36C24520Q0345 Attachment - Quality Assurance Surveillance Plan_QASP.docx

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Ambulatory cardiac monitoring devices and cardiac monitoring services (Holter and Cardiac Telemetry) for patient care

Contract Number: to be determined

Contract Description: Cardiac Monitoring Services

Contractor’s name: To be determined.

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. 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: As Assigned.

Organization or Agency: Washington, DC VA Medical Center

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: As assigned.

c. Other Key Government Personnel – Wanda Shannon, Chief, Health Information Management Section

3. CONTRACTOR REPRESENTATIVES

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

a. As assigned

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 Summary Matrix below includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). Relevant definitions / calculations are contained within the SOW.

TASK

ID

INDICATOR

STANDARD

ACCEPTABLE QUALITY LEVEL

METHOD OF SURVEILLANCE

INCENTIVE

All contractor equipment offered shall be U.S. Food and Drug Administration (FDA) approved.

Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

Monitoring

Education regarding the set-up and continuous wearing of the devices along with 24/7 technical support that will be offered on the phone.

Wireless equipment that is assigned to patients shall require monitoring 24 hours a day, while the devices are in use.

Capability of event transmissions being sent via wireless/cell phone technology.

Ability to store 100% of the ECG data in the device(s) when patient is in an area of no cellular service; no event can be lost due to memory limitations.

ECG real time transmissions and analysis to have a minimum of 3 leads, up to 6 leads (views) with no more than 3 electrodes.

Ability for 100% of ECG data to be transmitted in real-time to Receiving Center for entire monitoring period. Transmitted ECG data is reviewed in real-time by qualified cardiac technicians.

Ability to post daily Holter reports analyzing all ECG data over the monitoring period. ECG data is sent via wireless in real time and over each 24 hours, and at end of each 24-hour period, ECG data re-analyzed and posted for physician daily review.

Ability to immediately transmit, alert and report Patient Activated Events immediately upon Patient pressing “event” button. No further patient interaction needed. When meets physician notification criteria, physician will also be immediately called per facility instructions.

Ability to immediately transmit, alert and report Asymptomatic Events meeting the physician’s notification criteria. Physician will also be immediately called per facility instructions.

Technical reading of the device(s) along with a comprehensive report that is available online and will be interpreted by the medical staff.

Both patients and VA staff shall have unlimited 24 hours a day, 7 days a week, 365 days a year Call Center telephone access to certified cardiovascular technicians who review the recordings and respond according to physician orders, who are knowledgeable and shall supply help in resolving any monitoring problems.

Contractor shall electronically post the data, analysis, and interpretation for immediate review by the appropriate Washington, DC VAMC facility within 24 hours of receipt unless there is a potentially life-threatening arrhythmia and/or event. In the event of a life-threatening arrhythmia and/or event, the contractor shall call 911 and dispatch emergency services to ensure the patient receives adequate treatment.

Contractor shall post an all-results-data export file encoded as either XML or HL7 within 24 hours of receipt.

All events of an emergency or STAT nature shall immediately be phoned to the appropriate Washington, DC VAMC facility no later than one hour (1) after receipt and recognition of such data.

The contractor shall provide detailed reports for all Veteran patients receiving full services to the COR (Contracting Officer Representative) at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring monitoring services, have been assigned a monitor that has been returned to the contractor for interpretation, the interpretation has been reported back to the appropriate medical center, and the interpretation report is determined to be without technical error.

Ability to post an End of Study Remote Telemetry Report compiling all Telemetry and Holter ECG data into one conclusion report.

Telemetry

All Events whether symptomatic or asymptomatic will trigger immediately alerts to bring to reviewing technician’s attention. The ECG is automatically transferred to a cardiac monitoring center, where it is immediately reviewed, reported and the cardiologist is informed according to pre-selected notification criteria.

100%

Holter Monitoring

All ECG data will be reanalyzed daily as both a quality control and to provide comprehensive reporting to physician

Daily Wireless Holters shall be posted every 24 hours for physician review.

Non-Wireless Holter will be posted within 24 hours of download for physician review.

Daily Holter reports shall be standard Holter reports shall include:

1) Heart Rate ECG data including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, total number of Analyzed Minutes, total number of minutes in Sinus Bradycardia /Tachycardia and longest episode of each, total Pauses in excess of 2 seconds and max pause.

2) Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum and Minimum HR V- Run (if applicable), VE’s per 1000/per Hour ratio, and Ventricular R on T.

3) Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable), SVE’s per 1000/per Hour ratio.

4) Atrial Fibrillation / Flutter: Burden, Total number of minutes in A-Fib, Number of Episodes, A-Fib graph.

5) ST Segment Analysis: Max ST Depression and Elevation, Total number of ST minutes, Max ST Episode, and Max HR in ST Episode.

6) QT Analysis: When applicable, Max QT and QTc.

7) Heart Rate Variability: Time Domain and Spectral Power.

8) Full Disclosure capability.

End of Study Reports

Device Services:

Data Management

While patient is wearing the device, transmission patient activated report, urgent asymptomatic event report, daily Holter report and end of study report options will be made available online. The VA shall have access to patient reporting 24 hours a day at the physician’s or authorized representative’s convenience through password protection. Registration information will be entered by VA technician on the contractor’s web site, or by transmission of an XML or HL7 encoded data transfer file from VA to contractor to provide an automated registration process.

Workflow

The device(s) is given to patients to use for 1 to 30 days depending on the indication for continuous monitoring.

Initially, ECG technicians will instruct and explain to the patients what the device(s) is, how the patient will use it, how to hook it up, and how to place leads. They will then hook up the device(s), and let the patient go home with specific instructions in order to continue to have the device on for the duration of evaluation. Alternatively, the monitor(s) will be sent directly to the patient, and the patient will be hooked up at home with instructions from the vendor. In either of these cases a baseline is always submitted to the monitoring center where trained personnel record and interpret the strip. Physician notification criteria will be established prior to enrollment. When asymptomatic and/or symptomatic ECG events are alerted that meet the criteria, a call is made to the ECG director and an urgent report with the date is prepared and posted for physician evaluation. Each day a daily Holter report will be presented that includes all the data for the prior 24 hours. An end of service summary report shall be available 3-5 days after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data). Once the ECG data is ready for evaluation, the contractor shall post the End of Study for the department to review.

Instrument Capabilities

Capability of event transmissions being sent via wireless/cell phone or advanced technology.

Telemetry real time monitoring Capability transmitting and recording 100% of ECG data.

Customizable monitors.

Wireless 24/48-hour Holter / Cardiac Event/ Outpatient Telemetry devices providing all three monitoring functions over the 1 -30 days monitoring period.

Pacemaker pulse detection.

i. Instrument/Monitor has a date and time stamp for clinical reports.

j. Instrument/Monitor can correlate between time and symptom and identify/present all rhythm strips associated with all reported symptoms.

k. All monitoring devices must provide a of 1 to 6 diagnostic leads of continuous ECG data over entire monitoring period, 3 lead pacemaker annotations, and the ability to correlate symptoms and activity with ECG changes.

l. All consumable items (batteries, patches) are provided to patient by contractor who returns the item after monitoring period.

m. Contractor equipment shall be capable of storing up to thirty-day (30) of all ECG data, using standard size batteries readily available, and easily changed by the patient.

Training

The contractor shall provide comprehensive training to the Washington, DC VAMC staff. This may require multiple training sessions for numerous staff. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests.

Contractor shall also provide each participant at each facility copies of manuals, equipment checklists, surveys, and specific contact information if a medical center staff person needed to contact the contractor 24/7.

Technical Support

Technical support is required via telephone for troubleshooting of method and/or problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support.

Contractor must have appropriately trained personnel available by phone throughout the duration of all tests for patient support

Quality

Maintenance:

Quality Program:

b. Periodic reviews of monitor records

c. Analysis of Contractor’s software data entry for assigned codes for cases coded.

Option Exercise

Review of diagnoses and procedures to ensure that documentation supports assigned codes.

Option Exercise

Provider Quality Performance Performance Requirement:

Standard: OPPE documentation for all (100%) staff providing services under the contract. All staff (100%) meet Standards.

Acceptable Quality Level: ____meet Standards Surveillance Method: Ongoing Provider Performance Evaluation (OPPE) data pertinent to care performed for each provider working under this contract. OPPE data will review the following elements:

Medical/Clinical knowledge

Frequency:

Qualifications of Key Personnel Performance Requirement: All Contractor’s physician(s) shall be Board Certified /Board Eligible (edit per requirement) in accordance with ACC Standards.

Standard: All (100%) Contractor’s physician(s) s are board certified.

Acceptable Quality Level: ___% Surveillance Method: Random Inspection of qualification documents

Scope of Practice/Privileging Performance Requirement: Contractor’s physician(s) perform within their individual scopes of practice/privileging.

Standard: All (100%) Contractor’s cardiology technician(s) perform within their scope of practice/privileges 100% of the time.

Acceptable Quality Level: ___%Contractor’s cardiology technician(s)

Patient Access Performance Requirement: The Contractor shall provide Contractor’s cardiology technician c cardiac monitoring services in accordance with the operating hours and VA clinical schedule outlined in this PWS.:

Measure: Patient Safety Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Acceptable Quality Level: ___%of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Surveillance Method: Direct Observation

Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s cardiology technician(s) shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: ___%licensing, registration(s) and certification(s) for Contractor’s cardiology technician(s) shall be provided as they are renewed. Licensing and registration information kept current.

Surveillance Method: Periodic Sampling and Random Sampling Frequency

Mandatory Training Performance Requirement: Contractor shall complete all required training on time per VAMC policy Standard: All (100%) of required training is complete on time by Contractor’s cardiology technician(s) and contractor staff, as applicable..

Acceptable e Quality Level: ___%completions, Surveillance Method: Periodic Sampling

Measure: Privacy, Confidentiality and HIPAA Performance Requirement:

Standard: All (100%) Contractor’s physician(s) and staff comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Acceptable Quality Level: ___%compliance Surveillance Method: Periodic Sampling; Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6.

5. INCENTIVES

a. The Government shall use Incentives and Penalties: Exercise options and reporting past performance with the Federal Contractor Performance System (CPARS).

6. 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. The contractor agrees to establish/remain in compliance with any and all Joint Commission standards that are applicable to the services provided to the VA Maryland Health Care System. The contractor also agrees to abide by all requirements from any regulatory and/or other accrediting body that evaluate the organization. Further, the contractor agrees to provide information concerning service or personnel on request in an expedient manner.

Incentives listed above. 4. Performance Standards 1, 2 and 3

a. PERIODIC INSPECTION. Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required in Performance Standard 1 and 2.

b. 100% INSPECTION Performance Standard: 3 (Evaluation of outcomes.)

c. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)

Performance Standard: 1 and 2 (periodic sampling increased when deficiency arises)

d. Progress or status meetings.

Performance Standard: 1,2,3 (Quarterly status meetings or as needed pending periodic review)

e. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

Performance Standard:1, 2 (Quarterly progress reports)

8. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Metrics of performance evaluation will be based upon standards recorded in section Performance Standard: subsections 1 and 2.

9. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the CO and COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR 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 CDR will also state how long after receipt the contractor must present this corrective action plan to the CO and COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

10. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

The COR shall meet with the contractor Quarterly to assess performance and shall provide a written assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative