Author Archives: mike@standardsmichigan.com

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Health

Today we break down regulations, codes, standards and open-source literature governing the safety and sustainability of university-affiliated medical research and healthcare delivery facilities.   In large measure, the safety and sustainability agenda of the university-affiliated healthcare system infrastructure coincides with the private sector.   Accordingly, we confine our interest to systems — water, power, telecommunication and security; for example — that are unique to campus-configured, city-within-city risk aggregations.

We usually start with a scan of the following titles:

International Building Code (with particular interest in Section 308 Institutional Group I)

K-TAG Matrix for Healthcare Facilities

NFPA 70 National Electrical Code Article 517

NFPA 99 Healthcare Facilities Code

NFPA 101 Life Safety Code Chapters 18 & 19

ASHRAE 170 Ventilation of Healthcare Facilities

ASHRAE 189.3: Design, Construction and Operation of Sustainable High Performance Health Care Facilities

Some of the content in the foregoing links need weekly refresh.  We’ll get to that, time permitting.

We will thumb through the titles published by HL7 and NSF International — both Ann Arbor-based organizations.  A surprising number of medical data companies are domiciled in Ann Arbor; not far from our own offices on State Street.   We will also see if any bills and resolutions introduced into the 117th Congress will make into public law.

Finally, we collaborate with the IEEE E&H Committee on the following IEC committee projects from IEC/TC 62 Electrical equipment in medical practice.

– Common aspects of electrical equipment used in medical practice

– Diagnostic imaging equipment

– Equipment for radiotherapy, nuclear medicine and radiation dosimetry

– Electromedical equipment

 

As covered in previous posts, the original University of Michigan standards enterprise was one of the founding members of what has become ISO/TC 304 Healthcare organization management — following the lead set by Lee Webster at the University of Texas Medical Branch.  Since last month’s colloquium ISO TC/304 there has been a fair measure of the usual back-and-forth that we will cover in today’s colloquium.  We will examine the ideas in play in the links below today and try to organize them ahead of balloting:

ISO/TC 304 Catalog status

Legacy Workspace  (N.B. We are still in the process of uploading content onto the new University of Michigan Google Site facility)

Open to everyone.  Use the login credentials at the upper right of our home page.


Standing Agenda / Healthcare Facilities Monthly

More

Journal of Healthcare Management Standards: Operational Resilience of Hospital Power Systems in the Digital Age

Health care cost as percentage of Gross Domestic Product for six representative nations.

Association of Academic Health Centers

International Code Council Representation of Interests

Healthcare Organization Management

“Une leçon clinique à la Salpêtrière” 1887 André Brouillet

Many large research universities have significant medical research and healthcare delivery enterprises. The leadership of those enterprises discount the effect of standards like this at their peril. It is easy to visualize that this document will have as transformative effect upon the healthcare industry as the ISO 9000 series of management standards in the globalization of manufacturing.

Scope

Standardization in the field of healthcare organization management comprising, terminology, nomenclature, recommendations and requirements for healthcare-specific management practices and metrics (e.g. patient-centered staffing, quality, facility-level infection control, pandemic management, hand hygiene) that comprise the non-clinical operations in healthcare entities.

Excluded are horizontal organizational standards within the scope of:

    • quality management and quality assurance (TC 176);
    • human resource management (TC 260);
    • risk management (TC 262);
    • facility management (TC 267), and;
    • occupational health and safety management (TC 283).

Also excluded are standards relating to clinical equipment and practices, enclosing those within the scope of TC 198 Sterilization of health care products.

This committee is led by the US Technical Advisory Group Administrator —Ingenesis.   The committee is very active at the moment, with new titles drafted, reviewed and published on a near-monthly basis (See This Week’s Handouts).

 

[Issue 14-99]

Contact:  Lee Webster (lswebste@utmb.edu, lwebster@ingenesis.com), Mike Anthony (mike@standardsmichigan.com), Jack Janveja (jjanveja@umich.edu), Richard Robben (rrobben1952@gmail.com), James Harvey (jharvey@umich.edu), Christine Fischer (chrisfis@umich.edu), Dr Veronica Muzquiz Edwards (vedwards@ingenesis.com)

Category: Health, Global

Workspace / ISO 304 Healthcare Administration

More

Journal of Healthcare Management Standards: Operational Resilience of Hospital Power Systems in the Digital Age

ISO Focus Special Issue on Healthcare

ISO/TC 48 Laboratory equipment

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

ISO/TC 198 Sterilization of health care products

  • The American National Standards Institute — the Global Secretariat for ISO — does not provide content management systems for its US Technical Advisory Groups.  Because of the nascent committee, inspired by the work of Lee Webster at the University of Texas Medical Branch needed a content management system, we have been managing content on a Google Site facility on a University of Michigan host since 2014.Earlier this spring, the University of Michigan began upgrading its Google Sites facility which requires us to offload existing content onto the new facility before the end of June.  That process is happening now.  Because of this it is unwise for us to open the content library for this committee publicly.  Respecting copyright, confidentiality of ISO and the US Technical Advisory Group we protect most recent content in the link below and invite anyone to click in any day at 15:00 (16:00) UTC.  Our office door is open every day at this hour and has been for the better part of ten years.

Resilience of Hospital Power Systems in the Digital Age

Fondazione Policlinico Universitario Agostino Gemelli Rome

 

Operational Resilience of Hospital Power Systems in the Digital Age

Sapienza University of Rome, Roma, Italy
Ospedale Pediatrico Bambino Gesu, Rome, Italy
Parise professional office, Italy
Cosenza Hospital District, Cosenza, Italy
University of Michigan, Ann Arbor, MI, USA

 

Abstract: An advanced guideline is required to support the design of power supply systems for the performances of service continuity and power outage resilience, which are vital for hospital power systems and strategic operational structures (SOSs). The supply sources, the power system topology, and its management are fundamental in guaranteeing the electrical resilience of the power system. There is still no standard to evaluate the adequacy of hospital power systems for natural calamities and human-made disasters and, subsequently, for the ordinary operation. The World Health Organization recognizes it as a basic problem and at this aim has to claim clearly the status of SOSs for the hospitals, recommending to safeguard and plan the full operability. The hospital power systems need a local fortified electrical structure, designed for service continuity during fault events and managed to ensure an adequate dynamic response to any emergency and maintenance needs. The importance of the business continuity management is highlighted; it has to be qualified for a permanent design with both the in-op approaches for the initial installation of the system and its life cycle operation.

CLICK HERE to order complete paper

Healthcare Occupancies


Safety and sustainability for any facility, not just university-affiliated healthcare facilities, usually begin with an understanding of who, and how, shall occupy the built environment.  University settings, with mixed-use occupancy arising spontaneously and temporarily, often present challenges and they are generally well managed.

First principles regarding occupancy classifications for healthcare facilities appear in Section 308 of the International Building Code, Institutional Group I; linked below:

2021 International Building Code Section 308 Institutional Group I

There are thousands of healthcare code compliance functionaries and instructors; most of them supported by trade associations and most of them authoritative.   Hewing to our market discipline to track only the concepts that will affect university-affiliated healthcare enterprises only.  There are a few noteworthy differences between corporate healthcare businesses and university affiliated healthcare enterprises (usually combined with teaching and research activity) that we identify on this collaboration platform.

We collaborate closely with the IEEE Education & Healthcare Facilities Committee which takes a far more global view of the healthcare industry.  That committee meets online 4 times monthly in European and American time zones.

Finally, we encourage our colleagues to participate directly in the ICC Code Development process.  Contact Kimberly Paarlberg (kpaarlberg@iccsafe.org) for more information about its healthcare committees and how to participate in the ICC code development process generally.  Tranches of ICC titles are developed according to the schedule below:

2021/2022 ICC CODE DEVELOPMENT SCHEDULE

Soon: I-Code Group B Public Comment Hearings

 

Issue: [18-166]

Category: Architectural, Healthcare Facilities, Facility Asset Management

Colleagues: Mike Anthony, Jim Harvey, Richard Robben


More

Workspace / ICC

K-TAG Matrix for Healthcare Facilities

 

Syllabus: Autumn

Sedbergh School | North West England

Autumn Syllabus Week 49 | December 5 – 11

This Week’s Handouts

We sweep through the world’s three major time zones; updating our understanding of the literature at the technical foundation of education community safety and sustainability in those time zones 24 times per day. We generally eschew “over-coding” web pages to sustain speed, revision cadence and richness of content as peak priority.  We do not provide a search facility because of the time sensitivity of almost everything we do.

Our daily colloquia are typically doing sessions; with non-USA titles receiving priority until 16:00 UTC and all other titles thereafter.  We assume policy objectives are established (Safer-Simpler-Lower-Cost, Longer-Lasting).   Because we necessarily get into the weeds, and because much of the content is time-sensitive and copyright protected, we usually schedule a separate time slot to hammer on technical specifics so that our response to consultations are meaningful and contribute to the goals of the standards developing organization and to the goals of stewards of education community real assets.

1. Leviathan.  We find over 17-thousand bills and resolutions introduced into the United States Congress as of  6 December 2022 .

117

We do not advocate in legislative activity at any level.  We track federal legislative action because it provides a stroboscopic view of the cultural moment in communities that are simultaneously a business and a culture.  Even though more than 90 percent of such proposals are at the mercy of the party leadership the process does enlighten the strengths and weakness of a governance system run entirely through the counties on the periphery of Washington D.C.  It is impossible to solve technical problems in facilities without sensitivity to the zietgeist that has accelerated in education communities everywhere.

Standards Maine

We typically post one federal and one state level consultation or action every day for at least one of the 50-states — in the lower right corner of our home page when most education communities in the United States have begun a new work day.  Examples, irregularly linked:

U.S. Department of Commerce Bureau of Industry and Security: Public consultation on US standards system rule (November 8)

2National Institute of Standards and Technology (NIST)

Public Consultation on Semiconductor Manufacturing (November 28)

NIST Awards Funding to 5 Universities to Advance Standards Education

NIST Center for Neutron Research: 2022 Outstanding Student Poster Presentation

Commerce Levels Playing Field to Support U.S. Stakeholder Participation in International Standards Setting Activities

NIST Report Outlines Strategic Opportunities for U.S. Semiconductor Manufacturing

Occupational exposure and indoor environmental quality evaluation from operating multiple desktop 3D printers in an office environment within a library.

3ANSI ISO Business  (Many of these projects are normally covered during our Hello World! colloquia

November 2022 Government Relations and Public Policy Update

ANSI Seek Comments on ANSI Essential Requirements – See Page 65 (November 7)

ISO Standardization Foresight Framework | Trend Report 2022

Public Review of Revised Operating Procedures for a U.S. TAG to ISO TC 304, Healthcare organization management | See Page 75 (November 7)

September 2 Update: ANSI in China Newsletter

ISO Proposal for a New Field of ISO Technical Activity Management Consultancy by the Standards Administration of China (October 21)

New ISO Proposal for Management System for UN Sustainable Development Goals – Requirements for Any Organization (October 28)

New ISO Subcommittee ISO/TC 197/SC 1 – Hydrogen at Scale and Horizontal Energy Systems

New ISO Subcommittee ISO/TC 67/SC 10 – Enhanced oil recovery

Proposal for new field of standardization activity UN Sustainable Development Goals – Requirements for Any Organization (Comments on proposal from Dansk Standards due to ANSI by October 28.  See Page 50)

Update: Certification+Degree (C+D) pathways in information technology (IT) and health sciences.

Future Direction of ISO Management System Standards: Consultation closes 7 October

2023 Student Paper Competition Theme: Standards Supporting United Nations Sustainable Development Goals.  Submissions due 2 June 2023

U.S. Department of Commerce Bureau of Industry and Security Interim Final Rule regarding the release of certain technologies in standards-related activities. (Consultation closes 8 November 2022)

August 2022 Government Relations and Public Policy Update

July 2022 ISO, IEC nd ITU Listings of Work Items Published

Standards Coordination Office | USA WTO TBT Enquiry Point 

USNC/IEC

Summer 2022

IEC General Meeting San Francisco October 31- November 4

Consultations (Some posted with IEEE Education & Healthcare Facilities Committee) | Direct access to primary workspace

The Watson Institute Pennsylvania

4. Fast Forward  

Fast Forward

5. Rewind

Lights Out

6. Corrigenda


International Standardization Organization Week Date

Design & Operation of Health Care Facilities

The pandemic provides background for the importance of ventilation systems in healthcare settings and reminder that there is plenty of work to do.  The scope of ASHRAE 189.3 – Design, Construction and Operation of Sustainable High Performance Health Care Facilities — lies in this domain:

Purpose.  The purpose of this standard is to prescribe the procedures, methods and documentation requirements for the design, construction and operation of high-performance sustainable health care facilities.

Scope.This standard applies to patient care areas and related support areas within health care facilities, including hospitals, nursing facilities, outpatient facilities, and their site.  It applies to new buildings, additions to existing buildings, and those alterations to existing buildings that are identified within the standard.  It provides procedures for the integration of sustainable principles into the health care facility design, construction and operation process including:

    1. integrated design
    2. conservation of water
    3. conservation of energy
    4. indoor environmental quality
    5. construction practices
    6. commissioning
    7. operations and maintenance

Noteworthy: Related title ASHRAE/ASHE Standard 170 Ventilation of Healthcare Facilities

As of the date of this post, no redlines have been released for public consultation but we do a status check routinely; with an eye toward concepts that track in ASHRAE 90.1.   Where redlines are released they are posted at the link below:

Public Review Draft Standards / Online Comment Database

Because this title is administered on ASHRAE’s continuous maintenance platform, public consultations run 30 to 45 days.   You may also submit an original idea to the ASHRAE standards development enterprise.  CLICK HERE to get started.

We maintain this title on the standing agenda of our periodic Health, Energy and Mechanical colloquia.  See our CALENDAR for the online meeting; open to everyone.

 

Issue: [Various]

Category: Mechanical, Electrical, Energy, Facility Asset Management

Colleagues:  David Conrad, Richard Robben, Larry Spielvogel

Workspace / ASHRAE

Healthcare Facilities Code

“The Doctor”  1891 Sir Luke Fildes

The NFPA 99 Healthcare Facilities Code committee develops a distinct consensus document (i.e. “regulatory product”) that is distinct from National Electrical Code Article 517; though there are overlaps and gaps that are the natural consequence of changing technology and regulations.  It is worthwhile reviewing the scope of each committee:

NFPA 99 Scope: This Committee shall have primary responsibility for documents that contain criteria for safeguarding patients and health care personnel in the delivery of health care services within health care facilities: a) from fire, explosion, electrical, and related hazards resulting either from the use of anesthetic agents, medical gas equipment, electrical apparatus, and high frequency electricity, or from internal or external incidents that disrupt normal patient care; b) from fire and explosion hazards; c) in connection with the use of hyperbaric and hypobaric facilities for medical purposes; d) through performance, maintenance and testing criteria for electrical systems, both normal and essential; and e) through performance, maintenance and testing, and installation criteria: (1) for vacuum systems for medical or surgical purposes, and (2) for medical gas systems; and f) through performance, maintenance and testing of plumbing, heating, cooling , and ventilating in health care facilities.

NFPA 70 Article 517 Scope:  The provisions of this article shall apply to electrical construction and installation criteria in healthcare facilities that provide services to human beings.  The requirements in Parts II and III not only apply to single-function buildings but are also intended to be individually applied to their respective forms of occupancy within a multi-function building (e.g. a doctor’s examining room located within a limited care facility would be required to meet the provisions of 517.10)   Informational Note: For information concerning performance, maintenance, and testing criteria, refer to the appropriate health care facilities documents.

In short, NFPA 70 Article 517 is intended to focus only on electrical safety issues though electrotechnology complexity and integration in healthcare settings (security, telecommunications, wireless medical devices, fire safety, environmental air control, etc.) usually results in conceptual overlap with other regulatory products such as NFPA 101 (Life Safety Code) and the International Building Code.

Several issues were recently debated by the Article 517 technical committee during the 2023 National Electrical Code Second Draft meetings

  • The conditions under which reconditioned electrical equipment be installed in healthcare settings; contingent on listing and re-certification specifics.
  • Relaxation of the design rules for feeder and branch circuit sizing through the application of demand factors.
  • Application of ground fault circuit interrupters.
  • “Rightsizing” feeder and branch circuit power chains (Demand factors in Section 517.22)
  • Patient care space categories
  • Independence of power sources (517.30)

There are, of course, many others, not the least of which involves emergency management.  For over 20 years our concern has been for the interdependency of water and electrical power supply to university hospitals given that many of them are part of district energy systems.

We need to “touch” this code at least once a month because of its interdependence on other consensus products by other standards developing organizations.  To do this we refer NFPA 99 standards action to the IEEE Education & Healthcare Facilities Committee which meets online four times monthly in European and American time zones.

The transcript of NEC Article 517 Public Input for the 2023 revision of NFPA 70 is linked below.  (You may have to register your interest by setting up a free-access account):

Code-Making Panel 15 (NEC-P15) Public Input Report

Code-Making Panel 15 (NEC-P15) Public Comment Report

Technical committees will meet in June to endorse the 2023 National Electrical Code.

Public consultation on the Second Draft closes May 31st. Landing page for selected sections of the 2024 revision  of NFPA 99 are linked below:

Electrical Systems (HEA-ELS)

Fundamentals (HEA-FUN)

Health Care Emergency Management and Security (HEA-HES)

Second Draft Comments are linked below:

Electrical Systems (HEA-ELS)

Fundamentals (HEA-FUN)

Health Care Emergency Management and Security (HEA-HES)

NITMAM closing date: March 28, 2023

We break down NFPA 70 and NFPA 99 together and keep them on the standing agenda of both our Power and Health colloquia; open to everyone.  See our CALENDAR for the next online meeting.

Issues: [12-18, [15-97] and [16-101]

Contact: Mike Anthony, Jim Harvey, Robert Arno, Josh Elvove, Joe DeRosier, Larry Spielvogel

NFPA Staff Liaison: Jonathan Hart

Archive / NFPA 99

 

 

 

Interoperability of Distributed Energy Resources

IEEE Standard for Interconnecting Distributed Resources with Electric Power Systems is effectively the global standard for interconnection of distributed resources with large scale electric power systems.  It provides requirements relevant to the performance, operation, testing, safety, and maintenance of the interconnection.  Apart from the power reliability and sustainability zietgeist we have seen in campus bulk power distribution systems, this title is usually referenced in research projects undertaken in university research enterprises.  The standard is intended to be universally adoptable, technology-neutral, and cover distributed resources as large 10 MVA.  To wit:

IEEE 1547-2018 Standard for Interconnection and Interoperability of Distributed Energy Resources with Associated Electric Power Systems Interfaces: This standard — emerging from IEEE Root Project 1547.3 — 2007 asserts first principles for improved performance for distributed energy resources, connected to the grid. NIST funding aided this standard’s development.   Links to related titles, recently released for public consultation, are listed below:

1547.3 Guide for Cybersecurity of DER Interconnected with Electric Power Systems | Comments due May 27

Guide to Using IEEE Standard 1547 for Interconnection of Energy Storage Distributed Energy Resources | Comments Due May 6th

We collaborate with the IEEE Education & Healthcare Facilities Committee on this an related titles.   This committee’s meetings are held 4 times monthly in European and American time zones.  International Electrical Technical Commission titles are items on the standing agenda; a few representative titles are listed in addition to IEEE titles below:

IEC 62746-10-1:2018 Systems Interface Between Customer Energy Management System and the Power Management System – Part 10-1: Open Automated Demand Response: This standard specifies how to implement a two-way signaling system, between utilities and customers, thus allowing utilities to adjust the grid’s load, based on demand. NIST’s David Holmberg and Steve Bushby presented research to the International Electrotechnical Commission (IEC), aiding this US standard’s acceptance as an international one.

IEC 62746-10-3:2018, Systems Interface Between Customer Energy Management System and the Power Management System – Part 10-3: Open Automated Demand Response – Adapting Smart Grid User Interfaces to the IEC Common Information Model: Related to the previous standard, IEC 62746-10-3:2018 defines the interfaces, as well as, the messaging for this two-way signaling system. NIST’s Holmberg and Bushby also facilitated this international standard’s acceptance.

IEEE 21451-001-2017 Recommended Practice for Signal Treatment Applied to Smart Transducers: This guide supports the ability to uniformly processing and classifying data from sensors and actuators in a smart system. The standard enables a common interpretation of data and grid interoperability. NIST personnel served on this standard’s working group, providing NIST research on sensors and actuators.

IEEE 2030.7-2017 Standard for the Specification of Microgrid Controllers: This standard established requirements for controllers, used to sense and manage microgrids. These requirements inform the manufacturing of controllers, and ultimately enable grid interoperability. NIST funding aided this standard’s development.

IEEE 2030.8 Standard for Testing Microgrid Controllers: This testing standard helps verify that microgrid controllers meet these requirements, and, thus, will work as intended. NIST funding aided this standard’s development.

IEEE 1547-2018 Standard for Interconnection and Interoperability of Distributed Energy Resources with Associated Electric Power Systems Interfaces: This standard ushers in a new era of improved performance for distributed energy resources, connected to the grid. NIST funding aided this standard’s development.

To inform a United States position on IEC titles we follow the lead of the USNA/IEC whose activity we also track in the IEEE E&H Committee

Issue: [11-17]

Category: Electric, Energy

Colleagues: Mike Anthony, Bob Arno, Neal Dowling, Octavio Gonzalez, Peter Sutherland

Homeland Power Security

“Electric Production and Direction” 1933 / William Karp / Smithsonian American Art Museum

We collaborate with the IEEE Education & Healthcare Facilities Committee in assisting the US Army Corps of Engineers in gathering power system data from education communities that will inform statistical solutions for enhancing power system reliability for the Homeland.

United States Army Corps Power Relability Enhancement Program Flyer No. 1

United States Army Corps Power Reliability Enhancement Program Flyer No. 2

We maintain status information about this project — and all projects that enhance the reliability of education community power reliability — on the standing agenda of our periodic Power, Risk and Security colloquia.   See our CALENDAR for the next online meeting; open to everyone

Issue: [19-156]

Category: Power, Data, Security

Colleagues: Mike Anthony, Robert G. Arno, Mark Bunal, Jim Harvey, Jerry Jimenez, Paul Kempf. Richard Robben

Reliability Analysis for Power to Fire Pumps

H.R. 8220 One School, One Nurse Act of 2022

117th Congress Swearing In Floor Proceedings – January 3, 2021, House Chamber

Nursing

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