Autopsy Assistant-QASP.pdf

Quality Assurance Surveillance Plan (QASP)

Contract Number: TBD Task Order: 2237#

Contractor’s name: TBD

1. PURPOSE

a. 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.

b. 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.

c. 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.

Assigned CS: Cynthia Diezel

b. Contracting Officer’s Technical Representative (COTR) - The COTR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COTR shall keep a quality assurance file. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Lisa Narvaez

c. Other Key Government Personnel: TBD

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager – Papreddy V. Kashireddy, Supervisory Pathology Specialist

b. Other Contractor Personnel - TBD

4. PERFORMANCE STANDARDS

a. 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.

b. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

c. The Performance Requirements are listed below in. 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.

QUALITY ASSURANCE SURVEILLENCE PLAN (QASP)

Measure Performance Standard

Standard for Quality Level

Acceptable Quality Level

Method of Surveillance

Proper identification of the body prior to every autopsy procedure.

Proper Accessioning and labeling of surgical Specimens.

Accurate identification of the body and autopsy authorization.

Properly labeling of surgical specimens.

Contractor must handle the autopsies and surgical specimens properly during accessioning and processing.

100% satisfactory

Review at the Pathology monthly QI meeting.

All autopsy procedures performed as per SOP’s

Proper release of the body

Correct primary incisions, recording organ weights, proper fixation of specimens.

Suing the body after autopsy and releasing to morticians.

Contractor must handle all autopsies as directed by the pathologist using standard techniques and assures correct records and documentation.

Follow protocols for release of body

100% satisfactory

Review at monthly QI meeting

Quality and TAT of slides and reports.

Excellent quality of processing tissue and staining.

Leading to accurate diagnosis and quick turnaround time of reporting

Satisfactory rating of 100%

Review at monthly QI meeting

Safety standards, disinfection and disposal.

Maintains clean body storage area, work area and proper instrumentation.

Accurate decontamination of the morgue and instruments.

100% satisfactory with accurate diagnosis

If any discrepancy of safety will be discussed in QI monthly meeting.

Maintains necessary qualification and Certification

Licensing and registration information kept current.

Licensing for contract laboratory technicians shall be provided as they are renewed.

100% compliance

Periodic inspection

Privacy, Confidentiality and

HIPPA

Contractor technicians and pathologists must comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA

Licensing, registrations and certifications must be kept current 100%

Compliance Periodic inspection

5. INCENTIVES

The Government shall use the scoring methods above for continuing contract performance. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the following surveillance methods in the administration of this QASP.

The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. 100% surveillance: Used in monitoring attendances.

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

(i) Frequency of Measurement: During contract performance, the COTR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed. Quarterly reports will be prepared by the COTR.

(iii) Frequency of Performance Assessment Meetings. The COTR shall visit/correspond with the contractor either on an as-needed basis or, at a minimum, twice during the contract period: (1) middle of contract period, and (2) end of contract period to assess performance and shall provide a written assessment. This written assessment will be forwarded to the Contracting Officer as documentation of contractor’s performance and/or for a request to exercise option period, renewal of a contract or termination of a contract.

(1) Contractor Performance Evaluation: The contractor evaluated form is completed quarterly by the Contracting Officer Representative and sent to the Contracting Officer and to the VAMC-San Francisco Department of Quality Management for review. Performance elements a rated as follows: 1 – NA Not Applicable; 2-Meets Standards, and 3 – Does not Meet Standards. Performance elements are the following.

Takes appropriate steps to ensure correct identity of bodies prior to autopsy and identity of surgical specimens during accessioning and processing.

Properly handles surgical pathology biopsy specimens.

Follows safety and infectious control regulations Adheres to laboratory protocols for maintaining instruments and staining solutions Ascertains customers’ needs/requests and performs tasks to resolve situation in a timely and accurate manner.

Effective contractor communication (written and oral) with lab supervisor.

Submits required reports and documentation in timely manner.

Reports problems if any in timely and appropriate manner.

Contractor personnel demonstrate knowledge and skills to perform contract duties.

Contractor personnel display proper identification while performing duties on-site.

(2) Monthly Improvement Plan Monitors:

Appropriate handling of surgical pathology specimens Proper processing of cytology specimens Maintenance of lab instruments Staining for rapid assessment of FNA specimens

Appropriate handling of surgical pathology o SFVAMC-Pathology Department Goal: no more than one error per quarter o This is critical for proper identification and reporting of biopsies and specimens surgical resections from patients.

Proper processing of cytology specimens o SFVAMC-Pathology Department Goal: no more than one error per quarter o This is critical for making slides that can be reliably interpreted by pathologists to generate a diagnosis.

Maintenance of lab instruments o SFVAMC-Pathology Department Goal: this task is to be performed on a daily basis and recorded. Records will be reviewed at the monthly QI meeting.

o Cryostats and grossing instruments have to be properly maintained to ensure appropriate handling of tissue and to adhere to safety protocols.

CUSTOMER COMPLAINTS. Complaints are to be report to the COR and Chief of Pathology Service.

All complaints are reviewed and discuss monthly at the Pathology Department “Quality Improvement Meetings”, by the committee members..

TASK ID INDICATOR STANDARD ACCEPTABLE

QUALITY

LEVEL

METHOD OF

SURVEILLANCE

INCENT

IVE

Tissue Processing

1 Correctly labels specimens, bottles, slides and cassettes to ensure their identities during processing.

No more than 1 failure per quarter.

Error monitoring at meeting

Past performa nce

2 Properly trims and processes biopsy specimens to yield maximal diagnostic value avoiding tissue loss and malorientation.

No more than 1 failure per quarter.

Error monitoring at nce

3 Maintains adequate supplies in the surgical cutting room to accomplish daily tasks including formalin, gloves, aprons, blades, bottles, cassettes, etc.

Positive feedback from staff, residents and faculty

Reviewed at nce

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral or negative outcome.

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).

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 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 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.

9. FREQUENCY OF MEASUREMENT

a. The frequency of measurement is defined in the methods of surveillance table. The government (COR or CO) will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. 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.

Papreddy V. Kashireddy, Supervisory Pathology Specialist Signature – Contractor Program Manager

Lisa Narvaez Signature - Contracting Officer’s Representative