36C26318R0484-002.pdf

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: ______________________________________ Organization or Agency: VISN 23 Network Contracting Office

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: John Becker, 605-336-3230 Ext 9-6220, john.becker3@va.gov Organization or Agency: Sioux Falls SD VAHCS

3. CONTRACTOR REPRESENTATIVES

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

Primary Contact: _______________________________________

Alternate Contact: ______________________________________

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. The Chief of Medical Service and/or his designee will regularly observe the work performance of the contractor’s employee(s) during normal work hours and at dates and times consistent with operational efficiency.

b. PERIODIC INSPECTION. The Chief of Medical Service and/or his designee will perform periodic inspection of notes, encounters, and other standard documentation of clinics, procedures, and follow-up to ensure both, completion of the documentation and completion to the established standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Customer complaints will be reviewed and investigated as necessary. Results will be discussed with the vendor as required.

d. DOCUMENTATION. Documentation will be provided by the contractor as required and reviewed as necessary.

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6. QASP PERFORMANCE REPORT DATE:__________________

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

1. Patient Access to Care 6.4.4.1. Patients must receive treatment in a timely manner

Contract staff on site and available during all scheduled procedures

100% Direct Observation and/or Periodic Inspection

2. Administer Hemodialysis

6.4.4.2. Perform all treatments as

prescribed by the

Nephrologist, Setup and Safety Check of Equipment

Administer treatments prescribed by the

Nephrologist, comply with setup standards, and safety check equipment

100% Direct Observation and/or Periodic Inspection

3. Infection Control Measures and Reporting Requirements

6.4.4.3. Contractor shall follow

standard infection control precautions, document any incidence to identify trends, and take actions to reduce future incidents.

Contractor shall follow standard infection control precautions, document any incidence to identify trends, and take actions to reduce future incidents.

100% Review of contractor-provided documentation, Periodic Inspection, and/or Direct Observation

4. Progress/Procedure Note Signature Timelines

6.4.4.4.

Progress/Procedure Note Signature Timelines

Note and/or medical record documentation shall be signed the same day the procedure was performed

100% Review of appropriate documentation, Periodic

Inspection, and/or Chart

Review

5. Dialysis Committee Meeting Attendance

6.4.4.5. Contractor’s representative

present at monthly meetings

Contractor representative present at monthly meeting

100% Direct Observation

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Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

6. Patient Grievance and/or Complaints

6.4.4.6. Contractor to respond to

patient grievance and/or complaint and, if warranted, propose resolution and correction(s)

Contractor to respond within seven (7) business days regarding patient grievances and, if warranted, propose resolution/correction

100% Receipt of patient grievance and/or complaint

7. BLS certification and Talent Management System (TMS) Training Requirements

6.4.4.7.

Contractor shall maintain BLS certification (not expired) and complete all required training per the Sioux Falls VAHCS policy

Certification kept current and renewed as required; training completed prior to expiration

100% Contractor shall provide evidence of training required by the

Sioux Falls

VAHCS.

8. Licensure and Certifications

6.4.4.8. Contract employees shall

maintain licensure and certifications and renew prior to expiration; no lapse in licensure and/or certification.

Contract employees shall maintain licensure and certifications and renew prior to expiration; no lapse in licensure and/or certification.

100% Contractor shall provide evidence of new licensure or certification upon expiration of existing licensure or certification

9. Patient Safety Incident(s), adverse, and near miss events.

6.4.4.9. Report all Patient safety

incidents using Patient Safety

Report and immediately correct any identified problems that threaten the health and safety of patients and employees.

Patient safety incidents shall to be reported using Patient Safety Report. All incidents reported immediately (within 24 hours.)

100% Review of contractor-provided documentation, Periodic Inspection, and/or Direct Observation

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Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

10. Water Testing and System Operator Maintenance

6.4.4.10.

Conduct Water Testing and Operator Maintenance, provide copies of water tests to facility per contract

Adhere to and comply with all standards and requirements, deliver on time

100% Direct Observation, Periodic Inspection, and/or Review of contractor-provided documentation

11. Document patient medical record in accordance with the documentation policies of the Sioux Falls

VAHCS.

6.4.4.11. Documentation shall be within

the prescribed time limit established by the Sioux Falls VAHCS and shall include; (1) procedure and schedule for bacteriological and chemical water testing, (2) procedure and schedule to assure sterility and/or cleanliness of the equipment before each dialysis; and, (3) infection control procedure for the prevention and control of hepatitis

Documentation shall be within the prescribed time limit established by the Sioux Falls VAHCS and shall include; (1) procedure and schedule for bacteriological and chemical water testing, (2) procedure and schedule to assure sterility and/or cleanliness of the equipment before each dialysis; and, (3) infection control procedure for the prevention and control of hepatitis

100% Direct Observation, periodic inspection, and/or chart review

12. Progress/Procedure Note Signature Timelines

6.4.4.12. Progress/Procedure Note

Signature Timelines

Note and/or medical record documentation shall be signed the same day the procedure was performed

100% Review of appropriate documentation, Periodic

Inspection, and/or Chart

Review

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Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

13. Assignment of Contractor Coordinator and Timely Response to Information Requests

6.4.4.13. Assignment of Contractor

Coordinator and Timely

Response to Information Requests

The contractor shall designate, in writing, a coordinator who shall facilitate scheduling, problem solving, and communication needs related to this contract. The contractor coordinator shall respond timely to requests for any documentation relative to the contract. In the event an area of concern exists that is not addressed in written form, the contractor will provide the necessary documentation to satisfy the concerns of the VA.

100% Direct Observation and review of appropriate documentation

14. Compliance with regulations and standards

6.4.4.14. The contractor shall ensure

compliance with all relevant regulatory agencies and standards for their personnel, including, but not limited to;

the Joint Commission (JC), the Occupational Safety and

Health Administration (OSHA), and the State of South Dakota, for all dialysis services rendered under this contract.

The contractor shall, at all times, maintain full accreditation status through the Joint Commission

The contractor shall ensure compliance with all relevant regulatory agencies and standards for their personnel, including, but not limited to;

the Joint Commission (JC), the Occupational Safety and

Health Administration (OSHA), and the State of South Dakota, for all dialysis services rendered under this contract.

The contractor shall, at all times, maintain full accreditation status through the Joint Commission.

100% Direct Observation and

Periodic Inspections

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Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

15. Contractor shall record services performed

6.4.4.15. Contractor shall document

and record services in a timely manner.

The contractor is required to provide documentation on the hemodialysis flow sheet for all treatment/services provided on the day of the service.

Contractor shall record the the information listed at 6.4.4.15.

100% Direct Observation and

Periodic Inspection

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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/pdfs/CPARS- Guidance.pdf p. A2-1):

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).

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.

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf%20p.%20A2-1 https://www.cpars.gov/pdfs/CPARS-Guidance.pdf%20p.%20A2-1

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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).

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 determine, 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.

c. 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.

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

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

John Becker, Acquisition Utilization Specialist

SIGNED:

CONTRACTOR NAME/TITLE DATE

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CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS ISSUE

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

5. DATES

a. CDR 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

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER