QASP - Detroit Reference Lab.pdf

?.## QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

1. PURPOSE

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

Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule/Attachment A. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3. Departments being served, through the COR(s), will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (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.

Contracting Officer: Morgan Stein Address:

Email: Morgan.Stein@va.gov

b. Contracting Officer’s Representative (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: Erica Percy Address:

Phone: (313) 576-1000 Email: Erica.Percy@va.gov mailto:Morgan.Stein@va.gov mailto:Erica.Percy@va.gov

1. CONTRACTOR ROLES AND RESPONSIBILITIES

Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program shall minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the RLR VAMC staff for process review and improvement of contract performance on an as needed basis.

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

Program Manager: Other POC:

Address: Address:

Phone: Phone:

Email: Email:

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements are listed below. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

a. Licensing, Accreditation, & Certification

1. Performance Requirement: Contractor shall maintain and provide CLIA Certification, CAP Accreditation, or equivalent; along with applicable OSHA, Federal, and State Laws for all laboratories, including any subcontractors upon request by the VA.

2. Standard: Proper certifications shall be kept up to date for the entire performance of this agreement.

This includes all option years.

3. Acceptable Quality Level (AQL): 100% Meets Standard, no deviations are authorized.

4. Surveillance Method: Periodic Sampling

5. Frequency: Contractor shall provide all requested Licenses, Accreditations, and Certifications upon request of the Government at any time for all laboratories, to include all subcontractors.

b. Technical Quality

1. Performance Requirement: Produce high-quality, consistent access to reports, test code changes, errors in technical transmission issues.

2. Standard: Meets quality requirements.

3. Acceptable Quality Level (AQL): 95% Meets Standard

4. Surveillance Method: Quarterly Review

5. Frequency: COR to review issues with interfacing and notifications of test code changes, issues with test code results.

c. Timeliness

1. Performance Requirement: Processes specimens and report test results within the stated turn-around-times.

2. Standard: Timely courier pick-ups, specimen processing and reporting of all test results.

3. Acceptable Quality Level (AQL): 90% Meets Standard

4. Surveillance Method: Periodic Sampling

5. Frequency: COR will review monthly reports

d. Test Accuracy

1. Performance Requirement: Contractor shall provide accurate testing in accordance with the tests, test codes, test descriptions, specimen processing, and test results.

2. Standard: Number of modified test results, not due to incorrect requisition information from referring lab.

3. Acceptable Quality Level (AQL): < 0.02% of all patient results received.

4. Surveillance Method: Monthly review

5. Frequency: COR will review monthly reports.

e. Transportation & Sample Integrity

1. Performance Requirement: Transportation and Quality standards outlined in the Performance Work Statement (PWS).

2. Standard: Ensures integrity of samples during transportation to the performing laboratory.

3. Acceptable Quality Level (AQL): < 3 lost specimens.

4. Surveillance Method: Monthly review.

5. Frequency: COR will review monthly reports and courier pick-up logs.

f. Anatomic Pathology Random Review

1. Performance Requirement: Contractor shall perform retrospective case review.

2. Standard: Staff pathologist to provide case reviews of 10% of all cases for pathology, surgical, cytology, hematopathology, mohs, and fine needle aspirate, etc.

3. Acceptable Quality Level (AQL): 100% review and documenting of 10% of all cases.

4. Surveillance Method: Monthly review

5. Frequency: Contractor shall provide a monthly report to each facility COR providing all results of each review completed.

g. Billing and Invoicing

1. Performance Requirement: Contractor shall ensure only tests listed in the award (test codes and descriptions) are billed through the award account. Contractor shall ensure that they meet all invoicing and billing requirements established in the award.

2. Standard: Proper and correct invoicing.

3. Acceptable Quality Level (AQL): 90%

4. Surveillance Method: Monthly review.

5. Frequency: Contractor shall submit on-time invoices with all required information monthly as established in this award.