Attachment A - PWS - Medical Laboratory Staffing Services.pdf

PERFORMANCE WORK STATEMENT (PWS)

Medical Laboratory Staffing Services

Phoenix Area Indian Health Service

SECTION 1

PERFORMANCE-BASED SUMMARY

This requirement is structured as a performance-based service acquisition. The Contractor is responsible for achieving the performance outcomes defined in this Performance Work Statement (PWS), rather than adherence solely to prescribed processes.

INTRODUCTION

It is the intent of the Phoenix Area Indian Health Service (PAIHS) to establish a Blanket Purchase Agreement (BPA) for nonpersonal professional Medical Laboratory Technician (MLT) services in support of Phoenix Area Indian Health Service facilities. Services shall be ordered through individual BPA Calls identifying the Ordering Activity, place of performance, period of performance, and required laboratory coverage.

Contractor personnel shall perform clinical laboratory testing and related laboratory support services in accordance with this Performance Work Statement (PWS), applicable Federal and State requirements, accreditation standards, and accepted standards of clinical laboratory practice.

Selected Contractor personnel shall successfully complete all required qualification verification, security, onboarding, orientation, and mandatory training requirements before independently performing services under an individual BPA Call.

1. SCHEDULES / LOCATION / QUALIFICATIONS / CERTIFICATIONS

A. Schedule

The Contractor shall provide Medical Laboratory Technician (MLT) services during the period of performance established in each BPA Call.

Shift schedules are subject to change based upon patient volume, operational requirements, laboratory workload, and available funding. However, typical shift lengths are 8-hour and 10-hour shifts.

Services may be required twenty-four (24) hours per day, seven (7) days per week, including weekends and Federal holidays.

Typical shifts include, but are not limited to:

• Day Shift

• Evening Shift

• Night Shift

• Ten-hour shifts, when operationally required

The Contractor shall be responsible for developing staffing schedules sufficient to meet the Government's required laboratory coverage.

B. Estimated Quantities

Estimated quantities identified in each BPA Call represent the Government's anticipated operational requirements for that individual call.

Estimated quantities are provided solely for acquisition planning, quotation evaluation, and BPA and BPA Call administration.

Estimated quantities are not intended to represent:

• guaranteed minimum quantities;

• staffing positions;

• required Medical Laboratory Technicians; or

• full-time equivalents (FTEs).

The Contractor shall determine the number of qualified Medical Laboratory Technicians necessary to satisfy the Government's required laboratory coverage while maintaining continuity of laboratory operations.

Services exceeding funded estimated quantities shall require additional funding and appropriate contract action by the Contracting Officer prior to performance.

C. Location

Services shall be performed at the Phoenix Area Indian Health Service facility identified in the applicable BPA Call.

Each BPA Call shall identify:

• Ordering Activity

• Place of Performance

• Laboratory Department

• Period of Performance

• Required laboratory coverage

• Contracting Officer's Representative (COR)

D. Hours Control / Preapproval

All services shall be performed in accordance with Contractor-developed staffing schedules coordinated with the Ordering Activity.

Any hours worked beyond a scheduled shift shall require advance authorization by the COR for purposes of contract administration and payment approval. Such authorization does not constitute supervision or control over Contractor personnel.

In situations requiring continuation of laboratory operations to support patient care, Contractor personnel may extend services beyond scheduled hours when necessary to complete testing, ensure specimen integrity, or support emergency clinical operations. The Contractor shall notify the Ordering Activity COR within twenty-four (24) hours and provide appropriate justification.

E. Qualifications

The Contractor shall furnish Medical Laboratory Technicians who possess:

• An Associate's Degree in Medical Laboratory Technology or an equivalent qualifying education consistent with applicable certification requirements.

• Current certification as a Medical Laboratory Technician (MLT) by the American Society for Clinical Pathology (ASCP), American Medical Technologists (AMT), or another nationally recognized certifying organization acceptable to the Government.

• Current, active, unrestricted certification throughout the period of performance.

• Current Basic Life Support (BLS) certification, if required by facility policy.

• Demonstrated proficiency in clinical laboratory testing and laboratory quality practices.

F. Experience

The Contractor shall furnish Medical Laboratory Technicians possessing a minimum of one

(1) year of recent clinical laboratory experience.

Preference may be given to personnel with experience in:

• Indian Health Service facilities;

• Tribal healthcare facilities;

• Federal healthcare facilities;

• Hospital-based clinical laboratories;

• Critical Access Hospitals

• Rural healthcare facilities; and

• CAP- or CLIA-accredited laboratories.

Contractor personnel shall demonstrate proficiency in:

• Specimen collection, processing, and handling;

• Clinical chemistry;

• Hematology;

• Coagulation;

• Blood bank/transfusion services;

• Microbiology;

• Serology;

• Urinalysis;

• Quality control and quality assurance procedures;

• Laboratory information systems (LIS) and Electronic Health Records (EHR), as applicable.

Contractor personnel shall maintain professional standards of conduct, appearance, and hygiene appropriate for a clinical laboratory environment while performing under this BPA.

2. PERFORMANCE REQUIREMENTS

The Contractor shall provide qualified Medical Laboratory Technician (MLT) services that consistently meet the performance objectives established in this Performance Work Statement (PWS). Contractor performance shall be evaluated based on the quality, timeliness, responsiveness, continuity, regulatory compliance, and professional execution of services.

The Contractor shall furnish all management, supervision, personnel, recruitment, scheduling, administrative support, and other resources necessary to perform the required services in accordance with this Performance Work Statement and each individual BPA Call.

The Contractor shall maintain sufficient staffing resources to ensure uninterrupted laboratory operations throughout the period of performance identified in each BPA Call.

Performance objectives include, but are not limited to, the following:

A. Staffing Continuity

The Contractor shall maintain continuous coverage of all scheduled laboratory shifts identified by the Government.

The Contractor shall implement effective recruitment and retention practices sufficient to minimize staffing disruptions and ensure continuity of laboratory operations.

When Contractor personnel become unavailable due to resignation, illness, family emergency, military activation, or any other circumstance, the Contractor shall immediately initiate replacement efforts and coordinate with the Contracting Officer's Representative (COR) to minimize disruption of laboratory services.

Repeated staffing shortages, excessive vacancies, or failure to provide timely replacement personnel may be considered performance deficiencies and may be documented in the Contractor Performance Assessment Reporting System (CPARS).

Orientation

Contractor personnel shall successfully complete all orientation, security, competency validation, and mandatory training required by the Ordering Activity before independently performing services.

B. Technical Performance

Contractor personnel shall perform clinical laboratory services required by the applicable BPA Call within the scope of their education, certification, competency, and applicable regulatory requirements.

Contractor personnel shall:

• Collect, receive, process, analyze, and report laboratory specimens in accordance with laboratory policies and accepted laboratory practices.

• Perform laboratory testing using approved methodologies and laboratory instrumentation.

• Verify the accuracy of test results before release.

• Follow established quality control (QC), quality assurance (QA), and proficiency testing requirements.

• Comply with all applicable laboratory safety, infection prevention, and specimen handling requirements.

• Accurately document laboratory activities within the Laboratory Information System

(LIS) and other Government information systems, as applicable.

C. Qualification Verification and Compliance

The Contractor shall ensure all assigned personnel maintain current certifications, required training, competency assessments, qualification verification, and mandatory training throughout the period of performance.

The Contractor shall immediately notify the Contracting Officer and Ordering Activity COR of any change affecting an employee's ability to perform services under the BPA or BPA Call, including suspension, expiration, investigation, restriction, or loss of certification.

No Contractor employee shall independently perform laboratory testing until all required qualification verification, security requirements, orientation, and competency validation have been completed.

D. Responsiveness

The Contractor shall maintain effective communication with the Contracting Officer, COR, Ordering Activity Laboratory Manager, and other designated Government officials designated in the BPA Call regarding staffing, scheduling, qualification verification, performance issues, and operational matters.

The Contractor shall designate a Contract Manager who is authorized to act on behalf of the Contractor and who remains accessible during normal business hours. After-hours contact information shall also be maintained for urgent staffing matters.

The Contractor shall respond promptly to Government requests regarding performance, staffing issues, or operational concerns.

E. Quality of Services

The Contractor shall perform services in a professional, ethical, courteous, and patient-focused manner consistent with accepted standards of clinical laboratory practice.

Performance expectations include:

• Accurate laboratory testing and reporting.

• Timely processing of laboratory specimens.

• Compliance with quality control and quality assurance procedures.

• Compliance with laboratory safety requirements.

• Professional interaction with patients, laboratory personnel, providers, and healthcare staff.

• Accurate and timely documentation of laboratory activities.

• Continuous adherence to applicable laboratory accreditation standards and facility policies.

F. Performance Monitoring

The Government will monitor Contractor performance throughout the period of performance using the Quality Assurance Surveillance Plan (QASP) contained in this Performance Work Statement.

Performance monitoring may include:

• Review of staffing schedules and BPA Call staffing coverage

• Review of qualification verification and certification records.

• Observation of contract performance.

• Quality control and proficiency testing records.

• Laboratory quality assurance data.

• Review of contractor response times for replacement personnel.

• Incident reports.

• Customer feedback.

• Contractor reports and deliverables.

• Meetings with Contractor management.

The Government may document performance trends and identify areas requiring corrective action throughout contract performance.

G. Corrective Action

When performance deficiencies are identified, the Contracting Officer may require the Contractor to submit a written Corrective Action Plan (CAP) describing:

• The cause of the deficiency;

• Immediate corrective actions taken;

• Long-term preventive measures;

• The anticipated timeline for full resolution; and

• The method for monitoring continued compliance.

Failure to correct identified deficiencies may result in remedies available under the terms and conditions of the BPA, including adverse Contractor Performance Assessment Reporting System (CPARS) evaluations or other contractual actions deemed appropriate by the Contracting Officer.

H. Continuous Improvement

The Contractor is encouraged to identify opportunities to improve laboratory operations, workflow efficiency, specimen processing, turnaround times, communication, and overall contract performance throughout the life of the BPA.

Recommendations for process improvements may be submitted to the Ordering Activity COR at any time. Acceptance or implementation of any recommendation remains solely at the discretion of the Government.

3. SCOPE OF SERVICES

The Contractor shall provide all personnel, management, supervision, scheduling, recruiting, administrative support, and other resources necessary to furnish nonpersonal Medical Laboratory Technician (MLT) services under this Performance Work Statement (PWS) and individual BPA Calls issued against the resulting Blanket Purchase Agreement

(BPA).

Services shall support the laboratory departments of Phoenix Area Indian Health Service (PAIHS) facilities identified in individual BPA Calls. The Contractor shall furnish qualified Medical Laboratory Technicians who are appropriately educated, certified, qualified, and competent to perform clinical laboratory testing and related laboratory support services in accordance with applicable Federal and State regulations, accreditation standards, and accepted standards of clinical laboratory practice.

The Contractor shall be responsible for recruiting, employing, compensating, supervising, scheduling, replacing, and managing Contractor personnel. Contractor personnel shall remain employees of the Contractor at all times. Nothing in this BPA shall be construed as creating an employer-employee relationship between the Government and Contractor personnel.

Each BPA Call will identify the required laboratory coverage, estimated hours, place of performance, period of performance, and any facility-specific requirements necessary to support patient care operations. The Contractor shall determine the number of qualified Medical Laboratory Technicians necessary to satisfy those requirements while maintaining uninterrupted laboratory services.

The Contractor shall ensure all assigned personnel successfully complete all required qualification verification, competency validation, onboarding, mandatory training, security requirements, and orientation before independently performing services under this BPA.

Contractor personnel shall perform services in accordance with:

• The terms and conditions of the resulting BPA;

• This Performance Work Statement (PWS);

• Applicable Federal laws and regulations;

• Clinical Laboratory Improvement Amendments (CLIA);

• College of American Pathologists (CAP) standards, when applicable;

• Centers for Medicare & Medicaid Services (CMS) Conditions of Participation, when applicable;

• Indian Health Service (IHS) policies;

• Ordering Activity’s policies and procedures; and

• Generally accepted standards of clinical laboratory practice.

The Contractor shall maintain sufficient recruiting capability and staffing resources to support one or more BPA Calls throughout the ordering period. The Contractor shall immediately initiate replacement efforts whenever assigned personnel become unavailable and shall coordinate with the applicable Ordering Activity COR to minimize disruption of laboratory services.

The Contractor shall cooperate fully with Government personnel and any successor contractor to ensure continuity of laboratory operations during personnel transitions and at BPA completion.

The Contractor shall provide all services in a professional, ethical, courteous, and patient-focused manner while supporting the mission of the Indian Health Service and the Phoenix Area Indian Health Service.

3.1 BPA Calls

Services shall be ordered through individual BPA Calls issued by the Contracting Officer or other authorized ordering official in accordance with the terms and conditions of the Blanket Purchase Agreement.

Each BPA Call shall identify, at a minimum:

• Ordering Activity;

• Place of Performance;

• Laboratory Department;

• Period of Performance;

• Required shift coverage;

• Estimated hours;

• Applicable BPA or BPA Call Line Item Number(s) (CLINs), if applicable;

• Contracting Officer's Representative (COR); and

• Any facility-specific requirements not otherwise addressed in this Performance

Work Statement.

If multiple BPA Calls are active simultaneously, the Contractor shall perform in accordance with the terms and conditions of each accepted BPA Call. Acceptance of one BPA Call does not relieve the Contractor of its responsibility to perform under another accepted BPA Call unless otherwise authorized in writing by the Contracting Officer.

The Contractor shall perform services in accordance with this Performance Work Statement and the applicable BPA Call.

4. MAJOR DUTIES

The Contractor shall furnish qualified Medical Laboratory Technicians who are competent to perform clinical laboratory testing and laboratory support services consistent with their education, certification, demonstrated competency, and applicable regulatory requirements.

Contractor personnel shall perform duties that include, but are not limited to, the following:

A. Specimen Collection and Processing

• Collect, receive, verify, label, process, and prepare patient specimens in accordance with laboratory procedures.

• Verify specimen identification and integrity prior to testing.

• Process specimens using approved laboratory procedures and established chain-of-custody requirements, when applicable.

• Ensure proper storage, transportation, and disposition of laboratory specimens.

B. Laboratory Testing

• Perform routine and moderately complex laboratory testing within the scope of certification and competency.

• Operate laboratory instrumentation and analytical equipment in accordance with manufacturer instructions and laboratory procedures.

• Perform testing in the laboratory disciplines identified by the Ordering Activity and within the individual's documented competency, which may include:

o Clinical Chemistry o Hematology o Coagulation o Urinalysis o Serology o Microbiology o Blood Bank/Immunohematology, when performed by the Ordering Activity and within the Contractor employee's documented competency.

o Other laboratory disciplines required by the Ordering Activity and consistent with documented competency.

• Verify and report laboratory results in accordance with established laboratory policies.

C. Quality Assurance and Quality Control

• Perform required quality control (QC) procedures and document results.

• Participate in quality assurance (QA) activities, proficiency testing, and competency assessments.

• Recognize unacceptable quality control results and take appropriate corrective action in accordance with laboratory procedures.

• Report equipment malfunctions, quality issues, and testing discrepancies promptly.

D. Laboratory Safety

• Comply with laboratory safety policies, infection prevention practices, bloodborne pathogen requirements, hazardous materials procedures, and applicable Occupational Safety and Health Administration (OSHA) standards.

• Utilize appropriate personal protective equipment (PPE).

• Maintain a clean, organized, and safe laboratory work environment.

• Properly handle, store, and dispose of biohazardous materials and laboratory waste.

E. Documentation

• Accurately document laboratory testing, quality control activities, maintenance records, and other required information in the Laboratory Information System (LIS), Electronic Health Record (EHR), or other Government information systems utilized by the Ordering Activity.

• Ensure laboratory documentation is complete, accurate, and timely.

• Maintain records in accordance with applicable regulatory and accreditation requirements.

F. Equipment Maintenance

• Perform routine maintenance, calibration, and operational checks of laboratory equipment as assigned.

• Document maintenance activities in accordance with laboratory procedures.

• Identify equipment malfunctions and promptly notify appropriate laboratory personnel.

G. Professional Responsibilities

Contractor personnel shall:

• Maintain current professional competency within their scope of practice.

• Demonstrate sound technical judgment consistent with laboratory policies and procedures.

• Maintain patient confidentiality in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, and other applicable laws and regulations.

• Demonstrate professional conduct and effective communication with patients, providers, laboratory personnel, and other healthcare staff.

• Comply with all applicable Indian Health Service directives, Ordering Activity policies, accreditation standards, and laboratory procedures.

H. Exclusions

Contractor personnel shall not:

• Perform testing outside the scope of their education, certification, demonstrated competency, or applicable regulatory requirements.

• Report laboratory results that have not been appropriately verified in accordance with laboratory policy.

• Represent themselves as Government employees.

• Obligate the Government contractually or financially.

• Supervise Government employees except as specifically authorized within the normal course of laboratory operations.

• Perform inherently governmental functions.

4.1 – Facility-Specific Duties

Contractor personnel may perform additional laboratory duties unique to the Ordering Activity, provided such duties:

• are within the scope of the Contractor employee's education, certification, licensure (if applicable), and documented competency;

• are consistent with this Performance Work Statement;

• comply with applicable Federal, State, accreditation, and Indian Health Service requirements; and

• are identified during orientation or in the applicable BPA Call.

Facility-specific duties shall not constitute a change in the scope of the Blanket Purchase Agreement unless they require services outside the general scope of Medical Laboratory Technician practice.

5. CONTRACTOR REQUIREMENTS

The Contractor shall provide all management, supervision, personnel, recruitment, scheduling, administrative support, equipment (unless Government-furnished), and other resources necessary to perform the services required under this Performance Work Statement and individual BPA Calls issued under the resulting Blanket Purchase Agreement.

The Contractor shall be solely responsible for recruiting, hiring, compensating, training, supervising, evaluating, disciplining, and replacing Contractor personnel assigned under this BPA. Contractor personnel shall remain employees of the Contractor and shall not be considered Government employees for any purpose.

The Contractor shall designate a Contract Manager who shall serve as the primary point of contact for all contractual and administrative matters. The Contract Manager shall have the authority to make decisions and commit Contractor resources necessary to ensure successful contract performance.

The Contract Manager shall have the authority to coordinate staffing and administrative matters for multiple Ordering Activities when services are being performed under more than one BPA Call.

The Contractor shall maintain sufficient recruiting capability, staffing resources, and operational capacity to provide uninterrupted Medical Laboratory Technician (MLT) coverage throughout the BPA ordering period and under all active BPA Calls.

If Contractor personnel become unavailable due to resignation, illness, military activation, family emergency, termination, or any other circumstance, the Contractor shall immediately initiate replacement efforts and notify the Ordering Activity Contracting Officer's Representative (COR). The Contractor shall coordinate replacement personnel to minimize disruption to laboratory operations and maintain continuity of services.

The Contractor shall ensure all assigned personnel maintain current certifications, competency validation, mandatory training, qualification verification, and any other qualifications required to perform services under this BPA. The Contractor shall immediately notify the Contracting Officer and Ordering Activity COR of any circumstance affecting an employee's eligibility to perform services, including suspension, restriction, expiration, investigation, or loss of certification.

The Contractor shall comply with all applicable Federal laws, regulations, accreditation standards, Indian Health Service (IHS) policies, Phoenix Area policies, Ordering Activity policies, and the terms and conditions of the resulting BPA.

The Contractor shall ensure personnel conduct themselves professionally at all times while performing services under this BPA. Contractor personnel shall maintain appropriate professional appearance, identification, and behavior consistent with accepted healthcare standards.

The Contractor shall cooperate with Government personnel and any successor contractor during contract or BPA transition activities to ensure continuity of laboratory operations and uninterrupted patient services.

The Contractor shall maintain accurate records necessary to demonstrate compliance with BPA requirements and shall provide such records to the Contracting Officer or COR upon request, consistent with applicable privacy and confidentiality requirements.

5.1 Contractor Recruiting Capability

The Contractor shall maintain an active recruiting program capable of identifying, qualifying, onboarding, and deploying Medical Laboratory Technicians to support anticipated and emergent staffing requirements throughout the Phoenix Area Indian Health Service. Upon request by the Contracting Officer, the Contractor shall provide information describing its recruiting pipeline, anticipated availability of qualified personnel, and estimated deployment timelines.

5.2 Simultaneous BPA Calls

The Contractor shall maintain sufficient management and staffing capability to perform under multiple BPA Calls simultaneously. Performance under one BPA Call shall not relieve the Contractor of its responsibility to perform under any other active BPA Call unless otherwise authorized in writing by the Contracting Officer.

6. SUPERVISORY CONTROLS

This is a non-personal services Blanket Purchase Agreement (BPA). Services shall be performed under individual BPA Calls. The Government shall not exercise day-to-day supervision or control over Contractor personnel.

The Contractor shall be responsible for the direction, supervision, scheduling, evaluation, discipline, and overall management of Contractor personnel assigned under this BPA and any individual BPA Call.

The Government will identify required laboratory coverage through individual BPA Calls, establish performance expectations, evaluate Contractor performance, monitor compliance with the terms and conditions of the BPA and applicable BPA Calls, and coordinate laboratory operations necessary to support patient care. These actions do not constitute supervision or control of Contractor personnel.

Contractor personnel shall perform laboratory services in accordance with their education, certification, demonstrated competency, applicable regulatory requirements, and accepted standards of clinical laboratory practice. Technical decisions and laboratory testing activities shall be performed consistent with laboratory policies, quality standards, and applicable regulatory requirements.

The Contracting Officer retains sole authority to modify the Blanket Purchase Agreement, issue or modify BPA Calls as authorized, direct changes in scope, authorize additional work, or otherwise bind the Government contractually.

The Contracting Officer shall designate a Contracting Officer's Representative (COR) for each BPA Call, as appropriate. The COR is responsible for monitoring technical performance, coordinating contract administration, reviewing invoices, verifying services performed, and serving as the Government's primary point of contact for day-to-day contract administration. The COR is not authorized to modify the BPA, issue or modify BPA Calls, or direct changes affecting BPA price, scope, terms, or conditions.

Nothing in this BPA or any individual BPA Call shall be construed as creating an employer-employee relationship between the Government and Contractor personnel.

6.1 Clinical Coordination

Government laboratory personnel may provide technical direction regarding patient-specific testing priorities, specimen acceptance, quality control procedures, instrument operation, workflow coordination, and compliance with applicable laboratory policies.

Such technical coordination is necessary to ensure patient care and regulatory compliance and shall not be construed as supervision, direction, or control of Contractor personnel.

7. SECURITY

Contractor personnel shall comply with all applicable Federal laws, Department of Health and Human Services (HHS) policies, Indian Health Service (IHS) policies, Phoenix Area Indian Health Service policies, the policies and procedures of the applicable Ordering

Activity, and local security procedures governing access to Government facilities, information systems, laboratories, and sensitive information.

Prior to performing services under an individual BPA Call, Contractor personnel shall successfully complete all security requirements established by the Ordering Activity, including identity verification, fingerprinting, background investigations (when required), and issuance of Government identification badges and access credentials.

Contractor personnel shall safeguard all Government property, laboratory equipment, records, information systems, and sensitive information entrusted to them during BPA performance.

Access to Government information systems, Laboratory Information Systems (LIS), Electronic Health Records (EHR), and other Government information systems utilized by the Ordering Activity shall be limited to that necessary to perform services under the applicable BPA Call.

The Contractor shall immediately notify the Contracting Officer (CO), the applicable Ordering Activity COR, and the appropriate Ordering Activity Information Systems Security Officer (ISSO), when applicable, of any actual or suspected security incident, unauthorized disclosure, loss of Government property, cybersecurity event, or compromise of sensitive information involving Contractor personnel.

Upon completion, expiration, or termination of a BPA Call, or upon request by the Government, Contractor personnel shall immediately return all Government-issued identification badges, keys, access cards, Government-furnished equipment, and other Government property issued by the Ordering Activity.

The Contractor shall ensure assigned personnel comply with the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, the Federal Information Security Modernization Act (FISMA), applicable HHS and IHS information security policies, and all Ordering Activity privacy and information security requirements.

7.1 Access Control

Contractor personnel shall access only those Government facilities, laboratories, records, information systems, and patient information necessary to perform assigned duties under the applicable BPA Call. Access privileges shall be limited to the minimum necessary to perform BPA requirements and may be modified or revoked by the Government when operationally required.

7.2 Security Training

Contractor personnel shall complete all mandatory security, privacy, cybersecurity awareness, and information systems training required by the Ordering Activity before receiving access to Government information systems. The Contractor shall ensure such training remains current throughout the period of performance.

8. QUALIFICATION VERIFICATION

All Contractor personnel assigned under an individual BPA Call shall successfully complete the Ordering Activity's qualification verification, onboarding, and security requirements before independently performing laboratory services.

The Contractor shall provide all documentation required to verify personnel qualifications, including, but not limited to:

• Current certification as a Medical Laboratory Technician (MLT);

• Documentation of education and clinical training;

• Evidence of applicable laboratory experience;

• Current Basic Life Support (BLS) certification, if required by facility policy;

• Professional references;

• Professional liability insurance documentation, if applicable;

• Documentation necessary to verify competency, regulatory compliance, and any facility-specific qualification requirements identified in the applicable BPA Call;

• Documentation necessary to complete Ordering Activity security, onboarding, and access requirements; and

• The Contractor shall ensure all qualification documentation remains current throughout the period of performance and shall promptly provide updated documentation upon request.

Contractor personnel shall not independently perform laboratory services until qualification verification, security requirements, orientation, competency validation, mandatory training, and any facility-specific onboarding requirements have been successfully completed.

The Contractor shall immediately notify the Contracting Officer and the applicable Ordering Activity COR of any action affecting an assigned employee's certification, competency, qualification status, disciplinary action, investigation, exclusion from Federal healthcare programs, or any other matter affecting the employee's eligibility to perform services under the BPA.

The Government reserves the right to determine whether assigned personnel meet the qualification requirements established by this Performance Work Statement, the BPA, and the applicable BPA Call.

8.1 Substitution of Personnel

The Contractor may substitute assigned personnel during performance, provided the replacement individual meets or exceeds the qualification requirements of this Performance Work Statement and successfully completes all qualification verification, security, onboarding, and competency requirements before independently performing services. The Contractor shall coordinate all proposed substitutions with the Contracting Officer and the applicable Ordering Activity COR.

8.2Personnel Records

The Contractor shall maintain current qualification records for all personnel assigned under the BPA and shall make such records available to the Contracting Officer or COR upon request. Records shall include, as applicable, certifications, continuing education, competency documentation, training records, and other documentation necessary to demonstrate continued compliance with BPA requirements.

9. DELIVERABLES

The Contractor shall provide all deliverables necessary to support successful performance of the Blanket Purchase Agreement (BPA) and individual BPA Calls. Deliverables shall be submitted to the Contracting Officer (CO), Contracting Officer's Representative (COR), or other Government representative identified in the applicable BPA Call.

Required deliverables include, but are not limited to, the following:

Deliverable Frequency Recipient

Staffing Schedule As requested and updated Ordering Activity COR and Laboratory Manager

Monthly Staffing Report Monthly Ordering Activity COR

Current Personnel Roster Monthly and as changes occur

Ordering Activity COR

Updated Contractor Contact List As changes occur Ordering Activity COR

Copies of Current Certifications and Qualification Documentation

Upon assignment and renewal

Ordering Activity COR / Laboratory Manager

Qualification Verification Documentation

As required Ordering Activity COR

Professional Liability Insurance Documentation (if applicable)

Upon assignment and renewal

Ordering Activity COR

Corrective Action Plan (when requested)

Within timeframe specified by the Contracting Officer

Contracting Officer

Transition Plan (if requested) As directed by the Contracting Officer

Contracting Officer

Vacancy or Anticipated Staffing Shortage Notification

Within one (1) business day of identification

CO and Ordering Activity

COR

Deliverable Frequency Recipient

Replacement Personnel Status Report

Weekly until vacancy is filled Ordering Activity COR

New Employee Qualification Package

Prior to start of performance Ordering Activity COR

Monthly Performance Report Monthly CO and Ordering Activity

COR

Include:

• hours worked

• staffing coverage

• vacancies

• replacements

• recruiting efforts

• anticipated staffing issues

All deliverables shall be complete, accurate, and submitted within the timeframes established by the Contracting Officer, Ordering Activity COR, or applicable BPA Call.

Unless otherwise specified, deliverables shall be submitted electronically in a format acceptable to the Government.

Deliverable Format

Unless otherwise specified in the BPA Call, all reports and deliverables shall be submitted electronically in Microsoft Office or Adobe PDF format. The Government may require supporting documentation sufficient to verify compliance with the requirements of this Performance Work Statement.

10. PERFORMANCE CONDITIONS

The Contractor shall continuously maintain the capability to provide qualified Medical Laboratory Technicians (MLTs) sufficient to satisfy the Government's laboratory staffing requirements throughout the BPA ordering period and under all active BPA Calls.

The Contractor shall maintain an active recruiting and retention program capable of identifying, qualifying, onboarding, deploying, and replacing qualified Medical Laboratory Technicians as necessary to minimize staffing interruptions and support current and future BPA Calls.

Continuity of laboratory operations is a material requirement of this BPA. The Contractor shall take all reasonable actions to avoid staffing disruptions that could adversely affect patient care, laboratory operations, diagnostic testing services, or the Government's ability to meet mission requirements at any Ordering Activity.

The Government will evaluate Contractor performance throughout the BPA ordering period and during each BPA Call based on the quality, timeliness, responsiveness, staffing continuity, regulatory compliance, and overall effectiveness of contract performance.

Repeated staffing shortages, untimely replacement of personnel, failure to maintain required qualifications or certifications, poor responsiveness, or failure to comply with BPA or BPA Call requirements may result in corrective action, adverse Contractor Performance Assessment Reporting System (CPARS) evaluations, reduction or cancellation of BPA Calls when appropriate, or other contractual remedies available to the Government.

The Contractor is encouraged to identify opportunities for continuous improvement, enhanced laboratory efficiency, improved turnaround times, workflow optimization, staffing stability, and operational improvements that support the mission of the Indian Health Service and the Phoenix Area Indian Health Service

10.1 Readiness to Support Additional BPA Calls

The Government may issue additional BPA Calls during the BPA ordering period based on operational needs and available funding. The Contractor shall maintain sufficient organizational capability to respond to requests for additional staffing requirements within the timeframes established in the applicable BPA Call. Nothing in this Performance Work Statement guarantees the issuance of any BPA Call or a minimum quantity of services.

11. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

11.1 Purpose

This Quality Assurance Surveillance Plan (QASP) establishes the framework the Government will use to monitor and evaluate Contractor performance under the Blanket Purchase Agreement (BPA) and individual BPA Calls.

The QASP identifies the performance objectives, performance standards, acceptable quality levels (AQLs), surveillance methods, and Government remedies used to evaluate contract performance.

The Government may modify surveillance methods throughout the period of performance as necessary to ensure effective BPA oversight. The QASP does not limit the Government's rights or remedies under the BPA and applicable BPA Calls.

11.2 Performance Objectives

The Contractor shall consistently provide qualified Medical Laboratory Technician services that support accurate, timely, reliable, and compliant clinical laboratory operations while maintaining uninterrupted staffing and compliance with all BPA requirements.

11.3 Surveillance Methods

The Government may evaluate Contractor performance using one or more of the following methods:

• Observation of contract performance.

• Review of staffing schedules.

• Review of invoices and supporting documentation.

• Review of qualification verification and certification records.

• Review of quality control (QC) and quality assurance (QA) records.

• Review of proficiency testing results, when applicable.

• Laboratory quality indicators and turnaround time reports.

• Incident reports.

• Customer feedback.

• Contractor reports and deliverables.

• Meetings with Contractor management.

• Review of corrective actions.

• Review of vacancy notifications and replacement timelines.

• Review of contractor recruiting and staffing reports, when requested.

• Review of compliance with BPA Call requirements.

11.4 Performance Standards

Performance

Objective

Performance

Standard

Acceptable

Quality Level

(AQL)

Surveillance

Method

Government

Remedy

Staffing

Coverage

Scheduled laboratory shifts are staffed with qualified personnel.

100% scheduled coverage unless excused by the

Contracting

Officer.

Review of staffing schedules, Ordering

Activity COR monitoring, observation.

Request

Corrective

Action Plan

(CAP);

document repeated deficiencies in

CPARS;

pursue contractual remedies, as appropriate.

Personnel

Availability

Contractor provides qualified

100% compliance.

Ordering Activity

COR review of

Request CAP;

document replacement personnel within the timeframe established in the applicable BPA

Call.

staffing schedules, vacancy notifications, and replacement timelines.

repeated deficiencies in

CPARS;

pursue contractual remedies if staffing deficiencies affect contract performance.

Qualification

Verification

Assigned personnel maintain all required certifications, qualifications, and competency requirements.

100% compliance throughout contract performance.

Review of qualification records and competency documentation.

Remove ineligible personnel from contract performance until compliant;

require replacement personnel, if necessary.

Laboratory

Quality

Contractor personnel perform laboratory testing in accordance with applicable laboratory policies and regulatory requirements.

95% compliance.

QC/QA review, proficiency testing review, Laboratory quality reports and applicable laboratory performance indicators.

Request CAP;

monitor improvement through follow-up reviews.

Documentation Laboratory records are complete, accurate, and timely.

95% compliance.

Documentation review, laboratory record review.

Request CAP;

monitor improvement through follow-up reviews.

Professional

Conduct

Contractor personnel maintain professional behavior and effective communication.

95% compliance.

Customer feedback, observation, complaint review.

Request CAP;

document repeated deficiencies in

CPARS.

Contract

Administration

Required reports and deliverables identified in the

100% compliance.

Ordering Activity

COR review.

Return deficient deliverables for

BPA or applicable BPA

Call are accurate and submitted on time.

correction;

request CAP if deficiencies are repeated.

Responsiveness Contractor responds to

Government requests regarding staffing and contract administration.

Responses within one (1) business day unless urgent circumstances require immediate action.

COR monitoring. Request CAP;

document repeated failures in

CPARS.

Recruiting and

Replacement

Contractor maintains an active recruiting pipeline and timely efforts.

100% compliance

Review of recruiting reports, vacancy notifications, documentation.

Request CAP;

document repeated deficiencies in

CPARS.

Security and Privacy

Contractor personnel comply with security, privacy, and mandatory training requirements.

100% compliance

Review of security records, training documentation, incident reports.

Remove non-compliant personnel until compliant;

request CAP if repeated.

11.5 Corrective Action

When performance deficiencies are identified, the Contracting Officer may require the Contractor to submit a written Corrective Action Plan (CAP).

At a minimum, the CAP shall:

• Identify the cause of the performance deficiency;

• Describe immediate corrective actions taken;

• Identify long-term preventive measures;

• Provide implementation milestones; and

• Describe how continued compliance will be monitored.

Failure to implement an acceptable Corrective Action Plan may result in additional contractual remedies, including adverse Contractor Performance Assessment Reporting System (CPARS) evaluations or other remedies authorized by the BPA.

11.6 Performance Reviews

The Contracting Officer and COR may conduct periodic performance reviews with the Contractor to discuss:

• Staffing continuity;

• Recruitment efforts;

• Qualification verification status;

• Quality of laboratory services;

• Laboratory quality indicators;

• Deliverables;

• Corrective actions; and

• Opportunities for continuous improvement.

• Status of active BPA Calls;

• Recruiting pipeline and anticipated staffing availability.

The frequency of performance reviews will be determined by the Government based upon operational needs and Contractor performance.

11.7 Contractor Performance Assessment Reporting System (CPARS)

The Government intends to evaluate Contractor performance in accordance with FAR Subpart 42.15, Contractor Performance Information.

Performance evaluations may consider, among other factors:

• Quality of services;

• Schedule and staffing performance;

• Management responsiveness;

• Regulatory compliance;

• Business relations;

• Small business subcontracting (if applicable); and

• Overall BPA management.

Documented performance under the BPA and individual BPA Calls may be considered in future source selections in accordance with applicable regulations.