ATTACHMENT ONE- Quality Assurance Surveillance Plan.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.

CO Responsibilities: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

I. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

II. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for the contract staff to be provided by the VA or the contract agency as indicated; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract.Assigned CO: Isabel (Lupe) Arroyo

Organization or Agency: Network Contracting Office (NCO) 21, VISN 21

Contracting Officer’s Representative Responsibilities

I. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor or Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

II. 4.2.2. The COR will be responsible for monitoring the Contractors performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: average number of prescriptions filled per shift, Page 2 of 7 Revised 10/31/2012 number of incidents involving failure to pick up returned medications, failure to comply with institutional policy, inaccurate delivery or failure to delivery medications, and other individual or team-based performance measures as needed.

III. The COR will maintain a record-keeping system of services by reviewing the QASP, CPRS, and invoices submitted by the contractor. The COR will review this data on a regular when invoices are received and certify all invoices for payment. Any evidence of the Contractor's or Contractor’s staff non-compliance as evidenced by the monitoring procedures outlined in the QASP shall be forwarded immediately to the Contracting Officer.

IV. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

V. All contract administration functions will be retained by the VA.

Assigned COR: Esther Song, Esther.Song@va.gov, (650) 849-0566

Organization or Agency: VA Palo Alto Health Care System

3. CONTRACTOR REPRESENTATIVES

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

Primary:

Alternate:

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. INCENTIVES/DEDUCTS

The Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards (Inclusion of any monetary incentives requires approval through the

Department’s SPE).

6. 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.

mailto:Esther.Song@va.gov

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a. DIRECT OBSERVATION. 100% surveillance: (if this method is used, define how surveillance will be accomplished.) Performance and attendance will be monitored by the supervising clinical pharmacists that are working directly with the contractor’s employee.

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

(Define what and how often it will be inspected. For example, 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.) Time sheets and invoices will be reviewed by the Certifying Official to ensure the Government is being charged correctly and that the Contractor is being paid accordingly.

c. VALIDATED USER/CUSTOMER COMPLAINTS. If this method is used, explain how data will be collected and reported. Complaints will be handled via email or telephone, filed under the contractors file and forwarded to the CO.

d. RANDOM SAMPLING. If this method is used, define what and how often it will be sampled. (For example, 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.) No need for random sampling as technicians are under supervision of a pharmacist 100% of the time and their patient interactions on the phone and in person are under the direct supervision of a pharmacist. Any documentation into the chart done by the contractor employee is signed off by a supervising pharmacist.

e. Verification and/or documentation provided by Contractor. Review PWS and if this method of surveillance is selected, define how documentation will be verified and how assessment will be conducted. (For example, off-site contracts may require the contractor to provide information on services provided to patients). Contractor shall submit proof that all licensing and certifications specified in the contract are up to date and meet industry standards.

PERFORMANCE MEASURES

Measure

PWS

Reference Performance Requirement

Standard Acceptable

Quality Level

Surveillance Method

Incentive Disincentive

Key Personnel

Provide required personnel as specified in the requirements.

Qualified personnel are available and on-site as needed to properly perform tasks as specified.

100%

Direct observation;

Periodic inspection

Favorable contactor performance evaluation

Unfavorable contractor performance evaluation

Documentation 3

Submit documentation of services provided in patient’s electronic medical record in Computerized Patient Record System (CPRS).

Services provided will be documented in CPRS as required by

VAPAHCS

policy.

90% Periodic inspection

Favorable contractor performance evaluations

Unfavorable contractor performance evaluation

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Medication order/prescriptio n preparation

Process and fill medication orders/prescriptions accurately in accordance with all laws, rules, regulations, and policies.

Average number of prescriptions filled per assigned shift is within 40% of the average number of prescriptions filled by similarly scheduled technicians as indicated on workload reports

100%

Direct observation;

Periodic inspection

Favorable contractor performance evaluations

Unfavorable contractor performance evaluation

Sterile Compounding

Complex technical functions involved in compounding all intravenous (IV) admixtures are performed accurately and thoroughly in accordance with United States Pharmacopeia (USP) 797 and 800 guidelines and IV policies and procedures.

Completion of all competencies that are required to compound sterile products (e.g., media fill validation, aseptic technique, hand hygiene and garbing, finger-tip testing

100%

Direct observation;

Periodic inspection

Favorable contractor performance evaluations

Unfavorable contractor performance evaluation

Medication Stock and Storage

Adequate stock of pharmaceuticals and supplies for the pharmacy area of responsibility is maintained by communicating with the procurement personnel items that are low or out of stock.

Assigned ward inspections and pharmacy stock area inspections are completed within the specified timeframes as evidenced by completed reports.

100%

Direct observation;

Periodic inspection

Favorable contractor performance evaluations

Unfavorable contractor performance evaluation

Medication Stock and Storage

Refrigerators/ freezers are monitored and any problems resolved to ensure no drug is wasted due to improper storage.

Refrigerators have temperatures recorded per assigned shift and appropriate action is documented for temperatures outside of range.

100%

Direct observation;

Periodic inspection

Favorable contractor performance evaluations

Unfavorable contractor performance evaluation

Patient Safety 3 Patient safety incidents must be reported.

All incidents reported promptly (within 24 hours of discovery).

100% Direct Observation

Favorable contactor performance evaluation

Unfavorable contractor performance evaluation

Licensing Registration, and Certifications (as applicable)

Updated licensing, registration and certifications will be provided as they are renewed.

Licensing and registration information kept current.

100%

Documentation provided by Contractor;

Periodic Inspection

Favorable contactor performance evaluation

Unfavorable contractor

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Mandatory Training

Contractor completes all mandatory required training.

Contractor will complete all required training per

VAPAHCS

policy.

100% Documentation provided by Contractor

Favorable contactor performance evaluation

Suspension or termination of all physical and/or electronic access privileges until training is complete

Timely Invoicing

Within 60 days of when services were provided, the vendor shall provide itemized, electronic invoicing.

All itemized invoices provided within 30 days of end of each month services delivered

100%

Periodic Inspection;

Documentation provided by Contractor

Favorable contactor performance evaluation

Unfavorable contractor

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 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).

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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 perparing 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.

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:________________________________________

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COR NAME/TITLE: Esther Song DATE:

SIGNED:________________________________________

CONTRACTOR NAME/TITLE DATE