MCP 11HTM-01.pdf

ELECTRONIC TEMPERATURE AND HUMIDITY MONITORING

MCP 11HTM-01

VA Central Ohio Healthcare System Columbus, Ohio 43219

Signatory Authority:

VA Central Ohio Healthcare System Director

Responsible Owner:

Healthcare Technology Management Service

Rescinded Document:

MCP 11HTM-01, Electronic

Temperature and Humidity Monitoring, April 1, 2022.

Effective Date:

May 25, 2023

Recertification Date:

May 25, 2028

1. POLICY

This medical center policy (MCP 11HTM-01) establishes the processes for an electronic monitoring system to continuously measure the temperature and/or humidity of equipment and controlled environments containing pharmaceuticals, biologicals, reagents, patient nourishments, sterile supplies, or reusable medical devices/equipment. When temperatures/humidity falls out of the designated range for a critical period, the electronic monitoring system generates an alarm accessible via an electronic database and sends notifications to designated accountable staff/responsible service designees when applicable.

2. JUSTIFICATION

a. This policy establishes standards and requirements in addition to VHA Directive 1116 (2), Sterile Processing Services (SPS), dated March 23, 2016.

b. This policy establishes standards and requirements in addition to VHA Directive 1108.07, General Pharmacy Service Requirements, dated November 28, 2022 and VHA Notice 2022-17, Storage of vaccines and medications in pharmaceutical grade purpose-built refrigerators and freezers at a VA Medical Facility, dated December 15, 2022.

c. This policy establishes standards and requirements in addition to VHA Directive 1761, Supply Chain Inventory Management, dated December 30, 2020.

d. This policy exists to meet the requirements of The Joint Commission Standards

EC.02.05.01; EC.02.05.09; EM.02.02.09; TS.03.01.01; TS.03.02.01.

3. RESPONSIBILITIES

a. VA Medical Facility Director. The VA medical facility Director is responsible for:

May 25, 2023 MCP 11HTM-01

(1) Ensuring overall VA medical facility compliance with this policy, and appropriate corrective action is taken if non-compliance is identified.

b. Each Responsible Service. Each Responsible Service is responsible for:

(1) Compliance with this policy within their respective service lines. Service level standard operating procedures are not required but recommended if additional processes or procedures are necessary above and beyond the requirements outlined within this policy. Service level standard operating procedures may not replace or reduce the minimum requirements outlined within this policy.

(2) Assigning a primary accountable individual as well as multiple designees who will be responsible for reviewing, addressing, documenting, and clearing alarms as well as receiving notifications if applicable. All services shall log in to the electronic monitoring database daily during normal business hours to ensure the safety and efficacy of supplies, equipment, and/or pharmaceuticals.

(3) Maintaining a current file of equipment and locations being monitored with description, location, associated asset (i.e., MX) numbers, wireless sensor numbers, temperature and humidity parameters, responsible designees to view and address/clear alarms, individuals to receive alarm notifications, type of notifications to be sent, and the primary accountable individual. This file will be located on the Public Drive: Monitoring Temp and Humidity. The service will notify Healthcare Technology Management via email to VHACOS TEMP AND HUMIDITY MONITORING REQUEST whenever this file needs updated to ensure a system administrator is aware and updates the information in the electronic temperature and humidity monitoring system.

(4) Determining the maximum and minimum temperature/humidity parameters and time tolerance to trigger an alarm and/or notification that assures patient safety and quality control of the stored items. Subject Matter Expert and Service Chief verification for parameter changes or original parameter configurations is required. VHA directives, manufacturer, and/or authority having jurisdiction shall be used as resources to determine appropriate parameters and system configurations. The service will provide Healthcare Technology Management with these parameters prior to original configuration of sensors or when any changes are required via New Sensor Request Form (Appendix A) or Change Request Form (Appendix B) emailed to VHACOS TEMP

AND HUMIDITY MONITORING REQUEST.

(5) Contacting appropriate service lines in the event that corrective actions require repairs to equipment or adjustment to environmental controls, the responsible service designees will contact the appropriate responsible service line (i.e., Healthcare Technology Management (HTM) or Engineering) following established service request submission policies and procedures. When this repair work requires extended down time that would compromise the efficacy or safety of monitored perishables, services are required to relocate perishables to an appropriate location until the work has been completed.

(a) For temperature and/or humidity sensor, Electronic Temperature and Humidity Monitoring System, or medical equipment repairs or concerns, please contact HTM Service at phone extension 7123 or submit an electronic service request. Emergency requests must be submitted by calling extension 7123 during normal business hours 8:00 am to 4:30 pm (Monday – Friday) or by calling the Police Service at extension 5555 during non-business hours.

(b) For room temperature and/or humidity adjustments, please contact Engineering Service at phone extension 4000 or submit an electronic service request. Emergency requests must be submitted by calling extension 4000 during normal business hours 8:00 am to 4:30 pm (Monday – Friday) or by calling the Police Service at extension 5555 during non-business hours.

(6) Documenting the service request or work order number as part of the corrective action as appropriate.

(7) Updating the assigned primary accountable individual or emergency contacts as needed by sending updated information to the VHACOS TEMP AND HUMIDITY MONITORING REQUEST email group. HTM or alternative designated staff will then update the primary accountable individual or emergency contact list which will be located on the Public Drive: Monitoring Temp and Humidity. Police Service will utilize the emergency contact list to contact appropriate staff outside of normal operating hours as defined by individual services. During normal operational hours, the individual services are responsible for responding to and clearing alarms.

(8) Identifying which sensors and alarms under their responsibilities warrant being added to the Police Service’s notification list of sensors to be monitored outside of normal business hours (4:30PM – 8:00AM, Monday – Friday and 24 Hours per day on weekends and holidays). Any variations to this schedule will be communicated to Police Service and HTM in writing and identified on the emergency contact list.

(9) Continuously monitoring temperature and humidity in designated areas and records retained (hard copy or electronic) for 12 calendar months.

c. Healthcare Technology Management Service (HTM). HTM is responsible for:

(1) Maintaining the temperature and humidity monitoring system software and electronic components capable of providing 24-hour, 7 day per week monitoring and logging of temperature data.

(2) Ensuring that the temperature monitoring system is fully inspected, calibrated, and tested upon installation, after any system change or failures, and at least annually thereafter. Certificates of calibration should be readily available for accreditation or regulatory reviews and verifying the system is continuously collecting data.

(3) Ensuring that the alarm and response procedures are tested upon installation, after any system changes or failures, and at least semi-annually thereafter.

(4) Ensuring the temperature monitoring system contains the following features:

(a) A detachable probe that best reflects vaccine temperatures

(b) Alarm for out-of-range temperatures

(c) Low-battery indicator if applicable

(d) Current, minimum, and maximum temperatures

(e) Recommended accuracy of ±0.5 degrees Celsius

(f) Capable of sending a cascade alert if the monitoring system fails or goes off-line.

(g) Logging interval that can be programmed to be no less frequently than 30 minutes and whenever there is an excursion.

(5) Ensuring that all medication refrigerators and freezers are connected to emergency power supplied by the facility. For CBOC locations, the following must be followed:

(a) Provide a power monitoring system to alert staff that the VA has experienced a power loss.

(b) A cascade alarm system that is tested upon installation, after any system changes or failures, and at least semi-annually thereafter.

(c) Test power and temperature monitoring systems quarterly, including any battery back-up systems.

(d) A response process is defined and must occur before the pharmaceutical grade refrigerator or freezer experiences a temperature excursion. This response must be based on a documented risk analysis and must be tested annually. The risk analysis must include the actual conditions the plan is anticipated to be activated under.

(e) Staff must transport the refrigerated or frozen inventory to an alternative storage facility location that is compliant with these requirements, and the transport container must also be equipped with a temperature monitoring system. For pharmacy inventory, this should be done with pharmacy personnel to ensure appropriate security of medications during transport.

(6) Ensuring refrigerators and freezers used to store medications and vaccines are included in the facility’s routine maintenance and inspection program and in accordance with manufacturer recommendations. The following routine maintenance tasks are required for all units on a regular basis as determined by a risk analysis:

(a) Check door seals to ensure they are not torn or brittle and there are no gaps between the seals and the body of the unit.

(b) Ensure door hinges are aligned so that the door opens and closes smoothly and fits securely against the body of the unit.

(c) Clean unit coils and motor.

(d) Defrost manual-defrost freezers when the frost exceeds 1 centimeter or the manufacturer’s suggested limit.

(7) Treating equipment failures or concerns under the responsibility of HTM as priorities depending on the nature of the issue and updating service requesters on the status of repairs.

(8) Documenting repairs in the electronic work order system.

(9) Installing new sensors as well as updating configurations and alarm/notification parameters as requested by responsible services.

(10) Providing monthly status updates via report to the Environment of Care Committee and Service Chiefs regarding individual responsible service level compliance with this policy.

(11) Providing regular reminders via email to service chiefs and accountable individuals to provide updates per section 3.b of this MCP.

d. Engineering Service. Engineering Service is responsible for:

(1) Maintaining environmental controls and systems.

(2) Ensuring that pharmaceutical grade refrigerators and freezers are placed in well ventilated rooms with space between the units and walls and ceilings and must be away from direct sunlight.

(3) Treating controlled environment concerns and equipment failures or concerns under the responsibility of Engineering as priorities depending on the nature of the issue and updating service requesters on the status of repairs.

(4) Documenting repairs in the electronic work order system.

e. Police Service. Police Service is responsible for:

(1) Monitoring Temperature and Humidity alarms during designated off hours, weekends, and holidays as instructed by responsible departments and assigned to Police Service’s monitoring group in the electronic temperature and humidity monitoring system.

(2) Notifying respective service emergency designees during off hours as instructed by each responsible service. Off hours are generally defined as (4:30PM – 8:00AM, Monday – Friday and 24 Hours per day on weekends and holidays). Staff will continue notifying affected staff until contact is made via a warm handoff to ensure appropriate notification.

(3) Ensuring Police Service staff receive appropriate training on the use of the electronic temperature and humidity monitoring system so that alarms can be received and responded to appropriately during off hours. Training will also include guidance on where to find the facility list of emergency designees and their contact information.

(4) Notifying HTM, OIT, and all responsible services in the event the electronic temperature and humidity monitoring system loses functionality and or it becomes known that a facility loses power during off hours.

f. Veterans Canteen Service. Veterans Canteen Service is responsible for:

(1) Canteen Service designee monitors all refrigerators and freezers in the cafeteria, store, and vending operations electronically ensuring that all nourishments have been verified to be within appropriate temperature ranges at all times prior to sale or distribution.

(2) Police Service will contact Canteen Service emergency designee during off hours as instructed. Canteen Service reviews alarms each morning to take and document additional corrective actions.

g. Pharmacy Service. Pharmacy Service is responsible for:

(1) Ensuring medications and vaccines are stored only in pharmaceutical grade refrigerators and not in dormitory-style, bar-style, or combined refrigerator or freezer units.

(2) Ensuring that all medication and vaccine refrigerators and freezers are equipped with a temperature monitoring system and that a cascade alarm process is implemented and tested.

(3) Ensuring that newly installed or repaired refrigerators or freezers are monitored for two days to ensure temperatures remain in goal range prior to storing medication or vaccines in the unit.

(4) Ensuring that the buffered probe or DDL is placed in the center of the unit with the vaccines and medications, or as placed in the unit or recommended by the manufacturer.

(5) Ensuring that food and beverages are not stored with medications or vaccines.

(6) Ensuring the insides of refrigerators and freezers are cleaned at least annually or more frequently when necessary due to visible soil or dust accumulation.

(7) Ensuring that any loss of medication or vaccine is reported through an established issue brief process with patient impact and the cost of lost inventory.

(8) Chalmers P. Wylie Ambulatory Care Center (ACC)

(a) Pharmacy Service designee(s) monitor all medicine storage areas and refrigerators within the pharmacies at Chalmers P. Wylie ACC. Temperature and humidity monitoring of medication rooms and refrigerators outside of pharmacy will be monitored by clinical staff but remain accessible to Pharmacy in the electronic system.

Pharmacy Service personnel are assigned to monitor Outpatient and Satellite Pharmacy areas and medication refrigerators.

(b) Pharmacy Service investigates the medication refrigerator alarm and checks the equipment for power, door closure and other simple corrective actions. When the refrigerator cannot be returned to normal operation, Pharmacy will place the alarm into “Inhibited” status and notify HTM Service to respond and assess equipment or Engineering Service to address environmental controls. HTM or Engineering will consult with Pharmacy Service for guidance in the event of out-of-range temperature excursions to determine the appropriate corrective action.

(c) In the event a refrigerator or freezer loses power, Pharmacy Service will quarantine product immediately, move inventory to an alternate storage location, and refer to the manufacturer (direct communication or package insert) for excursion data.

Pharmacy will review temperature data, duration of excursion, and medication and vaccine-specific manufacturer guidance to determine viability of the affected inventory.

Product deemed inappropriate for continued use will be discarded as recommended by manufacturer. If no manufacturing data can be found for the affected inventory, caution will be used, and product will be discarded.

(d) Police Service will contact Pharmacy Service emergency designees during off hours as instructed. Pharmacy Service reviews alarms each morning to take and document additional corrective actions.

(9) Clinic Medication Storage Areas (Including Community Based Outpatient Clinics (CBOCs) and other Clinical Facilities)

(a) Clinical staff will monitor medicine storage rooms and equipment outside of pharmacy, during normal business hours, 8:00 am – 4:30 pm, Monday - Friday. Clinical staff must contact pharmacy for assistance in reviewing excursions. Personnel are assigned based on the location of the medication storage equipment.

(b) Police Service will contact Pharmacy Service for all medication room or refrigerator alarms during off hours as instructed.

(c) Police Service will contact CBOC emergency designee during off hours as instructed.

(d) Pharmacy Service and Clinical/CBOC designee reviews alarms each morning to take and document additional corrective actions.

h. Pathology & Laboratory Medicine Service (PALMS). PALMS is responsible for:

(1) PALMS designee monitors all temperature-controlled equipment, refrigerators, freezers, and room temperatures used for specimen and reagent storage in the laboratories at the Chalmers P. Wylie ACC during normal business hours.

(2) Police Service will contact PALMS emergency designee during off hours as instructed.

(3) PALMS designee reviews alarms daily before patient testing begins and all corrective actions are documented.

(4) The emergency storage of supplies in an alternate location should the temperature in the primary location become unsuitable or unstable.

i. Specialty Medicine and Urgent Care Center. Specialty Medicine Services and Urgent Care Center are responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) Any system user who witnesses malfunctioning controlled-temperature equipment or who is alerted to malfunctioning equipment will take corrective actions as defined in this policy.

(3) Police Service will contact Specialty Medicine and Urgent Care Center emergency designee during off hours as instructed. Specialty Medicine and Urgent Care Center designees review alarms daily to take and document additional corrective actions.

j. Surgical Services. Surgical Services is responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) The Operating Room nursing designee monitors temperature and humidity in the surgical suites during administrative hours. If room temperatures/humidity remains out-of-range for longer than two hours and the cause of the alarm cannot be corrected staff will place a work order with Engineering.

(3) During non-administrative hours, on weekends, and federal holidays Police Service will monitor all surgical suite equipment the service designates as critical.

Temperature/humidity problems can be corrected in most instances through the automated HVAC control System. In the event the alarm cannot be corrected remotely Police Service will notify the surgical service contact on the established call list in case of an alarm.

(4) If 2 unsuccessful attempts are made to the surgical service contact, the Police Service will notify the nursing supervisor to contact the surgical on-call team to relocate biological tissue or critical supplies.

k. Dental Service. Dental Service is responsible for:

(1) Temperature and humidity are monitored by designee during normal administrative hours, 7:30 am to 4:00 pm, Monday - Friday.

(2) Police Service monitors temperature and humidity of this area during non-administrative hours, on weekends, and federal holidays. If the temperature were to fall out of range, Police Service will notify the Dental Service contact on the established call list to determine appropriate response.

l. Primary Care Service. Primary Care Service is responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) Any system user who witnesses malfunctioning controlled-temperature equipment or who is alerted to malfunctioning equipment will take corrective actions as defined in this policy.

(3) Police Service will contact Primary Care emergency designee during off hours as instructed. Primary Care designee reviews alarms each morning to take and document additional corrective actions.

m. Supply Chain Management (SCM). SCM is responsible for:

(1) SCM Distribution Section monitors temperature and humidity in Primary and Secondary Inventory locations.

(2) SCM will place a work order with Engineering Service during administrative hours if room temperatures/humidity remains out-of-range. Police Service monitors designated critical areas during non-administrative hours.

(3) During non-administrative hours, on weekends, and federal holidays Police Service will monitor all designated critical Primary and Secondary Inventory locations. In the event the alarm cannot be corrected remotely Police Service will notify the SCM on call designee on the established call list in case of alarm that cannot be resolved remotely.

(4) The designee will be responsible for sterile items that are required to be checked for compromise and take appropriate action, including temporary re-location of sterile items, may be done to ensure sterility while problem is addressed.

(5) Storage locations where humidity exceeds the acceptable range of 60 percent, items must be relocated to a temperature and humidity-controlled environment until humidity control can be re-established.

(6) Items should be considered for removal if communication from Engineering corrective actions for the humidity cannot be immediately addressed.

(7) Ensuring that pharmaceutical grade refrigerators and freezers are placed on the VA medical facility equipment replacement plan prior to the unit’s expected end of life cycle.

n. Eye Care Service. Eye Care Service is responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) Any system user who witnesses malfunctioning controlled-temperature equipment or who is alerted to malfunctioning equipment will take corrective actions as defined in this policy.

(3) Police Service will contact Eye Care emergency designee during off hours as instructed. Eye Care designee reviews alarms each morning to take and document additional corrective actions.

o. Community Based Outpatient Clinics (CBOC’s). CBOC’s are responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) Primary Care Coordinator and designee(s) at each CBOC monitor medicine, specimen, and patient food refrigerators and temperature-controlled environments.

(3) Designating staff to perform weekly operator testing of refrigerator/freezer power monitoring systems in accordance with operator testing procedure provided by HTM Service.

(4) Primary Care designee(s) check equipment and take corrective action in response to an alarm as appropriate. When equipment cannot be returned to normal operation, designee(s) relocate contents to another unit and notify the Primary Care Coordinator to take further corrective action.

(5) After normal business hours, assigned personnel investigate the medication storage alarms remotely. If action needs to be taken, designated personnel will be notified to visit the appropriate clinic and provide a temporary solution until normal business hours resume.

(6) Police Service will monitor Viewpoint Alarms and Power Monitor Alarms outside of CBOC normal operation hours. If Police Service receives an alarm they shall contact CBOC emergency designees during off hours. CBOC emergency designee will determine appropriate response actions depending on the situation and notify other individuals as necessary. CBOC designees review alarms daily (excluding weekends and holidays) to take and document additional corrective actions.

p. Behavioral Health. Behavioral Health is responsible for:

(1) Monitoring every refrigerator, freezer, and designated areas that store medications and reusable medical equipment or supplies within the service. These items will be monitored electronically 24 hours a day, 7 days per week.

(2) Any system user who witnesses malfunctioning controlled-temperature equipment or who is alerted to malfunctioning equipment will take corrective actions as defined in this policy.

(3) Police Service will contact Behavioral Health emergency designee during off hours as instructed. Behavioral Health designee reviews alarms each morning to take and document additional corrective actions.

q. Sterile Processing Service (SPS). SPS is responsible for:

(1) SPS monitors temperature and humidity in all areas where RMD is stored and equipment within SPS areas.

(2) During non-administrative hours, on weekends, and federal holidays Police Service will monitor critical areas designated by SPS. In the event the alarm cannot be corrected remotely Police Service will notify the SPS on call designee on the established call list in case of alarm that cannot be resolved remotely.

(3) The designee will be responsible for ensuring safe usage of RMD when temperatures and humidity are compromised. If needed, temporarily relocate RMD or take appropriate actions while problem is addressed.

(4) A monitoring system capable of documenting continuous humidity and temperatures is required in all SPS areas.

4. ACTIONS

a. Notification of Alarm. Each Service has determined a method of receiving an alarm that is most appropriate for its operation. Methods for receiving notice of an alarm include email, text, and audible alarms.

b. Corrective Action. The Services document appropriate corrective actions in the electronic system database for each alarm. Common corrective actions include:

(1) Close open doors.

(2) Check power connection.

(3) Check and adjust temperature controls.

(4) Check internal thermometers and external readouts to determine if they agree with the wireless sensor reading. (There may be false alarms.)

(5) Check location of sensor. Relocate sensor away from door toward middle of refrigerator and assure that there is airflow around the sensor.

(6) Change battery in sensor.

(7) Prepare a work order for HTM or Engineering to adjust or repair equipment.

(8) Take refrigerators/freezers out of service when temperature problem cannot be resolved within two hours. Install an “Out of Order” sign until problem is resolved.

(9) Place sensor on inhibited status within the electronic monitoring system.

(10) Replace defective equipment.

c. System Failure/Contingency Plan. In the event of a system failure that persists for longer than twelve hours, or less depending on the items being monitored and consultation with the appropriate subject matter experts, User Group designees will be instructed to return to hands on monitoring until the system operation is restored.

d. Records. The wireless system maintains electronic records of temperature/humidity history and corrective actions taken following each alarm. When corrective actions require HTM or Engineering repair, these can be tracked by the service request or work order number in the electronic work order system.

e. Sensors and Sensor Maintenance.

(1) Process to obtain and install a new sensor:

(a) Installation of any temperature or humidity monitoring sensor must be approved by the Service that will be responsible for monitoring the sensor.

(b) When a new sensor is needed a request will be submitted via email to VHACOS TEMP AND HUMIDITY MONITORING REQUEST and be accompanied by a fully completed New Sensor Request Form (Appendix A) filled out by the requesting service.

(c) HTM will obtain and install the sensor following review of the New Sensor Request Form and verification of requesting service chief’s and subject matter experts’ approval.

(2) Process to move sensors to new location or change parameters.

(a) If a temperature/humidity sensor requires relocation or change to parameters, a request will be submitted via email to VHACOS TEMP AND HUMIDITY MONITORING REQUEST and be accompanied by a fully completed Change Request Form (Appendix B) filled out by the requesting service.

(b) When HTM Service receives a request to move a sensor, they are to immediately stop the historical record of the sensor to be moved in the software. It is prohibited to move a sensor from one location to another or from one piece of equipment to another without stopping the historical record in the software. After the historical record has been stopped in the software the sensor than can be renamed in the software and used in a new location or in a new piece of equipment which will begin the process of creating a new historical record.

(c) HTM will relocate and/or change the parameters of the sensor following review of the Change Request Form and verification of requesting service chief’s and subject matter experts’ approval.

(3) Process to discontinue sensors.

(a) If a sensor is to be discontinued, a request will be submitted via email to VHACOS TEMP AND HUMIDITY MONITORING REQUEST accompanied by the appropriate service chief’s approval.

(b) Once the sensor is removed by HTM the sensor’s historical record will be stopped. If the sensor is reutilized in the future, the sensor will be renamed.

5. RECORDS MANAGEMENT

a. All records regardless of format (paper, electronic, electronic systems) created in this policy shall be managed per the National Archives and Records Administration (NARA) approved records schedules found in VHA Records Control Schedule 10-1. If you have any questions regarding any aspect of records management, you should contact your facility Records Officer or your Department Records Liaison.

6. DEFINITIONS

a. None.

7. REFERENCES

a. VHA Directive 1116(2), Sterile Processing Services (SPS), dated March 23, 2016.

Sterile Processing Services

b. Deputy Under Secretary for Health for Operations and Management (10N), Interim Guidance for Heating, Ventilation and Air Conditioning (HVAC) Requirements Related to Reusable Medical Equipment (RME) Reprocessing and Storage, dated September 5, 2017. Interim Guidance for HVAC Requirements

c. VHA Directive 1108.07, General Pharmacy Service Requirements, dated November 28, 2022.

d. VHA Notice 2022-17, Storage of vaccines and medications in pharmaceutical grade purpose-built refrigerators and freezers at a VA Medical Facility, dated December 15, 2022,

e. VHA Directive 1761, Supply Chain Management Operations, dated December 30, 2020. Supply Chain Inventory Management

f. The Joint Commission Standards EC.02.05.01; EC.02.05.09; EM.02.02.09;

TS.03.01.01; TS.03.02.01, dated July 1, 2023. E-dition Joint Commission

g. 2017 Food Code, U.S. Department of Health and Human Services, Public Health Service, FDA. 2017 Food Code

8. RESCISSION

MCP 11HTM-01, Electronic Temperature and Humidity Monitoring, April 1, 2022, is rescinded.

9. REVIEW

This policy requires a recertification when there are changes to national directives or mandate from an authority of jurisdiction.

10. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of May 2028– 5 years from effective date. This MCP will continue to serve as local policy until it is recertified or rescinded. In the event of contradiction with national policy, the national policy supersedes and controls.

11. SIGNATORY AUTHORITY

Marc Cooperman, MD VA Central Ohio Healthcare System Director Date Approved: May 25, 2023

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: MCPs are available at: Clinic Policies – Active Library – All Documents (sharepoint.com)

A-1

APPENDIX A

New Sensor Request Form

B-1

APPENDIX B

Change Request Form

April 1, 2022 MCP 11HTM-01 Appendix B

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