ATTACHMENT 3 QUALITY ASSURANCE SURVIELANCE PROGRAM (QASP).pdf

Revision 04/28/2021 Page 26 of 35 that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

5.8.3.10. The Bay Pines VA Healthcare System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Bay Pines VA Healthcare System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

5.8.3.11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

5.8.4. Flowdown of requirements to subcontractors

5.8.41. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

5.8.42. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

5.9 VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

5.9.1. Contractor employees who work in or travel to VHA locations must comply with the following:

Documentation requirements:

5.9.1.1 If fully vaccinated, shall show proof of vaccination

NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

5.9.1.2 If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date.

Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

5.9.1.3 Documentation cited in this section shall be digitally or physically maintained on each contractor Please include the number suequence for this section:employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

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5.9.1.4 Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

5.9.2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website:

COVID-19 Screening Tool. Regularly check the website for updates.

5.9.2.1. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

5.9.3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

Quality Assurance Surveillance Plan (QASP)

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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: Rosetta Quinn

Organization or Agency:

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: Lauren Cochran

Organization or Agency:

3. CONTRACTOR REPRESENTATIVES

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

Primary Program Manager:

Alternate Program Manager:

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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: Visual observance of daily operations.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Ten (10) randomly selected patient files will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Formal complaints by patients or other staff members reported to the COR or Chief, Medicine Service will be reviewed and brought to the attention of the Chief of Staff or CO as appropriate. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

d. RANDOM SAMPLING. Ten (10) randomly selected patient files will be reviewed per quarter. 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 contractor may be required to provide information on services provided to patients as requested by COR or as notated in the PWS.

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6. SAMPLE QASP PERFORMANCE REPORT DATE: __________________

Measures PWS

Referenc e

Performance

Requirement

Standard Acceptable Quality Level

Surveillance

Method

Met AQL/DID NOT

MEET AQL-

CPAR RATING/ADD

COMMENTS

Provider Quality Performance

4.6.4.1 All Contractor’s

physician(s) shall perform in accordance with clinical standards

100% of care provided within clinical standards of care

100% OPPE

Qualifications of Key Personnel

4.6.4.2 All Contractor’s

physician(s) shall have current board certified in accordance with ACC Standards for cardiology.

All (100%) Contractor’s physician(s) are board certified.

100% Periodic Inspection or Random Sampling of qualification documents

Scope of Practice/Privileging

4.6.4.3 Contractor’s

physician(s) perform within their individual scopes of practice/privileging

All (100%) Contractor’s physician(s) perform within their scope of practice/privilege s 100% of the time.

100% Contractor’s physician(s) perform within their scope of practice/privilege s 100% of the time.

Random Sampling of records

Maintains licensing, registration, and certification

4.6.4.4 Updated

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

All (100%) licensing, registration(s) and certification(s) for Contractor’s

100% licensing, registration(s) and certification(s) for Contractor’s physician(s) shall

Periodic Inspection or Random Sampling

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Licensing and registration information kept current.

physician(s) shall be provided as they are renewed.

Licensing and registration information kept current.

be provided as they are renewed.

Licensing and registration information kept current. No acceptable deviation.

Mandatory Training 4.6.4.5 Contractor shall complete all required training per VAMC policy

All (100%) of required training is complete on time by Contractor’s physician(s).

100% completions, Periodic Inspection or Random Sampling

Privacy, Confidentiality and HIPAA

4.6.4.6 Contractor 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 (100%) Contractor’s physician(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA

100% compliance;

Pediodic Inpsection;

Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Handbook 6500.6.

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7. CPAR RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual: https://www.cpars.gov/documents/CPARS- Guidance.pdf.

EXCEPTIONAL: 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).

UNSATISFACTO

RY: 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.

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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).

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 Report (CR), 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 CR in writing. The CR 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 CR 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 CRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample on following page.

8. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

Lauren Cochran, DATE Administrative Officer, Medicine Service

SIGNED:

CONTRACTOR NAME/TITLE DATE

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CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. Issue Identified (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE OF COR Date:

8. SIGNATURE OF CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE AND ACTIONS TO PREVENT RECURRENCE. (Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

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12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER