Attachment 1 Quality Assurance Surveillance Plan (QASP).docx

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Instrument Sterilization Services for Fort Drum, NY
Solicitation number
HT001427QE009
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This document is a Quality Assurance Surveillance Plan (QASP) that establishes minimum performance standards and assessment methods for instrument sterilization services at Fort Drum, NY.

The QASP outlines specific performance objectives and compliance requirements for the contractor providing sterilization services to the Guthrie Army Health Clinic. Key requirements include: designation of a Project Manager in writing to the Contracting Officer; The Joint Commission (TJC) accreditation with certificate verification; receipt and preparation of instruments in closed, humidity-controlled containers with soil removed; clear wrapping of individual surgical instruments (including tenaculums, curettes, forceps, scissors, biopsy instruments, and speculums) for pre-use inspection; manual, mechanical, or combination cleaning with lubrication as appropriate; sterilization and packaging in clean shipping containers; and turnaround completion by the next scheduled delivery day (Monday deliveries picked up Wednesday, Wednesday deliveries picked up Friday, Friday deliveries picked up the following Monday). All performance standards require 100% compliance. Additional requirements mandate that instruments be returned in original sets with inventory lists and delivery lists attached; Fort Drum instruments marked with brown "F.D." indelible markings and clinic-specific color codes; documentation of unserviceable instruments upon receipt; and compliance with TJC standards and ANSI/AAMI ST79 sterilization standards. The Contracting Officer's Representative (COR) will conduct inspections throughout the process and maintain required logs to verify contractor compliance with all performance objectives.

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Solicitation_HT001427QE009.pdf PDF
Attachment 2 Instrument Listing.docx DOCX document

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ATTACHMENT #1

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The following minimum Quality Assurance Surveillance Plan applies. The Government may modify inspection methods in accordance with site specific requirements.

PERFORMANCE OBJECTIVE
PERFORMANCE STANDARD
REF PWS
METHOD OF ASSESSMENT
The Contractor shall designate in writing to the Contracting Officer a Project Manager (PM).
100% Compliance
Para 1.3.1
Notice to Contracting Officer
Contractor shall be TJC accredited.
100% Compliance
Para 5.1
Provide certificate.
The items shall be in closed containers and shipped with gross soil removed and prepared in such a way to prevent organic soils from drying, i.e., placed in a package designed to maintain humid conditions, or with a product designed for pretreatment applied.
100% Compliance
Para 5.2.2
COR and Contractor inspection of items.
A delivery list will be provided with the instruments and will include the items and quantities delivered to the Contractor including blue towels for the sets monthly.
100% Compliance
Para 5.2.2
COR and Contractor inspection of items.
Items are to be clear wrapped singly to include: tenaculums, EC curettes, ring forceps, Bozeman forceps, long Kelly clamps, long scissors, cervical biopsy instruments, and endocervical speculums, for easier visible inspection before use. Single instruments shall be packaged as to open at position of use, e.g., handle end of forceps.
100% Compliance
Para 5.2.4
COR inspection of wrapped instruments.
Instruments dropped off shall be cleaned manually, mechanically, or a combination of manually and mechanically, as appropriate; lubricated as necessary; packaged per set/individual instruments; sterilized assembled in a clean shipping container.
100% Compliance
Para 5.2.5
COR inspection of items.
Instruments shall be ready for pick up on the next scheduled delivery day, i.e., Monday delivery will be picked up on Wednesday, Wednesday delivery will be picked up on Friday, and Friday delivery will be picked up on the following Monday.
100% Compliance
Para 5.2.5
COR Maintain log.
Unserviceable instruments shall be annotated upon receipt 100% if the time, at the time received, and marked as such by the Contractor.
100% Compliance
Para 5.2.6
COR maintain log.
An inventory list detailing the contents of each set shall be attached. Instruments shall be returned in sets as originally marked. All Fort Drum instruments shall be identified with a brown “F.D.” indelible marking (e.g., Sharpie) on the outer packaging and an assigned color corresponding to the clinic.
100% Compliance
Para 5.2.7
COR inspection of items.
The original delivery list shall accompany all items returned to the Government to show quantities and items that have been serviced.
100% Compliance
Para 5.2.7
COR inspection of delivery list.
Any instruments arriving at the Contractor facility as a set shall come back as a set unless duly noted before sterilization.
100% Compliance
Para 5.2.8
COR inspection of items.
Contractor shall be compliant with TJC standards and ANSI/AAMI ST79
100% Compliance
Para 5.2.10
COR inspection.

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