Smith Seckman Reid - CMS Issues Some Physical Environment 1135 Blanket Waivers for ITM Deviations as well as Some Other New Life Safety Code Deviations

Archive for the ‘Compliance News’ Category

CMS Issues Some Physical Environment 1135 Blanket Waivers for ITM Deviations as well as Some Other New Life Safety Code Deviations

May 11th, 2020

CMS issued some new physical environment blanket waivers on April 29, 2020 permitting certain CMS-mandated inspection, testing, and maintenance (ITM) activities to be adjusted during the federal emergency declaration. The previous broadly-distributed April 29th version included the ITM blanket waivers on page 23, but additional changes since then included some other CMS physical environment blanket […]

Remember your CMS 1135 Waivers for Inspection, Testing, and Maintenance Deviations

April 9th, 2020

The Centers for Medicare and Medicaid Services (CMS) has a link to the mandatory 1135 Waivers posted on their website for the Emergency Preparedness Rule (originally called the Emergency Preparedness Final Rule or EPFR). The  1135 Waivers link above provides the full 1135 Waivers requirements.  However, the purpose of this article is not to discuss the […]

CMS Issues COVID-19 Related Changes to Survey Activities

March 9th, 2020

The Centers for Medicare & Medicaid Services (CMS) issued Quality Safety & Oversight (OSQ) Memorandum QSO-20-12-All, Suspension of Survey Activities, on March 4, 2020.  In the QSO Memorandum background message, CMS stated that “Specifically, CMS is suspending non-emergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety […]

Health Technology Changes Affect Power Systems

January 7th, 2020

A recent Health Facilities Management Magazine article entitled Powering up to meet today’s health technology demands discusses in detail the impacts of burgeoning health care technology on health care facility power systems. The consistently increasing technology changes are likely to ramp up even more throughout all health care facilities, not just in hospitals.  Clinical areas […]

USP Delays Chapters USP <795>, USP <797>, and USP <825>

October 3rd, 2019

The United States Pharmacopeia (USP) announced recently that it is postponing the official dates of pending revisions to the following three standards until further notice as a result of pending appeals to provisions on these standards: Revisions to: USP <795> Pharmaceutical Compounding – Nonsterile Preparations USP <797> Pharmaceutical Compounding – Sterile Preparations New chapter: USP […]

Compliance News: CMS Updates EPFR State Operations Manual

February 12th, 2019

CMS issued a February 1, 2019 update (Ref: QSO19-06-ALL) to the State Operations Manual (SOM) Appendix Z emergency preparedness interpretive guidance to clarify CMS requirements pertaining to alternate source power and emergency standby systems. The clarifications (in red) are easy to find within the 56-page document. In its Memorandum Summary, CMS stated “We are updating […]

Compliance News: CMS Emergency Preparedness Final Rule (EPFR) Impacts Generator Loading and Operation

January 9th, 2019

The discussion below is an update to our more comprehensive previous analysis entitled CMS Emergency Preparedness Final Rule Could Require More Equipment on Generators.  The Emergency and Standby Power Systems portion of the CMS Emergency Preparedness Final Rule (CMS EPFR) discussed “specific compliance with NFPA 99, NFPA 101 and NFPA 110 for generator design, location, […]

Compliance News: ECRI Publishes List of Top Health Technology Hazards for 2019

October 8th, 2018

ECRI Institute (ECRI) recently published its 2019 Top 10 list of health technology hazards. Healthcare organizations could consider this latest update of this list as one of many potential sources for identifying new safety risks or guiding due reconsideration of previously-identified safety risks. ECRI determines the content of the annual list, by considering adverse incidents, […]

Compliance News: CMS Requirements for AEM Inclusion Risk Assessments

July 26th, 2018

CMS changed the rules for both inventories and equipment inspection, testing and maintenance (ITM) requirements in December 2013.  The CMS changes require that, where law and regulations do not stipulate ITM, manufacturer ITM recommendations must be followed unless the organization has a compliant AEM Program and uses a risk-based process to determine how and when […]

Compliance News: TJC Releases Newly Updated LS & EC Document List and Review Tool

May 22nd, 2018

TJC recently released its newly updated Life Safety & Environment of Care Document List and Review Tool, marked REVISED: 4/30/2018.  The individual pages of the list are each marked with a 3/13/2018 revision date, which correlates to the TJC speaker’s 3/27/2018 PDC Conference general session reference to those revisions. This is the list of documents […]

Compliance News: TJC Releases Newly Updated LS & EC Document List and Review Tool

May 9th, 2018

TJC recently released its newly updated Life Safety & Environment of Care Document List and Review Tool, marked REVISED: 4/30/2018.  The individual pages of the list are each marked with a 3/13/2018 revision date, which correlates to the TJC speaker’s 3/27/2018 PDC Conference general session reference to those revisions. This is the list of documents […]

Compliance News: Survey Challenges

March 15th, 2018

Surveyors often seem to find the violations you did not see before they arrived at your facility.  Why is that?  It may be because they have never seen your facility before, so they see everything with what professionals in the field call “fresh eyes.”  A major contributing factor is also the important fact that surveyors […]

Compliance News: TJC 2018 Survey Activity Guide Changes

February 12th, 2018

TJC recently updated its Survey Activity Guide (SAG) for 2018.  Contained within that updated SAG is an updated Life Safety and Environment of Care Document List and Review Tool, found on SAG pages 101-108. It appears that the new LS/EC Document List and Review Tool included some of the January 2018 changes to TJC’s elements […]

Compliance News: Revisiting Utility Failure Procedures

January 8th, 2018

Most hospitals have utility failure procedures for major utility systems or equipment.  However, existing utility failure procedures may have room for improvement, particularly in how they deal with common-mode failure potential within their utility systems and equipment.  Reliability professionals generally consider that multiple failures, including failures in otherwise redundant equipment, attributable to a common cause […]

Compliance News: TJC publishes final January 2018 EC Chapter EP revisions

December 12th, 2017

TJC recently finalized the January 1, 2018 changes within its online Hospital Accreditation Standards Environment of Care (EC) and Life Safety (LS) chapters.  With a few exceptions, those changes were driven by the CMS September 2016 publication of the NFPA 101-2012 and NFPA 99-2012 K-Tags according to previous TJC announcements. This article discusses the major […]

Compliance News: TJC publishes new 2018 EC Chapter EPs

October 23rd, 2017

TJC recently published the January 1, 2018 changes to its online Hospital Accreditation Standards Environment of Care (EC) and Life Safety (LS) chapters. With a few exceptions, those changes were driven by the CMS September 2016 publication of the NFPA 101-2012 and NFPA 99-2012 K-Tags according to previous TJC announcements. This article discusses only the […]

Compliance News: CMS Emergency Preparedness Final Rule Could Require More Equipment on Generators

September 8th, 2017

The CMS Emergency Preparedness Final Rule (CMS EPFR) took effect on November 16, 2016, and compliance is expected by CMS starting November 16, 2017. Per the handout for CMS’ April 27, 2017 webinar, the new CMS-required all hazards approach “is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are […]

Compliance News: CMS Strengthens Regulations against Legionella in Healthcare Facilities

June 26th, 2017

The fight against Legionella bacteria within healthcare facilities has been a topic of healthcare industry discussions and concern for more than a decade. CMS substantially raised the bar in June 2017 when it issued a revised Survey & Certification Letter [S&C 17-30-Hospitals/CAHs/NHs REVISED 06.09.2017] PDF entitled “Requirement to Reduce Legionella Risk in Healthcare Facility Water […]

Compliance News: TJC publishes July 1, 2017 changes to EC and LS Chapters

May 24th, 2017

TJC recently published the July 1, 2017 changes to its online Hospital Accreditation Standards Environment of Care (EC) and Life Safety (LS) chapters. Published changes include some clarifications and corrections to previously-issued changes, such as EC.02.05.01 Element of Performance 6 (EP-6) regarding inspection, testing and maintenance (ITM) for non-high-risk utility system components.  This change modified […]

Compliance News: Operating Room Fire Loss Prevention and Emergency Procedures

April 12th, 2017

One important change in NFPA 99-2012 was the addition of Chapter 15, Features of Fire Protection.  Within that chapter is a new Section 15.13, entitled Fire Loss Prevention in Operating Rooms. Subsection 15.13.1, Hazard Assessment, requires an evaluation of FIRE hazards that could be encountered during surgical procedures, including “hazards associated with the properties of […]

Compliance News: More Pending Changes due to CMS 2012 Codes K-Tags

March 16th, 2017

During his late afternoon March 14th session at the just-completed 2017 ASHE PDC Conference in Orlando, TJC speaker George Mills (Director of TJC’s Department of Engineering) announced upcoming additions and changes that will supplement the newly-released January 7th Elements of Performance (EPs) and the already-pending July 1st EP changes.  Mr. Mills stated that the required […]

Compliance News: CMS 2012 Codes K-Tags Available

February 14th, 2017

CMS has published the long-awaited K-Tags that reflect the adoption of the 2012 codes (NFPA 101-2012® Life Safety Code® and NFPA 99-2012 Health Care Facilities Code).  Note that both of these codes also invoke many other NFPA codes and standards that can be between 10- and 15 years newer than the previously-enforced editions. K-Tags are […]

Compliance News: Importance of Alternate Equipment Management/Maintenance (AEM) Risk Assessments

January 11th, 2017

Many hospitals are still struggling with the AEM inclusion risk assessments required by both the CMS Survey & Certification Letter and Accrediting Organization (AO) requirements.  This newsletter revisits and updates a previous discussion of AEM risk assessment requirements. TJC-accredited hospitals, for example, now face an even more important reason for having an effective AEM-inclusion risk […]

Compliance News: Revisiting the Three-Year Four-Hour EPSS Load Test Requirements from NFPA 110-2010

December 13th, 2016

Now that CMS has adopted the 2012 Life Safety Code™ and 2012 Health Care Facilities Code, CMS is surveying for compliance with NFPA 110-2010.  NFPA 110-2010 has very specific requirements for the 3-year 4-hour EPSS load test, and many hospitals may not be complying with those requirements. From NFPA 101-2012® Life Safety Code® [referencing NFPA […]

Compliance News: TJC Releases 2012 Codes Changes with Some Surprises

November 8th, 2016

TJC released its long-awaited changes to its Life Safety (LS) and Environment of Care (EC) chapters Elements of Performance (EPs) on October 31, 2016.  These documents are entitled “Prepublication Standards – Standards Revisions Related to Life Safety Code Update” and cover six TJC accreditation programs.  The 49-page Hospital Prepublication Standards can be downloaded from that […]

Compliance News: Compliance with the 2012 Codes

October 13th, 2016

SSR’s May 2016 Compliance News article entitled CMS Adopts the 2012 Codes provided breaking news along with numerous hyperlinks to assist organizations in assessing the impact of CMS’ adoption of the 2012 codes. SSR’s June 2016 Compliance News article entitled CMS to survey 2012 codes starting November 1, 2016 passed along a few clarifications issued […]

Compliance News: Building Rehabilitation Chapter 43 – 2012 Life Safety Code® Required Reading

September 12th, 2016

One of the significant changes resulting from CMS’ adoption of the 2012 Life Safety Code® is the impact of the NFPA 101-2012 Building Rehabilitation Chapter 43.  Chapter 43 is intended to apply to work that the owner or occupant has elected to perform within an existing building. In its final rule adopting the NFPA 101-2012 […]

Compliance News: ASHE Addresses Historically Problematic Compliance Issues

August 15th, 2016

The November 2015 Compliance News issue discussed the joint work that both ASHE and TJC had performed to that point in providing assistance on major physical environment compliance problem areas.  Last month’s Compliance News issue discussed TJC’s contributions to that initiative through July 2016.  This article reviews ASHE’s ongoing contributions to their joint program through […]

Compliance News: TJC Provides more Assistance with Problematic Compliance Issues

July 12th, 2016

The November 2015 Compliance News issue discussed the joint work that both ASHE and TJC had performed in providing assistance on major physical environment compliance problem areas. The TJC Physical Environment Portal (TJC PE Portal) is still available at TJC’s website under the main TOPICS heading.  Interested parties can sign up at that location to […]

Compliance News: CMS to Survey 2012 Codes Starting November 1, 2016

June 14th, 2016

SSR’s May 2016 Compliance News article entitled CMS Adopts the 2012 Codes  provided breaking news along with numerous hyperlinks to assist organizations in assessing the impact of CMS’ adoption of the 2012 codes. In its June 20, 2016 Survey & Certification Letter S&C 16-29-LSC, CMS advised that CMS will begin surveying to the 2012 Life […]

Compliance News: CMS Adopts the 2012 Codes

May 9th, 2016

Changes take effect July 5, 2016. CMS has adopted the 2012 codes (NFPA 101®-2012 Life Safety Code® and most of NFPA 99-2012 Health Care Facilities Code.)  However, the full consideration of this change also requires taking into account the impact of changes in the referenced documents that will now be 10 to 15 years newer.  […]

Compliance News: New EPA Impact on Demand Response

April 11th, 2016

Changes to EPA regulations will soon prohibit or severely restrict participation in “emergency demand response” programs for owners of standby generators.  The change will take effect on May 1, 2016.  A number of hospitals with significant investment in standby generation participate in these programs, generating substantial revenue.  Most will soon see their participation curtailed.  Demand […]

Compliance News: Best Practices for Reliable Power Systems

March 15th, 2016

The March 2016 issue of Health Facilities Management Magazine discusses “Best practices for hospital power system reliability.”  The following highlights some of the topics contained within that detailed article, and we recommend that Compliance News readers review and share the hyperlinked HFM Magazine article within their organizations. Best practices can be undertaken throughout the life […]

Compliance News: Emergency Generator Starting Batteries

February 8th, 2016

There continue to be questions regarding the use of maintenance-free generator starting batteries since they seem to be the preferred starting battery type of most generator set manufacturers.  This article discusses the original prohibition and when it was removed from NFPA 110. Within the NFPA 110-1999 edition presently enforced by CMS and its accrediting organizations, […]

Compliance News: Compliance Challenges in 2016

January 11th, 2016

2016 brings a host of ongoing compliance challenges along with a few new ones.  The ongoing challenges often revolve managing and mitigating the myriad risks within our facilities: general safety hazards, utility risks, fire safety risks, and life safety risks.  Of concern is the accelerating pace of changes combined with increasing complexity of the impact […]

Compliance News: ECRI Publishes List of Top Health Technology Hazards for 2016

December 8th, 2015

ECRI recently published its 2016 Top 10 Health Technology Hazards list.  Healthcare organizations could consider the latest update of this list as one of many potential sources for identifying new safety risks or ensuring due consideration of previously-identified safety risks. Element of Performance # 1 under TJC’s Standard EC.02.01.01 requires identifying safety and security risks […]

Compliance News: ASHE and TJC Provide Joint Assistance with Problematic Compliance Issues

November 10th, 2015

Since ASHE and TJC announced their joint effort to address the most problematic physical environment issues at the July 2015 ASHE Annual Conference in Boston, both organizations have been making good on that promise. The TJC Physical Environment Portal (TJC PE Portal) is available at TJC’s website under the main TOPICS heading.  Interested parties can […]

Compliance News: Ongoing Challenges with HVAC Systems Addressed

October 13th, 2015

ASHE and five other professional organizations issued an important Joint Interim Guidance statement in late September addressing the ongoing challenges with HVAC systems serving operating rooms and sterile processing departments.  The Joint Interim Guidance document was dated September 21, 2015 and issued shortly thereafter as a PDF file by the signatory organizations. The six signatory organizations […]

Compliance News: What About the Other Standards?

September 8th, 2015

The healthcare facilities community is expecting CMS adoption of NFPA 101-2012 (Life Safety Code®) and NFPA 99-2012 (Health care Facilities Code) later this year or sometime early next year.  While we have been awaiting adoption, may organizations have already made it a point to become familiar with some of the major changes within those two […]

Compliance News: TJC Clarifies Life Safety Surveyors’ Survey Assessments

August 11th, 2015

TJC Director of Engineering George Mills announced some July 2015 changes to the Life Safety Surveyor’s portion of hospital triennial surveys during his recent TJC Update session at the ASHE Annual Conference in Boston. Mr. Mills covered many important subjects during this presentation.  This SSR Compliance News issue discusses only some changes that directly affect […]

Compliance News: Evolution of Utility System Technology

July 14th, 2015

Hospitals are dealing with the issues of utility system equipment technology failures and managing the need for ongoing technology upgrades as equipment designs evolve. Many hospitals have varying generations of utility system digital control technology built into major electrical, mechanical, vertical transportation, etc. operating components that were installed over the past few decades. Examples include […]

Compliance News: Upcoming NFPA 110 Change- Guidance for Rotating Starting ATSs

June 8th, 2015

In its June 3, 2015 issue of the NFPA TODAY blog, (also in the June 5, 2015 NFPA conference blog post), NFPA stated that 27 standards in the Annual 2015 revision cycle, including the new NFPA 110, were issued by the NFPA Standards Council on May 26, 2015 as Consent Standards. The new NFPA 110 […]

Compliance News: Utility Failure Procedures

May 11th, 2015

Most hospitals have utility failure procedures for major utility systems or equipment.  However many utility failure plans have room for improvement, particularly in how they deal with common-mode failure potential within those utility systems. The HFM Magazine article How to Plan for Water Outages published in early 2015 referenced an excellent document published by the […]

Compliance News: Construction-Renovation Projects and Utility Inventories

April 14th, 2015

A historical area of compliance challenges, related to hospital construction/renovation projects, may be getting worse.  Many organizations have struggled with obtaining timely receipt of details relating to new utility system components as well as manufacturer’s operating and maintenance manuals. The CMS December 2013 Alternate Equipment Management changes (related TJC July 2014 Alternate Equipment Maintenance changes), […]

Compliance News: Alternate Equipment Management/Maintenance (AEM) Risk Assessments

March 10th, 2015

Many hospitals are struggling with the AEM risk assessments required by both the CMS Survey & Certification Letter and the TJC July 2nd revisions.  This newsletter discusses the AEM risk assessment requirements. Compliance News previously discussed the driving CMS 2014 Survey & Certification Letter S&C:14-07-Hospital and its enclosed Appendix A interpretive guidelines generally in our […]

Compliance News: Emergency Management Planning for Hospital Water Outages

February 10th, 2015

An article just published in the February 2015 issue of Healthcare Facilities Management (HFM) Magazine discusses in detail many issues related to planning for hospital water outages.  The article is available online at the HFM Magazine website. Water outages are unfortunately a common cause or effect of cascading failures.  They can occur as a result […]

Compliance News: CMS Guidance for AEM Tracers

January 13th, 2015

By now many hospital facility directors have reviewed the Hospital Equipment Maintenance Requirements contained within the current CMS Alternate Equipment Management (AEM) program rules being enforced by CMS and all of its deemed accrediting organizations.  We previously discussed the driving CMS 2014 Survey & Certification Letter S&C:14-07-Hospital and its enclosed Appendix A interpretive guidelines generally […]

Compliance News: ECRI Institute Lists Top 10 Health Technology Hazards for 2015

December 8th, 2014

Hospitals are expected to identify risks that can adversely affect the safety of patients and others.  As an example, under TJC’s Standard EC.02.01.01, Element of Performance 1 lists examples of both internal and external sources of information on probable risks.  The annually updated ECRI list of Top 10 Health Technology Hazards is not listed but […]

Compliance News: New ASHE Monograph Addresses Hospital Emergency Power Issues

November 11th, 2014

ASHE just published a new 80+ page management monograph detailing a comprehensive program for managing hospital emergency power systems.  This document addresses recent lessons learned, best practices, and new regulatory issues.  Readers who have questions on the content of the monograph are invited to email the author at DStymiest@ssr-inc.com. Entitled Managing Hospital Emergency Power Systems: […]

Compliance News: Alternate Equipment Management (AEM) Requirements Alter Existing Processes

October 13th, 2014

The new AEM program requirements can represent a sea change in hospital utility system management. The new requirements can affect a multitude of existing processes as laid out in a hospital’s current Plans, Policies or Procedures (PPPs). This article briefly discusses a few of those processes. We previously discussed the driving CMS 2014 Survey & […]

Compliance News: TJC Discusses Equipment Inventories

September 8th, 2014

In a new Clarifications and Expectations article entitled “Revised Equipment Maintenance Standards for Hospitals” published in the September 2014 issues of Environment of Care News and TJC Perspectives, TJC Director of Engineering George Mills provided guidance regarding the enhanced TJC equipment maintenance requirements that took effect on July 2, 2014. We previously discussed the driving […]

Compliance News: Additional Information on Relocatable Power Taps

August 12th, 2014

There has been activity without many answers since TJC Director of Engineering George Mills announced a change in TJC’s approach to power strips in patient care areas on June 1, 2014 at the AAMI Conference. Although most facility managers call these devices power strips, both Underwriters Laboratories (UL) and CMS call them relocatable power taps […]

Compliance News: Changes to The Joint Commission’s Standards

July 8th, 2014

The Joint Commission recently issued numerous changes to its Hospital Accreditation Standards (HAS) Environment of Care (EC) and Life Safety (LS) chapters. TJC accredited hospitals should closely review all changes within the HAS book itself. TJC’s Prepublication Requirements issued June 20, 2014 identified the below-listed EC chapter changes that took effect July 2, 2014. There […]

Compliance News: TJC Announces CMS-driven Restrictions on Relocatable Power Taps

June 3rd, 2014

According to a new press release from AAMI, TJC Director of Engineering George Mills announced new restrictions on the use and application of Relocatable Power Taps during his speech at the AAMI 2014 Conference in Philadelphia on June 1, 2014. According to Underwriters Laboratories (UL) relocatable power taps, often also called outlet strips, are listed […]

Compliance News: TJC Clarifies Medical Gas Cylinder Storage Requirements

May 20th, 2014

TJC Director of Engineering George Mills clarified TJC’s requirements for safe storage of medical gas cylinders in the February 2014 editions of both TJC Perspectives and EC News. The TJC articles, both entitled Maintaining Medical Gas Safety and located within the Clarifications and Expectations portion of each periodical, referred to NFPA 99-1999 section 4-3.5.2.2(b). Section […]

Compliance News: CMS Changes Hospital Equipment Maintenance Requirements

May 8th, 2014

CMS recently issued Survey & Certification Letter S&C:14-07-Hospital, which changed the requirements for hospital equipment maintenance. The new requirements apply to utility systems equipment as well as medical equipment. The CMS letter can be found at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf, and hospital facility directors should obtain and review a copy of it. That letter also includes as Appendix […]

Compliance News: CMS Proposes to Adopt NFPA 101-2012 and NFPA 99-2012

April 30th, 2014

CMS recently announced its intent to adopt the 2012 editions of the NFPA 101 Life Safety Code® (LSC) and the NFPA 99 Health Care Facilities Code with modifications.  This process in now within a 60-day public comment period, and all public comments must be submitted by June 16, 2014. This round of public comments followed, […]

Compliance News: TJC MODIFIES EMERGENCY POWER TEST INTERVALS FOR 2014

January 7th, 2014

The 2014 TJC Hospital Accreditation Standards include wording changes in Standard EC.02.05.07, EP-4 (generator test intervals) and EP-6 (transfer switch test intervals) that tweak the required test intervals a little. The new 2014 test interval language in both EPs states “At least monthly, the hospital tests ….” This is a change from the 2013 TJC […]

Compliance News: TJC REDEFINES “QUARTERLY” AND “EVERY 3 YEARS” FOR 2014

January 1st, 2014

Take a close look at your 2014 schedules for quarterly requirements such as fire safety system testing found in several elements of  performance (EPs) under Standard EC.02.03.05. The brand new 2014 TJC definition of QUARTERLY can be found on page EC-3 at the beginning of the EC Chapter in the 2014 Hospital Accreditation Standards. The […]

Compliance News Volume XIII, Issue III

July 1st, 2013

In its Joint Commission Online article, dated June 26, 2013,(www.jointcommission.org/assets/1/23/jconline_June_26_13.pdf) The Joint Commission announced a new 2014 National Patient Safety Goal NPSG .06.01.01 on clinical alarm safety for both hospitals and critical access hospitals. The July 2013 issue of Joint Commission Perspectives discusses the new NPSG in detail. The NPSG requirements include 4 elements of […]

Compliance News Volume XIII, Issue III

May 1st, 2013

The Centers for Medicare & Medicaid Services (CMS) issued a categorical Life Safety Code waiver permitting new and existing ventilation systems supplying hospital and critical access hospital (CAH) anesthetizing locations to operate with a relative humidity (RH) of ≥20%, instead of ≥35%. CMS is also recommending that RH not exceed 60% in these locations. CMS […]