36C25619Q0828-004.pdf

Quality Assurance Surveillance Plan (QASP)

Regulated Medical Waste (RMW) Services

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 Contracting Officer (CO): Joey Grismore

• Organization or Agency: Department of Veterans Affairs, Network Contracting Office (NCO) 16

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(S): Anthony Landry, 713-791-1414 Ext. 24805

3. CONTRACTOR REPRESENTATIVES

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

a. Program Manager –

b. Other Contractor Personnel –

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.

QASP

# PWS

Paragraph

Indicator/Performance Standard

Standard for

Quality Level

Acceptable Quality Level

Method of Surveillance

0F

Incentive

1 3.1.1 The contractor shall furnish appropriate and adequate (at least 115) amounts of 97/100-gallon, portable pre-labeled bio-hazard containers with closeable lids for the daily collection, storage and transportation of medical waste, and 20 each for chemotherapy waste containers. All containers shall be washed and sanitized daily before delivery and reuse. Containers shall be maintained per manufactured-design or replaced to meet manufacturer’s specifications, OSHA, DOT, and TCEQ regulations.

100% 100% Periodic Inspection

Positive Past Performance

Rating

2 3.1.3 Containers shall be picked up daily, Monday through Saturday (and as needed) between the hours of 6:00 am and Noon, excluding Federal holidays. The contractor is responsible for adhering to established methods for picking-up, manifesting, transporting, documenting, labeling, processing, and delivery verification to the treatment and disposal facility VAMC generated infectious medical, pathological, and chemotherapy waste per State, Local, CDC, OSHA, DOT, and EPA regulations/laws/codes, etc.

Positive Past Performance

Rating

3 3.1.4 The Contractor shall ensure treatment and disposal of VAMC generated chemotherapy (CD) wastes and Pathological Waste are segregated at storage on site, in separate pre-labeled containers provided by the vendor. CD and Pathological Waste shall be treated (incinerated) and disposed in accordance with the approved treatment method enforced by federal, state, and local laws, regulations, and ordinances, including the TCEQ, TDH, OSHA, CDC, and EPA.

Positive Past Performance

Rating

4 3.2.1 The contractor shall furnish appropriate and adequate amounts of containers for the daily collection, storage and transportation of medical waste. Containers shall be maintained per manufactured-design or replaced to meet manufacturer’s specifications, OSHA, DOT, and TCEQ regulations

100% 100% Periodic Inspection

Positive Past Performance

Rating

1 See “Methods of Surveillance,” paragraph 6 of this QASP, for additional methods of monitoring performance.

5 3.2.3 The Contractor shall ensure the waste stream is managed and picked-up at each facility weekly/as needed on a normal working day between the hours of 10:00 am – 2:00 pm, unless otherwise approved by the Contracting Officer (CO) or COR.

The off-site VA facilities managed by the MEDVAMC currently include

100% 100% Periodic Inspection

Positive Past Performance

Rating

6 3.3.1.1 The Contractor shall furnish a Contingency Plan (CP) in the event any VA facility, listed in the SOW is affected by a major disaster or shut down, planned or unplanned. The contingency plan shall be active within 12 hours of notification from the COR. A copy of this plan shall be provided to the CO with their technical quote submission

100% 100% Periodic Inspection

Positive Past Performance

Rating

7 4.2 The Contractor shall provide evidence that their off-site or on-site medical/special waste treatment and disposition system for processing untreated RMW/special/infectious waste meets the performance standards, as outlined in 25 TAC 226 and TCEQ 30 TAC 330, Subchapter Y, 330.1201-

330.1221. Failure to meet this requirement shall

call for immediate termination of requested service stated and required in this contract.

Positive Past Performance

Rating

8 4.3 The Contractor shall ensure an electronically generated copy of the medical waste manifest or a written record per 30 TAC, Chapter 330.1211 is attached to each electronically generated invoice showing proof of the daily quantity and total monthly amount of medical waste treated in pounds, prior to requesting and receiving payment for services rendered. The inventory report shall include each site listed in this SOW; along with the amount of RMW, Chemotherapy Waste, and Pathological Waste.

Positive Past Performance

Rating

9 4.4 The Contractor shall maintain documentation demonstrating its employees or contractors are properly trained, medical tested and wear an appropriate level of Personal Protective Equipment (PPE). The Contractor shall ensure employee or contractors wear personal protective equipment, prior to engaging in any activities involving maintenance of processing equipment or handling of infectious waste generated by this health care facility per 29 CFR OSHA 1910.1030.

Positive Past Performance

Rating

10 4.9 The Contractor shall as a separate contingency option, furnish all services, materials, equipment, transportation, storage and manpower, as necessary to treat and dispose of DOT Infectious Substances, i.e., identified as “Category A and Category B” mixed with medical/infectious waste on a fixed per-drum-fee, in strict compliance with Federal (CDC, OSHA, EPA, and DOT) and State (TCEQ) regulations

100% 100% Periodic Inspection

Positive Past

11 4.12 The contractor shall submit requests for payment electronically to the VA’s Tungsten Network.

Invoices shall be paid monthly in arrears for all authorized work performed upon receipt of a properly prepared invoice. Invoices must include contract number, purchase order number, location inspected/treated, and date inspected/treated. Non-performance or late performance may result in delayed or reduced payment under this contract.

100% 100% Periodic Inspection

Positive Past

5. INCENTIVES/RATING STANDARDS

Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance.

a. DIRECT OBSERVATION

b. PERIODIC INSPECTION

c. USER SURVEY

d. VALIDATED USER/CUSTOMER COMPLAINTS

e. INSPECTION

f. PERIODIC SAMPLING

g. RANDOM SAMPLING

h. PROGRESS OR STATUS MEETINGS

i. ANALYSIS OF CONTRACTOR’S PROGRESS REPORTS

7. 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:

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

See above Acceptable Quality Level & Method of Surveillance located in QASP

The Government shall document positive OR NEGATIVE 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 work with the Contracting Officer (CO) 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. To assure that the contractor receives impartial, fair, and equitable treatment under this contract, the COR will work with the contractor to increase performance to an acceptable level.

When the COR and CO determines formal written communication is required, the COR and CO 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 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.

9. 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.

b. Frequency of Performance Assessment Meetings.

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

Contractor

Anthony Landry Contracting Officer Representative

Various methods exist to monitor performance.