onboarding, Clinical Laboratory Improvement Amendments

(CLIA) requirements, current IHS requirements, applicable privacy and security rules, and current accreditation standards applicable to the facility.

• Collect, label, handle, process, and transport specimens accurately; perform phlebotomy safely when included in the

BPA call services; and maintain specimen integrity from collection through testing, storage, referral, or disposition.

• Perform pre-analytic, analytic, and post-analytic laboratory tasks within authorized complexity levels, validated competencies, and local laboratory procedures, including quality control, instrument checks, calibration or maintenance tasks, result verification, and documentation required for release of test results.

• Document laboratory activities, test results, quality control data, critical values, specimen disposition, and related patient information accurately and timely in the Government laboratory information system (LIS), electronic health record (EHR), and local laboratory records when applicable.

• Promptly communicate critical or panic values, specimen problems, instrument downtime, quality control failures, or testing issues in accordance with local laboratory procedures and escalation protocols.

• Support safe laboratory operations and timely availability of results during BPA call coverage periods while applying independent professional and technical judgment within authorized scope, validated competencies, valid test orders, and local procedures.

• Protect patient rights, privacy, dignity, and cultural considerations in all interactions.

• Comply with infection prevention, bloodborne pathogen, exposure control, workplace safety, hazardous materials, emergency response, specimen integrity, and laboratory safety requirements applicable to the laboratory and ambulatory care setting.

• Participate in required orientation, competency validation, patient safety, quality control, quality assurance, proficiency or quality review activities, and other administrative requirements reasonably associated with the BPA call services.

• Meet the measurable performance standards and deliverable requirements stated in this PWS and the applicable

BPA call.

3. Nonpersonal Health Care Services and Independent Contractor Relationship

This requirement is for nonpersonal health care services. The contractor and all contractor personnel perform in the capacity of independent contractors and are not Government employees. Contractor personnel shall not receive

Government employee benefits, shall not be integrated into Government personnel-management systems, and shall not be supervised or managed as Government employees.

The Government may identify required workload, laboratory coverage periods, specimen collection requirements, testing requirements, service outcomes, Government-furnished systems and facility rules, and performance expectations.

The Government may also evaluate the quality, timeliness, completeness, accuracy, and acceptability of services for contract administration, competency validation, credentialing or privileging when applicable, quality assurance, patient safety, CLIA compliance, laboratory safety, and acceptance purposes. These functions do not create an employer-employee relationship and do not authorize Government personnel to perform contractor supervisory functions.

The contractor is solely responsible for recruiting, employing, compensating, scheduling, directing, supervising, training, evaluating, disciplining, retaining, and replacing its personnel. Government personnel shall not assign daily work to contractor employees, approve contractor employee leave, prepare contractor employee performance appraisals, discipline contractor employees, direct contractor staffing decisions, or otherwise exercise employer authority over contractor personnel.

Routine contract administration, staffing continuity, leave coverage, backfill, performance deficiencies, corrective action, and personnel matters shall be communicated through the Contracting Officer, COR, and the contractor's designated contract manager. Communications needed for valid test orders, specimen routing, critical value notification, patient flow, testing priorities, send-out processes, instrument downtime, emergency response, LIS/EHR use, infection control, laboratory safety, privacy, or compliance with facility rules are clinical and operational coordination only and do not constitute Government supervision of contractor personnel.

The Government retains no control over professional or technical laboratory judgment within the CLS scope of practice, validated competencies, authorized testing complexity, local laboratory procedures, and applicable CLIA requirements.

Contractor laboratory professionals remain responsible for exercising independent professional and technical judgment within their licensure or authorization, validated competencies, valid test orders, and local procedures while complying with applicable facility rules, patient safety requirements, specimen integrity requirements, quality control requirements, and laboratory safety requirements.

4. Place of Performance

All services shall be performed on-site at Fort Yuma Health Care Center (FYHCC), 401 Picacho Road, Winterhaven, California 92283.

Remote or telework performance is not authorized unless specifically ordered in writing by the Contracting Officer.

FYHCC does not provide housing.

5. Period of Performance and BPA Calls

• Services shall be performed during the period of performance identified in each BPA Call issued under the resulting

BPA.

• Each BPA call will identify required laboratory coverage dates, shift or session times, anticipated start and end dates, required service outcomes, testing menu or complexity limitations when applicable, operating constraints, and any unique support requirements applicable to the ordered services.

• The contractor shall submit a complete candidate package for each proposed laboratory professional at least forty-five (45) calendar days before the proposed start date unless a shorter lead time is expressly approved by the

Contracting Officer.

• No contractor employee may begin performance until all required security, onboarding, competency validation, any credentialing or privileging actions when applicable, laboratory authorization, and system access requirements are completed and the Government issues written authorization to start.

• The Government will not direct which contractor employee must be assigned to a BPA call. The contractor may use any qualified, cleared, competency-validated, licensed or otherwise authorized personnel who meet BPA, call, and

PWS requirements.

6. Laboratory Coverage, Scheduling, and Staffing Responsibility

Normal laboratory operating hours are Monday through Friday, 0800-1700 Pacific Time, excluding Federal holidays, unless otherwise stated in the BPA call. BPA call coverage may consist of full-day, partial-day, or intermittent shifts or sessions. The Government will identify required laboratory coverage windows, service requirements, and performance expectations. The contractor is responsible for scheduling and managing its personnel to meet those requirements.

The contractor shall maintain staffing continuity sufficient to perform all BPA call laboratory coverage with personnel who are qualified, cleared, competency-validated, oriented, licensed or otherwise authorized, and approved to begin performance. The contractor shall designate a contract manager and an alternate contract manager responsible for staffing plans, schedule coordination, coverage continuity, leave coverage, backfill, and prompt communication with the

CO and COR.

During BPA call coverage periods, contractor personnel shall be available to perform specimen collection and phlebotomy when included in the ordered services, laboratory testing, quality control, documentation, critical value notification, and coordination with FYHCC staff regarding valid test orders, specimen priorities, specimen routing, send-out processes, instrument status, downtime procedures, and emergency response requirements. Workload may vary based on patient demand, order volume, specimen volume, test complexity, urgency of testing, instrument availability, quality control status, send-out requirements, documentation requirements, facility workflow, and system availability.

Patient safety, specimen integrity, CLIA requirements, and professional or technical judgment govern the pace and sequence of laboratory services.

Coverage beyond BPA call periods, including after-hours testing, on-call coverage, weekends, holidays, or additional shifts or sessions, requires prior written authorization under the BPA or applicable BPA call.

If a contractor employee becomes unavailable for a BPA call coverage period, the contractor remains responsible for maintaining or restoring required service coverage through any qualified and authorized personnel. The Government may coordinate patient-care priorities, valid test orders, critical-value needs, and laboratory-flow requirements, but the contractor determines how to staff the BPA call requirement.

7. Minimum Qualifications and Credentials

• Bachelor's degree in clinical laboratory science, medical technology, or a related laboratory science discipline meeting applicable California licensure requirements, or higher.

• Active, unrestricted California Clinical Laboratory Scientist license, or other California laboratory personnel license or authorization legally sufficient to perform the ordered testing menu at FYHCC.

• Minimum two (2) years of recent experience performing clinical laboratory testing in a CLIA-certified laboratory;

experience with specimen collection or phlebotomy is required when included in the ordered duties.

• Current Basic Life Support (BLS) certification from an American Heart Association or American Red Cross approved provider, when required by local policy or the BPA call.

• Demonstrated ability to document activities and results in a laboratory information system and electronic health record, as applicable.

• Ability to obtain and maintain FYHCC security access and all required onboarding, competency validation, and any local laboratory authorization requirements applicable to the BPA call services.

• Compliance with continuing education, immunization, exposure control, and mandatory training requirements applicable to the laboratory professional and the facility.

• Any additional certification, documentation, or local authorization required by law or local policy to perform specialized testing, blood bank duties, phlebotomy duties, point-of-care testing oversight, or other restricted functions included in the ordered services.

• Demonstrated competency to perform the specific test systems, equipment, specimen collection duties, quality control requirements, and post-analytic tasks included in the ordered services.

8. Security, Credentialing, Competency Validation, and Onboarding

The contractor shall submit complete and accurate onboarding material for each proposed laboratory professional as required by the Contracting Officer, the FYHCC Security Office, and the offices responsible for competency validation, access processing, and any local laboratory authorization requirements. Required material may include, as applicable, resumes, licenses, education verification, immunization records, exclusion screening results, fingerprint paperwork, identification documents, mandatory training records, competency documentation, laboratory authorization documentation, and any other documents identified in the solicitation, BPA, applicable BPA call, or onboarding instructions.

The contractor is responsible for ensuring all credentials and required documents remain current throughout the period of performance and for immediately notifying the Contracting Officer and COR of any adverse licensure action, exclusion, sanction, lapse, investigation, failed competency validation, laboratory authorization limitation, quality control or proficiency concern, testing restriction, or other status change that could affect performance.

The Government may deny a proposed start date, suspend system or facility access, reject services, or require removal from performance when security, training, onboarding, licensure, competency validation, laboratory authorization, privacy, conduct, or any applicable credentialing, privileging, or access prerequisites are incomplete, expired, inaccurate, or no longer meet BPA, call, or PWS requirements. Such action is a contractual, facility access, competency validation, credentialing, privileging, laboratory-safety, or patient-safety action and does not constitute Government discipline of contractor personnel.

9. Performance Standards and Quality Assurance Surveillance Plan (QASP)

The following outcome-based standards establish the basis for Government acceptance and surveillance of BPA call services. Surveillance will focus on service outcomes, compliance, deliverables, and BPA/call performance rather than day-to-day supervision of individual contractor employees. The Government may assess performance through document review, schedule and coverage verification, invoice reconciliation, LIS/EHR audit, quality control review, critical value log review, specimen rejection tracking, incident review, compliance review, deliverable review, and other surveillance methods consistent with the BPA, applicable BPA call, and applicable law and policy.

If performance does not meet BPA, call, or PWS standards, the Contracting Officer may require a written corrective action plan within three (3) business days or another stated period. Continued failure to meet standards may result in rejection of services, denial or suspension of access, nonpayment for unaccepted services, removal from performance, or other contractual remedies available under the BPA or applicable BPA call. Communications regarding performance deficiencies shall be made through the contractor's designated contract manager, except where immediate patient safety, specimen integrity, privacy, security, laboratory safety, or facility access action is required.

Performance Objective Standard Government Surveillance / Acceptance Method BPA call laboratory coverage 100% of BPA call shifts or laboratory sessions covered by qualified, cleared, competency-validated, licensed or otherwise authorized contractor personnel. Any anticipated coverage gap reported to the CO and COR as soon as known with a proposed continuity plan.

Review of BPA calls, coverage reports, access rosters, staffing records submitted by the contractor, and invoice support records.

Licensure, security, onboarding, and competency status 100% current before start of performance and maintained throughout performance for each laboratory professional providing services.

Document review; verification of licensure or authorization, exclusions, security status, mandatory training, competency validation, laboratory authorization, and onboarding status.

Specimen collection, identification, and handling 100% compliance with patient identification, specimen labeling, specimen handling, chain-of-custody when applicable, and specimen integrity requirements; zero unreconciled mislabeling events attributable to contractor performance.

Specimen rejection tracking, incident review, record audit, and compliance review.

Laboratory testing within authorized scope and valid orders 100% compliance with authorized test complexity, validated competencies, valid test orders, local procedures, CLIA requirements, and escalation requirements for specimen problems, downtime, quality control failures, or out-of-scope testing.

LIS/EHR audit, quality review, incident review, competency review, and compliance review.

Test result timeliness and critical value notification At least 95% of ordered tests completed and documented within turnaround standards established by local procedure; 100% of critical or panic values reported in accordance with local policy.

LIS/EHR audit, turnaround-time review, critical value log review, and record review.

Quality control and instrument readiness 100% completion of assigned quality control, instrument checks, calibration, maintenance, and required documentation before patient testing when required by local procedure.

Quality control record review, instrument logs, maintenance records, and compliance review.

Documentation accuracy and timeliness At least 95% of required LIS, EHR, quality control, and local laboratory documentation completed on the day of service; 100% completed within 24 hours absent documented system outage or emergency circumstances.

LIS/EHR audit, quality control record review, and local record review.

Patient rights, privacy, infection control, and safety 100% compliance with patient identification, patient rights, privacy, bloodborne pathogen, infection control, hazardous material, emergency response, and workplace safety requirements.

Observation, incident review, complaint review, and compliance review.

Required orientation, training, and quality activities 100% completion of mandatory orientation and training and participation in required competency validation, patient safety, quality control, proficiency, and quality assurance activities reasonably associated with the BPA call services.

Training records, attendance records, competency records, and quality documentation review.

Timely deliverables and corrective action 100% of required reports, invoice support records, incident notices, and corrective action responses submitted by the required due dates unless otherwise approved by the Contracting Officer.

Deliverable log, invoice review, correspondence review, and corrective action tracking.

10. Government-Furnished Support and Interfaces

The Government will provide access to laboratory work areas, Government-furnished analyzers, collection supplies, reagents, equipment, and supplies customarily available to FYHCC laboratory staff, and access to the Government LIS, EHR, and other required systems as needed to perform accepted services.

The Government will provide orientation to local laboratory procedures, emergency response procedures, infection control and safety rules, documentation requirements, critical value notification processes, specimen routing and send-out procedures, quality control requirements, instrument downtime reporting processes, and facility-specific administrative requirements applicable to the BPA call services. Such orientation is limited to facility-specific procedures and requirements and shall not be construed as contractor employee training, supervision, or personnel management.

The Contracting Officer, COR, and any designated ordering or technical points of contact will address BPA administration, acceptance, and BPA call matters. FYHCC staff may communicate valid test orders, specimen priorities, specimen routing requirements, send-out needs, critical value notification requirements, quality control requirements, downtime procedures, laboratory safety requirements, and other clinical interface information necessary for safe patient care. Such operational coordination does not relieve the contractor of responsibility for supervising and managing its personnel and does not convert this BPA or any BPA call into a personal services arrangement.

Government-furnished systems, equipment, supplies, work areas, orientation, procedures, laboratory safety requirements, and clinical-interface communications are provided to enable safe, compliant performance and

Government acceptance of services. They do not authorize Government personnel to direct contractor employee assignments, schedules, leave, discipline, performance appraisals, or other contractor personnel-management functions.

The Government may communicate directly with contractor laboratory professionals when immediate communication is necessary for patient safety, specimen integrity, critical value notification, quality control failures, instrument downtime, privacy, security, emergency response, infection control, hazardous materials, laboratory safety, or system access matters. Routine personnel-management and performance-deficiency communications shall be routed through the contractor's contract manager.

11. Contractor Management, Staffing Continuity, Removal, and Substitution

The contractor shall designate a contract manager and an alternate contract manager with authority to resolve staffing, coverage, performance, and administrative issues. The contractor shall provide the names, titles, telephone numbers, and email addresses of both individuals and shall update the Government within one (1) business day of any change.

The contractor's contract manager is the primary interface with the Contracting Officer and COR for scheduling coordination, staffing continuity, leave coverage, backfill, corrective action, performance management, and substitution decisions affecting contractor personnel. The contractor remains responsible for employee supervision, schedule management, work assignments, internal performance management, corrective actions, and any employee-relations matters.

If the Government determines that a contractor employee fails to meet BPA, call, or PWS requirements, poses a patient safety, specimen integrity, test integrity, laboratory safety, infection control, privacy, or security risk, lacks required licensure, authorization, competency validation, or access, violates privacy or conduct rules, cannot safely perform required laboratory duties, or otherwise is unsuitable for continued performance, the Contracting Officer may require removal from performance or may deny continued access. For immediate patient safety, specimen integrity, laboratory safety, security, privacy, or compliance concerns, removal or access suspension may be effective immediately.

The contractor shall acknowledge any removal notice within one (1) business day and provide an interim coverage plan within one (1) business day unless another period is stated in the notice. The contractor shall restore required coverage using qualified, cleared, competency-validated, licensed or otherwise authorized personnel as necessary to meet BPA call service requirements. Any newly proposed laboratory professional must satisfy all onboarding, security, competency validation, laboratory authorization, and system access requirements before beginning performance.

The Government may reject services that fail to meet BPA, call, or PWS requirements. Requiring removal from performance, denying facility or system access, rejecting services, or requiring corrective action is a contractual or facility access action and does not constitute Government supervision or discipline of contractor personnel.

12. Deliverables Deliverable Content / Description Due Date Recipient Contract manager contact information Name, title, phone number, and email address for the contractor's primary and alternate points of contact.

Within 2 business days after award and within 1 business day of any change.

CO and COR

Candidate package Complete security, onboarding, qualification, licensure or authorization, competency validation, laboratory authorization, and any required access or credentialing documentation for each proposed laboratory professional.

At least 45 calendar days before proposed start date, unless otherwise approved by the Contracting Officer or

BPA call.

CO/COR and designated

FYHCC offices

Monthly Coverage and

Credential Status Report Monthly coverage report identifying personnel who performed services, credential status, coverage provided, and any anticipated risks to continuity of services.

Monthly, by the fifth (5th) business day after the end of the service month, unless otherwise stated in the BPA call.

CO and COR

Monthly coverage report BPA call shifts, sessions, or hours; completed shifts, sessions, or hours;

unfilled or partially filled coverage; explanation for any coverage gap; and contractor action taken to maintain or restore coverage.

Monthly, with invoice support record or by the fifth (5th) business day after the end of the service month.

CO and COR

Monthly quality assurance summary Summary of required documentation, quality control, critical value notification, specimen integrity, patient safety, training, competency validation, proficiency or quality assurance participation, and compliance matters for the reporting month; include known issues, trends, and corrective actions when applicable.

Monthly, by the tenth (10th) business day after the end of the service month, unless otherwise stated in the BPA call.

CO and COR

Laboratory documentation and result entry Accurate specimen, quality control, instrument, critical value, and test-result documentation entered in Government systems and local records required by procedure.

Same day of service; critical values per local policy; 100% within 24 hours absent documented system outage or emergency circumstances.

Entered in Government

LIS/EHR and local laboratory records

Deliverable Content / Description Due Date Recipient Incident or status notification Notification of any patient safety, specimen integrity, privacy, security, licensure, competency, exclusion, quality control, instrument downtime, hazardous material, laboratory safety, or other event affecting performance.

Within 1 business day of discovery, or sooner when immediate patient safety, specimen integrity, privacy, security, laboratory safety, or operational action is required.

CO and COR

Corrective action response Written plan or response describing root cause, immediate corrective action, preventive measures, responsible contractor official, and implementation status when requested by the Government.

Within 3 business days of request unless another period is stated.

CO and COR

Monthly invoice support record Dates of service, authorized shifts, sessions, or hours completed, laboratory professional name(s), BPA call or line item reference, coverage confirmation, and any other information needed for acceptance and reconciliation. Names are included for credentialing, competency validation, LIS/EHR reconciliation, laboratory service verification, invoice reconciliation, and acceptance verification only.

With each monthly invoice. CO/COR/IPP as applicable

13. Invoicing and Payment

Invoices shall be submitted electronically through the Invoice Processing Platform (IPP) or other Government-designated payment system. Each invoice shall include, at a minimum, the invoice number and date, BPA number and

BPA call number, applicable BPA or call line item number, dates of service, laboratory professional name(s), authorized shifts, sessions, or hours actually ordered and performed, unit prices, total charges, and the supporting service record required for Government acceptance and reconciliation.

Laboratory professional names are required for credentialing, competency validation, laboratory authorization, LIS/EHR reconciliation, specimen and test-result verification, invoice reconciliation, and acceptance verification only. Inclusion of laboratory professional names in invoice support records shall not be used to establish Government supervision, labor-hour control, or employee-management authority over contractor personnel.

The Government will pay only for accepted services that were ordered and performed. Additional coverage beyond ordered quantities or periods requires prior written authorization under the BPA or applicable BPA call. The contractor shall not bill IHS patients or third-party payers for services covered by this BPA or applicable BPA call.

14. Applicable Requirements

• Applicable provisions of the Indian Health Manual relating to laboratory services, onboarding, competency validation, quality activities, medical records, patient rights, infection control, laboratory safety, emergency response, and security.

• Current FYHCC laboratory procedures, test menus, quality control procedures, specimen handling instructions, critical value notification procedures, send-out testing procedures, instrument maintenance or downtime procedures, and local operating procedures provided during onboarding.

• Current accreditation standards applicable to FYHCC pathology and medical laboratory services and ambulatory care services.

• The Clinical Laboratory Improvement Amendments (CLIA), the Health Insurance Portability and Accountability

Act (HIPAA), the Privacy Act, and applicable Federal information security and privacy requirements.

• Applicable Federal and State licensure, laboratory personnel, workplace safety, bloodborne pathogen, hazardous materials, child protection, immunization, and exposure control requirements.

• Applicable HHS and IHS mandatory training, tobacco-free workplace, and facility access rules.

• Applicable solicitation, BPA, and BPA call terms, including inspection, acceptance, invoicing, security, privacy, laboratory safety, and service-performance requirements.

• The solicitation, resulting BPA, and applicable BPA calls shall include FAR 52.237-7, Indemnification and Medical

Liability Insurance, with the required medical liability insurance amount inserted by the Contracting Officer, as applicable to the nonpersonal health care services requirement.

This PWS states the required results and operating constraints for the service requirement. Solicitation clauses, BPA terms, pricing terms, insurance requirements, and other legally operative terms shall be addressed in the solicitation, resulting BPA, and applicable BPA calls.