2. Statement of Work.pdf

Statement of Work

USP Consultant Services

1. Description Phoenix Area Indian Health Service (PAIHS) sites abide by United States Pharmacopeia (USP) General Chapters <795>, <797>, and <800>. USP <795> and <797> were recently updated and will be enforceable by accreditation bodies as of 11/1/2023. A gap analysis is required to assess the current processes and provide for a report with recommendations and a plan to achieve USP compliant operations at PAIHS sites. There is also a need for facility design document review services to provide cleanroom suite design consulting to confirm current projects underway will meet the updated USP <797> standards. The purpose of this buy is to provide all applicable Phoenix Area Indian Health Service healthcare facilities with USP General Chapters <795>, <797> and <800> consultant services. These USP consultant services will be utilized to analyze current processes, review construction plans, list deficiencies and to put a plan in place to ensure compliance for accreditation body surveys.

• Requirements for a PAIHS USP <795>, <797> and <800> gap analysis:

o Conduct current state operational assessment of all facilities to determine if any practices need to be altered immediately, e.g. any patient or employee safety concerns.

o Perform onsite or remote reviews to identify gaps in compliance for USP standards.

Onsite or remote review preference should be determined by complexity of services performed at each facility. Onsite review is preferred, and will be required for sites utilizing hoods or cleanrooms to compound. This review of USP-relevant factors should, at a minimum, include:

Determination of design, process, medication use and current sterile and non-sterile compounding medications Review of applicable local policies, supplies, IV room certifications, surface and air samples, and personal protective equipment related to non-sterile, sterile and hazardous medication handling, preparation and administration.

Assessment of facilities intended use along with:

• compounding category and general process flow;

• specific airflow requirements;

• filter requirements;

• engineering control requirements;

o primary engineering controls (e.g., hoods) o secondary engineering controls (e.g., buffer and ante-room)

• room pressurization requirements;

• temperature and humidity requirements;

• architectural finish requirements.

Observation of receiving, stocking, dispensing, preparing and administering medications, if applicable to the site and current USP standards.

Work with Chief Pharmacist and/or Area Pharmacy Consultant to establish a plan to ensure USP compliance as of November 1, 2023.

o Provide a report no later than 6 weeks after onsite or remote review that includes:

Detailed report documenting all findings, which would preferably include resources (articles, guidelines, and references) to address any areas that do not meet regulatory compliance.

List of deficiencies that need to be addressed to achieve a USP compliant program, preferably (not required) ranked in order of highest concern and the needed to address first versus last

List of recommended equipment, supplies and PPE needed at the facility Plan to meet USP standards as of November 1, 2023.

• Requirements for PAIHS facility design/remodel document review services:

o Provide review services of construction drawings and documents to ensure that the proposed pharmacy design will conform to current USP and federal sterile compounding standards of practices.

o Provide a report with findings no later than six weeks post-delivery of required construction drawings and documents. These should include information regarding, at a minimum, the following:

compounding category and general process flow;

specific airflow requirements;

filter requirements;

engineering control requirements;

• primary engineering controls (e.g., hoods)

• secondary engineering controls (e.g., buffer and ante-room) room pressurization requirements;

temperature and humidity requirements;

architectural finish requirements.

The PAIHS is seeking a one-time purchase of these consultant services.

Independent government cost estimates (IGCE) are included through GSA schedules, online research and historical data. The included estimate is intended to be used for comparison to determine reasonableness of contractor responses.

2. Location

Site Services Needed Description of Current Services and Facility Phoenix Indian Medical Center, 4212 N 16th St, Phoenix, AZ 85016

USP <795>, <797> & <800> GAP

Analysis (onsite) - Hospital with clean room or segregated compounding area AND USP <797> & <800> Facility design document review - clean

One open hood in a segregated compounding area – mostly trying to purchase premixed and closed-system reconstitution; One hazardous chemotherapy area with closed system transfer devices. In process of designing new clean room setup. No immediate use IVs are made outside room construction or remodel for facilities of the pharmacy segregated compounding areas.

Whiteriver Hospital (critical access hospital), 200 W Hospital Dr, Whiteriver, AZ 85941

AND

Cibecue Health Center (small outpatient Whiteriver Hospital satellite clinic) W Cromwell Rd, Cibecue, AZ 85911

USP <795>, <797> & <800> GAP

Analysis (onsite) - Hospital with clean room or segregated compounding area AND USP <797> & <800> Facility design document review - clean room construction or remodel for facilities

Whiteriver: Two cleanroom suites, one hazardous (only use MTX for RA, no chemo) and one non-hazardous. One immediate use IV prep area. In process of remodel of cleanrooms.

Cibecue: Rare immediate use compounding on back counter away from traffic.

*Only Whiteriver Hospital would require onsite review

Hopi Health Care Center (critical access hospital)

Highway 264 Mile Post 388, Polacca, AZ 86042

USP <795>, <797> & <800> GAP

Analysis (onsite) - Hospital with hood in pharmacy area AND USP <797> & <800> Facility design document review - clean room construction or remodel for facilities

Glove box located in room off of outpatient pharmacy. New clean room design approved.

Two immediate use areas, one in pharmacy glove box room and one in ED.

Parker Indian Health Center (critical access hospital), 12033 W Agency Ave, Parker, AZ 85344

USP <795>, <797> & <800> GAP

Analysis (onsite) - Hospital with hood in pharmacy area

Enclosed glove box hood located in outpatient pharmacy.

Peach Springs Indian Health Center (small outpatient clinic), 943 Hualapai Way, Peach Springs, AZ 86434

USP <795>, <797> & <800> GAP

Analysis (remote) - Outpatient pharmacy with immediate use IV compounding

Peach Springs: Immediate use compounding rarely on their "compounding table".

Supai: No specific area designated for immediate use compounding, but possibly the counter in the med room, as there is not a pharmacist onsite. This is a remote facility at the bottom of the Grand Canyon, accessible via foot, donkey or helicopter. All medications and any

AND Supai Canyon Health Station (small critical access health station), 10 Main St Supai, AZ 86435 pharmacy services provided by Peach Springs.

The new facility should be completed soon.

Fort Yuma Health Center (outpatient clinic), Winterhaven, CA

401 Picacho Road Winterhaven, CA 92283

USP <795>, <797> & <800> GAP

Analysis (remote) - Outpatient pharmacy with immediate use IV compounding

One immediate use compounding area within pharmacy on counter.

3. Estimated Period of Performance June 1, 2023 through October 31, 2023

4. General The PAIHS Area Pharmacy Consultant would like to serve as the Subject Matter Expert (SME) to assess any USP consultant services prior to awarding a contract.

Proposals will be evaluated with the Best Value with tradeoffs measures.

5. Method of Payment The vendor shall submit invoice through IPP and the Area Pharmacy Consultant (COR) will review for accuracy and approve for payment.

6. Points of Contact PAIHS Contracting Officer Representative (COR):

Rachelle Green, Area Pharmacy Consultant Rachelle.green@ihs.gov 480-845-4549

Alternate Point of Contact for PAIHS:

Kendall Van Tyle, Area Pharmacy Informaticist kendall.vantyle@ihs.gov 602-364-5040 mailto:Rebecca.reyes@ihs.gov

The COR responsibilities will be to coordinate with the Contractor the technical aspects of the service, and perform ongoing inspection and review of the performance. The COR does not have the authority to change or alter the order amount, or terms and conditions of the contract.

The COR shall:

a. Monitor the Contractor’s technical performance, including surveillance and assessment of performance and recommending to the Contracting Officer changes to the contract.

b. Perform final inspection and acceptance as required by the contract.

c. Assist the Contractor in the resolution of technical problems encountered during performance.