RSSAll Entries in the "Standards and Elements of Performance" Category

EPA announces final rule to set new standards on hazardous waste pharmaceuticals

By A.J. Plunkett

Get the word out to everyone in your organization who handles hazardous waste pharmaceuticals that soon, flushing or rinsing those drugs down a drain into the sewers will be specifically prohibited by the EPA.

That’s harder. On the easier end, you can tell your nurses that the packaging for a patient’s nicotine patch, gum, or lozenge might soon go straight into the regular trash—as long as it is FDA-approved as an over-the-counter nicotine replacement therapy and your state signs off on the exemption of the packaging as hazardous waste under the federal Resource Conservation and Recovery Act (RCRA).

Those are just some of the changes you can expect in handling hazardous waste pharmaceuticals at your facility or business now that the Environmental Protection Agency has finalized its long-awaited “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.”

The rule creates a new subpart P under RCRA that manages hazardous waste pharmaceuticals across a wide array of industries, including hospitals, physician offices, ambulatory care, and other providers who “distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals,” according to the EPA.

The rule has benefits

Under the provision, in general, the EPA says hospitals

  • will no longer have to count hazardous waste pharmaceuticals in calculating generator status (those drugs often sent facilities into large-quantity generator, or LQG, status);
  • can collect and manage hazardous waste pharmaceuticals from satellite facilities as long as they are under the same business umbrella;
  • can accumulate the drugs on site without a RCRA permit for up to 365 days, an increase of 275 days over current regulations;
  • but will have specific basic training requirements associated with those managing hazardous waste pharmaceuticals.

Experts in hazardous waste management in healthcare hailed the ruling as a breakthrough in finally putting a regulatory focus on the need to better control the amount of pharmaceuticals going into the environment while easing up on confusing and often unnecessary restrictions that cost both money and cause aggravation in the healthcare sector.

Another big plus for hospitals in the final rule is that drugs considered controlled substances are no longer considered hazardous waste, erasing concerns about competing regulations between the EPA and the Drug Enforcement Agency.

The rule’s provisions will become effective within six months of its publication in the Federal Register. While the rule has been signed and is expected to be published in the Federal Register before the end of December, there is still the question of when states with their own RCRA-authorized programs will adopt the new regulations.

Avoid Eyewash-Related Regulatory Compliance Issues

Eyewash stations continue to confuse and confound healthcare organizations (HCO). Not only can they pose infection control and safety issues for workers, they can be a point of contention between HCOs and surveyors, who often seem to work by different sets of rules.

During this 90-minute webinar on May 31, former hospital administrator and accreditation expert John R. Rosing, MHA, FACHE, will explain what regulators like CMS, The Joint Commission, and OSHA expect from an HCO’s eyewash stations. He will provide the steps personnel can take to keep staff safe and the organization in compliance with rules and regulations. Attendees will learn how to avoid eyewash-related regulatory compliance issues, how to perform a risk assessment to determine when an eyewash station is necessary, and what type of eyewash station they need.

At the conclusion of this program, participants will be able to:

  • Avoid eyewash-related regulatory compliance issues
  • Perform a risk assessment to determine when an eyewash station is needed
  • Identify what type of eyewash station is needed
  • Properly maintain eyewash stations

Presented on:
Thursday, May 31, 2018
1:00-2:30 p.m. ET

Presented by:
John R. Rosing, MHA, FACHE

Level of Program:


To register or get more information, please visit the event page at

Joint Commission plans to make new suicide prevention standards

This December, The Joint Commission (TJC) convened the fourth meeting of a suicide prevention expert panel. The accreditor announced in the March edition of Perspectives that the recommendations they came up with went beyond what’s in the standards. So they intend to convert some of them into new Elements of Performance in National Patient Safety Goal 15.01.01. When they are finished updating the NPSG, it will be sent out for national field review, just like it normally would.

The first and second panels were published in November and centered on inpatient psychiatric units, general acute inpatient settings, and emergency departments. The third panel discussed other behavioral healthcare settings and had its recommendations published in January.

Public comments open for NFPA active-shooter standards

Preparing to respond to an active-shooter event, whether that involves a surge of patients to your facility because of an incident off-campus or a hostile intruder inside your building, has become a major concern to most hospital officials.

For only the second time in its history, the National Fire Protection Association (NFPA) is fast-tracking development of a standard to help first responders, healthcare providers, facility managers and others to prepare for an active shooter incident, and they are looking for public input.

NFPA 3000, Standard for Preparedness and Response to Active Shooter and/or Hostile Events, could be ready as early as April, so public comments must be submitted by Feb. 23.

A draft copy is available online but you may be required to register with the NFPA first. To comment on draft of NFPA 3000 go to . And to read the NFPA 3000 fact sheet  go to

Workplace violence prevention resources

More than 70% of significant WPV injuries occur in healthcare and social service settings. That number has been on the rise, and the victims are primarily healthcare workers. Here are some other free resources and training on workplace violence prevention in your healthcare organization:

1.    The Center for Health Design’s Safety Risk Assessment Toolkit
2.    The CDC’s Workplace Violence Prevention for Nurses  
3.    OSHA’s Guidelines for Preventing Workplace Violence in Healthcare and Social Services    
4.    OSHA’s Preventing Workplace Violence: A Road Map for Healthcare Facilities
5.   The Emergency Nurses Association’s Workplace Violence Page
6.    ASIS International’s Managing Disruptive Behavior and Workplace Violence in Healthcare

Know the medical gas cylinder storage requirements

Editor’s note: This update was provided by Brad Keyes, CHSP, owner and senior consultant for Keyes Life Safety Compliance, LLC, and a consulting editor for Healthcare Life Safety Compliance.

 The following medical gas cylinder storage requirements are relative to the National Fire Protection Association (NFPA) Standards 99 Health Care Facilities (2005 edition) and are updated for 2017. In January 2007, CMS issued Survey and Certification memo 07-10, which clarified how oxygen cylinders should be stored, based on the 2005 edition of NFPA 99. The Joint Commission and the other accreditation organizations (AO) have adopted these clarifications and established clear requirements concerning medical gas cylinder storage. These AOs will assess your facility for compliance based on the following standards.

Medical gas cylinder storage

  • An aggregate total of compressed medical gases (e.g., oxygen, nitrogen, nitrous oxide) up to 300 cubic feet may be stored per smoke compartment in any room or alcove without special requirements for that room. Compressed gas cylinders must be secured in racks or by chains.
  • Quantities of compressed medical gases of more than 300 cubic feet but less than 3,000 cubic feet must be stored in specially designated rooms that meet the following requirements:
    • Rooms must be of noncombustible or limited-combustible construction (gypsum wallboard, tiled walls, etc.) with a door that can be secured from unauthorized entry (e.g., locked).
    • Oxygen may not be stored with other flammable gases or liquids.
    • Oxygen cylinders must maintain a minimum distance of 20 feet from combustibles (5 feet if room is sprinklered) or be placed within an enclosed cabinet having a fire rating of at least a half hour.
    • Cylinders must be secured in racks or by chains.
  • Quantities of compressed medical gases more than 3,000 cubic feet must be stored in specially designated rooms that meet the following requirements:
    • The room must have sufficient room to maneuver cylinders.
    • The room is able to be secured with lockable doors.
    • The room is constructed with noncombustible or limited-combustible construction, with a minimum fire rating of one hour (no allowances for fully sprinklered rooms). The entrance door to this room must also be fire rated for one hour, and not ¾ hour as allowed for other one-hour rated barriers.
    • The room is compliant with NFPA 70 National Electric Code, with electrical devices located at or above 5 feet from the finished floor.
    • The room is heated by indirect means, if heat is required. “Indirect” means gas-fired unit heaters and electric unit heaters are not permitted. Steam or hot water heating systems are permitted.
    • The room contains adequate racks constructed of noncombustible or limited-combustible materials and chains to secure all cylinders, full or empty.
    • The room contains a dedicated, continuously operating mechanical ventilation system that draws air from within 12 inches of the floor, with a means of make-up air provided.
    • In lieu of a mechanical ventilation system, and where natural ventilation is permitted, the room includes a natural ventilation system consisting of two louvered openings, each having a minimum free area of 72 square inches with one opening located 12 inches from the floor and the other located 12 inches from the ceiling. NOTE: Louvered natural ventilation openings are not permitted in an exit access corridor.


  • One E-size cylinder = 24.96 ft.³
  • Twelve E-size cylinders = 299.52 ft.³
  • Therefore, up to 12 E-size cylinders may be stored in any smoke compartment without special requirements for the room.
  • One H-size cylinder = 250 ft.³
  • Therefore, one H-size and two E-size cylinders may be stored in any smoke compartment without special requirements for the room.
  • Cylinders on gurneys, crash carts, wheelchairs, etc., are considered “in use” and not subject to the total count for “in storage.”
  • Cylinders in a rack are “in storage.”
  • Empty cylinders are not considered part of “in use” or “in storage.”
  • A cylinder is considered “full” provided it still has its seal from the supplier. Once the seal has been removed, the cylinder is no longer considered full.
  • TJC says that full and partially full cylinders are permitted to be stored together, unless the organization’s policy requires further segregation.
  • NFPA 99 requires empty cylinders to be stored separately from full cylinders. This means partially full cylinders must be stored with the empty cylinders or stored separately from full or empty cylinders.
  • NFPA 99 does not define the point where a cylinder is considered empty. All storage
    requirements are based on the total volume of gas in cylinders being stored. For the purpose of
    segregating empty and full cylinders, the facility should establish a level of where this delineation
    would be made. The Joint Commission issued a clarification on this issue, stating that for the
    purposes of segregating cylinders, once one has been opened it is then considered empty
    regardless of how much of the gas has been used. This is specifically for segregation purposes
    and does not prevent a facility from having a “partial” cylinder designation. For facilities not
    accredited by The Joint Commission, NFPA 99 is still silent on this and leaves it to the facility to
  • For the purpose of calculation of aggregate quantities of stored medical gas cylinders, empty cylinders must be considered as full cylinders since residual gas will remain in the cylinders.

Updated to reflect The Joint Commission’s stance on storing partials and full cylinders 

See the 2016 Joint Commission Standards FAQ here


Joint Commission revises Medication Management EPs

The Joint Commission has revised Medication Management elements of performance (EP) for several of its programs. The changes will go into effect on January 1, 2018 and will impact hospitals, ambulatory care, behavioral care, home care, nursing care centers, critical access hospitals, and office-based practices accredited by The Joint Commission. The revisions will require organizations to:

•    Record the date and time of any medication administered in the patient’s clinical record.
•    Implement a policy to provide emergency backup for essential medication dispensing equipment and for essential refrigeration for medications.
•    Have a written policy addressing the control of medications between when they are received by a provider and given to a patient. Those policies should now include what to do for the “wasting of medications.”
•    Implement a policy describing the types of medication overrides for automatic dispensing cabinets that will be reviewed for appropriateness and the frequency.

The revisions vary depending on the program.

CMS withdraws proposal to have AOs post survey reports online

A proposal by CMS to have accrediting organizations (AOs) post the details of survey reports online was withdrawn by the agency, not because of negative comments — although there were plenty — but because, well, it might be prohibited under federal law.

CMS first made the proposal in April, tucking it into the latter pages of the always-long proposed on changes to the Inpatient Prospective Payment System (IPPS) for the upcoming fiscal year.

The proposal was to have AOs post final survey reports online within 90 days that the same information is available to the hospital or other health care organization, including details of all initial and recertification surveys at that provider in the prior three years, as well as the accepted plans of correction (PoCs).

AOs now post only whether an organization is accredited or not, and do not make details of findings public.

CMS argued its proposal was to promote transparency in health care, and noted that it posts its own  survey reports online. But critics responded that the CMS reports are made available in a hard-to-read spreadsheet and that the federal agency was responsible for far fewer surveys at health care organizations that were often surveyed only after a complaint (IJC 5/1/17).

In public comments to CMS concerning the proposal, The Joint Commission said that requiring survey details be made public would have “chilling effect” on efforts to raise standards of quality. Dr. Mark R. Chassin, president and CEO of The Joint Commission, wrote: “There will be a race to the bottom on quality as health care organizations seek out oversight bodies that will report on the least number of standards comparable to the Medicare requirements. This may also lead to a growth in non-accredited facilities that will then be surveyed at taxpayer expense and with fewer oversight visits.”

Other groups similarly weighed in against the proposal, and offered alternatives. In the end though, it was shot down because it might potentially be prohibited.

In the IPPS final rule published Aug. 2, CMS noted that its proposal included revising the federal regulations overseeing Medicare to incorporate the requirement for AOs to post report details publically.

“Section 1865(b) of the Act prohibits CMS from disclosing survey reports or compelling the AOs to disclose their reports themselves. The suggestion by CMS to have the AOs post their survey reports may appear as if CMS was attempting to circumvent the provision of section 1865(b) of the Act. Therefore, this provision is effectively being withdrawn.” — A.J. Plunkett (


The clarification process: Is it worth it?

It can’t be emphasized enough that you should consider which issues have the potential for successful clarification as soon as you are aware of the findings. Start your research as soon as you suspect there is an issue. Don’t waste valuable time waiting for the final report to be posted to your extranet site.  Because clarification audits are very time-consuming and must be completed within 10 days of the survey, any extra time you can buy for the data review process is helpful. Focus on the key issues and problem areas, especially direct impact findings.

Important Note: If you feel you can successfully clarify a specific issue and you will need to go beyond the ten days allowed, consider asking your accounting representative for an extension. Organizations have stated that The Joint  Commission is open to an extension, so asking for one can work to your advantage.

Think about how you would respond to the actual requirements. This means noting surveyor scoring errors (yes, they do still occur). Avoid responding to a surveyor’s misunderstanding of a standard or his or her preference in how it “should” work in your organization. The Joint Commission has been very careful in standards development and interpretation to allow organizations the flexibility in implementing them. However, your process should parallel acceptable practices, such as those recommended by the U.S. Centers for Disease Control and Prevention (CDC) or specialty societies, for example. Many organizations and some consultants even preach “best practices” for all, but in reality, patient issues and resources may vary across the United States, and you need to find the process that works for you while being compliant.

Consider all sources of information from The Joint Commission, such as the actual EPs in the standards manual and  the officially published Perspectives and standards FAQs on the Internet.

Editor’s note: This blog post is an excerpt from The Joint Commission Survey Coordinator’s Handbook, Thirteenth Edition, by Jean S. Clark, RHIA, CSHA, and Jodi Eisenberg, MHA, CPHQ, CPMSM, CSHA