A07 - Exhibit A_QASP Tele-Radiology.docx

Quality Assurance Surveillance Plan 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: DeeAndra Salabye Organization or Agency: Billings Area Office Indian Health Service

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: Brandon Miller Organization or Agency: Billings Area Office Indian Health Service

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract: Primary Program Manager: Janice Roth Alternate Program Manager: TBD

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 QUALITY ASSURANCE 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.

c. VALIDATED USER/CUSTOMER COMPLAINTS.

d. RANDOM SAMPLING.

e. Verification of timely documentation provided by Contractor.

6. QASP PERFORMANCE REPORT DATE:

Measure

PWS

Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

Incentive

Quality/Peer Review

3.1.7 Quarterly Quality Control Peer review on interpretations from electronic images specific to each facility location.

This Quality Control (QC) peer review shall occur as part of the Contractor’s The Joint Commission-Compliance Quality Control program. Discordant interpretations must be graded as to their clinical significance (agree, disagree-insignificant, disagree-significant).

1. Supply COR with quarterly report dates

2. Submit quarterly reports within 10 working days of quarterly report dates to the BAIHS Centralized Credentialing Office

3. Report needs to include workload, discordance rates, and any other information requested or for the use of quality assurance.

100%

Quarterly reports, via either hard copy or electronic mail, should be forwarded to the COR Quarterly discordant interpretation rates greater than 3% for “disagree-significant” category discordant interpretations require that the Contractor submit to the IHS a detailed plan for quality improvement. Persistent discordant rates greater than 3% for “disagree-significant” category may lead to discontinuation of the contract.

Timeliness

3.1 Routine/Standard Interpretations of Radiographic/Medical Images: of a non-emergent nature. Written interpretations required within 24 hrs.

Stat (includes emergency and or critical) Interpretations of Radiographic/Medical requires Telephonic interpretations from the referring facility physician or designee are required within 20 minutes of image submission, with the written interpretation to follow.

1. The facility shall receive a written interpretations of Routine/Standard Radiographic/Medical Images within 24 hrs. of transmission.

2. The facility clinician shall receive a telephonic interpretation on Stat Radiographic/Medical Images within 20 mins. of transmission, followed by a written interpretations within 24 hours

Periodic Inspection.

Unsatisfactory service may result in unfavorable contractor performance evaluation, which could result in not exercising option year period.

Customer Service

3.3 The Contractor shall identify a lead point-of-contact for questions and issues related to clinical service delivery.

The Contractor shall also identify a customer service representative to assist IHS staff with billing and/or administrative questions during regular business hours 8:00 A.M. to 5:00 P.M. Monday through Friday (Mountain Time).

The Contractor shall maintain a toll-free telephone number or equivalent telephone service 24 hours per day with an answering service

1. Name submitted of the identified customer service representative to assist IHS staff with billing and/or administrative questions during regular business hours 8:00 A.M. to 5:00 P.M. Monday through Friday (Mountain Time).

2. Changes in customer service representative must be sent within 24 hours of change

3. The Contractor shall maintain a toll-free telephone number or equivalent telephone service 24 hours per day with an answering service.

Direct Observation.

Customer/Service Unit Feedback

Unsatisfactory service may result in unfavorable contractor performance evaluation, which could result in not exercising option year period.

Reporting Requirements

Key Personnel Changes: All changes that affect the contract must be communicated to the CO, COR and SU, as soon as possible.

1. The contractor shall provide a monthly report of service volume of all modalities and over-read activities to the COR within 5 working days of the first of each month. These reports shall be provided to the SU POC.

2. Contractor shall inform the COR and SU contact any Key personnel changes within 48 hours of the change

Monthly Reports from the contactor to the SU.

Unsatisfactory service may result in unfavorable contractor performance evaluation, which could result in not

Training

3.5 The Contractor shall provide training and support to participating IHS facilities for any secure internet/server-based platform or software used to transmit work orders and Tele-Radiology images from IHS facilities to Contractor and interpretations from Contractor back to IHS facilities, within 10 working days of the contract award date.

In addition, the Contractor shall provide, upon request, as needed training and support based on the needs of the IHS facility, for example, when staff turnover occurs. Training and support shall be provided within 5 working days of the request.

Also, the Contractor shall make an initial site visit to each facility participating under this contract within 45 calendar days of the service start date.

1. Within 10 working days of the contract award date the contractor shall provide training and support regarding secure/internet/server-based platform or software used to transmit work orders and Tele-Radiology images.

2. The contractor will Supply training and support within 5 working days of a request.

3. Contractor will have an Initial site visit to each facility participating under the contract within 45 calendar days of the service contract start date.

Direct Observation. Periodic Inspection Written report reflecting visits

Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option year period.

Credentialing and Privileging

3.4.6 The Contractor shall fulfill the BAIHS Centralized Credentialing Office requirements

1. The contractor must submit a list of radiologists(s) credentialed and privileged to provide services under this contract.

2. Documentation of credentialing and privileging approval to the BAIHS Centralized Credentialing Office.

3. The contractor is responsible for providing the BAIHS Credentialing Specialist with updated information regarding the status of each radiologist(s) credentialing and privileging expiration dates and renewal status.

4. Contractor must fill out, sign and return the Distant Site Hospital Provider Credentialing and Privileging Agreement, see Appendix E

Security/ISSO Clearances

3.6

The Contractor shall obtain completed IHS ISSA Security Clearance prior to the start of this contract. This clearance will establish that the Contractor has provided sufficient local telecommunication network firewalls and procedures to ensure patient confidentiality and security consistent with HIPAA (Health Insurance Portability and Accountability Act of 1996) regulations, FIPS, and ACR (American College of Radiology) Guidelines.

All documents shall be supplied to the BAIHS

1. Contractor shall provide and complete and ISA

2. Contractor shall complete and approved copy of a BAA

3. Contractor shall describe the security plan for patient data, location of physical servers and reading centers in support of contractor servers, including encrypted wireless systems used by the reading providers.

4. Contractor will provide the ability to comply with IPSec VPN standards for encrypting communications.

5. Contractor shall conform to Federal 508 requirement which address accessibility for personnel with disabilities.

Government and Contractor Furnished Property

All digital medical imaging files provided to the Contractor for interpretation shall remain the property of the government.

1. The contractor will request from the COR and the SU facility an express written consent form prior to the consent to use of digital or analog images outside the contractor’s organization.

2. The SU facility will provide any digital images that are requested by other entities for the flow of patient care or comparison interpretations 3.

Qualifications and Accreditation

Contractor qualifications and Relevant Experience Requirements as listed

1. Contractor shall possess a minimum of 1 year experience in the practice of Tele-Radiology. References shall be made available upon request

2. References shall be made available upon request.

3. All radiologists providing interpretations under this contract shall be English-speaking.

4. License: All radiologist(s) shall possess a current, valid unrestricted license in a state, the District of Columbia, the Commonwealth of Puerto Rico, or a Territory of the United States, throughout the term of this contract.

5. Board Eligibility: All radiologists shall be Board Eligible or Certified by the American College of Radiology (ACR) throughout the term of this contract.

6. All radiologists shall be eligible to participate in the Medicare or Medicaid programs.

7. Credentialing and Privileging: The contractor shall be accredited by The Joint Commission. Each radiologist must be currently credentialed and privileged by the contractor, which shall meet or exceed the privileging and credentialing standards of The Joint Commission. The radiologist shall render contracted services within the scope of each radiologist’s respective privileges.

8. All radiologists shall meet the “Qualifications and Responsibilities of Personnel” in the American College of Radiology Technical Specification for Tele-Radiology Section III, A, Physician.

Suspension or termination of all privileges and removal from work on the contract, until competency information is provided to the BAO.

4. 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/documents/CPARS- Guidance.pdf.

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:

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).

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 on following page.

5. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

, Administrative Contracting Officer DATE

, Contracting Officer’s Representative DATE

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

5. DATES

6. Issue Identified (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

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

CONTRACTOR NOTIFIED

COR

CONTRACTING OFFICER

END OF QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)