D.4 Attachment 4 - Quality Assurance Surveillane Plan.pdf

Quality Assurance Surveillance Plan (QASP)

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 Goverm:nent 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 relationshJp. 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 Contract Officer, Department of Veterans Affairs Network Contracting Office (NCO23) HCT1, 316 Robert Street N, Suite 506 Saint Paul, MN 55101 Office: 651-293-3040 Email: daniel.vagts@va.gov

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: Julie Brown Agency: Minneapolis V

AHCS

3. CONTRACTOR REPRESENTATIVES

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

Primary:

Primary Contractor POC

Alternate:

mailto:daniel.vagts@va.gov

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: Nurses, Technologists, and Radiologists all work together. In this environment, the lnterventional Radiologist's work is directly observed and monitored. Any patient safety issues would be also identified by this method.

b. RADIOLOGY ANALYTIC SYSTEM: Used to evaluate outputs through analytic reports and identify patients for random sampling.

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

Inspections scheduled and reported quarterly per COR delegation or as needed. Licensing, mandatory training, and attendance will be monitored quarterly by reviewing timesheets, TMS reports, and licensing documentation from the Credentialing Office. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards. •

d. VALIDATED USER/CUSTOMER COMPLAINTS. Complaints that come from the patient advocate, kiosks, and Press Ganey are monitored by the customer service committee and reported to the Imaging Executive Team. The Chief addresses the issues with the lnterventional Radiologist and the COR notifies the CO.

e. RANDOM SAMPLING. To verify scope of practice, five (5) 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.

f. VERIFICATION AND DOCUMENTATION: Contractor must supply certification licensing documentation and update as necessary.

6. QASP PERFORMANCE REPORT

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

Frequency MetAQUDid Not Meet AQL- CPAR Rating/

Add Comments Provider Quality Performance (Clinical)

4.5.4.1. All contractor's

Radlologists(s) shall perform in accordance with clinical standards.

100% of care provided within clinical standards of care.

100%, OPPE

Staff observation

At award and as required.

Provider Quality Performance Re: Follow-up Exams for Radiation Skin Dose (Specific for Interventional Radiology).

4.5.4.2. All contractor's

Radiologists shall perform in accordance with VA administrative process.

Documented Follow up exam for Radiation Skin dose exceeding:

a. > 3 Gy dose and location recorded in

CPRS; PT

instructed in self-exam for erythema and report effects to the Physician.

b. > 5 Gy Arrangement s made to have patient examined by a provider 4- 8 weeks following the procedure with subsequent exams as appropriate;

RSO

notified.

c. > 15 Gy cumulative dose over 6 month to 1-year period;

this is a “sentinel Event” per

100% , OPPE data will review radiation skin dose exceeding 3Gy, 5Gy, 15Gy

Ongoing

Joint Commision’s definition and must be reported to the RSO and to the Patient Safety Manager

Provider Quality Performance Re:

Procedure Complications (Specific for Interventional Radiology).

4.5.4.3. All contractor's

Radiologists shall perform in accordance withVA administrative process.

Procedure complications (Other than Radiation Skin Dose): ≥ 2 cases per year (other than radiation skin dose) that exhibit potentially significant quality of care concerns and meet criteria for a major complication as defined by policy

99% OPPE will review qualifying Procedure Complications

Ongoing

Provider Quality Performance VA Administrative Processes and Policies

4.5.4.4. All contractor's

Radiologists shall perform in accordance withVA administrative process. a.

Physicians on duty will be on site from 8am-4:30pm, b.Case start time, c.

Provision of staff schedules 60 days in advance, d.

Performs only work related to Veteran healthcare during scheduled Va hours, e.Response time to call: Answer pages during business hours within 1 hour;

during on-call hours withing 15 minutes,

f. Ensure protocoling has been completed and g.ensure all reports have been dictated into the patient’s record before leaving each day – this includes on-call cases.

100% of services provided arewithin administrative processes and policies of the VA

100% OPPE

At award and as required.

Qualifications of Key Personnel

4.5.4.5. All Contractor's All (100%). 100% Nodeviations Random At award and

Physicians shall be contractor's accepted. Inspection of as required.

in accordance with board certified. documents.

ACR Standards for lnterventional

Radiology and IAC Standards for complex Vascular Ultrasound.

a.Actively supervises residents per VHA

DIRECTIVE

1400.01, b. One Point of Contact physician must be onsite each business day, c.Respond to all TEAMS messages same day, when possible, VA e-mails, and EMR chart alerts and messages within 3 business days.

Scope of Practice/Privileging 4.5.4.6. Contractor's All (100%} All (100%} Random Quarterly Radiologists perform contractor's contractor's Inspection of within their individual Radiologlsts Radiologists perform records.

scopes of perform within their within their scope of practice/privileging scope of practice/privileges a.Physicians with practice/privileges 100% of the time. No .

Radioactive Materials licenses will provide up-to-date RAM license information, b. Same Phycians will apply for Active VA RAM Authorized User (AU) status and maintain, c.

Physicians will obtain tumor volumes for pre- Y-90 procedures from images in PACS.

100% of the time. deviations accepted.

Patient Access 4.5.4.7. Contractor's All (100%) Contractor's Periodic Monthly Radiologists shall be contractor's Radiologists are on- Sampling of available and in Radiologist(s) are time and available to Time and location as needed to on time and perform services 95% Attendance properly perform available to of the lime. Sheets.

tasks as specified. a. 2 physicians on site every weekday Mon – Fri, b. 1 physician on-call for all off tour h perform services.

Patient Safety 4.5.4.8. Patient safety All (100%} of All (100%) of patient Direct Daily incidents shall be patient safety safety incidents are observation.

reported using Patient incidents are reported using Patient Safety Report reported using Safety Report (ePER) (JSPR). Qualifying

Patient Safety within 24 hours of within 24 hours. Report (ePER} incident. No within 24 hours of incident.

deviation.

Maintains licensing, registration, and certification

4.5.4.9. Updated Licensing, registration and

All (100%) licensing, All (100%) licensing, registration(s) and

Periodic Sampling

Quarterly certification shall be registration(s) and certiflcation(s) for Random provided as they are certificatlon(s) for contractor's

Sampling renewed. Licensing contractor's Radiologists shall be and registration Radiologlsts shall provided as they are information kept be provided asthey renewed. Licensing current. are renewed. and registration Licensina and information keot

Mandatory Training 4.5.4.10. Contractor physician(s) shall complete all required training per MVAHCS policy

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

100% completions, no deviations.

Periodic Sampling of TMS records

Monthly

Privacy, Confidentiality and

HIPAA

4.5.4.11.

Contractor and its physician(s) shall comply with 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 and its Radiologists comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

100% compliance; no deviations.

Contractor shall provide evidence of annual training required by

MVAHCS,

reports violations per VA Directive 6500.6.

As required.

Report and CPRS note verification

4.5.4.12. All notes signed

within twenty-four

(24) hours.

a.Licensed Independent Provider (LIP)/Moderate Sedation notes must be signed prior to procedures

100% compliance 100% compliance Report run by COR or designee

As required.

Licensed Independent Provider (LIP) Pre-Sedation Assessment - (Moderate Sedation Note)

4.5.4.13. All Moderate

Sedation notes must be signed prior to procedures

100% compliance 100% compliance Report run by COR or designee

Random / Periodic Audit.

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 sho.uld 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 hich 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 contr ctor'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 maanitude that it alone constitutes an unsatisfactorv rating. An http://www.cpars.gov/documents/CPARS

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

CONTRACTORPERFORMANCEASSESSMENTREPORT(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 CORshall 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 CR below.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

Julie Brown, COR

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS ISSUE

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:

12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS