QUALITY ASSURANCE SURVEILLANCE PLAN.doc

QUALITY ASSURANCE SURVEILLANCE PLAN

Augusta VA Healthcare System Home Oxygen and Ventilator Services Quality Assurance Surveillance Plan

For: Home Oxygen and Ventilator Services Contract Number: TBD Contract Description: This Performance Work Statement (PWS) defines the effort required for the setup, installation, and management of Home Oxygen and Ventilation, in accordance with Joint Commission (JC) standards for Homecare, to Veteran beneficiaries serviced by VISN 7-Staion 509-Augusta Veterans Medical Center (AVAMC). This PWS includes the associated program management, human engineering, and logistic support planning requirements. The use of terms, “beneficiary”, “Veterans”, “Patients”, and “Patient” are used interchangeably and refer to the recipient of required supplies, equipment, and services required under the contract.

Contractor’s name: TBD

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: Leonard Robinson @ leonard.robinson@va.gov Organization or Agency: Department of Veterans Affairs, Office of Acquisition and Materiel Management

b. Contracting Officer’s Technical Representative (COTR) - The COTR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COTR shall keep a quality assurance file. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COTR: TBD

c. Other Key Government Personnel: TBD

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

a. Program Manager – TBD

b. Other Contractor Personnel – TBD

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, paragraph 7 in the Performance Work Statement (PWS), includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

2.2(a) Notification to VA Regarding Status of Delivery of Home Oxygen Service

Customer Complaint 95% or greater compliance. If less, requires action plan for improvement.

Customer Complaint 98% or greater compliance. If less, requires action plan for improvement.

2.2(c) Notification to VA Regarding Status of Delivery of Home Oxygen Service.

3.2(g) Employee Identification and Delivery of Medical Equipment.

Random Site Visit.

If less than 100%, Action plan submitted within two weeks if not meeting threshold with outliers.

Random Site Visit.

98% or greater compliance. If less, requires action plan for improvement.

4.2 (a)

Equipment and Services

6.1-6.3

Reports

Timely submission of reports by dates stipulated in paragraph 6.1-6.3.

5. Incentives There are no incentives pertaining to this contract.

6. Methods of QA Surveillance Various methods exist to monitor performance. The COTR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. Direct observation is required periodically for compliance to contract of comtractor facility, services, documentation, invoices, and other listed in the administration of this QASP

b. PERIODIC INSPECTION. Scheduled and unscheduled Inspections will be conducted by the COR/CO or designated personnel to ensure contract compliance.

c. USER SURVEY. Complaints received from customers reported to contractor and VA will be logged and submitted to the contractor for immediate resolution/corrective action. Contract will monitor complaints monthly and report to the Home Oxygen Coord. on a quarterly basis.

d. VALIDATED USER/CUSTOMER COMPLAINTS. VA beneficiaries complaints reported to contractor and VA will be logged and submitted to the contractor for immediate resolution/corrective action. Contractor will monitor complaints monthly and report to the COR.

e. RANDOM SAMPLING. Option to be utilized by the COR and CO in reviewing vendor employee training records and VA beneficiaries’ folders to ensure contract compliance.

f. Monthly Invoice accuracy, patient home inspection, patient satisfaction/complaints reports, timeliness of equipment delivery, accuracy of required documentation submitted, and adherence to Joint Commission Standards, HIPPA, other regulation specified in the contract will be monitored by the COR.

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:

PERFORMANCE RATINGS

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 COTR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COTR shall document the discussion and place it in the COTR file.

When the COTR determines formal written communication is required, the COTR 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 has to present this corrective action plan to the COTR. 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.

REQUIRED REPORTS AND DOCUMENTS

DAILY REPORTS

Incident Report;

Reporting special incidents found or occurring during a home visit, to include finding patients in need of emergency medical assistance, safety hazards that do not fall into the category of presenting immediate life-threatening danger to the patient or Contractors staff, inability to contact a patient within a reasonable period of time, and any other incident meeting the Contractors written policy for incident reporting according to accreditation standards.

COR/designee

Report of accidents, malfunctions, injuries, deaths, and equipment recalls All accidents, malfunctions, injuries, deaths, and equipment recalls, related to the provision, delivery and use of equipment and supplies herein, shall be immediately reported to the COR and to the manufacturer of the equipment.

COR/designee

Sentinel Events.

The contractor is required to inform the Home Oxygen personnel within one business day of a sentinel event (as defined by JC standards) that occurs during the performance of this contract that involves VAMC beneficiaries COR/designee

Patient Refusal of Service Refusal of service - All beneficiaries have the right of refusal of service. In the event a beneficiary refuses service or orders equipment to be removed from the home, the Contractor shall comply with the beneficiary’s wishes,however in addition to a written report; the Contractor shall report the specifics of the refusal to the COR by telephone within 1 hour. If the refusal occurs during a home visit, the Contractor’s staff shall make an attempt to notify the COR of the refusal during the home visit. Notification on refusal of backup equipment may be accomplished verbally, in writing or via email.

COR/designee

Suspected Abuse or Neglect The contractor shall report suspected incidents of abuse or neglect to the patient by family members or caregivers. Suspected incidents shall be reported immediately (within 24 hours during business hours) to the COR, as well as to the adult protective agency. The contractor will follow all state and local laws in reporting suspected incidents of abuse or neglect.

COR/designee

MONTHLY REPORTS

Prescription Renewals Contractor will notify the COR of needed prescription renewals for patients two (2) months prior to the expiration date of the existing prescription.

COR or designee

Equipment Summary Listings Provide for each VA Site (using Excel worksheets) to the COR, listing all items issued to each patient. Lists are to be sorted alphabetically by item then by patient’s name. A total will be reflected at the end of each item column to indicate how many of that item is in patient’s homes (i.e. concentrators, conservers, B-tanks, E-tanks, Lbs of LOX, etc.)

Provided as part of the billing package each month. Also acts as a statistical information sheet in determining quantities of items out to patients and total costs of those items.

COR or designee

Compliance/Educational Needs Report Service Reports to include documentation of prescription compliance (i.e. correct liter flow, hours of usage, etc.) for each patient, after each scheduled visit Inventory Report of Government Owned Equipment A complete listing of all government owned equipment in storage to include make, model and serial numbers, new, used, in need of repair or in need of disposal.

COR or designee

QUARTERLY REPORTS

SEMI-ANNUAL REPORTS

ANNUAL REPORTS

REPORTS PROVIDED AS REQUESTED BY COR

10. Frequency of Measurement

a. Frequency of Measurement.

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

b. Frequency of Performance Assessment Meetings.

The COTR shall meet with the contractor QUARTERLY to assess performance and shall provide a written assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Technical Representative

CONTRACT DISCREPANCY REPORT

5. DATES

a. CDR PREPARED

6. DISCREPANCY OR PROBLEM (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

10. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION AND ACTIONS TO PREVENT RECURRENCE. (Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

12. GOVERNMENT EVALUATION. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

14. CLOSE OUT

a. Contractor notified

b. COR

c. Contracting Officer

SUBMIT QUARTERLY / END OF CONTRACT REPORT TO CONTRACTING OFFICER (90C)

CONTRACTOR / SUB-CONTRACTOR TRAINING REPORT

Note: If any of the training below is not applicable to subject Contract, the COR will notate N/A, add initials and date each line.

VA Privacy and Information Security Awareness and Rules of Behavior (VA 10176)

Target audience: This course is for all VA staff, contractors and volunteers who use a computer to perform their job.

Privacy and HIPAA Training (VA 10203)

Target audience: Any VA employee or non-VA employee with access to Protected Health Information (PHI)

Integrity and Compliance Awareness Training for all Staff -

(VA 43790)

Emergency Preparedness / Disaster Policy and Procedures (location specific)

Initial competence assessment/employee competencies

Area / Program / Unit Specific Orientation

Specific MCM requirements:

NEW PROVIDERS

PROVIDERS NO LONGER PROVIDING SERVICES

MATERIALS NEEDED TO COMPLETE ASSESSMENT

· Current Home Oxygen Prescription

· Most recent Delivery Maintenance Ticket (DMT) or Customer Follow up Form

List type of smoking materials (e.g., cigarettes, cigars):

c.

Did the vendor document any identified safety risks, e.g., open flames?

If yes, list required actions for each risk:

List recommendations given to patient (if any):

f.

Did the vendor document that the smoke detectors or fire alarms were recently tested?

List recommendations given to patient (if any):

g. Did the vendor document that the oxygen equipment can be used safely, including grounded outlets, electrical cords, and no use of extension cords?

a.

Does the oxygen concentrator serial number match the delivery/maintenance ticket (DMT)?

c.

Does the veteran have appropriate disposable equipment (e.g., tubing, cannulas)?

a. Did the vendor document that O2 tanks are stored safely (e.g., lying down in storage rack, chained upright to a wall, in an oxygen transport unit)?

b. Did the vendor document that the Veteran has a back up oxygen tank or has a document signed by the Veteran showing that they have refused a back up oxygen tank.

Good Fair Poor List identified concerns or complaints (if any):

REVIEW PARTICIPANTS

COR QUARTERLY FACILITY INSPECTION AND MEETING

Department of

Veterans Affairs Facility Inspections

Date:

COR:

Contractor:

Address:

The inspection is conducted to ensure the contractor is compliant with JC standards, OSHA standards, contract, and other federal and state regulations. Facility inspections and meetings should be conducted every quarter. Inspections are to be conducted the first week from the start of the quarter. The quarterly meeting should be conducted in the 2nd week from the start of the quarter. This document is not considered complete unless both occurred.

Inspection Date:

1. Were the findings discussed in the meeting?

2. Were there corrective actions discussed?

3. Are the findings repetitive?

4. Was it determined that a Contract Discrepancy Report was warranted?

Note: If discrepancies are found, ensure to document Contractor corrective action(s) and follow-up to confirm issues were resolved.

Quarterly Meeting Date of Meeting:

Location:

Attendees:

COR actions to resolve the matter:

COR Name

Facility/ Program Office

Findings:

Topics/ Discussion: