Healthcare Compliance Updates – November 2021

ACCREDITATION UPDATES

 

FGI to Release Updated Guidelines for 2022

Sometime in early 2022, the Facility Guideline Institute (FGI) will release the four-year update to the Guidelines for Design and Construction. Although the document is referred to as a “guideline,” it is considered a requirement for many state and accreditation organizations for the design and construction of healthcare facilities. There are three distinct Guidelines publications for Hospitals, Outpatient Facilities, and Residential Health, Care, and Support Facilities.

Additionally, the Joint Commission (TJC) requires the use of the Guidelineswhen planning for new, altered, or renovated space, the hospital uses one of the following design criteria: Guidelines for Design and Construction of Hospitals, 2018 edition in the 2021 Environment of Care standards (EC.02.06.05 EP1).

Examples of the anticipated 2022 changes for hospitals include the following:

  • Guidelines for “free-standing” emergency facilities are now found in the Outpatient Facilities section.
  • Flexible, secure treatment rooms, capable of serving as either a secure holding room or a single-patient treatment room, are now allowed in the emergency department for hospitals and outpatient facilities.
  • Infection control risk assessment (ICRA) is conducted for airborne infection isolation (AII) rooms to determine whether an anteroom is necessary, including number and placement of anterooms rooms (Note: currently, anterooms are not required)
  • Design guidance included for space for storage of supplies, donning and doffing personal protective equipment (PPE), and disposal of PPE based on infection prevention considerations.
  • Size of interior rooms, used for human decontamination, has increased from 80 to 100 square feet for an emergency facility in both the Hospital and Outpatient Facilities requirements.
  • Video surveillance and a “duress” alarm system at public entrances are required where emergency department entrances may be locked. (Note: based on the event involving a 34-year-old Massachusetts woman who suffered an asthma attack and died outside of an emergency department because she couldn’t find an unlocked entrance).
  • Newborn intensive care unit (NICU) room sizes have increased for multiple-infant rooms from 120 to 150 square feet per patient and for single-infant rooms from 155 to 180 square feet, to accommodate family members.
  • Non-recirculated, fixture branch piping in hospitals reduced from a maximum of 25 to 10 feet to minimize the risk of waterborne pathogens.

The 2022 Guidelines identifies the fact that healthcare facilities are constantly adding and updating spaces with “new” technologies which don’t always align perfectly with the “scope and goals” in the Guidelines. Therefore, hospital designers are “permitted and encouraged” to identify and include elements from other facility chapters without needing to apply the entire chapter for types not addressed in common element chapters 2.2 through 2.8.

 

Updates to ASHRAE 170 – 2017 in ADDENDUM “P” 2020

Addendum “P” to ASHRAE 170-2017 provides some significant changes to Table 7.1, which itself had a significant name change to Design Parameters – Inpatient Spaces  from Design Parameters – Hospital Spaces.” The changes were approved by ASHRAE Standard Committee and the ASHRAE Board of Directors on February 5, 2020; by the American Society for Healthcare Engineering (ASHE) on December 19, 2019; and by the American National Standards Institute (ANSI) finally, on March 2, 2020.

The FOREWORD to the Addendum identifies changes that should simplify the application of ASHRAE -170 to the design of healthcare facilities. The significant changes include updates to Table 7.1 as follows:

  • The column, Unoccupied Turndown, was created indicating that ventilation systems serving unoccupied spaces could be adjusted and “turned downed” for energy savings when not in use.
  • Filter information previously in Table 6.4, Minimum Filter Efficiencies, was incorporated into Table 7.1 to remove confusion in applying filter requirements uniformly.
  • Space “names” are aligned with names appearing in FGI 2014 Guidelines, along with the notation of the appropriate sections where that space design is referenced.

Numerous spaces were relocated within the tab, with no changes to their previous requirements to allow alignment with spaces in the FGI Guidelines. The new section and examples of the spaces include:

  • Nursing Units and Other Patient Care Areas – surgery, critical care, patient rooms, AII rooms, other inpatient nursing, etc.
  • Diagnostic and Treatment – imaging spaces, medication rooms, dialysis, etc.
  • Patient Support Facilities – laboratories, food preparation areas, pharmacy, etc.
  • General Support Facilities – sterile processing (clean assembly/workroom), soiled workroom/decontamination, sterile storage room (clean/sterile medical/ surgical supplies)
  • Other General Support Facilities – autopsy room, clean linen storage, laundry processing room, hazardous material storage, toilet, linen and refuse chute room, regulated waste holding, etc.
  • Support Areas for Nursing Units and Other Patient Care Areas – clean supply room, clean workroom, soiled work and holding.

Additionally, there were significant additions to the Normative Notes for Table 7.1, beginning on page 9 of the Addendum. The additions include the following:

  • (u)Unoccupied Turndown – turndown of minimum air changes for the AII anteroom shall be based around the use of the associated AII room(s).
  • (ab)Minimum Filter Efficiencies – minimum filter efficiencies required for the space described in Section 6.4 indicated by: (Filter Bank No. 1 / Filter Bank No. 2)
  • (ac) Filter Bank No. 2 HEPA Filters Alternative – MERV-14 rated filters may be used in Filter Bank No. 2 if a tertiary terminal HEPA filter is provided for this space.
  • (ad)Space-name Parenthetic Notations – references added from the 2014 FGI Guidelines for design requirements, i.e. Laundry, processing room (2.1–5.2.2 [2])
  • (ae)Unoccupied Turndown, Time-Delay Controls – ventilation systems serving the spaces cannot be turned down for the first 20 minutes after the space becomes unoccupied. (Informative Note: The 20 minute delay approximates the time required for 90% reduction in airborne contamination at 6 air changes per hour, assuming perfect mixing.)

There was also an update to Informative Appendix A, Operations and Maintenance Procedures, which serves as an informative guidance, but not requirements concerning Unoccupied Turndown:

 (A1.5) Unoccupied Turndown – relative humidity (RH) of 60% is not exceeded in the space when turndown is implemented.

The new alignment of ASHRAE 170 to the FGI Guidelines will allow an organization to design new and renovated spaces for optimal ventilation efficiency and increased energy savings.

 

STANDARD REQUIREMENT UPDATES

 

FDA Medical Devices Labeling Guidance for MR Environment (EC.02.01.01)

In an effort to minimize the risks to patients from the adverse effects of a “Magnetic Resonance (MR) Environment” caused by medical devices, the Food and Drug Administration (FDA) has issued guidance on May 20, 2021, “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment.” The guidance provides recommendations to medical device manufacturers regarding the testing of medical devices to determine the safety and compatibility in the MR environment.

Based on the safety information, the proper “safety” labeling can be attached to the medical device. The guidance for MR labeling of devices is consistent with ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The Joint Commission (TJC) also requires an organization to “manage MR safety risk associated with patients with medical implants, devices, or imbedded metallic foreign objects, such as shrapnel” (EC.02.01.01 EP14).

This guidance document applies to all medical devices which might be used in the MR environment. This includes:

  • Implanted medical devices
  • Medical devices fastened to or carried by a patient (i.e., external insulin pump, pulse oximeter, etc.)
  • Medical devices which would reasonably be anticipated to enter the MR environment during clinical care
  • Medical devices which are intended to enter the MR environment

The main risk to patients comes from the interaction of the magnet field with the medical device. The device should be tested for the following hazards:

  • Magnetically Induced Displacement Force – may cause tissue damage by inducing unwanted movement, or dislodging the medical device or tipping over large equipment (i.e., patient monitors, injectors) when subjected to magnetically induced forces or torques.
  • Magnetically Induced Torque – can produce a torque on magnetic materials, causing tissue damage by inducing unwanted movement or dislodgement of the medical device.
  • Heating – can induce heating of the tissue adjacent to the medical device and/or heating of the medical device itself.

Based on the safety testing data, a medical device should be labeled according to the potential hazard as follows.

  • MR Safe – medical devices composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic, which can be taken into any MR environment and should be labeled as:

  • MR Unsafe – non-implanted medical devices which should remain outside the MRI scanner room with the label appearing directly on the device, if possible, and should be labeled as:

  • MR Conditional – device can safely enter the MR environment under certain conditions, which may include a patient with an implant or a medical device fastened to or carried by the patient, with the conditions printed on the label and the symbol:

The FDA states this guidance “does not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract, but clarity to the public regarding existing requirements under the law”. Public comment is accepted at any time. Review of the labeling is included in most inspecting, testing, and maintenance activities for medical equipment (EC.02.04.03).

 

Electing the CMS Low Humidity Categorical Waiver (EC.02.05.01)

Current ventilation design guidelines for the relative humidity (RH) in operating rooms and other areas using anesthetizing incorporates a range of 20-60% (ASHRAE 170 2017). However, the Center for Medicare and Medicaid Services (CMS) requires a Categorical Waiver for these locations if the RH is less than 35% (CMS- Ref: S&C: 13-25-LSC & ASC, 4/2013). Should the organization elect to implement this waiver, the Joint Commission (TJC) states that the organization demonstrate that medical supplies “must be compatible with the humidity reduction” to 20% (EC.02.05.01. EP15).

In order to implement the Waiver, an assessment should be conducted to determine the impact of low humidity on medical supplies used in operating rooms and other anesthetizing locations. Since this requirement resides in the Utility Systems Management standards of the Environment of Care, conducting the assessment may become the responsibility of the Facilities Director rather than of the Procurement Department.

Based on the medical supply assessment and selected precautions, election of the CMS Categorical Waiver can be evaluated and taken when appropriate. A similar assessment must be conducted for medical equipment for the Waiver. If taken, the Waiver should be listed on the organization’s TJC Basic Building Information (BBI) for Life Safety (EC.02.05.01 EP15 Note 1).

For further assistance in conducting the assessment for electing this Categorical Waiver, please sign in to your COHAN Membership Dashboard account or reach out to Info@cohan.co to learn about our membership services!

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