QASP (R).docx

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

For: Upstate VISN 2 Medical Centers:

Albany Stratton VA Medical Center 113 Holland Avenue, Albany, NY 12208

Buffalo VA Medical Center 3495 Bailey Avenue, NY 14215

Finger Lakes VAMC 260 Calkins Road, Rochester, NY 14623

Syracuse VA Medical Center 800 Irving Avenue, Syracuse, NY 13210

Contract Number:

Contract Description: The contractor must be able to provide instrument Sharpening Services and Maintenance for Upstate VISN 2 per the scope of work, for the period of May 1, 2022 to June 30, 2023, with 4 option years available.

Contractor’s name: (hereafter referred to as the contractor).

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored.

· How monitoring will take place.

· Who will conduct the monitoring.

· How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Kimberly Wiatrowski Organization or Agency: Department of Veterans Affairs, RPO East, NCO 2

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Thomas Nojaim

c. Other Key Government Personnel – Point of Contact:

Albany: Glen Leblanc Buffalo: Frank Riggi Finger Lakes: Thomas Nojaim Syracuse: Michelle Benedict

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager - <Enter name.>

b. Other Contractor Personnel - <Enter name(s) or delete these lines if not applicable> Title: <Enter title(s) or delete these lines if not applicable.>

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

5. INCENTIVE

The incentive for all tasks will be the exercising of option periods and past performance.

Timeframe - The Contractor must complete instrument sharpening and maintenance within the allowed timeframe outlined in the PWS

Flawed Product - The Contractor must rework flawed products within the allowed timeframe outlined in the PWS

QUALITY ASSESSMENT OF INSTRUMENT SHARPENING AND MAINTENANCE:

A. The contractor shall perform onsite same day full service which will include the following:

(1) Vendor will provide onsite repair services including instrument stain removal, alignment, adjustments, pins, sharpening, inserts, laparoscopic shaft insulation, springs and manufactured parts and/or screw replacements for all clinical hand instruments in primary care and specialty etc.

(2) Inspection and repair of rigid containers and cassettes

(3) Inspection, sharpening, and repair of various stainless-steel instruments, complete instrument trays and peel pack single instruments, power equipment repair, pneumatic equipment repair, power equipment battery service, light cables, fiberoptic retractors, phaco handpieces, dental handpieces and laparoscopic instruments

(4) Replace damaged instrument parts with new, OEM medical grade parts

(5) Replace unserviceable Reusable Medical Device (RMD), if there is an additional cost a modification will be issued, if it is within the scope of the contract.

(6) Electrosurgical instrument re-insulation

(7) Loaner equipment available while instruments are being repaired off-site

(8) Removal of instrument indicator tape

(9) Case carts shall be on a preventive maintenance program each site shall have ten (10) carts checked per month. Inspection shall include ensure wheels are cleaned and move freely, doors are aligned, knobs allow for proper opening and closing of doors, shelves are properly aligned, bumper guards are in place, and tray and count sheet holders are properly attached. In the event any items listed need repair a quote will be sent to the COR requesting repairs. COR will contact SPS chief for approval and separate P.O. will be created for stated repairs.

(10) The contractor shall coordinate specific dates for maintenance and repairs with the Point of Contact (POC) at each location. Notification and confirmation for maintenance and repairs must be coordinated one week prior to the date requested.

(1) Albany VA Medical Center: MONTHLY SERVICE (1X PER MONTH)

Refurbish approximately 10 trays and items in repair bin monthly. Repair bin may include loose instruments, cords, handpieces and laparoscopic instruments. Repairs are to be done each month.

(2) Buffalo VA Medical Center: MONTHLY SERVICE (1X PER MONTH)

Refurbish approximately 10 trays and items in repair bin monthly. Repair bin may include clinic trays, loose instruments, cords, handpieces and laparoscopic instruments. Vendor will approximately service 40 trays and 4 repair bins. Vendor must provide service on Tuesdays.

(3) Finger Lakes VA Medical Centers: MONTHLY SERVICE (1X PER MONTH)

Vendor will service approximately 100 Instrument trays containing one (1) to twenty (20) instruments and 200 peel pack single instruments with a quarterly target of 100 instrument trays and 50 peel-pack instruments.

(4) Syracuse VA Medical Center: WEEKLY SERVICE

Vendor will service approximately 700 instrument trays and 400 peel pack instruments annually with a quarterly target of 175 instrument trays and 100 peel-pack instruments.

B. Vendor will provide immediately after service (same day), each time, an Observation and Activity Report (OAR). This will include an Activity Summary, a Beyond Repairable Summary, an Instrument Exchange List, an Offsite Repair List, an Appendix, and Before and After Pictures in Color of Extensive Repairs Done to Specific Instruments. All trays and single items will be listed by contractor for accountability. The contractor will tag or label completed trays to identify the instrument inspection date. These instruments must be labeled, marked, or separated to prevent reuse. A comprehensive maintenance report which includes a description of the instruments refurbished, price, and specific defect must be provided within 3 business days.

1. In the event that an instrument is found to be defective beyond the capabilities of the mobile service, or in the event an instrument requires repair or sharpening and cannot wait until the scheduled service period, it may become necessary for the government to ship items to the contractor for service or repair.

1. SPS staff will inspect 100% of instruments serviced using standard tools designed for the testing of surgical instrumentation. Any instruments, after testing, that are found to be of poor repair, will be documented in writing and returned to the contractor for proper repair. The contractor will not bill for items that have not been repaired to acceptable standards

C. Other than exception noted in below, Instruments will be retrieved by the contractor and returned by the contractor on the same day unless the instrument needs repairs that cannot be accomplished on site at that time. These instruments must receive approval from SPS staff before any other work is performed not outlined in the Performance Work Statement.

(1) Dental Handpieces will be retrieved by the contractor and returned to the VA Medical facility within four (4) days. If an instrument has extensive damage, the Contracting Officer Representative (COR) must be provided within 3 business days a description of the defect, repair options, cost, and estimated time of repair. The COR will determine whether to pursue repair option, under a separate purchase or return instrument without repair. All instruments will be returned to the appropriate VA Medical Center warehouse or predetermined return location. Under no circumstance will the contractor retain VA property.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

c. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. May also generate inspections and sampling.)

d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

e. 100% INSPECTION. (Evaluates all outcomes.)

f. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)

g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

h. Progress or status meetings.

i. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

PASS – Met the standard FAIL – Did not meet the standard

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COTR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

<After award, both the contractor’s Program Manager and the COR shall sign this document.>

Signature – Contractor Program Manager

Signature – Contracting Officer’s Technical Representative

SAMPLE QUALITY ASSURANCE MONITORING FORM

SERVICE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

LEVEL OF SURVEILLANCE (Check):

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Narrative of Performance During Survey Period:

PREPARED BY: ___________________________________ DATE: _________________