36C26319R0095-003.pdf

Quality Assurance Surveillance Plan (QASP)

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: Kyle Bauman Network Contract Office 23

316 North Robert Street, #529 kyle.bauman@va.gov Phone - (651) 293-3012

Organization or Agency:

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: Tracy Kolosik, Administrative Officer Iowa City VA HCS 601 Hwy 6 West Iowa City, Iowa 52246 Email: tracy.kolosik@va.gov Phone: 319-338-0581, ext. 5202

3. CONTRACTOR REPRESENTATIVES

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

Primary:

Alternate:

mailto:kyle.bauman@va.gov mailto:tracy.kolosik@va.gov

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. INCENTIVES

The Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards (Inclusion of any monetary incentives requires approval through the Department’s Senior Procurement Executive (SPE).

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.

a. DIRECT OBSERVATION. 100% surveillance: This will be accomplished by visually observing the documentation and/or the process.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Periodic could also mean weekly, monthly or sporadically as well. For example, ten (10) randomly selected patient files will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.)

c. VALIDATED USER/CUSTOMER COMPLAINTS. When used, this method will be received using Patient Advocate Office, “Tell it to the Director,” as well as phone calls directly to leadership and/or administrators.

d. RANDOM SAMPLING. If this method is used, ten (10) randomly selected patient files will be reviewed per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.)

7. PERFORMANCE MEASURES

Measures ID Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

1. Inventory Levels 7 The inventory levels will be maintained by Contractor via replacement shipment within 24 hours of patient registration.

Tracking information shall be provided to appropriate ICVAHCS contact upon shipment. Up to 30-day memory loop inventory shall remain at ten (10) and up to 14-day telemetry inventory shall remain at thirty (30).

100% of the cardiac monitors requested will be monitored unless canceled by facility.

100% Observation and/or random sampling.

2. Equipment 6 (e) The contractor shall provide a system with an overall uptime rate of 98%-100%

98% of the equipment and availability (denominator) and equipment failures when issued (numerator) will be monitored on a daily basis. Any issues that arise shall be reported immediately to VA. Any monitors with reported problems will be replaced immediately with no additional costs to VA.

98% Observation and/or Random sampling

3. Interim Reports 2 Within 30 minutes of an immediate notification 100% of notifications shall be followed up with an interim report supported by pertinent tracings – including tracings showing preceding activity and subsequent activity for said adverse event –notification. Additionally, Contractor shall notify ICVAHCS personnel when there are occurrences of “no tracings” for 12 consecutive hours.

100% of notifications will be followed up with an interim report supported by pertinent tracings.

Additionally, Contractor shall notify ICVAHCS personnel when there are occurrences of “no tracings” for 12 consecutive hours, 100% of the time.

100% Observation and/or periodic inspection

4. End of Study reports 2 Contractor shall make end of study reports available to ICVAHCS personnel within 24 hours after receipt of recorded data. These reports must be in Microsoft Word or .pdf format and must be available for electronic download/fax transmission via a secure internet website

100% of end of study reports shall be available within 24 hours after receipt of recorded data, must be in appropriate format and be available for electronic download/fax transmission via a secure internet website

100% Observation and/or periodic inspection

5. Maintenance 8 Contractor shall perform all preventive maintenance, repairs, quality control, cleaning, disinfecting and decontamination according to accreditation standards of all 30-day memory loop monitors (standard event) and 14-day ambulatory cardiac telemetry monitor (ACT or telemetry) equipment used in performance of this contract.

100% of monitors are to be cleaned, disinfected, and decontaminated according to accreditation standards, each time before they are sent back to the facility or the patient, after download.

100% Observation, and/or periodic inspection

6. Quality Program 9 Contractor shall provide a detailed monthly invoice for all patients receiving full services to the COR

100% of the time, monthly invoicing of all patient tests completed in a calendar month will be provided to the VA per Tungsten Network. This invoicing shall be provided no later than the10th of each following month.

100% Observation

8. CPAR RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual https://www.cpars.gov/pdfs/CPARS-Guidance.pdf p. A2-1):

Table 42-1—Evaluation Ratings Definitions Rating Definition Note

(a) Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being evaluated was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

To justify an Exceptional rating, identify multiple significant events and state how they were of benefit to the Government. A singular benefit, however, could be of such magnitude that it alone constitutes an Exceptional rating.

Also, there should have been NO significant weaknesses identified.

(b) Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being evaluated was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

To justify a Very Good rating, identify a significant event and state how it was a benefit to the Government. There should have been no significant weaknesses identified.

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf%20p.%20A2-1

(c) 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.

To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract/order. There should have been NO significant weaknesses identified. A fundamental principle of assigning ratings is that contractors will not be evaluated with a rating lower than Satisfactory solely for not performing beyond the requirements of the contract/order.

(d) Marginal Performance does not meet some contractual requirements.

The contractual performance of the element or sub-element being evaluated reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

To justify Marginal performance, identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the Government. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g., management, quality, safety, or environmental deficiency report or letter).

(e) 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 contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

To justify an Unsatisfactory rating, identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the Government. A singular problem, however, 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).

9. 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 CR on the following page.

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS ISSUE

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

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

7. SIGNATURE OF COR Date:

8. SIGNATURE OF CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE AND ACTIONS TO PREVENT RECURRENCE.

(Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE