P09 COURIER SERVICE PERFORMANCE WORK STATEMENT 20240617.pdf

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Attached to
R602--Medical Courier Services
Solicitation number
36C26124Q0612
Issued by

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This document is a Performance Work Statement (PWS) for courier services at the VA Palo Alto Healthcare System. The PWS defines the requirements for a contractor to provide laboratory specimen, pharmaceutical, and medical supply transportation services to the VA Palo Alto Division, Menlo Park Division, VA Fremont CBOC, Livermore Division, Mountain View HR Building, San Jose CBOC, and Monterey CBOC facilities. Key requirements include providing experienced, trained drivers, secure vehicles with GPS tracking, maintaining temperature controls, and adhering to federal regulations for handling hazardous and biohazardous materials. The contractor must establish a quality control plan and comply with VA security and conduct policies.

The related federal contract opportunity is a solicitation (Solicitation Number: 36C26124Q0612) for an Indefinite-Delivery-Indefinite-Quantity contract for medical courier services at the VA Palo Alto Healthcare System. The Period of Performance is 10/01/24 to 09/30/29. The Government anticipates awarding a single contract to a Service-Disabled Veteran-Owned Small Business. All questions must be submitted to the specified Contracting Officers by 05/17/24.

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Veterans Affairs Palo Alto Health Care System Courier Services

PERFORMANCE WORK STATEMENT (PWS)

DEFINITION AND ACRONYMS:

ANM – Assistant Nurse Managers

BPA - Blanket Purchase Agreement

CBOC - Community Based Outpatient Clinic

CDC - Centers for Disease Control and Prevention

CDR - Contract Discrepancy Report

CLC – Community Living Center

Contracting Officer (CO) - The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

Contracting Officer’s Representative (COR) - A person appointed by the CO to take necessary action to ensure the Vendor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government.

The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

CPARS - Contractor Performance Assessment Reporting System, which is the official Government reporting system for Vendor past performance on awards.

CPRS – Computerized Patient Record System

DOT - U.S. Department of Transportation

ED – Emergency Department

HIPAA - Health Insurance Portability and Accountability Act

TJC – The Joint Commission, hospital and laboratory regulatory and accrediting body

JPSR – Joint Patient Safety Reporting. This is the system used by both the Department of Defense (DOD) and Veterans Health Administration (VHA) to report patient safety events.

NM – Nurse Managers

OIG – Office of Inspector General

OSHA - U.S. Occupational Health and Safety Administration

PHI – Patient Health Identifiers

POP - Period of Performance

QASP - Quality Assurance Surveillance Plan

RMD – Reusable Medical Devices

STAT – The term to describe the most urgent of orders. This special designation is meant to be used in case of an emergency where the results of a test, procedure or medication may mean the difference between life and death.

SPS – Sterile Processing Service

VAPAHCS – Veterans Affairs Palo Alto Healthcare System

SCOPE OF WORK

VAPAHCS needs contracted laboratory courier services to support public health efforts.

The contractor will provide VA-designated courier services, including drivers, dedicated company transportation vehicles (non-personally owned), and equipment.

The courier will pick up and deliver laboratory specimens such as anatomic/surgical pathology, blood, coagulation, hematology, serology, pharmaceutical prescriptions/supplies, RMD, and stock medication. It may also include but not limited to specimen containers, medical records and other packing supplies may also be included.

The contractor must ensure that all vehicles used for this service are designed to transport specimens and materials without compromising their integrity and confidentiality. They should also provide labor, vehicles, dispatch communication equipment, vehicle transport containers, refrigeration/freezer accommodations, and full-time supervision to offer excellent courier services.

Current courier expires 6/30/2024; therefore, services from new courier contract must begin at the start of the new period of performance, 7/1/2024.

The vendor must provide all necessary management, labor, equipment, vehicles, transportation, information security (HIPAA), and insurance to provide laboratory, medical medication and supplies courier services to and from the VAPAHCS main campus, including the CLC and CBOC addresses cited under "Places of Performance."

VAPAHCS' CBOCs provide primary care services to eligible veterans in their communities. These clinics offer preventive care, immunizations, dental and physical therapy, specialist referrals, and more. Services in each VAPAHCS facility may vary.

VAPAHCS' CLC (Extended Care Service) is a VA nursing home where veterans receive 24-hour nursing home-level care, including geriatrics and extended care services, help with daily living activities, skilled nursing, and medical care.

VAPHCS SPS (Nursing Service) to.

All work must comply with federal, state, and local regulations or ordinances, including any specific rules for hazardous materials, information security (HIPAA), dangerous goods, diagnostic specimens, or bio-hazardous materials.

PLACES OF PERFORMANCE

Palo Alto Division (PAD) 3801 Miranda Avenue, Palo Alto, CA 94304 Service Building Floor/Room # Pathology and Laboratory Medicine Service (Path & Lab)

100 4th Floor, Room F4-130

Pharmacy Services 100 1st Floor, Room E1-120 Sterile Processing Services (SPS) 100 Basement, Room EB-320

100 Room EB-356

Menlo Park Division (MPD) 795 Willow Road, Menlo Park, CA 94025 Service Building Room # Path & Lab 334 Room D-11 Pharmacy Services 360 Room J101-360 Sterile Processing Services 334 Room F-103 (Dental) Extended Care Services (CLC) 331 Unit 331B, D

360 Units 360A, B, D, E, F, and G

VA Fremont CBOC 31999 Liberty Street Fremont, CA 94538 Service Building Room # Path & Lab B Blood Draw Room (101)

Livermore Division (LVD) 4951 Arroyo Road, Livermore, CA 94550 Service Building Room # Extended Care Services (CLC) 90 CLC 1 Path & Lab 62 2nd Floor, Room 202 Pharmacy Services 62 1st Floor, Room 123 Sterile Processing Services (SPS) 62 6th floor, Room 613A

Mountain View Human Resource (HR) Building

1776 Old Middlefield Way, Mountain View, CA 94043 Service Building Room #

Occupational Health (OH) 801 2nd Floor, Reception

San Jose CBOC (SJC) 5855 Silver Creek Valley Place, San Jose, CA 95138 Service Building Room # Path & Lab N/A Room 140 Pharmacy Services N/A Pharmacy Front Desk Sterile Processing Service N/A Lab Room 140

Monterey CBOC 201 9th Street, Marina, CA 93933 Service Building Room # Path & Lab N/A Room 160 Pharmacy Services N/A Pharmacy Front Desk Sterile Processing Service N/A Lab Room 160

VAPAHCS retains the full authority to alter, add, or revoke facilities and routes to cater to its organizational requirements. Such changes shall be communicated in writing, and the payment for additional routes shall remain at the same rate as specified in this contract.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

As per the Federal Acquisition Regulation (FAR) subparts 46.103, the contractor is required to create and implement a quality control plan that will report quality metrics to the VAPAHCS Contracting Officer Representative (COR) to ensure high levels of performance throughout the contract's Period of Performance (PoP). The quality assurance plan must be provided to the respective Contracting Officer (CO) and Contracting Officer Representative COR for review at least 10 business days before the contractor begins work. The plan should include, but is not limited to, the following aspects:

1. A method of monitoring to verify and ensure that the requirements and quality, as described by state and federal regulations, are met.

2. A method of maintaining quality control records in accordance with state and federal regulations on the transportation and handling of specimens, pharmaceutical medications, and federal property.

3. A method of providing temperature conditions for the transport of biologic specimens, medications and other prescriptions, transport containers, including preserving the integrity of samples.

4. A method of safely transporting RMD in accordance with DOT regulation on the transportation and handling clean /contaminated RMD.

5. A method of maintaining compliance in transportation training requirements/certification annually to current and new VA-designated team members.

6. A method of submitting accurate electronic invoices timely and efficiently and communicate these to COR or representative as appropriate.

7. A method of document management of all training, certifications, attestations, deficiencies, log sheets, and other requirements. In the event of a survey/audit, the contractor should be ready and able to provide this documentation to VAPAHCS.

For more detailed information, please refer to Attachment A, QASP which provides a detailed performance evaluations for the contract.

COURIER SERVICE

The courier service will cover a wide range of items, including the transportation of pharmaceuticals, medical supplies, diagnostic specimens with PHI, prosthetic equipment, RMD (sterile and contaminated instruments), laboratory specimens (blood/body fluids), housekeeping supplies, equipment such as wheelchairs and walkers, documents, medical records, x-rays, and any other hand-carried materials. All items will be securely always locked while in the possession of the vendor to ensure their safety and the integrity of the items being delivered.

Courier services between VAPAHCS and CBOCs will operate daily from Monday to Friday, except on federal holidays or any day declared a federal holiday by the President of the United States. The Federal Government observes eleven holidays including New Year’s Day, Martin Luther King Jr. Day, Presidents’ Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

Path & Lab, and Pharmacy are open 24-hours at the PAD. CLC provides 24-hours care for Veterans. For federal holidays and after-hours specimen transport, the CLC can contact the vendor and request "on-demand delivery” or “STAT delivery” to or from the PAD Pathology and Laboratory, and Pharmacy. The contractor shall have adequate quantity of experienced VA- designated drivers and shall deliver specimen depending on the need of the type of delivery. Full definitions of these deliveries will be cited under “Schedules”.

TEAM MEMBERS. The contractor is responsible for ensuring that all drivers (D), and administrative/operational (A/O) team members meet the following requirements:

1. Possess a valid California driver’s license. (D)

2. Complete training in handling biohazardous materials, bloodborne pathogen exposure, and spill cleanup procedures in compliance with Department of Transportation (DOT) and CDC Transportation rules and regulations. (D)

3. Training for handling and transport of Diagnostic or Infectious Laboratory specimens, including dry ice.

4. Complete training in RMD handling and transportation in compliance with DOT.

(D)

5. Complete training in the Health Insurance Portability and Accountability Act

(HIPAA). (D, A/O)

6. Acknowledgement and acceptance of VA Privacy and Information Security Awareness and Rules of Behavior (required of all non-driver courier who are in correspondence with VA personnel) Page 25. (D, A/O)

7. Acknowledgement in writing by all drivers that containers must not be opened under any circumstances. (D)

8. Ensure that all drivers are well-prepared to take assigned VAPAHCS delivery route(s) by providing adequate on-site training and guidance, especially to new drivers and those unfamiliar with the facility and service route. It may include but is not limited to parking area instructions, the locations of pickup and delivery areas, facility operating hours, and point of contact details, and other critical information. (D, AO)

IDENTIFICATION. The personnel of the contractor shall wear uniforms that are easily identifiable with the name of the company printed on them. Additionally, the contractor is required to issue an identification badge to the driver which should ideally have a picture and the name of the driver. This badge must be worn by the driver while providing contracted services at all VAPAHCS facilities.

CONDUCT. Unacceptable behavior by Contractor personnel will not be tolerated. These behaviors include, but are not limited to, improper physical actions (touching), improper verbal statements (using derogatory comments and verbal abuse), and improper visual actions (ogling, making sexual gestures).

Photography, video, or audio recording of any kinds is not permitted within, nor outside the premises in any VAPAHCS facilities.

VAPAHCS is committed to creating an environment where everyone is treated with civility, compassion, and respect. Sexual assault, sexual harassment, and other forms of harassment violate our values and make our workplace unsafe for everyone.

Sexual Assault is any type of sexual contact or attempted sexual contact that occurs without the explicit consent of the recipient of the unwanted sexual activity. Sexual assaults may involve psychological coercion, physical force, or victims who cannot consent due to dementia, anesthesia, severe mental illness, or other factors that remove the capacity to consent. Sexual assault is a crime. Report sexual assaults immediately to VA Police at (56) 65891 or (56) 65892. Report even when the assault is committed by a patient with diminished capacity. We have an obligation to report assaults and to support victims. Timely reporting is imperative as VA Police are mandated to report incidents within two hours of discovery.

https://www.va.gov/files/2021-10/Privacy_Info_Sec_Awareness_Annual_Training.pdf https://www.va.gov/files/2021-10/Privacy_Info_Sec_Awareness_Annual_Training.pdf

Sexual Harassment is any unsolicited or unwanted verbal, gesture, or conduct that is sexual in nature. VAPAHCS has a zero-tolerance sexual harassment policy.

Management will take prompt and effective action to address the harassment. Harassment is any unwelcomed conduct that creates an intimidating, hostile, or offensive environment.

Federal law prohibits the possession of firearms or other dangerous weapons in Federal facilities and Federal court facilities by all persons not specifically authorized by Title 18, United States Code, Section 930. Violators will be subject to fine and/or imprisonment for periods up to five (5) years.

VEHICLES. Contractor must provide adequate number of vehicles to provide the needs as described on this PWS. The contractor is responsible for providing enclosed vehicles, such as automobiles, vans, or trucks, with adequate space, air conditioning, and proper security devices like door locks and alarms. These vehicles must be capable of transporting specimens, medications, and other pharmaceuticals, RMD, and other clinical supplies.

All vehicles used for services under this contract must be equipped with GPS or transponder applications that provide real-time tracking of all drivers. The application may also include but not be limited to scheduling of non-fixed routes for pickup and delivery, providing confirmation of pickup and delivery, and capability to rate quality of deliveries. Information/data should be provided to the on COR in a semi-annual basis.

The contractor must grant application access to each service/location that utilizes the courier service. During application maintenance or any reasons of downtime, courier company will communicate promptly via phone or email with all services or locations that utilize courier services.

SPECIAL HANDLING REQUIREMENTS

TRANSPORT. According to transportation guidelines, contractors must keep records of all the specimens, medications, RMD, medical/lab supplies transported in vehicles.

These records should include refrigerators, freezers, coolers, heating blocks, warm and cold packs, and dry ice. Personally owned vehicles for transporting specimens, medications, RMD, and other medical supplies must not be utilized.

The contractor is responsible for ensuring the safety and integrity of the equipment, medications, specimens, and laboratory supplies during transport. Labels must comply with relevant state, federal, and local laws such as DOT and Cal/OSHA. Clean and contaminated items should be separated to prevent cross-contamination during transport.

If VAPAHCS conducts an inquiry or survey, the contractor/vendor must provide a detailed description of the specimens (container types and quantities), medications, RMD, and transportation used.

https://www.ecfr.gov/current/title-41/subtitle-C/chapter-102/subchapter-C/part-102-74/subpart-C/subject-group-ECFR4fb2ebab81ea92f/section-102-74.440 https://www.ecfr.gov/current/title-41/subtitle-C/chapter-102/subchapter-C/part-102-74/subpart-C/subject-group-ECFR4fb2ebab81ea92f/section-102-74.440

Delivery vehicles should not be parked in patient parking lots. Contractors are to utilize delivery parking areas and access points. Wherever possible (PAD), contractors are to utilize cargo elevators instead of patient elevators.

HANDLING. During transportation, it is the contractor's responsibility to maintain the integrity of the specimens by preserving their temperatures and security seals in accordance with VAPAHCS' storage requirements at the time of pick up or as directed by VAPAHCS staff. If supplies need to be stored overnight in courier vehicles, the vehicles must remain secure and be kept away from extreme hot or cold environments to ensure the integrity of the supplies. VA items must never be stored overnight in courier vehicles without written consent from VAPAHCS.

These are the required storage temperatures:

Detail Ambient Refrigerated Frozen Lab Specimen 20-25°C/68-77°F 2-8°C/36-46°F <-15°C/<5°F Medication 20-25°C/68-77°F 2-8°C/36-46°F 58°C/ to +5°F

RMD 18- 22°C/ /66-72 °F N/A N/A

Temperature exceeding the acceptable range during delivery must be reported to the relevant service point of contact for proper documentation. The service will then assess the integrity of the specimen, RMD, medications, and other important items that is related to the care of our Nation’s Veterans. During the assessment, if any article is compromised and, / or the seals have been tampered with, the issue will be reported through logs by service (i.e., data sheet, general reports, delivery slips, JPSR, etc.).

Each service will have specific special handling requirements which will be detailed separately on this PWS.

LOSS OF SPECIMEN, MEDICATIONS, RMD AND OTHER SUPPLIES. In any case of loss of specimens, supplies, or government documents, by the contractor in connection to the transport or delivery, there shall be an inquiry regarding the event. If the contractor has been determined to be at fault, the contractor may be held responsible for any damages resulting from the loss, including but not limited to replacement of the lost item(s) or subsequent patient damages from loss of specimen(s) or patient medical records and subsequent HIPAA violations.

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated Information Security Officer (ISO) and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

The contractor must create a VA-specific contingency plan to ensure safe and timely transportation of specimens, medications, and supplies, including potential solutions to disruptions like hazardous spills, driver or vehicle shortages, and damaged containers.

SCHEDULES

Establishing and following fixed route delivery is crucial for ensuring timely pickup and delivery of items at specified times and locations. Laboratory specimens are extremely sensitive to time and temperature, which means that they must be taken directly to the VA facility without being redirected to other non-VA pickups in-between. This could potentially delay or compromise the specimens. It's important to strictly adhere to pickups and drop-offs just before laboratory closures to avoid delays and overtime pay.

In case of any extenuating circumstances resulting in delays, the pickups must occur before clinic closure; and the contractor is responsible to communicate via current applications that provide real-time tracking of their vehicles, and drivers and by calling the laboratory regarding the delay.

There are various hours of operations for each VAPAHCS’ divisions and CBOCs.

Attachment B, VAPAHCS Locations details the sites under this health care system.

The contractor will provide the following types of courier services during the term of the contract:

FIXED-ROUTE DELIVERY. This type of services is for the transport of items along a set route regularly. Packages are being delivered and picked up from multiple locations as dictated by route schedule.

Schedules are detailed on Attachment C, Pickup/Delivery Locations.

Contractor may provide suggestions on route planning recommendations and improvements for review, approval, trial, and implementation. The fixed route delivery location timings will be modified to ensure the PWS requirements are followed.

STAT-DELIVERY. This type of services will allow time sensitive medications, medical instruments, and specimens to be delivered as quickly as possible. Locations may include areas not defined under Place of Performance. Deliveries will be within 1-2 hours of scheduling this type of services through an application or phone call when application is not available due to maintenance or any reasons of downtime.

ON-DEMAND DELIVERY. This type of services will allow medications, medical instruments, and specimens to be delivered outside the fixed-route delivery schedules (e.g., after hours, weekends, federal holidays, etc.). Locations may include areas not defined under Place of Performance. Deliveries will be within 4-5 hours of scheduling this type of services through an application (or phone call when application is not available due to maintenance or any reasons of downtime).

VAPAHCS SERVICES

The contractor's primary responsibility will be to provide courier services to CLC, Path & Lab, Pharmacy Service, SPS, and OH. In addition to the fixed-route delivery schedules, courier services will also be for other VAPAHCS requests/programs.

Pathology and Laboratory Medicine Service will be the primary point of contact for any business-related issues concerning the contract. Direct communication will be established with their respective point of contact if there are any operational issues, such as late deliveries, compliance, or lost specimens with other specific services. The contractor is responsible to provide the services and provide contingencies in the event of their inability to fulfill the service.

Service: Community Living Center (Extended Care Service) Courier Service Types: MPD: Fixed, Stat & On-Demand Deliveries

LVD: On-Demand Delivery Articles: Laboratory Specimens, Health Documents, Packing Supplies Article Container(s): Coolers, boxes with Styrofoam

Schedule: See Attachment C, Pickup/Delivery Locations Brief Description: CLC is part of Extended Care and Palliative Medicine

Service. They provide long-term care services for chronic illnesses, disabilities, terminal illnesses, and aging-related health issues. They offer 24/7 nursing and medical care, pain management, palliative care, hospice care, etc.

The courier service will navigate through the MPD campus to pick up time sensitive specimens for testing.

POINT OF CONTACTS. The following contacts are actively working on the following divisions:

MPD

LVD

In the absence of a Nurse Manager (NM) or an Assistant Nurse Manager (ANM), it is advised to communicate with the charge nurse for any urgent matters, particularly after hours. If no available Nurse Manager (NM) or Assist Nurse Manager (ANM) on duty, courier must speak to the charge nurse especially after hours or any urgent issues that arise.

The following management contact for Extended Care Service are:

Joy Abbey, Acting Chief Nurse 650-614-9997, ext. 23659

Dr. Jon Fuller, Service Chief 650-493-5000, ext. 64463

SPECIAL HANDLING SPECIMEN REQUIREMENTS. The CLC team members will follow special handling requirements of each specimen noted on CPRS and, or guidance provided by Path & Lab. It is the contractor's responsibility to comply with the special handling requirements listed under Path & Lab. Driver/Dispatch should contact the designated CLC POC for any delays and issues.

Unit/ Location Name Position Contact Information Nurse Managers 331B Charlene Dumlao ANM 650-614-9997, ext. 27185

Emmanuel Gonong ANM Jessica Calderon ANM

360A 650-614-9997, ext. 27420

360B 650-614-9997, ext 23212

360D Sonia Levy-Dacus 650-614-9997, ext. 22323

360E 650-614-9997, ext. 23118

Danielle Seiple ANM 360F Kristina Garcia 650-614-9997, ext. 22500

Esther Yang ANM 360G Sarah Puso-Pastor ANM 650-614-9997-, ext. 23215

Jennifer Santos

Jonas Jacoba 360A & B

360D & E

360F & G

331D 650-614-9997, ext. 27193

ANMRichard Del Rosario

Jonathan Rabena ANM

Melissa Young ANM

Gay Marie Aquines ANM

Unit/ Location Name Position Contact Information Nurse Managers Caroline Montiel Cynthia Garcia

Maureen Mariano Nicole Bronte Sharmine Stewart925-373-4700, ext. 35430ANMCLC1

Service: Occupational Health Program (OHP) Courier Service Types: Fixed- Route

Articles: Specimen Article Container(s): Coolers, boxes with Styrofoam

Schedule: See Attachment C, Pickup/Delivery Locations Brief Description: OH, is an employee program that offers occupational health services to all employees, volunteers, and staff who work without compensation (WOC). These services include, but are not limited to, treatment of work-related injuries, tuberculosis surveillance, needlestick (sharp injury) management, respirator protection, immunizations, infection control, medical surveillance, and pre-employment physicals.

POINT OF CONTACTS. OH, in Mountain View is in an administrative building. The office is open Monday to Friday, from 0800H to 1200H and 1300H to 1600H.

Area Closure time Contact Contact Information Reception Area

1600H OH Team member on duty

650-694-6000, ext. 16001 (Reception) 650-694-6000, ext. 15167 (OH)

The following management contact for Occupational Health:

Brian Linde, MD, OH Service Chief brian.linde@va.gov

No secondary POC

SPECIAL HANDLING SPECIMEN REQUIREMENTS. The OH team members will follow special handling requirements of each specimen noted on CPRS and, or guidance provided by Path & Lab. It is the contractor's responsibility to comply with the special handling requirements listed under Pathology and Laboratory Medicine. Driver/Dispatch should contact the designated OH POC for any delays and issues.

Service: Pathology and Laboratory Medicine Service Courier Service Types: Fixed- Route, STAT and On-Demand Deliveries

Articles Specimen, Health Documents, Packing and Laboratory Supplies

Article Container(s): Coolers, Boxes with Styrofoam Schedule: See Attachment C, Pickup/Delivery Locations

Brief Description: Our Pathology and Laboratory Medicine Service processes, tests, coordinates, and reports blood, body fluid, and tissue samples from Palo Alto and surrounding clinics and hospitals. We perform over 100,000 blood draws and report results on almost 3 million samples each year with a focus on accuracy and timely delivery

The courier service will navigate through the VAPAHCS facilities to pick up time sensitive specimens for testing.

POINT OF CONTACTS. Laboratory hours vary by site and does not coincide with the division or CBOC hours of operations. The PAD Laboratory is the only laboratory facility open 24/7, serving as the primary hub for all sample testing. Contractors must adhere to laboratory closure and contingency times. Below is key information regarding laboratory locations:

The following management contact for Pathology and Laboratory Medicine Service:

Lana Hur, Laboratory Manager lana.hur@va.gov 650-493-5000, ext. 66722

Dominique Bertrand, LVD Lab Supervisor dominique.bertrand@va.gov 925-373-4700, ext. 35270 *Covering for SJC CBOC

Mitesh Patel, Monterey Medical Technologist mitesh.patel@va.gov 831-884-1149

SPECIAL HANDLING REQUIREMENTS. It is the contractor's responsibility to comply with SPS-specific requirements, which may include, but are not limited to:

1. Ensure that their vehicles are large enough to hold up to fifteen (15) containers, boxes, specimen coolers and they separated, upright, and secure throughout transport.

2. Label/tag and store laboratory containers accordingly. Specimens will be packed according to the temperature requirements - ambient, refrigerated, or frozen conditions.

The sending laboratory staff will prepare the specimens for transport and may occasionally use dry ice during packing.

3. Ensure cabins or storage areas for the specimen coolers/boxes kept between 20- 25°C/68-77°F throughout the entire transport length. Driver/Dispatch may call the laboratory POC for guidance if there are temperature excursion during transport.

Location Lab Area Closure Time Contact Contact Information After Closure Instructions Blood Draw Room

1500H Phlebotomist on duty 510-791-4028 Courier to contact lab

CBOC

Front Desk

1630H Medical Support Asssitant

510-791-4001 Courier to pick up at the CBOC Front Desk

CBOC

Lobby

1800H Security Courier needs to locate security guard by1800H to unlock door upon arrival.

LVD

Lab Processing Room 202

1630H Phlebotomist on duty 925-373-4700, ext.

35272/35268

Courier to contact lab if late, lab staff will stay until courier arrives, Secuirty/VA Police close the building at 2000H

MPD

Bldg. 334, Room D-

1330H Phlebotomist on duty 650-614-9997 ext.

22382

Courier to contact lab if late

1C564-

MON OPC

1600H Phlebotomist on duty 831-884-1000, ext.

41149

Courier to contact lab if late, lab staff will notiffy security

Room C-

1800H Security Courier needs to locate security guard by 6pm to unlock door upon arrival.

SJC

Room C-

1630H Phlebotomist on duty 408-363-3000, ext.

79218

Courier to contact lab if late, lab staff will notifify security, and courier will need to locate the security guard to unlock the lab by 1800H

FRC

MON

mailto:lana.hur@va.gov mailto:dominique.bertrand@va.gov mailto:mitesh.patel@va.gov

4. Ensure availability of transport containers appropriate for specimens under pre-arranged circumstances, STAT, or on-demand deliveries, for which the laboratory cannot provide coolers/ boxes.

5. Ensure specimen integrity during transport and arrival at the testing laboratory. The specimens must arrive at the testing laboratory in the same conditions they were sent (room temperature, refrigerated, or frozen); and the transport vehicles must maintain these conditions. Laboratory personnel will conduct the assessment upon arrival of the specimen. The laboratory personnel will report compromised specimens and compromised sealed tape via logs (i.e., data sheet, general reports, delivery slips, JPSR, etc.).

6. Compliant transportation of laboratory specimen and supplies per Department of Transportation and OSHA Codes of Federal Regulations (CFR) 29 and 49.

7. Acknowledgement of accreditation requirements. The laboratory manager will provide the initial requirements with the expectation that the contractor will disseminate and train VA-designated team members (drivers, administrative, etc.) annually. Any new accreditation requirement(s) will be provided to the contractor by the Laboratory Manager with the same expectation of annual training completion.

8. Driver/Dispatch should contact the designated Path & Lab POC for guidance on any special handling issues and communicate any delays.

Service: Pharmacy Service Courier Service Types: Fixed Route, STAT AND On Demand Deliveries

Articles Medications, Medication Supply items Article Container(s): Coolers, totes

Schedule: See Attachment C, Pickup/Delivery Locations Brief Description: Pharmacy Service is staffed by over 130 pharmacists, residents, students, and technicians. They provide patient care in both inpatient and ambulatory care settings and offer a Pharmacoeconomics Center.

Hours of operations vary on each VAPAHCS facility, except for PAD Pharmacy which operates 24/7.

The courier service will navigate through the VAPAHCS facility campus to pick up and deliver medications.

POINT OF CONTACTS. Pharmacy hours varies per site and does not coincide with the division or CBOC hours of operations. The PAD Pharmacy is the only facility open 24/7.

Contractors must adhere to pharmacy closure and contingency times. Below is key information regarding Pharmacy locations:

Location SPS/

CBOCs Area

Closure time

Contact After Closure Instructions

FRC Bldg.

B, Room

1630 Anna Kari Low annakari.low@va.gov

(510) 791-4023, ext.

84023

Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most instances medications will have to be returned to Palo Alto Diversion and delivered the next day.

LVD Bldg.

62, Room

1630 Steven Khong, Pharmacist Steven.khong@va.gov Huong Nguyen, Pharmacist Huong.Nguyen@va.gov

(925) 373-4700, ext.

35280 or

(925) 449-6408

Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most instances medications will have to be returned to Palo

MONT Room

1630 Mahin Azerang, Pharmacist Mahin.azerang@va.gov Carlin Haston, Pharmacist Carlin.haston@va.gov

(831) 884- 1000, ext.

42266

Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most instances medications will have to be returned to Palo

San Jose

Room

1630 Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most instances medications will have to be returned to Palo

Menlo Park

Bldg.

360, Room J101

1630 Menlo Park Pharmacy:

Kacy Tran, Pharmacy Manager Kacy.tran@va.gov

Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most mailto:annakari.low@va.gov mailto:Steven.khong@va.gov mailto:Huong.Nguyen@va.gov mailto:Mahin.azerang@va.gov mailto:Carlin.haston@va.gov mailto:Kacy.tran@va.gov instances medications will have to be returned to Palo

Capitola Suite 102, Room

1630 Laura Bencomo, RN, Nurse Manager laura.bencomo@va.gov

Courier to contact Pharmacy Management POC for further instructions by 1600 if delivery time is estimated to occur after 1630. In most instances medications will have to be returned to Palo

The following management contact for Pharmacy:

Lananh Dam, Pharmacy Procurement Program Manager lananh.dam@va.gov

(650) 493-5000, ext. 69655

Chad Colwell, Associate Chief of Outpatient Pharmacy chad.colwell@va.gov

(650) 849-0125

SPECIAL HANDLING REQUIREMENTS. It is the contractor's responsibility to comply with laboratory-specific and pharmacy requirements, which may include, but are not limited to:

1. Ensure transport container are secured and able to maintain temperature of 2- 8°C/36-46°F for cold chain product or 15-30°C / 59-86 °F for medications stored at room temperature. A temperature monitoring device must be utilized to at least document the minimum and maximum temperature readings during transport.

2. Ensure pharmaceutical integrity during transport and arrival at the pharmacy.

Pharmacy Service determines/ review all the medication that they have not exceeded manufacturer recommended limits for temperature (e.g., ambient temperature > 30 C).

Driver/Dispatch should call the Pharmacy POC for guidance. The pharmacy personnel will report compromised medications on through a log (i.e., data sheet, general reports, delivery slips, JPSR, etc.). Pharmacy administrative team will document list of medications, and vaccines, along the with the cost as per medical center’s standard operating procedure (SOP) and will be provided to the contractor.

3. Ensure cabins or storage areas for the pharmacy are clean and free of spills.

4. Ensure compliant transportation of pharmaceutical specimen and supplies per Department of Transportation, CDC Guidelines, and OSHA Codes of Federal Regulations (CFR) 29 and 49.

mailto:laura.bencomo@va.gov mailto:lananh.dam@va.gov mailto:chad.colwell@va.gov

5. Adhere to U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Vaccine Storage and Handling Toolkit

6. Driver/Dispatch should contact the designated Pharmacy POC for guidance on any special handling issues and communicate any delays.

Service: Sterile Processing Service (SPS) Courier Service Types: Fixed Route, and On Demand Deliveries

Articles Dirty and Soiled Reusable medical devices (RMD) Article Container(s): Totes

Schedule: See Attachment C, Delivery Locations Brief Description: SPS serves all clinical areas, from inpatient care units, operating rooms, and procedure rooms to outpatient surgical units, clinics, and ED. SPS ensures timely provision of properly cleaned, disinfected, and sterilized RMD. SPS recaptures reusable medical equipment (RME), reprocess, and repackage them before delivery.

SPS play a key role in providing quality healthcare services to veterans and is regulated through various VA Directives, Handbooks, and Policies.

The courier service will navigate through the VAPAHCS facility campus to pick up and deliver RMD.

POINT OF CONTACTS. SPS hours varies per site and sometimes does not coincide with the division or CBOC hours of operations. Contractors must adhere to SPS closure and contingency times. Below is key information regarding SPS locations:

Location SPS/

CBOCs Area

Closure time

Contact Contact Information

After Closure Instructions

LVD SPS

Room 613E, 6th floor

SPS

1530H

LVD

Bldg.

1730H

Medical Supply Tech, SPS

650-391- 925-373- 4700 ext.

35350

Courier to visit the Police Office at Bldg.

74 or at 925-373- 4700, ext. 35185 to open building.

Monterey Lab room # 160

1530H Lab Technician

831-884- 1000 ext.

41149

Courier to contact Lab before 1530H for afterhours pick-up or contact Security at 831-884-1165 for building access from1530H to 1800H.

There will be no access after 1800H.

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

San Jose Lab room #140

1600H Lab Technician

408-574- 9100 press 1 to enter extension, press 4 for San Jose clinic, enter Lab ext.

79218

Courier to contact Lab for afterhours pick-up or contact Security at 408-574- 9100 (follow the prompt), ext. 79266.

There will be no access after 2300H.

Menlo Park

Dental room #F103

1630H Dental Technician

650-493- 5000 ext.

22127

Courier to contact Dental Technician for afterhours pick-up and contact Security at 650-493-5000 ext.

65891. There will be no access after 1630H.

The following management contact for SPS:

Divina Abella, SPS Chief divina.abella@va.gov 650-493-5000, ext. 60678

Florence Yap, SPS Deputy Chief Florence.Yap@va.gov 650-493-5000 x 69997

SPS Hotline: 650-304-9000

SPECIAL HANDLING REQUIREMENTS. It is the contractor's responsibility to comply with RMD-specific requirements, which may include, but are not limited to:

1. Ensure that their vehicles can keep containers separated that contains dirty and sterilized RMDs, upright to avoid risk of damage and cross- contamination.

2. Ensure that RMD containers are labelled, tagged, and stored accordingly. RMD will be packed based on requirements (temperature, sterile versus non-sterile instruments, etc.). Contractor will pick up these containers on designated locations provided by SPS.

3. Ensure RMD’s integrity during transport and arrival. The instruments and containers of these instruments must arrive undamaged, and uncompromised. The SPS personnel will conduct the assessment upon arrival of these containers and instruments and will report compromised instrument or container on a log (i.e., data sheet, general reports, delivery slips, JPSR, etc.)..

4. Ensure compliance in transporting of RMDs per DOT regulations for Hazardous Materials Regulation 126 (HM126) and Hazardous Materials Regulation 181 (HM181).

These regulations are codified in Title 49, Parts 170 through 178 of the Code of Federal Regulations.

5. Follow the RMD special handling requirements when contaminated items are transported between buildings the controlled environment of a healthcare facility, certain precautions should be taken. These precautions include proper containment or packaging of the items, careful loading procedures, temperature control in transport vehicles, and consideration of temperature changes that could enhance microbial growth. Additionally, it is important to separate clean and contaminated items during transport to prevent any cross-contamination. These guidelines are outlined in detail on page 37-38, paragraph 6.5.6 of the American National Standards Institute /Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79: 2017 document.

6. Follow the RMD special handling requirements when clean and contaminated items are transported off-site. Clean and contaminated items must be separated during transportation to prevent cross-contamination. According to ANSI/AAMI ST79: 2017, page 37-38, para 6.5.7, vehicles used for transporting contaminated items between healthcare facilities must provide complete separation of contaminated items from clean and sterile items. They should be secured within the vehicle to prevent damage to contents and contamination by spills. The vehicles should allow for easy loading and unloading and should be decontaminated after use. They should always remain closed except during loading and unloading, be completely enclosed to prevent leaks, and be checked periodically to ensure that there are no leaks. It is important to note that transport vehicles that are loaded and ready for transport should not be left unattended in unsecured areas.

7. Acknowledgement and document management of accreditation requirements. The SPS point of contact will provide the initial VA-centric requirements with the expectation that the contractor will disseminate and train VA-designated team members (drivers, administrative, etc.) annually. Any new VA-centric accreditation requirement(s) or guideline(s) will be provided to the contractor by the SPS point of contact with the same expectation of annual training completion.

8. Driver/Dispatch should contact the designated SPS POC for guidance on any special handling issues and communicate any delays.

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

6. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures.

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