Attachment 1 - QASP VISN Lab Referral Testing 2024_Updated.pdf

Attachment 1 Quality Assurance Surveillance Plan (QASP) Solicitation 36C26324R0072 VISN 23 Lab Referral Testing Services

The contractor will be evaluated in accordance with the following:

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.

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: Michael Casper

Organization or Agency: Veterans Affairs Contracting Officer, NCO 23

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: Chasity Vigliotti

Organization or Agency: Department of Veterans Affairs NWIHCS

CONTRACTOR REPRESENTATIVES

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

Primary:

Alternate:

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.

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

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

c. VALIDATED USER/CUSTOMER COMPLAINTS.

d. RANDOM SAMPLING. (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.)

e. Verification and/or documentation provided by Contractor. (For example, off-site contracts may require the contractor to provide information on services provided to patients).

QASP PERFORMANCE REPORT DATE:__________________

Measures PWS

Reference

Performance

Requirement

Standard Acceptable Quality Level

Surveillance

Method

Met AQL/DID NOT

MEET AQL-

CPAR

RATING/ADD

COMMENTS

1- Licensing and Accreditation 2.1

8.3.1

The Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law.

100% The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP), The Joint Commission or (other Accreditation Body). In addition, the laboratory must be certified and maintain certifications meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

100% meet Standards (No Deviations)

Direct Observation

2 - Qualifications of Key Personnel 2.2

8.3.2

The Contractors' Laboratory Director, Medical Technologists, Medical Technicians, Cytotechnologists and Pathologists shall meet and maintain the Personnel qualifications required by

(100%) All Pathologists and Testing Personnel shall be appropriately licensed/accredited by the College of American Pathologists (CAP), The Joint

100% meet Standards (No Deviations)

Direct Observation https://www.cap.org/ https://www.cap.org/ https://www.cap.org/ https://www.hhs.gov/ https://www.hhs.gov/ https://www.hhs.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.cap.org/ https://www.cap.org/ https://www.cap.org/

Clinical Laboratory Improvement Act of 1988

Commission or (other Accreditation Body). In addition, the laboratory must be certified and maintain certifications meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 The Testing Laboratory must be certified by an Accreditation Body:

JC Requirement HR.01.01.01 and

HR.01.02.03.

3 - Professional Liability Insurance 2.4

8.3.3

The Contractor shall provide and maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage.

The Contractor shall obtain and maintain 100% professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage..

100% (No Deviations) Random Sampling of records.

4- Interfacing/Communication Requirements

3.1 – 3.8

8.3.4

The Contractor shall provide and maintain an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing and reporting.

100% The Contractor shall maintain integrated system approach, and respond timely to any service interruptions..

95% functionality A combination of Direct Observation and Validated User /Customer Complaints

5 - Test Results 3.13

8.3.5

The Contractor shall follow test result protocols as identified.

100% The Contractor shall meet testing

95% Timeliness A combination of Direct https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.hhs.gov/ https://www.hhs.gov/ https://www.hhs.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text protocols as identified..

6 - Telephone Consultation 3.14

8.3.6

The Contractor shall provide a Pathologist to conduct telephone consultation with the assigned point of contact for each participating facility (identified in Section 1.2), requesting Clinician, or designee as needed.

100% The Contractor shall have an assigned POC for each of the participating facilities identified in Section 1.2.

100% (No Deviations, Contractor is responsible to ensure adequate coverage)

A combination of Direct

7 - Specimen Handling 4

8.3.7

The Contractor shall store all specimens as required by the regulatory agencies IAW Minimum Period of Retention of Laboratory Records and Materials and ANP 12500 Record Retention Phase II (or subsequent release).

100% compliance with regulatory, and agency prescriptions.

100% (No Deviations) A combination of Direct

8 - Transportation, Specimen Pick up Times

5.1

8.3.8

The Contractor shall follow all requirements listed in Section 5.1

100% The Contractor shall follow all requirements listed in Section 5.1.

90% compliance

9 – Transportation, Shipping Biological and Infectious Substances

5.2

8.3.9

The Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the

100%The Contractor shall maintain compliance with all laws, regulations and policies.

100% (No Deviations) A combination of Direct https://documents-cloud.cap.org/pdf/PubPolicy_PP_Lab_Record_Retention.pdf?_gl=1*n2l5bw*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcxMjk1Mjg0OS4zLjEuMTcxMjk1MjkxMS4wLjAuMA..

https://documents-cloud.cap.org/pdf/PubPolicy_PP_Lab_Record_Retention.pdf?_gl=1*n2l5bw*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcxMjk1Mjg0OS4zLjEuMTcxMjk1MjkxMS4wLjAuMA..

https://documents-cloud.cap.org/pdf/PubPolicy_PP_Lab_Record_Retention.pdf?_gl=1*n2l5bw*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcxMjk1Mjg0OS4zLjEuMTcxMjk1MjkxMS4wLjAuMA..

https://documents-cloud.cap.org/pdf/ANP.12500.pdf?_gl=1*1psnv5m*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcxMjk1Mjg0OS4zLjEuMTcxMjk1MzExNS4wLjAuMA..

https://documents-cloud.cap.org/pdf/ANP.12500.pdf?_gl=1*1psnv5m*_ga*MTU5MjIyNDIxLjE3MDc4NDA2OTI.*_ga_97ZFJSQQ0X*MTcxMjk1Mjg0OS4zLjEuMTcxMjk1MzExNS4wLjAuMA..

Centers For Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs,, including all regulation IAW 49 CFR Parts 100-185, and 397.

10 – TurnAround Time 5.3

8.3.10

Turnaround times shall begin at the time the Contractor was notified by the participating facilities as noted in Section 1.2;

and shall comply with the negotiated (at time of award) scheduled pick-up time with the Contractors’ courier service. The Contractor shall maintain compliance thereof and with the following Quality Assurance guidelines relating to shipping and test performance for Turnaround Times:

80% of monthly results will be reported within established contractor published

TAT

No more than 1 outlier per month, per facility

A combination of Direct

11 – Service and Maintenance 6

8.3.11

The Contractor shall meet the requirements for service and maintenance as outlined in Sections 6.1 and 6.2.

100% The Contractor shall meet the response times as listed in Section 6.1 and 6.2.

95% Timely Response Time

12 – Reports & Deliverables 7.1

8.3.12

The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and

100% of Reports and Deliverables are reported as specified in the PWS

90% of Reports and Deliverables are reported as specified in the PWS https://www.transportation.gov/ https://www.transportation.gov/ https://www.iata.org/ https://www.iata.org/ https://www.va.gov/ https://www.va.gov/ completeness of all reports and other documents as well as the timely submission of each.

Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

13 - Subcontracting 7.2

8.3.13

The Contractor shall be responsible for ensuring that subcontractor possess and maintain the same qualifications, accreditations and certifications as required for the Contractor

100% Subcontractor compliance with qualifications, accreditations and certifications, etc.

that apply to the Contractor

100% (No Deviations) Direct Observation

14- Access to Medical Records 7.8

8.3.14

The Contractor’s personnel(s) are responsible for protecting that data received in the performance of services under this agreement from unauthorized release or from loss, alteration, or unauthorized deletion and following all applicable regulations and instructions regarding access to the VA’s computerized files, release of VA access codes, etc., as set out in VHA Directives, and computer access

100% Compliance with PWS

100% (No Deviations) A combination of Direct agreement Rules of Behavior (or equivalent) which the Contractor’s personnel(s) must sign.

The Contractor’s personnel are required to protect VA patient information within the departmental office and keep it secure.

15-HIPPA Compliance 7.9

8.3.15

All Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act

(HIPAA).

100% Compliance with PWS

100% (No Deviations) A combination of Direct

16- Compliance with Regulations and Policies

7.10

8.3.16

The Contractor shall maintain compliance with all regulations as cited within the PWS

100% Compliance with PWS

100% (No Deviations) A combination of Direct

17-Training 7.13

8.3.17

All Contractor and Subcontractor personnel shall comply with Mandatory Training Requirements can complete Contractor Rules of Behavior (Section D, Attachment 2)

100% Compliance with PWS

100% (No Deviations) Direct Observation

18 – Contractor’s Performance Report

9.9

8.3.18

COR will assess the summary of the contractor’s performance and shall provide a written assessment, which is forwarded to the Contracting Officer

100% correspondence with the Contracting Officer

100% (No Deviations)

Observation, Periodic Inspection and/or Random Sampling and Validated User/Customer Complaints.

The table below is a sample that can be tailored – note that the table must identify where in the PWS the standards are found for monitoring performance. Check the MSO Customer Resource Center for approved mandatory QASPs.

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.

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

DOCUMENTING PERFORMANCE

f. 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).

g. 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.

COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

Chasity Vigliotti, Laboratory Manager/COR DATE

SIGNED:

Michael Casper, Contracting Officer NCO 23 Contracting Office DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS ISSUE

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 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

COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP