The first step in streamlining an ASC’s Medicare survey for Life Safety Code® (LSC) compliance is to understand where requirements come from, and that is the CMS "State Operations Manual, Appendix L – Guidance for Surveyors: Ambulatory Surgical Centers." The State Operations Manual (SOM) document is updated periodically, so organizations should check the CMS web site for the most recent version on a regular basis. The current version, as of this writing is "(Rev. 99, 01-31-14)."
The SOM includes a few important spatial requirements for an ASC physical environment, including:
• The ASC is a distinct and separate entity, both in terms of legal entity and physical separation from any other use. That physical separation means all areas that make up the ASC (including waiting and reception) must be separated from any other use or entity by a 1-hour fire rated wall. CMS does permit a “temporal separation” where non-clinical areas (like waiting and reception) may be used by something else when the ASC is closed.
• A patient toilet must be accessible from the Pre-op and Recovery area(s) without passing through any public areas. This requirement is to assure patient privacy during periods of “personal hygiene.” The implication though is a separate toilet is available to the public that can be reached without entering ASC clinical areas, such as might be provided outside the ASC in shared public toilets.
• O.R. temperature, humidity, and “flow”(air moves out of the O.R. toward adjacent areas) must be maintained according to an accepted industry standard. Organizations must identify what standard they are applying, and document their compliance. The AORN standards are probably the most often referenced, and allow the broadest humidity range (20% to 60% relative humidity).
• Procedure rooms are considered by CMS as requiring the same “protection” as Operating rooms, including the maintenance of temperature, humidity, and air flow as well as National Fire Protection Association (NFPA) requirements for electrical and medical gas systems.
• Limitations on Alcohol-based Hand Rub (ABHR) dispenser locations and stored refill fluid quantities are also established in line with NFPA standards were not yet included in the edition formally adopted by CMS (see immediately below).
In terms of the physical environment, the most significant CMS requirement explained in the SOM is that ASCs comply with the 2000 edition of NFPA 101®, the Life Safety Code®. ASCs first applying for Medicare Certification on or before March 11, 2003 are considered “existing” in terms of NFPA requirements, and the rest are “new.” One consequence of the CMS definition of existing Vs. new, is that an organization that choses to get an new agreement for and older ASC (with a new owner, for instance) must assure that facility complies with the 2000 edition’s standards for new ASCs regardless of the year built and/or prior approvals.
NFPA 101 is the document that guides requirements based on the use or occupancy of the given building or space. The 101 document itself deals directly with requirements for construction, fire protection, exiting, fire alarms, etc., a subject group generically described as “life safety requirements.” NFPA 101 also establishes the cross reference paths to specific editions of all other NFPA standards that apply to the given occupancy. For ASCs, the most frequently referenced other standards include:
• NFPA 70 -- the National Electrical Code®
• NFPA 99 – for medical gas and emergency power requirements
• NFPA 110 – for emergency generator set requirements, if applicable
• NFPA 111-- for battery-based emergency power source requirements
• NFPA 13 -- fire sprinkler system installation requirements
• NFPA 25 –maintenance requirements for fire sprinkler systems
• NFPA 72 – fire/smoke alarm system installation and maintenance requirements
While most organizations trust and believe their facilities were built in compliance with all applicable requirements that may not be the case. Even prior approval by State authorities, or prior surveys, is no guarantee. The official CMS position is that anything discovered out of compliance must be corrected even if previously overlooked, which is to say “prior approvals made in error are null upon discovery.” Experience has shown, unfortunately, that many architects, engineers, and code officials do not have a truly comprehensive knowledge of CMS and NFPA requirements for ASCs.
To avoid unpleasant surprises during a qualified (expert) survey, the organization should proactively do whatever it can to verify their facility fully complies, which I refer to as “achieving baseline compliance.” The AAAHC Medicare Deemed Status Handbook includes, as an appendix, a resource for organizations to use in assessing their baseline compliance, called the Physical Environment Checklist (PEC). The PEC does not include specific detail of requirements, but identifies the visually obvious manifestation of code compliance. If such issues have been overlooked, it is likely other more detailed problems exist as well.
Once baseline compliance is achieved, there remains the long-overlooked requirement for organizations to monitor continued compliance with NFPA requirements though specific periodic inspection, testing, and maintenance (ITM) activities. These “operational” requirements are often the most frequent source of LSC survey citations, usually because organizations are not adequately aware of the specific requirements for them. There are two main groups of operational requirements that must be in place prior to any LSC survey. The first group relates to the initial approval of “engineered systems,” and includes documentation by installers and/or third party certifiers of:
• The fire alarm system (NFPA 72)
• The sprinkler system, if provided (NFPA 13 & 25)
• The piped medical gas system, if provided (NFPA 99)
• The alternate source of hard-wired emergency power, if provided, be it a generator set or battery system (NFPA 110 or 111)
These engineered systems also tend to have the greatest requirement for ongoing ITM activities, usually involving agreements with specialized companies to come on-site to perform the work. Often however, those services rely on quarterly or annual site visits which ignore higher frequency requirements – especially for fire alarm and sprinkler systems. The best approach to staying up with all the ITM requirements is probably to work with the specialized companies to assure full compliance with the code-based requirements – they after all are far more likely to have the actual codes and understand what each test or inspection involves. Many if not most of the higher frequency inspections are not too complicated, and may be performed by ASC staff . . . with the side benefit they become much better aware of the overall system, and able to monitor the progress of specialized companies in covering the more complicated tasks.
In addition to the engineered systems, there are dozens and dozens of otherNFPA-required features and/or clinical equipment subject to ITM activities. Portable fire extinguishers require monthly inspection, and annual testing or maintenance. Electrical receptacles in patient care areas also require periodic testing, especially if they are not hospital grade. The list is long, but the AAAHC’s PEC provides a lot of direction in terms of specific requirements for ITM. Beyond that it is best to understand that anything important to code compliance or patient safety that can wear out, or otherwise degrade with time, must be inspected, tested, and/or maintained to assure they remain reliable -- from fire-rated door closers and latches, to light bulbs in exit signs, to electrical patient care appliances, and on.
William E. Lindeman, AIA, President / WEL Designs PLC
Physical Environment Consultant to the AAAHC