How long do we need to keep hyperbaric oxygen therapy chamber  logs/records/annual preventative maintenance records?

As healthcare continues the process of transitioning to paperless documentation, provision(s) should be made for the storage of chamber maintenance logs, records and preventative maintenance records. The following is a discussion that was presented in the Undersea Hyperbaric Medicine Journal 2017, Vol. 44. Number 1.[1]

Q: How long do we need to keep maintenance logs/records/annual preventative maintenance records?

A: This is not a one-size-fits-all question. We suggest that you work with your Authority Having Jurisdiction (AHJ), your facility administration, and your quality, risk and clinical engineering departments to make this determination.

• There are specific regulations in force regarding record retention in code (see examples below). The National Fire Protection Association’s glossary of terms defines the AHJ as: “An organization, office, or individual responsible for enforcing the requirements of a code, or for approving equipment, materials, an installation, or a procedure.
• Note: There is more than one AHJ that have interest in the records kept. AHJs would include: NFPA, ASME (PVHO-1 and PVHO-2), UHMS, FDA, TJC, OSHA, CMS, state-specific departments of health, local fire authority, interest-specific insurance carriers/under- writers, and institution-imposed standards.
• It must also be understood that many standards have the force of law only if recognized by a governmental agency with authority in your area. The others are enforceable only if agreed to by the institution – for example, insurance carrier/underwriter rules.
• There are valid legal reasons for not maintaining records past seven years. The Joint Commission has typically asked for preventive maintenance history and service history for three successive years. Other regulatory agencies may go back further in time: for example, if it is a pediatric/neonatal/L&D/maternity area, ideally 21 years. Some facilities we are aware of never really purge the database, and records are kept indefinitely.

Q: Which resources can be used when questions regarding regulatory requirements on record retention arise? 

A: As a general rule when questions regarding regulatory requirements arise the NFPA and ASME PVHO-2 are the first resources to be reviewed. 

• NFPA-25, 2011 ed. 4.3 Records 4.3.4 - As-built system installation drawings, hydraulic calculations, original acceptance test records, and device manufacturer’s data sheets shall be retained for the life of the system.
• NFPA-25 2011 ed. 4.3.5 - Subsequent records shall be retained for a period of one year after the next inspection, test, or maintenance of that type required by the standard
• ASME PVHO-2-2003, 4.5 QUALITY ASSURANCE (c) - Retain all maintenance inspection forms and all window repair forms, as applicable, throughout each window’s service life.
• ASME PVHO-2-2003 7.1.2 - Written records of the results of maintenance inspections shall be retained throughout the service life of each window.
• ASME PVHO-2-2003 7.5 - All records including the original PVHO-1 documentation package, the maintenance inspection reports and all repair-related forms set forth in this Standard (plus any additional documentation that the cognizant jurisdictional authority may require) shall be retained by the user for the duration of the window’s service life, plus one year.
• ASME PVHO-2 2003 7.5 provides minimum guidance for establishing your Chamber Maintenance Records Retention policy: “All records including the original PVHO-1 documentation package, the maintenance inspection reports and all repair-related forms set forth in this Standard (plus any additional documentation that the cognizant jurisdictional authority may require) shall be retained by the user for the duration of the window’s service life, plus one year”.  Interpretation of the codes, regulations and guidelines will ultimately be the responsibility of the institution or organization that is accountable to the AHJs.[1]

What if AHJs have different record retention requirements? 

Determining the hierarchy of AHJ that must be considered while establishing the chamber maintenance records retention policy can be difficult. Consideration must be given to the fact that the hyperbaric chamber was used to provide to patient care. As a result, retention of records that confirm the chamber was properly maintained and operational should be consistent with state requirements for medical record retention. The length of time states require records to be retained varies. Some states require as few as three years to as long as ten years. State laws generally govern how long medical records are to be retained. However, the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (HIPAA) administrative simplification rules require a covered entity, such as a physician billing Medicare, to retain required documentation for six years from the date of its creation or the date when it last was in effect, whichever is later. HIPAA requirements preempt State laws if they require shorter periods. Your State may require a longer retention period. The HIPAA requirements are available at 45 CFR 164.316(b)(2).[2]

References:

1. UHMS. MEDFAQS - maintenance records and no-go lists UHM Journal. 2017;volume 44(1):.
2. Centers for Medicare and Medicaid Services. MLN Matters® Number: SE1022 Medical Record Retention and Media Formats for Medical Records MLN Matters. 2012;.