RFP Attachment 1 QASP Medical Device Support.docx

Quality Assurance Surveillance Plan (QASP) Version – July 02, 2021 Version 1.0

For: Division of Facilities Operation (DFO)

Contract Number: XXXXXXXXXXXXXX

Contract Description: Clinical Engineering Medical Device Support

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

1. Introduction The Quality Assurance Surveillance Plan (QASP) contains the high-level technical and professional requirements for the software services that will provide medical device support to the Indian Health Service (IHS) Clinical Engineering Program. The contractor must have technical experience or competency in the field of medical device technology and evaluation. The QASP focuses on “how” service quality will be delivered along with targets in the form of acceptable quality limits (AQLs). These AQLs. These AQLs define the parameters for the services provided.

2. Work Requirements The detailed work requirements of the Clinical Engineering (CE) Medical Device Support contract are set forth in the Performance Work Statement (PWS).

In brief, the work requirements correspond to the following categories:

· Medical device evaluation capability

· Medical device recall alert capability

3. Purpose This Quality Assurance Surveillance Plan is a government-developed document used to determine if the contractor’s performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

· What will be monitored

· How monitoring will take place

· Who will conduct the monitoring

· How monitoring efforts and results will be documented

The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government’s surveillance of the contractor’s performance and their Quality Assurance/Quality Control (QA/QC) actions to assure they meet contract standards. It is the government’s responsibility to be objective, fair and consistent in evaluating contractor performance.

The QASP is not part of the contract nor is it intended to duplicate the contractor’s quality control plan. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. Authority Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5. Roles and Responsibilities The following personnel shall oversee and coordinate surveillance activities.

Program/Project Manager (PM) or Functional Services Manager (FSM) – The PM/FSM provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR’s performance assessment activities. While the PM/FSM may serve as a direct conduit to provide Government guidance and feedback to the contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Assigned PM/FSM: Gordon Delchamps Organization or Agency: Indian Health Service, Division of Environmental Health Services (DEHS) Telephone: (301) 443-1367 Email: gordon.delchamps@ihs.gov

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 ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine the final assessment of the contractor’s performance.

Assigned CO: XXXXXXXX Organization or Agency: Division of Engineering Services (DES) Telephone: (206) xxx-xxxx Email: xxxxxxxx.ccccc

Contracting Officer’s Representative (COR) - The COR is responsible for providing continuous technical oversight of the contractor’s performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor’s actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the CO. The COR is required to provide an annual performance assessment to the CO which will be used in documenting past performance. The QASP is the primary tool for surveillance of the contractor’s quality program and help the COR to document contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government’s behalf.

Contractor Representatives

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. (Complete this section after the contract award)

Contractor Program Manager – Name Telephone:

Email:

Contractor Task Manager – Name Telephone:

Email:

6. Performance Requirements and Method of Surveillance

6.1. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR’s contribution is their professional, non-adversarial relationships with the CO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor’s performance. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

6.2. Surveillance Matrix

The Surveillance Matrix (Attachment 1) is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance and frequency the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor’s performance as it relates to the performance element standards. The Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

6.3. Performance Rating Definitions

The performance ratings below reflect definitions at FAR 42.1503 Table 42-1. The COR will use these rating to evaluate the quality of contractor’s performance.

Performance Rating Definition

Note 1: Plus or minus signs may be used to indicate an improving (+) or worsening (-) trend insufficient to change the evaluation status.

Note 2: N/A (not applicable) should be used if the ratings are not going to be applied to a particular area for evaluation.

7. Performance Reporting

7.1. Corrective Action Report (CAR) Describes how discrepancies are reported and resolved (see sample CAR below).

7.2. Customer Complaint Form (see sample customer complaint form below)

7.3. Performance Assessment Report (PAR) (see sample customer PAR below)

Attachment 1 CE Medical Device Support Contractor

QASP

Surveillance Matrix

Users can access the software platform, and through a standardized global naming convention, obtain the following information:

· Manufacturers and suppliers

· Repair/service providers

· Specific medical device models

· Specific types of devices (asset types) and/or services of medical devices, medical device systems, and related items.

Negative: Document past performance report card, paying particular attention to performance that is below the standard.

Medical device recall alert capability

Through an application interface, users can interconnect to the Nuvolo CMMS in order to:

· Import/update various tables within the CMMS including:

· Manufacturers and suppliers

· Repair/service providers

· Specific medical device models

· Asset types (specific types of devices)

· Import/update device safety alert and recall notices within a specific section, and related tables

· Automatically match safety alerts and recalls to specific manufacturer models and individual devices (assets) in order to create the proper work orders and track corrective action(s)

· Automatically match safety alerts and recalls to specific manufacturer models and provide a ‘negative report’ if the individual devices within the CMMS do not meet the criteria for corrective action(s) 100%

Review processes to ensure these essential features are functional and accurate, and conduct system testing

Positive: Document past performance report card, paying particular attention to performance that exceeded the standard

Negative: Document past performance report card, paying particular attention to performance that is below the standard.

Inspection Metrologies:

M1: Inspection of Reports. All reports shall be reviewed upon receipt. The reviewer will report any flaws in the document and categorize the flaws (Editorial, Format, and/or Substance).

Appendix 1 – Surveillance Matrix

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR

2. CONTRACT NUMBER

3. TYPE OF SERVICES

4. FUNCTIONAL AREA

5. SUSPENSE DATE

6. CONTROL NUMBER

7. DEFICIENCY |_| MAJOR |_| MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

|_| ACCEPTED |_| REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING NUMBER

INDIVIDUAL

PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE

I. PERFORMANCE

7. |_| DEFICIENCY (CHECK ALL BOXES THAT APPLY)

|_| NEW

|_| REPEAT

|_| NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE |_| CONCUR |_| NON-CONCUR

12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR REASON FOR NON-CONCURRENCE OF COR CITED DEFICIENCY

III. ACTION CORRECTED

14. |_| CONCUR |_| NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

6. CONTRACTOR REPRESENTATIVE REMARKS