Attach 3 - Teleradiology PWS.pdf

B-1 PURPOSE OF CONTRACT

The purpose of the contract is to obtain interpretation of electronic medical images. Contractor shall furnish all necessary personnel, supplies, materials, network service and equipment to perform under the terms of this contract. All services supplied by contractor under the terms of the contract shall be performed in compliance with all requirements and regulations of Food and Drug Administration (FDA), Mammography Quality Standards Act (MQSA), the Joint Commission (TJC), Centers for Medicare & Medicaid Services (CMS) and Health Insurance Portability and Accountability Act of 1996 and Privacy Act (HIPAA).

Service are for the Phoenix Indian Medical Center (PIMC), located in Phoenix, AZ.

B-2 FEE SCHEDULE

PIMC may submit imaging examinations of varying numbers, exam types and urgency for interpretation services under the terms of the contract.

Workload may vary depending on the varying needs of PIMC including number of onsite radiologists, type and/or time of examination, and a number of other factors. The need may be less if PIMC can recruit/retain radiologists staffing.

Imaging examinations may be sent to contractor for routine, urgent or stat interpretation twenty-four hours per day, seven days per week.

The following are annual estimated volumes of different categories of imaging examinations. Cost estimates should be submitted per exam category.

Additionally, contractor may estimate costs based on number of images per examination for cross sectional imaging exams (e.g., CT and MRI).

Contractor may break down cost per exam and type of exam.

Description Unit Base Year OY I OY2 OY3 OY4

Plain Film EA

29,000

30,450

31,972 33,571 35,249

Ultrasound EA

8,000

8,400

8,820 9,261 9,724

Magnetic Resonance Imaging

EA

1,500

1,575

1,653 1,736 1,823

Mammography EA

5,000

5,600 5700 5800 5900

Computed Tomography

EA

7,900

8,295

8,709 9,145 9,602

DEXA EA

1,000

Total Number of Exams

52,400 55,320 57,854 60,513 63,298

B-3 PERFORMANCE WORK STATEMENT (PWS)

1.0 INTRODUCTION

Phoenix Indian Medical Center (PIMC) is a general medical and surgical hospital which provides comprehensive health services primarily to Native American /Alaska Natives and other eligible beneficiaries. PIMC serves as a referral hospital for the more difficult and complex cases from other hospitals and health centers located throughout the Phoenix Area Indian Health Service (includes health facilities in the states of Nevada and Utah).

PIMC also serves as the primary health facility for a large number of urban Native American/Alaska Natives. It is one of the only three referral hospitals in the Indian Health Service (IHS) which provides complex highly technical health services to an entire Indian Health Area.

PIMC has a requirement for Teleradiology Services with the interpretation of medical images including X-ray (DR), Computed Tomography (CT) (to also include 3D reconstructions), Mammography (MM) (to also include 2D and 3D screening and diagnostics), Ultrasound (US), Magnetic Resonance Imaging (MRI), and Dual Energy x-ray (DEXA).

2.0 DEFINITIONS:

A. Area: A defined geographical region for Indian Health Service administrative purposes.

Each Area Office may administer several Service Units.

B. Customer Evaluation/Input: Written comments made to the Contracting Officer regarding the Contractor’s performance. This is one of the criteria used to evaluate the Contractor’s performance.

C. Facility Point of Contact: A Government employee designated by the facility receiving service, who assists the Authorized Ordering Official in the administration of task orders and payment of invoices issued under this contract. Has limited authority to contact Contractor regarding routine daily service issues and special requests within the scope of the contract. Assists the Contracting Officer’s Representative to monitor the Contractor for performance.

D. Holiday: A day marked by a general suspension of work in commemoration of an event.

E. Performance-Based Matrix: Lists the services to be monitored and the standards to be applied.

F. Quality Assurance Surveillance Plan (QASP): A written document prepared and used by the government for Quality Assurance surveillance of the contractor’s performance.

G.Quality Control: Those actions taken by the contractor to control quality of services provided.

3.0 CONTRACTOR REQUIREMENTS

A. PIMC Facility Data and Images: Except as necessary to provide services under the contract, Contractor shall not share, distribute or publish any PIMC facility business data, patient data or information, or patient images without the express written consent of the originating facility and any such data, information or images shared, distributed or published with the express written consent of the originating facility shall be in accordance with all applicable regulations and requirements of Health Insurance Portability and Accountability Act (HIPAA), Privacy Act, The Joint Commission (TJC), Center for Medicaid and Medicare Service (CMS) and other applicable privacy standards.

B. The contractor shall be in compliance with CMS requirements §§482.12(a)

(1) through (a) (7) and §482.12 (e) stated in the written agreement.

C. Contractor’s Equipment and Software: Hardware and software utilized by contractor to provide services under the contract shall be compliant with all regulations and requirements of FDA, ACR, TJC, CMS and HIPAA. Shall be able to receive DICOM images for interpretation of exams.

D. Contractor’s Professional Liability Insurance: Contractor shall maintain, at contractor’s sole expense, Professional Liability Insurance for each of contractor’s radiologists providing services under the contract in the amount of at least Two Million Dollars ($2,000,000) per claim and Six Million Dollars ($6,000,000) in the annual aggregate, AND General Liability Insurance in an amount at least commensurate with industry standards.

E. All interpretations provided to PIMC facilities under the terms of the contract shall be performed by radiologists located in the United States of America.

F. Credentialing of Contractor’s Radiologists: Contractor shall maintain at all times during the contract period certification by TJC (MS 13.01.01 and MS 13.01.03) and CMS, §482.22 (a) (3) and §482.22 (a) (4) including credentialing of contractor’s radiologists providing services to PIMC facilities under the terms of the contract.

Contractor shall notify PIMC immediately in writing of any limitations on contractor’s TJC and/or CMS certification or restrictions on credentials of any of contractor’s radiologists. Contractor shall provide to Contracting Officer Representative (COR) and subsequently update a list of all radiologists that will be providing interpretations under the terms of the contract, said list including Provider Identification Number (PIN) and other identifying information required by government and private third-party payers. Contractor shall provide PIMC with signed billing waivers for each interpreting radiologist as required to facilitate billing of government and private third-party payers by PIMC. Contractor shall provide PIMC all documentation, information and permissions required by PIMC to properly complete their credentialing actions as required by TJC and CMS. Contractor shall provide PIMC at least five working days (excluding weekends and Federal holidays) notice of any additions to contractor’s interpreting radiologist staff, said notice to be accompanied by all identification, billing, privileging and credentialing documentation specified above this paragraph.

The government will require the Distant Site Telemedicine Entity Credentialing and Privileging Agreement along with radiologist documentation to include:

a) All settled malpractice cases to include court documents along with physician’s summary.

b) All dismissed malpractice cases to include legal documents showing the dismissal date along with a physician’s summary.

c) Doctor’s summary for all open malpractice cases.

d) Court documents for any misdemeanor or felony

e) Explanation for any gaps in practice.

f) PIMC privilege form

g) Documentation that the radiologist is credentialed and privileged and in good standing.

Contractor is to submit these documents when credentialing radiologist.

In addition, PIMC may request additional documentation related to National Practitioners Data Bank (NPDB) reports, any current or past professional liability claims, current or pending challenges to licensure or registration, voluntary or involuntary relinquishment of such licensure or registration, voluntary or involuntary reduction or limitation or loss of clinical privileges at another institution, and any prior felony or misdemeanor convictions or charges. Contractor to notify PIMC credentialing and COR of any new physician malpractice cases within 10 days.

G. Radiology Staff Quality Assurance (QA) Activities and Requirements: The contractor shall establish and maintain a QA program consistent with all TJC or CMS requirements including quarterly evaluations of interpretations by every interpreting radiologist. These requirements may be amended from time to time to maintain compliance with applicable laws, rules and regulations.

a. QA evaluations shall classify contractor’s radiologist’s imaging examination clinical report as:

1. No Discrepancy: Reviewer fully agreed with initial clinical interpretation.

2. Minor Discrepancy: Reviewer noted or disagreed with one or more findings reported on the initial interpretation that would likely not alter PIMC facility’s patient’s care or clinical course.

3. Significant Discrepancy: Reviewer noted or disagreed with one or more findings on the initial interpretation that would likely alter PIMC patient’s care or clinical course. Note that contractor shall take action within one (1) hour to communicate to PIMC facility responsible provider notice of any significant discrepancies found in initial reads.

b. QA evaluations shall include a sufficient number of interpretations for each of contractor’s radiologists providing services under the contract to meet all TJC and CMS requirements for accredited QA programs.

c. QA evaluations shall be conducted by a Board Eligible/Board Certified (BC/BE) radiologist (not currently in residency training) at contractor’s sole expense.

d. QA evaluations must be reported to the PIMC COR within thirty calendar days of the end of the quarter or as required by TJC and CMS.

e. Performance Improvement Plans (PI Plans) must be included for any of contractor’s interpreting radiologists with a rate of clinically significant discrepancy greater than 1%.

e.f. Contractor to review and approve imaging protocols (all modalities) per Joint Commission requirement. This will include the contractors Radiologist to sign protocols at each medical facility, as needed. COR will make this request with the contactor.

H. Preliminary and Final Interpretations: All interpretations will be final once BC/BE radiologist (not currently in residency training) complete the report and transfers the report PIMC medical record. All interpretations will be final.

I. Digital Mammography Requirements: Contractor shall provide the following services related to PIMC screening and diagnostic mammography programs including support for Mammography Quality Standards Act (MQSA) activities with FDA and ACR. Contractor may be required to provide the following services depending on the needs of PIMC.

a. Lead Interpreting Physician (LIP), as defined by MQSA.

b. Medical Physicist Survey, as required by MQSA, with all required reporting to COR as required by MQSA. Contractor shall maintain full MQSA accreditation while performing mammography services under the terms of the contract. Contractor will also provide copies to PIMC for record maintenance or review by FDA/ACR.

c. Contractor’s Lead Interpreting Physician and Medical Physicist shall consult with PIMC and assist PIMC with all clinical issues and MQSA accreditation issues as requested by the referring facilities and required by MQSA. Contractor shall be responsible for physician’s portions of MQSA accreditation and annual inspections. Contractor’s LIP shall also assist PIMC with the process of ACR certification every three years, including selection of sample images and completion of all supporting documentation required by the ACR. Contractor will also provide copies to PIMC for record maintenance or review by FDA/ACR.

d. If Contractor provides the sole group of radiologists interpreting mammograms at PIMC, Contractor shall prepare a report for the hospital Peer Review Committee as regards breast biopsies recommended by radiologists interpreting PIMC mammograms. The report should indicate the true positive, true negative, false positive, and false negative biopsy results, considering the department collectively and each radiologist’s rates individually. This is one part of the MQSA report.

e. Contractor’s Lead Interpreting Physician and staff Mammographers shall be available to assist PIMC clinical providers with clinical consultations related to mammography services performed under the terms of the contract.

f. Contractor will need to submit physician credentials, certifications, exam quantity numbers, physicists reports, continuous medical education for record keeping during FDA and ACR inspection.

J. Contractor’s Customers’ Assistance: Contractor shall provide contacts for PIMC for assistance for clinical, technical and business-related issues as follows.

a. Contractor shall provide a customer representative to assist PIMC staff with business questions during regular business hours Monday through Friday, 0800 – 1700 AZ time.

b. Contractor will maintain an 800 number or equivalent telephone service to permit twenty-four hours per day and seven days per week immediate contact with contractor’s clinical staff by clinical providers at PIMC.

c. Contractor will maintain an 800 number or equivalent telephone service to permit twenty-four hours per day and seven days per week immediate contact with contractor’s technical and Information Technology staff by clinical providers or technical support personnel at PIMC.

d. Contractor shall identify a Medical Director for its services. COR, PIMC clinical providers and administrators may contact contractor’s Medical Director with clinical issues and concerns, and service requests.

d.e. Contactor to provide fax number where PIMC technologist can fax technologist sheets to contractor for detailed information on exam to contractor (CT, US, Mammography, DEXA).

K. Contractor’s Communications Network and Interface Requirements

a. Communications Interface: Contractor shall interface with Government furnished PACS (Picture Archiving and Communication System) communications platform(s) at PIMC.

b. Storage and Display of Imaging Examinations: All interpretations shall be performed on FDA, TJC, CMS and HIPAA compliant equipment operating FDA, TJC, CMS and HIPAA compliant software. All equipment and software shall be calibrated and maintained to FDA, TJC, CMS and HIPAA compliant standards.

c. Required Communications and Information Systems Agreements:

Contractor shall work with PIMC and facility Information Technology (IT) Departments to complete all IHS required Information Systems Agreements. This includes but not limited to Interconnection Security Agreement (ISA) (Required for prime vendor and subcontractors (if any)).

d. Contractor’s network must have established firewalls and procedures to ensure patient confidentiality and security consistent with HIPAA regulations and American College of Radiology (ACR) guidelines.

e. Contractor shall transmit reports to PIMC facilities by electronic means in format acceptable to referring facility.

f. Contractor shall upon request work with PIMC to develop: a) bidirectional

HL – 7HL7 and tunnel interface with IHS database to allow direct communications of patient demographic and clinical information, imaging examination information and work orders from PIMC database to contractor’s information system and bidirectional HL – 7HL7 and tunnel interface for transmission o f i m a g i n g e x a m i n a t i o n r e p o r t s f r o m contractor’s information system back to PIMC database.

Contractor must also fax reports to PIMC Emergency Department and medical Medical Imaging Department.

g. Contractor’s server and telecommunications network must have built in redundancy to allow for 100% receipt and processing of all PIMC data.

h. Contractor will be responsible for all costs to set up HL7 and tunnel interface on contractors side of the HL7 and tunnel interface. PIMC will cover all costs on the Governments side of the H7L and tunnel interface.

i. All contractor cloud-based systems must be Federal Risk and Authorization Management Program (FedRAMP) approved. FedRAMP security authorization requirements will include a standardized baseline of security controls, privacy controls, and controls selected for continuous monitoring from NIST Special Publication 800-53 and in accordance with NIST publications.

The following link can be used to review FedRAMP, apply and monitor contractor participation.

https://marketplace.fedramp.gov/products?status=authorized

L. Contractors providers shall not be mentioned or a party on the OIG (Office of

Inspector General) Exclusions List and Excluded Party List.

M. Contractor shall perform quarterly Quality Assurance and Peer Review (QA) including review of all radiologists providing interpretive services under the terms of this contract as defined in section B-3, subsection (3.0) item no. (F) and (G) of this document. Contractor shall report results of all QA performed as part of this Performance Work Statement (PWS) to the Contracting Officer Representative (COR), PIMC as required by section B- 3, subsection (3.0) item no. (F) and (G).

N. The Contractor shall notify PIMC upon the appearance of a provider on the National

Data Bank with a new event or has a change in license status.

O. Contactor will provide a secure website where Radiologic Technologist, PIMC physicians and Radiology Management can access patient reports, monitor receipt of images and completion. Contractor shall list the website:

_____________________________. The Government may not allow for contractor software application on Government computer systems.

P. Service hours – Tele-Radiology is 24 hours per day, 7 days a week, 365 days per year to include all Holidays, weekends and nights. The majority of reports will be requested Monday through Friday nights 5 pm to 8 am and weekends 24 hours, followed by Monday through Friday from 8 am to 5 pm.

Q. Comply with Veteran Administration Vista Imaging and Vista Radiology, and Indian

Health Services Security Network standards and protocols. The government is in transition from VistARad application to ISI Rad commercial off the shift (COTS) equivalent solution. Complete transition may be complete by 2024.

4.0 THIRD PARTY BILLING:

PIMC will bill for all third-party insurance for all studies covered in the contract. The contractor shall not bill insurance for services rendered. The contractor shall be required to have all participating radiologist sign billing waiver.

5.0 PROFESSIONAL QUALIFICATIONS

The Contractor physicians shall:

A. Be Board Eligible or / Board Certified (BE/BC) in Diagnostic Radiology by the

American Board of Radiology (ABR).

B. Possess an unrestricted license to practice medicine in the state where they will be providing professional services (the state where contractors’ radiologist will be located while interpreting and reporting exams). The states services to be provided are in the state Arizona.

C. Be credentialed by Contractor under The Joint Commission (TJC) or Center for

Medicaid/Medicare Services (CMS) accredited methods to provide diagnostic imaging professional services.

D. Provide under the contract only diagnostic imaging professional services within the scope of their credentials as granted by contractor under TJC or CMS accredited methods.

E. Meet the “Qualifications of Personnel” in the America College of Radiology (ACR)

Technical Standard for Teleradiology, Section III, A. Physician (http://www.acr.org/Hidden/Economics/FeaturedCategories/useful_links /medicare_info/teleradiology/ACRTechnicalStandardsDoc4.aspx).

6.0 POST-AWARD ADMINISTRATION MONITORING:

a) PIMC shall provide an ongoing method of monitoring and evaluation of the quality and appropriateness of services and of identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable.

b) If a Contractor’s employee fails to provide services for a scheduled shift, the Contractor must provide coverage by another provider. If no coverage is provided, the Contractor shall be required to pay the IHS for the cost incurred for providing that coverage. Not providing coverage on more than one occasion will be reviewed and discussed by the Chief Medical Officer and the Contracting Officer as to whether there was a compromise of patient care. All situations that arise from compromise of patient care by the Contractor shall be referred to the Contracting Officer for action and resolution.

c) CONTRACTOR QUALITY CONTROL PROGRAM:

The Contractor shall have a Quality Control program to assure compliance with contract. Quality Control program shall minimally have the following elements:

(1) A method for identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable.

(2) A file of all quality control inspections, inspection results, and any corrective action required shall be maintained by the Contractor throughout the duration of this contract. This file shall be the property of the Government and shall be available to the COR during normal working hours. The file shall be turned over to the Government within 14 days of completion or termination of the contract.

d) QUALITY ASSURANCE (QA):

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contract performance is in accordance with the contract performance standards. The QASP defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

e) PERIODIC PERFORMANCE EVALUATION MEETINGS:

The Contractor shall meet, via in-person or teleconference meeting, with the Contracting Officer’s representative (COR) at the Phoenix Indian Medical Center a minimum of every six months according to availability. The purpose of these meetings shall be to review the Contractor’s performance to the critical minimum performance standards set forth in this contract, as documented by the COR’s periodic surveillance of the Contractor’s performance to these standards.

The issuance of a Contract Discrepancy Report (CDR) may be cause for the scheduling of additional meeting(s) between the Contractor and PO. A mutual effort will be made to resolve all problems identified. The PO will prepare written minutes of these meetings. Should the Contractor not concur with the minutes, a written statement will be presented to the Contracting Officer (CO), and the Contractor will be notified of the decision in writing by the CO.

f) PERFORMANCE STANDARDS:

(a) Introduction – Performance Requirements:

(1) A Quality Assurance Surveillance Plan (QASP) has been developed for in-house operations or to implement a service contract. It is designed to aid the COR in providing effective and systematic surveillance of all aspects of services. This plan provides for monitoring the contract requirements

(b) The objective of this surveillance plan is to evaluate how the Contractor is performing in key areas. The government is primarily interested in the final service being provided and not in the details of accomplishment.

(c) The principal method of surveillance will be daily in some cases or by use or periodic inspections. Appropriate indicators are provided for recording observations in this type of surveillance.

(d) How to Use the Performance-Based Matrix

(i) Each defect observed will be recorded on the tally report. These documents will then become a formal record for later reference.

The tally of defects at the end of each clinic or year (dependent on criteria) will be compared to the acceptable number of defects appearing in the surveillance plan. Errors detected by the PO in the course of surveillance will be transmitted to the Contractor or in-house personnel for correction. Notification of errors will take place within five (5) working days. Specifics concerning any errors should be recorded on the tally checklist. The Contractor or in-house personnel, as applicable, should be asked to initial this record.

(ii) COR shall forward a copy of Contractor’s compliance with performance and non- performance compliance reports.

(e) Quality Assurance Surveillance Plan (QASP):

(i) The Government shall monitor the Contractors’ performance through a Quality Assurance Surveillance Plan (QASP). The QASP is for informational purposes only and not considered part of the contract.

(ii) Surveillance systems will include periodic inspection and acceptance of all deliverables as cited in the contract.

The Quality Assurance Surveillance Plan (QASP) outlines required standards and will be a part of the contract.

Performance Objective

Performance Standards

Performance Threshold

Method of Surveillance

Incentives and Disincentive

PRS #1. The contractor will provide quality customer service.

Validated customer complaints by Medical Staff or Rad Technologist or Supervisory Radiological Technologist.

No more than one validated customer complaint per 1-month time period.

*Validated customer complaints from Medical Staff or Medical Imaging Staff.

Incentives:

None

Disincentives:

Do not exercise the contract.

PRS#2. Contractor will submit QA/Peer review evaluation reports quarterly.

Submit QA/Peer report every quarter.

No later than 30 days after the end of the quarter.

Submit QA/Peer report every quarter. No later than 30 days after the end of the quarter.

Review receipt of QA/Peer report no later that 30 days after the end of the quarter.

Incentives:

None

Disincentives:

Do not exercise the contract.

PRS#3: Contractor medical interpterion reports are submitted timely per the requirements stated in the PWS.

Routine reports submitted within 8 24 hours.

Urgent/STAT reports submitted within 60 minutes.

Urgent reports submitted within 4 hours.

10095% of reports are submitted timely.

Random review and PIMC provider reporting to Medical Imaging of delayed reports.

Incentives:

None

Disincentives:

Do not exercise the contract.

PRS#4: Contractor provider to contact

PIMC provider to report critical findings.

Contactor to call PIMC provider to report Critical Findings within 30 minutes.

100100% critical findings notification.

Random review and PIMC provider reporting to Medical Imaging of delayed findings.

Incentives:

None

Disincentives:

Do not exercise the contract.

PRS#5: Contractor medical interpterion reports are accurate.

Reports are accurate and corrected within the time stated per the PWS.

10099% clinically significant accuracy rate

Random review and PIMC provider reporting to Medical Imaging of accuracy.

Incentives:

None

Disincentives:

Do not exercise the contract.

*Complaints must be validated. Complaints are validated if found to be reasonable and true after an administrative investigation.

B-4 PERIOD OF PERFORMANCE

1. The effective date of this contract is from XXX 1, 2024 or Date of Award to xxx 31, 2025 with four (4) one (1) year option periods.

2. If the Government exercises its option pursuant to FAR 52.217-9 Option to Extend the Term of the Contract, the period of performance will be extended in accordance with the following schedule:

OPTION PERIODS PERIOD OF

PERFORMANCE

Option Period One (1) xxx 1, 2024 to xxx 30, 2025 Option Period Two (2) xxx 1, 2025 to xxx 30, 2026 Option Period Three (3) xxx 1, 2026 to xxx 30, 2027 Option Period Four (4) xxx 1, 2027 to xxx 30, 2028

B-5 CONTRACTING OFFICER (CO) RESPONSIBILITY

Authority to negotiate changes in terms, conditions and amounts cited in this contract is reserved to the Contracting Officer (CO).

B-6 CONTRACTING OFFICER REPRESENTATIVE (COR):

The COR for this contract shall be:

Name Location Address Contact email Contact phone

The COR is responsible for:

1. Monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the Contracting Officer changes in requirement(s).

2. Performing technical evaluation as required.

3. Performing technical inspections and acceptance required by this contract; and,

4. Assisting the Contractor in the resolution of problems encountered in performance.

B-7 CUSTOMER POINT OF CONTACT:

Name:

Title:

Phone Number:

Email:

B-8 MEDICAL DIRECTOR POINT OF CONTACT:

As stated in section B-3, Contractor Requirements, section J, d:

Name:

Title:

Phone Number:

B-9 REPORTS

The following are the required timelines for reports sent as ‘routine’, ‘urgent’ and/or ‘stat’:

1. Routine Exams: Interpretation should be available at the referring facility within

8 24 hours of receiving images. Provide 95% response time for routine exams.

2. Urgent: Interpretation should be called, faxed and transmitted to the responsible provider at the referring facility within 4 hours of receipt of the study.

Contractor shall also keep a written or electronic log of telephone and/or fax urgent reports and shall conduct a monthly review of data consistent with TJC and CMS requirements. The results of said review are to be reported to the PIMC COR within twenty calendar days of the end of the report month. Provide 95% response time for urgent exams.

3. Stat Exams: Interpretation should be called, faxed and transmitted to the responsible provider at the referring facility within sixty (60) minutes of receipt of the study. Contractor shall also keep a written or electronic log of telephone and/or fax stat reports and shall conduct a monthly review of data consistent with TJC and CMS requirements. The results of said review are to be reported to the PIMC COR within twenty calendar days of the end of the report month.

Provide 95% response time for Stat exams.

4. Critical Results: Contractor should provide a verbal report to the provider within

30 minutes of interpretation of a study that could have a critical impact on the patient’s care (critical results). Examples of critical results include, but are not limited to, tension pneumothorax, ectopic pregnancy, intracranial hemorrhage, and unexplained free air in the abdomen. Provide 100% response time for critical results exams. The protocol for calling critical results is as follows:

a) Contact the ordering provider. If they are not available,

b) For an ED case, give the verbal report to any available ED provider. If none is available, give the report to the ON CALL provider.

c) For an inpatient, give the report to the ON CALL provider.

d) If none of the above providers is available, give the report to a registered nurse in the ED or on the floor, as appropriate to the location of the patient.

e) The written report will document the time that critical results are called and the name of the individual receiving the results.

5. CT Angio Chest to r/o PE and CT Brain to r/o Stroke: Provide a verbal report to the emergency department (ED) physician or other ordering provider on Pulmonary Embolism CTs or Stroke CTs within 30 minutes of receipt of the study, whether it is positive or negative. The written report should be completed as soon after that as possible, and definitely within one hour. The written report should document the time that the study was received, the time that the verbal report was given to the provider, and the name of the provider.

If the provider is not immediately available, the times of attempted contacts should also be recorded on the written report. If the ordering provider is not immediately available, the following protocol should be used:

I. For an ED case, give the verbal report to any available ED provider.

If none is available, give the report to the ON CALL provider.

II. For an inpatient, give the report to the ON CALL provider.

III. If none of the above providers is available, give the report to a registered nurse in the ED or on the floor, as appropriate to the location of the patient.

6. Accuracy of Reports: All reports shall maintain a 99% clinically significant accuracy rate. Any errors found in reports, must be communicated within 12 hours by telephone and fax to the responsible provider at the referring PIMC facility.

7. Provide a detailed list of all examinations interpreted by the contractor, including the patient name, medical record number, date of exam, date and time of interpretation, name of exam, accession number, and modality. Include CT radiation dose in all reports.

8. Manage the interpretation of suboptimal studies as follows:

a. If the study is of such poor quality that it is completely non-diagnostic, the contractor should not interpret it. They should contact the technologist on duty immediately to see if it can be repeated at that time to correct the problem. If that is not possible, they should send a fax to the radiology administrators by the end of the next business day to advise them of this deficiency. (No Patient Information shall be sent by unsecure email to the Phoenix Indian Medical Center.)

b. If the study is significantly suboptimal by American College of Radiology (ACR) standards but can be interpreted, the radiologist should render an interpretation, with a notation in the written report of the deficiency of the study, and should report the case to the radiology administrators by fax by the end of the next 2 business days. (No Patient Information shall be sent by unsecure email to the Phoenix Indian Medical Center.)

B-10 DELIVERABLES:

Contractor shall provide the following documents:

1. Interpretation Reports.

2. Critical Result Reports.

3. Monthly Critical Results Reports.

4. Quarterly Quality Assurance (QA) (Peer Review).

5. Quality Assurance Program.

6. Medical Liability Insurance --FAR 52.237-7

7. Distant Site Telemedicine Entity Credentialing and Privileging Agreement

8. Business Partner Interconnection Security Agreement (BPISA)

9. IHS Security Agreement (ISA)

10. Business Associate Agreement (BAA)

11. Invoice Itemization (Show patient name, MRN, accession number and exam) (Send by secure email, monthly. Report will be used to support invoice per month.)

12. Schedule 1 Updates, per the Distant Site Telemedicine Entity Credentialing and

Privileging Agreement the contractor is submit new Schedule 1 forms when physicians are added or removed.

SECTION D – ATTACHMENTS

D-1 Contractor Performance Assessment Report System (CPARS) D-2 Business Partner Interconnection Security Agreement (BPISA) D-3 Distant Site Telemedicine Entity Credentialing and Privileging Agreement D-4 Internal Use Software D-5 IHS Security Agreement (ISA) D-6 Business Associate Agreement (BAA)

ADDENDUM

ACRONYMS:

A. ACR: American College of Radiology (ACR)

B. CMS: Center for Medicaid and Medicare Services

C. DICOM: Digital Imaging and Communications in Medicine, standard for the communication and management of medical information and related data

D. FDA: Food and Drug Administration

E. HIPAA: Health Insurance Portability and Accountability Act

F. HL7: Health Level 7, Medical informatics standard that facilities communication among different digital systems.

G. MQSA: Mammography Quality Standard Act

H. PIMC: Phoenix Indian Medical Center

I. OIG: Office of Inspector General

J. PACS: Picture Archiving and Communications System

K. TJC: The Joint Commission

Performance Work Statement

(PWS)

Radiology Ready Colorado River Service Unit

General: This Performance Work Statement (PWS) describes the requirement for the provision of teleradiology interpretation and on-site radiologist services for the Phoenix Area Indian Health Service (PAIHS) Colorado River Service Unit (CRSU), Parker, Peach Springs, Supai, Moapa and Chemehuevi clinics.

Background: PAIHS is an agency within the US Department of Health and Human Services, DHHS and is responsible for providing health services to American Indians and Alaska Natives in the Phoenix, Arizona area. The provision of health services to members of federally recognized tribes grew out of the special government-to-government relationship between the federal government and American Indian tribes. IHS is the principal federal healthcare provider and health advocate for the American Indian and Alaska Native peoples of the United States.

The goal is to ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to American Indians and Alaska Native people. IHS currently provides health services to approximately

1.5 million people who belong to more than 557 federally recognized tribes across 34 states.

CRSU is a principal medical provider of comprehensive direct and high-priority contract inpatient, ambulatory care, preventive and community health, and environmental health services for members of the surrounding Native American population. IHS continues to experience difficulties in recruiting and retaining radiologists who can provide radiology services within IHS medical facilities. Given the current availability of teleradiology/telemedicine technology, IHS is pursuing contracts to provide these services within IHS facilities.

SECTION 1: (Continued) Description/Specification

Statement of Objectives (SOO)

A. The Contractor shall provide routine teleradiology services to the Colorado River Service Unit.

B. Specific to teleradiology services, the Contractor shall be responsible for:

1. Reading all plain radiographs (X-ray), sonograms, computerized tomography (CT) studies, and other diagnostic radiology studies performed at Parker Indian Health Center, Peach Springs Health Clinic, and Supai Health Center. Studies will be designated by the Parker Diagnostic Imaging department as “routine” or “emergent” (24/7).

2. Providing a final written interpretation of all routine studies within 24 hours after receipt of the study.

Interpretations on studies received with less than 24hrs remaining in the business week (Monday – Friday, excluding Federal holidays) will be provided on the first business day of the following week.

3. Providing a preliminary written interpretation on all emergent studies (24/7) within one (1) hour of receipt of the study, stroke protocol response within 30 minutes of receipt of the study. Emergent interpretation services will be available 24 hours per day, seven (7) days per week.

4. Contacting the IHS emergency room physician, or Clinical Director, immediately in the event that the interpretation of a study suggests a significant health risk to the patient that was unappreciated by the referring provider or interpreting radiologist on their preliminary impression. *Significant health risk shall be defined by health industry standards.

5. Be available 24/7 for questions from providers concerning the Contractor’s study interpretations. The contractor will define the method for contacting the Radiologist.

6. Providing teleradiology reception capability compatible with the CRSU teleradiology system. The contractor is responsible for expenses outside of the IHS network.

7. Providing all transcription services, including an HL-7 bidirectional interface for transcription reception utilizing “Thin-air Teleris” software or other methods deemed acceptable by government. Contractor is responsible for all expenses including, but not limited to, technical support, license fees, software, etc., to provide the interface and transcription services.

8. Providing any supplies, service personnel and transportation required to perform the contractual services obligation.

9. Providing a point of contact for network and technical issues 24 hours a day, seven (7) days a week.

10. Providing a point of contact for interpretation/clinical issues 24 hours a day, seven (7) days a week.

C. Specific to departmental administrative responsibilities, the Contractor shall be responsible for:

1. Providing technical assistance and feedback to staff technicians/technologists on the quality of films taken.

2. Working closely with the department supervisor to solve administrative problems and ensure optimal utilization of departmental resources.

3. Annually reviewing and signing off on departmental policies and procedures as a technical consultant.

4. Demonstrate an active involvement in the following departmental programs to assure compliance with The Joint Commission (TJC) requirements:

a. Quality Management programs (X-ray, CT, and Ultrasound.)

b. Safety programs

i. Infection control programs

ii. Health information management programs

5. The contractor shall meet all applicable criteria to become a credentialed and privileged member of the

CRSU medical staff. The contractor shall provide CRSU a completed credentials file, which shall consist of the following documentation:

a. Radiology residency training

b. Board certification radiology

c. Medical school training

d. Tort claims history and liability coverage

e. Experience appropriate to the scope of service

f. Licensure (active unrestricted U.S. medical license)

D. Quality management The contract shall have the following:

a. A daily proactive monitoring system to ensure that contract interpretation benchmarks are met.

b. A designated coordinator for technical and medical staff issues.

c. A designated primary technical consultant for computer, network and software issues relative to this contract.

d. Develop or shall demonstrate a Quality Assurance (QA) program to monitor performance and submit monthly reports to the Contracting Officer Representative (COR).

E. Radiology History. Currently there is no known record of anticipated historical reads for the area.

Radiology Statistics by Fiscal Year

YEAR 2024 2025 2026 2027 2028

X-ray

CT

Ultrasound

Average increase over base year

F. Protocol for Critical Results Reporting:

The contractor will call the requesting provider of a radiology exam immediately upon interpretation and determination that the results of the interpretation can have a critical impact on the patient's care (critical results).

Below is a list of the criteria for critical results. This list may be modified through a contract modification. Results will be communicated to the ordering provider. If the provider cannot be reached, the results will be called to Parker, Peach Springs or the Supai designee in the following protocol:

If the requesting provider cannot be reached, contact the emergency room provider and call the results to the provider.

If the Emergency Room provider is unavailable, then give the results to a registered nurse in the emergency room.

The contractor’s report will document the time critical results are called in and the individual receiving the results.

The contractor will also submit a monthly report of all critical results called into CRSU.

CRITICAL RESULTS:

Anatomical Area

CNS

ACUTE STROKE

Cerebral Hemorrhage/Hematoma Cervical Spine Fracture Depressed Skull Fracture Spinal Cord Compression Brain Tumor (mass effect) Brain Tumor (no mass effect) Cerebral Aneurysm Orbital Injury

Neck Carotid Artery Dissection Epiglotitis Paratracheal Abscess Critical Carotid Stenosis

Chest

Aortic Dissection Tension Pneumothorax Pulmonary Embolism Ruptured Aneurysm or Impending Rupture Hemothorax Lung Nodule Pericardial Effusion Pleura Effusion (massive) Pneumothorax (new) Pneumonia (new) Mediastinal Emphysema Evidence of TB (new)

Abdomen

Appendicitis Aortic Aneurysm (leaking) Biliary Obstruction Bowel Obstruction Hemoperitoneum (massive) Ischemic Bowel Pneumoperitoneum (not post-op) Portal Venous Air Retroperitoneal Hemorrhage Traumatic Visceral Injury Volvulus Cholecystitis Diverticulitis Intussusception Meckel’s Diverticulum Pancreatitis

Uro-Genital

Ectopic Pregnancy Placental Abruption Testicular or Ovarian Torsion Fetal Demise Placental Previa (near term)

Vascular

Pseudoaneurysm DVT or Vascular Occlusion Arteriovenous Fistula (new)

Bone

Spinal Fracture including mechanical or neurological instability (new) Spinal Tumor affecting mechanical or neurological stability (new) Joint Dislocation (new) New finding suggestive of new fracture (other than those described in Critical

Category)

General Misplaced Catheter/Line/Tube

RETAINED FOREIGN OBJECT

Unexpected abscess New finding highly suggestive of malignancy

E. General

The department currently uses digital radiography (DR) as the primary means of capturing images.

In addition, the radiologist will act as a subject matter expert in reviewing radiology policies and procedures, protocols, and standards of care relative to meeting all regulatory and compliance issues for Government or accrediting agencies. When deemed necessary by the radiology manager or medical staff the radiology will provide in-services and training to the radiology technical staff to improve or enhance their services.

SECTION 2: Packaging and Marking

Submission of Information

The Contractor shall be responsible for all postage, fees, electronic commerce transmission, etc. related to the submission of required and general information, including forms, reports, etc., to the Contracting Officer, the COR, or the person(s) designated to receive.

Electronic commerce format shall be submitted either in Microsoft Office Word and Excel or both.

Marking Deliverables

The Contractor shall mark all shipments in accordance with best commercial practices. Additional packing, packaging, and marking requirements shall include the contract award number.

SECTION 3: Inspection and Acceptance

This Quality Assurance Surveillance Plan (QASP) and Performance Based Matrix has been developed to evaluate contractor actions while implementing this Statement of Work. It is designed to provide an effective surveillance method of monitoring contractor performance for services under this contract. The QASP provides a systematic method to evaluate the services the contractor is required to furnish.

The QASP is based on the premise the government desires to maintain a quality standard in operating services to be performed in the best means of achieving that objective.

The contractor is responsible for management and quality control actions to meet the terms of the contract. The government's role in quality assurance is to ensure the standards are achieved.

In this contract, the quality control program is the driver for service quality. The contractor is required to develop a program of inspections and monitoring actions. The first major step to ensuring a “self-correcting” contract is to ensure the quality control program approved at the beginning of the contract provides the measures needed to lead the contractor to success.

Once the quality control program is approved, careful application of the process and standards presented in the remainder of this document will ensure a robust quality assurance program.

SECTION 3: (Continued) Inspection and Acceptance Performance – Based Matrix

Performance- Based Task

Indicator Standard Quality Assurance Incentives/De-Incentives

State the end results or outputs that you will formally accept or reject.

For the Requirement, state the features(s) of end result that will be surveilled.

For each "indicator" state a performance level that, when met, means the task has been performed satisfactorily.

This Standard describes "What Success Looks Like".

For each "Standard", state the method used to check performance (ie. random sampling 100% inspection, periodic inspection, customer input).

List of Positive and Negative Incentives. Address method of linking payment to quality of service.

1) The Contractor shall provide routine, emergent, and critical interpretations of x-ray, ultrasound, and computed tomography exams by utilizing Teleradiology.

Timeliness Interpretations

100% of routine interpretations were reported within 24 hrs. (See section B.2). 95% rate is considered non-compliance.

100% of stat (emergent and critical) interpretations were reported within 60 minutes.

(See Section B.3) 98% rate is considered non-compliance

Surveillance systems will include periodic inspections and customer inputs.

Payment of contract price for satisfactory service.

De-incentive if applied: 2% reduction in monthly payment for each 1% increment below the satisfactory timeliness threshold reduction in timeliness.

2) On-site/Off- Site Radiology Services

Accuracy, Peer Review

98% of interpretations are read without significant discrepancies that adversely affect the treatment of IHS patients.

100% compliance with section 1 of the Scope of Services.

Peer Review done by Contractor on 100% of all selected films “Blinded over-readings” by the end of the quarter.

Below 95% is considered non-compliance.

Surveillance systems will include periodic inspections and customer inputs.

The government will periodically conduct random sampling in order to assure compliance.

Contractor performance will be evaluated and posted at the government site, Contractor Performance Assessment Reporting System (CPARS).

Payment of contract price for satisfactory service.

De-incentive if applied: 2% reduction in monthly payment for each 1% increment below the satisfactory timeliness threshold reduction in timeliness.

3) Calling ordering provider with Critical results

Reporting requirements

95% of “Critical results are called to the ordering provider and documented in the report when and whom the report was called into at the facility. Below 93% is considered non-compliance

Surveillance systems will include periodic inspections and customer inputs.

The government will periodically conduct random sampling in order to assure compliance.

Payment of contract price for satisfactory service.

De-incentive if applied: 2% reduction in monthly payment for each 1% increment below the satisfactory timeliness threshold reduction in timeliness.

4) Radiology Reporting Requirements

Timelines, Accuracy, and Compliance

Contractor shall provide monthly statistical reports 100% with sufficient information to identify compliance with…