36C26318R0480-004.pdf

Quality Assurance Surveillance Plan - Perfusion Services

The contractor will be evaluated in accordance with the following:

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 through contract modification. 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: Daniel Vagts

Organization or Agency: NCO23

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: Lynda Dent

D.3 Attachment 3

Quality Assurance Surveillance Plan

Organization or Agency: MVAHCS

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.

Primary: Lynda Dent

Alternate: Jeffrey Fuqua

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

5. 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. 100% surveillance.

For this service, 100% direct observation will not be performed by the COR. Direct observation will be through quarterly observations provided by Service Chief, SSC-PSL Director or clinical representative.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed.

Quarterly periodic inspection will be completed by the PSL Director or designee and reported to the COR. Physical presence is checked on a monthly basis by COR checking with the using service to see if provider is present in the medical center and providing the services as required by the contract. Additional monitoring is provided through On-going Provider Practice

Evaluations (OPPE) every 6 months.

c. VALIDATED USER/CUSTOMER COMPLAINTS.

Discussion with individuals involved in patient care and who are familiar with the provider’s work will be randomly polled quarterly or as needed by the COR.

d. RANDOM SAMPLING.

Patient charts will be randomly sampled semi-annually by COR reviewing up to 10 randomly selected

CPRS records to verify required documentation. (All reviews and reports will be conducted in compliance with VA Privacy and Information Security Standards.)

e. Verification and/or documentation provided by Contractor.

The SSC CORs review the contract requirements with the Contractor and the Contract Officer during the post-award meeting.

Documentation requirements are also reviewed quarterly and presented at the SSC COR

Quarterly Meeting. Documentation updates are sent to the Contracting Officer.

Measures PWS

Referenc e

Performance

Requirement

Standard Acceptabl e Quality

Level

Surveillance

Method

Met AQL/DID

NOT MEET

AQL-

CPAR

RATING/AD

D

COMMENTS

1 – Provider Quality

Performance

4.6.4.1

Ongoing Provider

Performance

Evaluation

(OPPE) shall perform in accordance with clinical standards.

OPPE

documenatation for all (100%) staff providing services under the contract.

100% OPPE

a. Patient Care

Performance b.Medical/Clinical knowledge c.Practiced

Based Learning

& Improvement d.Interpersonal &

Communication

Skills e.Professionalis m f.System Based

Practice

2 - Qualifications of Key

Personnel

4.6.4.2. All contract

Perfusionists shall have current certification in accordance with

American Board of Cardiovascular

Perfusion and maintain license, registration and/or certification

All Perfusionists shall be certified and compliant with all certifications

100% Random

Inspection of qualification documents

3 – Scope of

Practice/Privileging

4.6.4.3. Contract

personnel (s) perform within their individual scopes of practice/privilegin g

All (100%) contract personnel (s) perform within their scope of practice/privilege s 100% of the time

100% Random inspection of records

4 – Patient Access (A) 4.6.4.4. Patient must receive treatment in a timely manner

Perfusionists shall be onsite and available during all scheduled OR hours and within

30 minutes of the facility

100% Direct

Observation and random

Inspection

5- Patient Access (B) 4.6.4.5. Perfusionists shall be available and be in location as needed to properly perform

Perfusionists shall be onsite and available during all scheduled OR hours and within

30 minutes of the facility

100% Periodic sampling of time and attendance sheets tasks as specified

6. Patient Safety 4.6.4.6. Patient safety incidents shall be reported using Patient

Safety Report

All incidents shall be reported immediately

(within 24 hours)

All of patient safety incidents are reported using Patient

Safety Report within 24 hours of incident

100% Direct observation and periodic inspection

7 – Maintains licensing, registration, and certification.

4.6.4.7. Updated

Licensing, registration and certification shall be provided as they are renewed

Licensing and registration information shall be kept current

All licensing, registration(s) and certification(s) for contract personnel (s) shall be provided as they are renewed

Licensing and registration information shall be kept current

100% Periodic

Sampling and

Random

Sampling

8 – Mandatory Training, Privacy, Confidentiality and HIPAA

4.6.4.8. Contractor

personnel (s) shall complete all required training on time per VAMC policy. Contractor personnel (s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

All contractor personnel (s) shall comply with all laws, regulations, policies and procedures relating to

Privacy, Confidentiality, and HIPPA.

100% Periodic sampling

Contractor personnel (s) shall provide evidence of annual training required by

VAMC, reports violations per VA

Directive 6500.6

9 – Clinical Information

Return

4.6.4.9. Perfusionists shall

be responsible to check and compute all calculations of perfusion, autotransfusion and cell saver treatments.

All cases 100% Direct observation and random sampling.

10 –

Documentation/Timeshee t

4.6.4.10. Time sheet

documentation to be completed weekly and turned

Weekly 100% Periodic inspection and random sampling in to Section Chief for concurrence

7. RATINGS

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

OUTSTANDING: Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also there should have been NO significant weaknesses identified.

VERY GOOD: Performance meets contractual requirements and exceeds some to the Government’s benefit.

The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also there should have been NO significant weaknesses identified.

SATISFACTORY: Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also there should have been NO significant weaknesses identified.

MARGINAL: Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g,. Management, Quality, Safety or Environmental Deficiency Report or letter).

UNSATISFACTORY: Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An

Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

8. DOCUMENTING PERFORMANCE

a. The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using

CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR).

b. If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor.

This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.

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 CO. The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.

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

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement. The frequency of measurement is defined in the contract or otherwise in this document. The government (COR or CO) will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Reporting. The COR shall communicate with the Contractor and will provide written reports to the Contracting Officer quarterly (or as outlined in the contract or COR delegation) to review

Contractor performance.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

QASP Perfusion final updated 4-18-2018 (003)