36C79118R0006-008.docx

ATTACHMENT 8

Quality Assurance Surveillance Plan (QASP) Hearing Aid Repair, Parts and Accessories 36C79118R0006 Contractor Name Dated

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) has been developed as the principal basis for assessing overall performance of the support services identified in the Performance Work Statement (PWS). This document will be used by the Government to evaluate the Contractor’s performance to assure they are timely, effective, and are delivering the services and products specified in the contract.

This QASP provides the methodology by which the Contractor's performance will be monitored and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed to limit surveillance to the minimum necessary to verify that the Contractor is satisfactorily performing services directly related to the performance requirements of the PWS. The performance requirements are those designated with corresponding performance measures and performance standards.

2. GOVERNMENT SURVEILLANCE

The Contracting Officer’s Representative (COR) is identified in the PWS. COR authority will be limited to administering specific technical aspects of the contract. The PWS will identify specific guidelines and clearly detail the limits of the COR’s authority. The COR will:

1. Monitor Contractor performance in accordance with this QASP.

1. Coordinate priorities of support, resources, and associated schedules.

3. SURVEILLANCE METHODS

Surveillance of contractor performance is the method used by the Government to determine whether the contractor is effectively and efficiently complying with all terms and conditions of the contract. The COR may use the surveillance methods listed below in the administration of this QASP:

1. Inspection: A method carried out by visual examination of a product (e.g., data from testing, or documentation).

1. Customer Feedback: A method carried out by soliciting customer/end user satisfaction of technical services performed by the contractor.

4. PERFORMANCE REVIEWS AND EVALUATIONS

COR Responsibility: The COR will conduct monthly performance reviews and evaluations with the Contractor based upon the information obtained through the surveillance methods identified above pertaining to the performance outlined in the PRS. The following criteria will be used for performance evaluations:

Contractor Responsibility: The failure of the Contractor to meet the Acceptable Quality Level (AQL) set in the Performance Requirement Summary (PRS) may result in a negative Contract Performance Rating System (CPARS) rating. Reviews and evaluations will form the basis for determining compliance with performance requirements, measures, and standards. Performance reviews will be used to identify the degree of success or failure by the Contractor.

Incenctive:

Positive CPARS rating and option years exercised Negative CPARS rating and option years not exercised The Contractor will be given a reasonable time after notification by the Contracting Officer to correct the unacceptable performance if such correction is possible. This reasonable length of time allowed to correct the problem will depend upon the requirement and the deficiency, and the Contractor will be notified by the Contracting Officer of the time allowed for correction when the deficiency is reported to the Contractor. Should the CO and Contractor reach an impasse on any matter dealing with inspection and re-performance, the Contracting Officer will determine for resolution.

Performance Requirement Summary

b. Battery contacts are clean and adjusted to insure they make contact

c. All items are returned configured as received (earhook, waxguard, domes, etc.)

d. Controls are returned to settings as received

e. Receiver/earmold tubes are cut to the correct length and are in new condition

f. Receiver/earmold tubes are secured with glue or other appropriate mechanism

g. Earmold is reattached to the hearing aid. If the earmold cannot be serviced then the device should be configured (acoustically similar) so that it is still useable to the Veteran (i.e. dome appropriate for their hearing loss, comply tip, etc.)

h. All components and accessories sent in with the device and listed on the repair order are returned and are in new or like new condition

i. The serial number is a permanent part of the device, as required by FDA labeling requirements

b. Volume control works through the full range

c. There is no case noise or internal oscillation

d. There is no intermittency

e. The telephone coil operates correctly

f. Distortion levels are within manufacturer’s specifications

g. If there is a remote or wireless device, it operates the programs or changes the volume as applicable

b. The device has the correct battery drain

c. Equivalent Input Noise (EIN) is within standards (below 30dB)

b. If a rechargeable device charger was sent in then it should be returned. If the charger did not require repair or was repairable/replaceable, it will be in working order. If the charger was unrepairable/unreplaceable, the VA has been notified.

b. Make, model, and serial number of device

c. Repair action taken or not taken

d. Annotation of programmed settings (patient, audiometric, full gain, etc.)

e. Indication of a serial number change (old and new serial numbers)

b. Outside of shipping container/package will not contain any patient information

c. Outside of shipping container has been identified as containing hearing devices rather than parts and accessories