REV SOW PATHOLOGY AND LAB MEDCINE.pdf

STATEMENT OF NEED

1.GENERAL: The Contractor shall provide the following services Document Storage and Retention Services to Pathology & Laboratory Medicine Services at the Bay Pines VA Healthcare System (BPVAHCS), Bay Pines, FL 33744.

2.BACKGROUND: C.W. Bill Young VA Medical Center Pathology & Laboratory Medicine services Request the services of a NARA approved facility for the storage and retention of clinical laboratory logs, records, paraffin blocks, glass slides and ancillary items related to laboratory documents, records, and supplies.

3.PURPOSE: Services must include the storage of blocks and slides including empty block and slide filing cabinets, retrieval, delivery and refile of clinical laboratory records, paraffin blocks and glass specimen slides, transportation of clinical and anatomic pathology materials to/from the facility and the storage location, destruction of clinical laboratory and pathology materials and the management of all materials within the storage facility. All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances with all terms, conditions, provisions, schedules and specifications provided herein.

4.TECHNICAL REQUIREMENTS:

a. Receipt and Storage

1) All inventories must be identified using a unique barcode system that tracks all movement of clinical records and pathology materials into and out of the Records Center.

2) Records must be stored in a NARA approved site.

3) Provide storage for various clinical and anatomic pathology materials, including but not limited to laboratory logs and records, paraffin blocks, glass slides, and ancillary items related to these materials; these must be stored in a secure facility used exclusively for records storage.

4) Provide environmentally controlled storage for materials as requested including but not limited to paraffin blocks and glass slides.

5) Pick up clinical laboratory logs and records and pathology materials for storage and deliver requested materials and supplies.

b. Retrieval & Refile

1) Facility should be within proximity to the Medical Center and able to provide deliver of clinical records and anatomic pathology materials requested by BPVAHCS authorized users. Records and other materials must be able to be retrieved per our request within 24 hours or within 4 hours and 30 minutes for a stat request.

2) All inventories must be identified using a unique barcode system that tracks all movement of clinical records and pathology materials into and out of the Records Center.

3) Records must be stored in a NARA approved site.

4) Provide storage for various clinical and anatomic pathology materials, including but not limited to laboratory logs and records, paraffin blocks, glass slides, and ancillary items related to these materials; these must be stored in a secure facility used exclusively for records storage.

5) Provide environmentally controlled storage for materials as requested including but not limited to paraffin blocks and glass slides.

6) All inventories must be identified using a unique barcode system that tracks all movement of clinical records and pathology materials into and out of the Records Center.

7) Records must be stored in a NARA approved site.

8) Provide storage for various clinical and anatomic pathology materials, including but not limited to laboratory logs and records, paraffin blocks, glass slides, and ancillary items related to these materials; these must be stored in a secure facility used exclusively for records storage.

9) Provide environmentally controlled storage for materials as requested including but not limited to paraffin blocks and glass slides

c. Transportation

1) Transport clinical records and pathology materials between BPVAHCS and Contractor’s facilities for purposes of storage and retrieval in enclosed, secured vehicles.

2) Permit scheduled site visits by BPVAHCS authorized staff.

3) Provide optional emergency rush service as requested.

4) In the event the Contractor uses a third party to transport BPVAHCS clinical laboratory records or Pathology Materials, the Contractor shall ensure that the third-party handles BPVAHCS materials in accordance with the Security and Proprietary Information Agreement requirements specified herein. Third party providers shall be bonded and subject to witness and approval by BPVAHCS.

d. Destruction

1) Calculate destruction review dates for BPVAHCS clinical records and pathology materials automatically in Contractors automated materials management system, based on BPVAHCS records and pathology materials retention information at no cost to

BPVAHCS.

2) Provide standard system generated reports of BPVAHCS records and pathology materials automatically on periodic basis to be determined by BPVAHCS at no cost to BPVAHCS.

3) Destroy only those clinical records or pathology materials approved for destruction in writing by BPVAHCS Authorized Users.

4) Process to completion BPVAHCS clinical records or pathology materials approved for destruction within 30 days of receipt by Contractor from BPVAHCS to destroy. A Certificate of Destruction will be provided to BPVAHCS attesting the destruction of records.

5) Ensure that BPVAHCS clinical records or pathology materials removed from BPVAHCS facilities for the purpose of physical destruction are, in fact, physically destroyed within 3 business days after removal from BPVAHCS facility.

6) Destroy BPVAHCS clinical records and pathology materials by burning/incineration, shredding, pulping, pulverizing, melting or chemical decomposition. Residue shall be inspected to ensure complete destruction.

7) Update and maintain data related to BPVAHCS Pathology Materials as a result of destruction or permanent withdrawal at no cost to BPVAHCS

5. SERVICES AND PERFORMANCE CHARACTERISTICS:

b) Facilities

8) Contractor warrants that its facilities are, and shall continue to be, designed, constructed and protected in accordance with the requirements of the authorities having jurisdiction and National Fire Protection Association and other appropriate fire codes. Contractor agrees to maintain, monitor and routinely test all detection and alarm systems. Such testing shall be documented and inspection of facilities available to BPVAHCS Authorized Users.

9) Records must be stored in a NARA approved facility.

10) Maintains BPVAHCS pathology materials in indoor, climate-controlled environment on rack or shelf storage. Pathology Materials shall not be maintained in palletized storage, outdoor storage, in temporary structures on in 3rd party supplier facilities.

11) Maintain and routinely test disaster emergency management recovery plans.

12) Maintain a pest management program to eliminate damage to Pathology Materials due to insects, rodents, etc.

13) Report any incidents in facilities that house BPVAHCS pathology materials within 24 hours and provide root cause analysis and corrective action plan.

14) Be open and operational during regular business hours (Monday through Friday, 8:00AM to 5:00PM) in accordance with BPVAHCS’s work calendar.

15) Provide for 24 hour/7 days a week/365 days per year on call, emergency access to

BPVAHCS clinical records and pathology materials.

e. Security

1) Maintain and routinely test a 24-hour monitored intrusion detection system and access control system to prevent unauthorized access to BPVAHCS records and pathology materials. Such tests shall be documented and available for inspection by BPVAHCS Authorized Users.

2) Contractor must have a full-time Chief Security Officer as part of its Safety and Security organization.

3) Contractor must have a comprehensive Disaster Planning/Business Recovery plan in place for its business operations.

4) Contractor must have a fully staffed Risk Management department within its corporate finance group which is dedicated to protecting both corporate and customer assets.

5) Contractor must be a member of the NFPA (National Fire Protection Association) Technology Committee to ensure compliance to fire safety codes and procedures.

6) Contractor must conduce pre-employment screening, drug testing, and background investigations on all employees prior to hiring.

7) Contractor must have a valid Affirmative Action/EEO Policy Statement in force.

8) All employees must be regularly trained on issues such as Security, Privacy and HIPAA compliance.

f. Best Practices

1) Contractor must be a member of ARMA (Association for Records Managers and

Administrators and PRISM (Professional Records and Information Management)

2) Contractor must have SysTrust Certification (SysTrust is a type of assurance service performed by a licensed CPA or CA to independently test an organization's system and to offer assurance on the system's reliability)

3) Contractor must observe all applicable ANSI standards as well as ISO standards for the preservation of information storage media.

g. HIPAA Compliance

1) Contractor must have taken documented steps to be compliant with the Privacy Rule established in the HIPAA legislation of 2001

2) Contractor must have taken documented steps to be compliant with the Security Rule established in the HIPAA legislation of 2003 and have achieved full compliance under this rule.

6.SOFTWARE: . N/A

7.TRAINING: . N/A

8.WARRANTY OF EQUIPMENT: . N/A

9.DELIVERY/SERVICE SCHEDULE: . N/A

10.PLACE OF Delivery/Service: C.W. Bill Young VA Medical Center Pathology & Laboratory Medicine Service Bldg. 100, Room 2B-102 10,000 Bay Pines Blvd. Bay Pines, Florida 33744

STATEMENT OF NEED