D.2 QASP.pdf

Attachment D.2 Quality Assurance Surveillance Plan Cincinnati VA P&LMS: Traveling Tech - Medical Technologists and Histology Technician

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: Karen Williams

Network Contracting Office (NCO) 10 2780 Airport Dr.

Columbus, Ohio 43219 614-257-5220 Karen.Williams4@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: Toriano Bowens Alternate COR: Elizabeth Verdon

Cincinnati VAMC Cincinnati VAMC 3200 Vine Street 3200 Vine Street Cincinnati, OH 45220 Cincinnati, OH 45220 Email: Toriano.Bowens@va.gov Elizabeth.Verdon@va.gov Telephone: 513.475.6321 513.475.6321 mailto:Toriano.Bowens@va.gov mailto:Elizabeth.Verdon@va.gov

Attachment D.2 Quality Assurance Surveillance Plan Cincinnati VA P&LMS: Traveling Tech - Medical Technologists and Histology Technician

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. 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: The COR will gather records to verify work performed (e.g. laboratory software)

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. The invoices and attendance log will be checked will be reviewed on a monthly basis. Random surveillance will be conducted quarterly.

c. VALIDATED USER/CUSTOMER COMPLAINTS. The VAMC Detroit may receive complaints directly within the department of via the Patient Advocate Office. The complaints will be reviewed and the patient will be contacted.

d. RANDOM SAMPLING. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

e. Verification and/or documentation provided by Contractor. NA

6. QASP PERFORMANCE REPORT DATE:

Measures PWS Refere nce

Performance Requirement

Standard Acceptable Quality Level Surveillance Method

Met AQL/DID NOT

MEET AQL –

CPAR

RATING/ADD

COMMENT

S

1) Personnel Quality Performance 4.6.4.1 and 5.2

All contractor’s personnel (s) shall perform in accordance with the Cincinnati

VAMC

Laboratory standards

100% of care provided within Lab standards of care

90% IAW the standards listed in

4.6.4.1 of the PWS and

5.2 of the PWS

- Chemistry, Attachment D.6

- Hematology/Blood Bank

Attachment D.7

- Microbiology, Attachment D.8

- Specimen Processing and Accessioning, Attachment D.9

- Histology Technician, Attachment D.10

Direct Observation

2) Qualifications of Key Personnel

4.6.4.2 and 4.6.4.4

Medical Technologist All contract MT’s shall have current certification in accordance with the American Society of Clinical Pathologists (ASCP) or American Medical Technologists (AMT) or an equivalent MT, MLS, CLS certification with appropriate training and a minimum of one year of experience.

All MT’s shall be certified and compliant with all certifications

100% of all Medical Technologists have current certification with the ASCP, AMT, or an equivalent MT, MLS, CLS certification with appropriate training and a minimum of 1 year of experience

Random Inspection of qualification documents and certifications

Submission of relevant documents by the contracted employee or the company upon appointment

Histology Technician Services if, certified by the American Society for Clinical Pathology (ASCP) or American Medical

Histology Technician:

All certified HT’s shall be compliant with all certifications

100% of all Histology Technicians must have current certification with the ASCP, AMT, or an equivalent certification with appropriate training and a minimum of 1 year of experience

Random Inspection of qualification documents and certifications

Submission of relevant documents by the contracted employee or the company upon appointment

3) Patient Safety 4.6.4.3 Patient safety All (100%) of 100% No deviations Direct incidents shall to be patient safety accepted.

Observation

Random sampling of JPSR’s, test result reporting errors and accessioning errors-by relevant supervisor/manager reported using Patient incidents are Safety Report. All reported using incidents reported Patient Safety immediately (within Report within 24 24 hours.) hours of incident.

4) Maintains certification

4.6.4.4 Updated certification shall

be provided as they are renewed. Certification information shall be kept current

All certification(s) for contract personnel (s) shall be provided as they are renewed, and information shall be kept current

100% Direct Observation and periodic inspection

4) Mandatory Training, privacy, Confidentiality and

HIPPA

4.6.4.5 Contractor personnel

(s) shall complete all required training on time per VAMC policy.

Contractor personnel (s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

All required training is complete on time by Contractor personnel (s).

Contractor personnel(s) shall comply with all laws;

regulations, policies and procedures relating to Privacy, Confidentiality and HIPPA.

100% completions Training certificates to be presented on appointment

Followed by Periodic Inspection

5) Documentation/Timesheet 4.5.4.6 Time Sheet Documentation to be completed weekly and turned in to the Laboratory Administrative Officer (Alternate COR) for concurrence

Weekly, Every Monday for the previous week, the Contractor will submit a complete timesheet.

100% completions Monitoring by timekeeper with report to manager or relevant supervisor if any issues identified

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

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).

UNSATISFACTO RY:

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).

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf

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 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 on the following page.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

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, CORRECTIVE ACTION 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. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER