36C26119Q1055-004.pdf

Quality Assurance Surveillance Plan (QASP)

Project Title: INPATIENT DIALYSIS TREATMENT SERVICES

Contract Description: (Scope of Work) The contractor shall provide all personnel, transportation, and equipment, to perform inpatient Hemodialysis treatment services to Veteran patients who are being cared for as inpatients at VA Central California Health Care System (VACCHCS). The equipment is required to have a mandatory blood leak detector (BLD) in a hemodialysis machine is intended to protect patients from loss of blood, and infusion of non-sterile dialysate, through a rupture in the dialyzer membrane. The contractor shall provide the necessary nurses who have certifications, experience, knowledge, abilities and skills in operating a dialysis machine to provide hemodialysis, CRRT (continuous renal replacement therapy), apheresis, and PD (peritoneal dialysis) treatments to Veteran patients.

All services will be performed at VACCHCS in the ICU/Stepdown Unit, Medical/Surgical Ward, in the Same Day Procedures suite or ED (Emergency Department). The services will be performed at any time, 24 hours/7 days a week. The services will be coordinated by the staff dialysis nurse at VACCHCS.

The payment of services shall be per patient, per treatment/procedure. The contractor dialysis nurse will generally consult with the Charge Nurse, Staff Nephrologist or Chief of Medical Service at VACCHCS when unusual circumstances arise. VACCHCS will provide physician oversight services and retain ultimate authority over and responsibility for each patient’s care and treatment.

Also included in this contract, the contractor is to provide a patient-pathways onsite liaison. The individual will coordinate education, post discharge care, outpatient clinic appointment and any necessary outpatient dialysis treatment. The liaison shall conform to VA policies in coordinating the services needed for the patient upon discharge. This may require understanding the processes of the VA social work, health care benefits, and other care services for veterans.

Contractor’s Name: TDB

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

a. What will be monitored.

b. How monitoring will take place.

c. Who will conduct the monitoring.

d. How monitoring efforts and results will be documented.

e. 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 . 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.

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.

3. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. The COR will provide contract progress reports 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. INCENTIVES/DEDUCTS

a. Incentives: The Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards.

b. Deducts: The Government shall apply deducts in accordance with Section 6 below:

6. METHODS OF QA SUREVEILLANCE

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: Reportable by VACCHCS staff during patient treatment services.

b. PERIODIC INSPECTION. Inspections performed during the treatment as appropriate by the RN Clinical Director/Program Management and staff Nephrologist/attending physician to ensure compliance.

c. VERIFICATION OF DOCUMENTATION PROVIDED BY THE CONTRACTOR: Quarterly Joint Dialysis Oversight Committee meetings; contractor’s employees documentation presented to VACCHCS.

MEASURE/

INDICATOR

SOW

Ref Paragraph Number

PERFORMANCE

REQUIREMENT

STANDARD ACCEPTABL

E QUALITY

LEVEL

SURVEILLANCE

METHOD

INCENTIVE DISINCENTIVE

1 Registered 1 Provide RN for Contract RN 100% Observation Favorable Unfavorable Nurse (RN) dialysis responds to by Staff RN contractor contractor qualified to services as requested services; and/or staff performance performance perform dialyis specified in set-up, treatment, Physician evaluation. evaluation.

the termination of requirements. treatment, and clean-up

2 Water Qualtiy 2 Test quality of Acceptable level of 100% Direct Favorable Unfavorable & Dialysis water used in water quality per observation, contractor contractor Machine the dialysis AAMI standards; random performance performance Operability process; Regularly scheduled inspection, evaluation. evaluation.

perform PM’s shall be analysis of periodic completed according contractor’s preventative equipment reports;

maintenance specification Infection Control Coordinator review

3 Patient Safety 2 Patient safety All incidents reported immediately to staff RN and/or attending physician

100% Direct Favorable contractor performance evaluation.

Unfavorable contractor performance evaluation.

incidents, Observation as including time- appropriate.

out, must be reported using Patient Safety Report.

4 Contractor 2 Contractor to Contractor monitor 100% Present and Favorable Unfavorable quality provide quality own employees discuss contractor contractor Assurance control reports treatment process; report to VA performance performance reports on a quarterly practice, staff evaluation. evaluation.

basis skills/competencies, trainining;

credentials

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

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 many 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 Satistactory 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 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 a Marginal perfomance, you should indentify 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 be referencing the management tool that the contractor of the contractual deficiency (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter).

UNSATISFACTORY: Performance does not meet some contractual requirements and recovery is not likely in a time 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 indentify 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 be referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter).

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 SYSTEM(CPARS).

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.

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 negotiated 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 needed (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