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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. |