P09 Final PWS - Surgical Cell Services.pdf

Performance Work Statement (PWS)

For

“AUTOLOGOUS TRANSFUSION (CELL SAVER) SERVICES”

1. SERVICE AND EQUIPMENT/SUPPLIES TO BE PROVIDED

A. General:

The contractor shall provide all labor, equipment, management, materials, supplies, and other elements necessary to provide complete “Autologous Transfusion (Cell Saver) Services” for the Southern Arizona VA Health Care System (SAVAHCS), Tucson Arizona. Registered nurses shall be fully qualified and possess direct, documented experience in the performance of the referenced services.

B. Services:

1) Basic autotransfusion will be used where large blood loss is anticipated. Procedures will include but not be limited to: Cardiac, vascular, trauma, transplant, gynecological, and some orthopedic cases. Any procedure in which medical staff determine this service is required, shall be covered under this contract. Basic service will include use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a four (4) hour period.

2) Mini autotransfusion will be used either intra or post operatively on surgical procedures where nominal to moderate blood loss is anticipated. Procedures will include but not be limited to:

Orthopedic cases such as total knee and total hip arthroplasties, ORIF, and retropubic prostatectomy. Mini autotransfusion will include all use of contractor provided equipment, disposable supplies, setup and take down of equipment, and one registered nurse operator or certified technician for approximately a two (2) hour period.

C. Equipment and Supplies:

The contractor shall provide only equipment and supplies that are approved by the Food & Drug Administration (FDA) for autotransfusion. The Contractor shall obtain written approval from the Contracting Officer (CO) prior to implementing any changes or substitution of equipment/supplies during the term of this contract. An approved list of supplies shall be submitted to, and maintained by, the Contracting Officer’s Representative (COR). The contractor shall be responsible for providing the necessary machine along with the disposable bowl and reservoir. The SAVAHCS, Tucson, AZ is not responsible for Contractor provided equipment/supplies. Contractor shall ensure all equipment and supplies are in pristine condition. They shall be maintained in a condition suitable for operating room applications. No other condition is considered acceptable and shall not be used in the performance of this contract. Maintenance and repair of the Contractor’s equipment is the sole responsibility of the Contractor.

2. TRANSPORTATION AND TRAVEL TIME

The price of this service shall include the transportation of personnel and equipment. No additional charges shall be authorized for transportation.

3. RESPONSE TIME AND QUANTITIES

A. The Contractor shall provide all necessary equipment, supplies, and a registered nurse or certified technician within 30 minutes of notification of needed services by the COR or other authorized representative as identified by the CO or COR.

B. One contractor owned cell saver machine shall be placed in the operating room area and remain there for the duration of the contract. It is agreed that SAVAHCS personnel shall not, at any time, set-up or operate contractor equipment or machines. However; SAVAHCS personnel shall be authorized to begin all necessary operations required for emergency collection set-up when they deem necessary for appropriate patient care.

C. Upon arrival, the registered nurse shall immediately report to the SAVAHCS circulating nurse assigned to the procedure.

D. The Contractor shall not be required to perform in excess of three (3) Basic and one (1) Mini service at any one time under this contract.

E. When the Contractor determines equipment require additional maintenance, they shall schedule the time with the COR. Contractor shall only be in the facility when government personnel are aware of the duration of the visit.

4. HOURS OF COVERAGE

The contractor shall provide coverage twenty-four (24) hours per day, seven (7) days per week. This is a critical, life saving component for patient care. Accordingly, Contractor shall be prepared to perform services at all times.

5. QUALITY MANAGEMENT PROGRAM

The Contractor shall have a quality management program in place, that ensures equipment and personnel perform in accordance with American Association of Blood Banks (AABB), College of American Pathologists (CAP), Joint Commission (JC) standards as applicable. The Contractor shall submit a detailed planned which accurately details their quality control management program to the CO prior to contract start-up. Contractor shall obtain written approval from the CO prior to implementing any changes in their approved quality management program. Failure of the Contractor to ensure personnel and equipment conform to these standards shall be cause for termination of the contract.

6. PERFORMANCE MONITORING: The contractor will be monitored through a variety of mechanisms, including but not limited to:

A. QA monitors to assess the quality of care provided by the contractor.

B. Review of medical record documentation.

C. The Contractor is required to meet Joint Commission standards, as applicable. These performance standards may change during the course of the contract. Any new or revised quality/performance criteria or standards will be provided to the contractor before their implementation date and renegotiated into the contract as necessary. Attachment 1 contains the Performance Metrics that will be used to monitor the contractor.

D. Monitoring of contractors time shall be demonstrated through sign-in/ sign-out sheets. The contractor shall be required to sign an attendance log upon reporting to work and departing from work. The Contracting Officer’s Representative (COR) is designed to be the Surgical Care Line’s Administrative Officer. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

7. PERSONNEL QUALIFICATIONS/TRAINING

The Contractor shall ensure all personnel are fully qualified, competent, and have the training, and experience to perform the services in accordance with the terms & conditions of this contract and all other applicable regulations. The Contractor shall provide documentation/certification letters of qualifications, training, licensure, and experience of proposed personnel which the Contractor anticipates utilizing to perform services under this contract. Contractor shall provide evidence their prospective personnel have received all Vaccines (with TB immunization being the most critical), as well as training for safety/blood borne pathogens and HIPPA. Personnel shall not be used prior to approval by the CO or COTR. This approval shall be in writing. Information shall be provided prior to the addition of new staff members.

Failure to ensure personnel meet the minimum qualification requirements shall represent grounds for contract termination. The qualifications of Contractor personnel performing under this contract are subject to review and approval by the SAVAHCS Chief of Staff and the SAVAHCS Director prior to acceptance by the CO. Accordingly, Contractor shall supply the list of prospective employees as quickly as possible, but not later than three days after contract award, to ensure personnel are in place in an acceptable period of time. Contractor personnel will be subject to a Special Agreement Check (SAC) via electronic fingerprinting prior to or simultaneous with entry on duty to SAVAHCS premises. Contractor shall supply their Cellsaver orientation and worksite lists to the COR.

7.1 CREDENTIALING/PRIVILEGING:

A. The contractor shall insure that all contract physicians are credentialed and privileged according to the Credentialing and Privileging process as described in VHA Handbook 1100.19 and local policy. No services will be provided by any contract physician prior to obtaining approval by the VA's Professional Standards Board, Medical Executive Board, and Facility Director. The contractor will be provided copies of current requirements and updates as they are published.

B. The contractor shall allow a minimum of 90 calendar days for review of credentials by the

SAVAHCS Professional Standards Board and the SAVAHCS Director or his/her designee.

Period required for review of credentials shall be at no additional cost to the Government.

C. Privileges will require renewal at least every two (2) years in accordance with Medical Center and Joint Commission requirements.

D. Physicians assigned by the contractor to work at the SAVAHCS will be required to report specific patient outcome information, such as complications, to the Service Chief. Quality improvement data provided by the physicians and/or collected by the Service will be used to analyze individual practice patterns. The Service Chief will utilize the data to formulate recommendations for the Professional Standards Board to consider in the renewal of clinical privileges.

7.2 APPROVAL OF CONTRACTOR PERSONNEL:

The SAVAHCS reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor employee or subcontractor employee who, by reason of previous unsatisfactory performance at the VA or for any other reasonable cause, is considered by the Contracting Officer to be objectionable, as long as thirty (30) days written notification of unsatisfactory performance has been provided to the contractor and the problem has not been cured in the thirty (30) day period.

7.3 KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:

a. The Contractor shall assign to this contract the following key personnel:

Key Registered Nurse ____________________________________ Key Registered Nurse ____________________________________ Back up Registered Nurse ____________________________________ Back up Registered Nurse ____________________________________ Back up Registered Nurse ____________________________________ Back up Registered Nurse ____________________________________ Certified Technician Certified Technician

b. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

c. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

d. For temporary substitutions where the key person will not be reporting to work for three

(3) consecutive work days or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

8. REPORTING REQUIREMENTS

A. The contractor shall provide a log report for each procedure to include the date, patient’s name, locally assigned patient identification number, volume processed, volume returned, and name & signature of the registered nurse.

B. All reports shall be provided to the materials management nurse located in the operating room.

9. UNUSED WHOLE BLOOD

When there is whole blood remaining at the completion of a surgical procedure the nurse operator shall ensure proper labeling as follows: Patient’s name, locally assigned patient identification number, and date & time. The nurse operator shall inform the Operating Room staff nurse when there is remaining whole blood.

10. SERVICES

A. Universal precaution procedures, in accordance with CDC, OSHA, & JC guidelines, shall be adhered to for services provided under this contract.

B. The services to be performed by the Contractor shall be performed in accordance with SAVAHCS policies and procedures and the regulations of the medical staff by-laws (available upon request) of the SAVAHCS.

11. PERSONNEL POLICY

The Contractor shall be responsible for protecting the personnel furnishing services under this contract.

To conform with this policy, the Contractor shall provide the following minimum requirements:

-worker’s compensation -professional liability insurance -health examinations -income tax withholding, and -social security payments

The personnel performing under this contract shall not be considered SAVAHCS employees for any purpose and shall be considered employees of the Contractor.

12. PERSONAL ARTICLES

A. The SAVAHCS shall provide a locker for contractor personnel to store personal articles for safekeeping. Contractor shall be responsible for any lock they wish to utilize

B. To maintain environmental sanitation no personal articles shall be brought into the operating room.

13. DEFINITIONS/ACRONYMS -

A. AABB – American Association of Blood Banks

B. CAP – College of American Pathologists

C. CDC – Centers for Disease Control

D. CO - Contracting Officer.

E. COTR - Contracting Officer’s Technical Representative.

F. JC – Joint Commission.

F. OSHA – Occupational Safety and Health Administration

G. SAVAHCS – Southern Arizona VA Health Care System

14. FEDERAL HOLIDAYS OBSERVED BY THE SAVAHCS:

New Year’s Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day

*Note – Please ensure you understand this contract is in effect 365 days a year, 24 hours a day.

15. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

A. It is the responsibility of the contractor to park in the appropriate designated parking areas.

Information on parking is available from the VA Police Section. The SAVAHCS will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

B. Smoking is prohibited inside any buildings at the SAVAHCS and on VA property.

C. Possession of weapons and alcohol are prohibited.

D. Enclosed containers shall be subject to search.

F. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

16. PRIVACY AWARENESS TRAINING:

A. Privacy Training: Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statutes.

Training must meet VHA’s and the Department of Health and Human Services Standards for Privacy of Individually-identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to Protected Health Information have received annual training. Proof of training is to be forwarded to the Contracting Officer. Information on fulfilling the training requirement as stated in this paragraph can be found at https://www.ees-learning.net. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS standards.

B. A Business Associate Agreement (BAA) may be required for any contract that requires either a SAC or a NACI or higher and that is not otherwise exempt from the requirement for a BAA. The BAA shall be attached to solicitation document for this requirement. Contractor shall supply completed BAA with their solicitation offer.

17. ORDERS:

A task order shall be placed against the basic contract on an annual basis to provide funding for services.

In no event shall the established limit be exceeded without prior modification by the CO. See contract documents for complete procedures and requirements.

Attachment 1 Performance Metrics

Task

PWS

Para

Performance Measures

Acceptable Quality Level

Method of Surveillance

Basic Autotransfusion 1.B.1 At All Times 100% Observation and random inspection

Mini Autotransfusion 1.B.2 At All Times 100%

Observation and

Equipment and Supplies 1.C At All Times 100%

Response Times 3. At All Times 100%

Personnel Qualifications 7, 7.1,

7.2 & 7.3

At all times 100 % Observation and random inspection (auditing)

Reporting Requirements 8 At all times 100% Observation and random inspection (auditing)

Privacy Awareness 16 At All Times 100 % Observation and

(auditing)