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DECEMBER 2016 Volume 24 Issue No. 12 Briefings on Hospital Safety How surviving a disaster changes the disaster plan As the South recovers from Hurricane Matthew, heed lessons from facilities that survived natural disasters Changes to the HFAP standards manual In this Q&A, learn how the new Life Safety Code® will affect standards you are used to following for compliance Developing a crisis plan for disaster recovery Contingency plans help manage the aftermath of disasters that impact facility operations Disposable GI scopes will hit market in 2017 German company gets FDA approval for disposable device, but will hospitals benefit despite costs? Drug diversion regulatory changes This excerpt from a new HCPro book examines recent regulatory changes made to prevent drug diversion. Healthcare Security Alert In this month’s security insert, learn about how to put together a mobile hospital unit. P6 P11 P12 P18 Putting a disaster plan in place is a critical step for a healthcare facility, but it becomes especially important for the facility operations depart- ment—without its proactive action, doctors and nurses will have nowhere to practice, and a community safe house could be lost. In reality, how- ever, it’s difficult to truly prepare for the chaos of a disaster. Each event teaches a lesson, and it’s the facility manager’s job to make sure this lesson isn’t learned at the expense of patient or staff lives. An evolving plan Few recent events have had the impact of Hurricane Katrina, not only on affected localities but also on building codes as a whole. “Hurricane Katrina was an indescribable event that forced the hospital and the community to deal with issues that were not planned for,” recalls Ken McDowell, CHSP, CHEP, safety officer for Memorial Hospital at Gulfport (Mississippi). Prior to the 2005 arrival of the largest hurricane ever to make landfall in INSIDE THIS ISSUE Copyright: Pixsooz. Image Source: istock.com P15

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Page 1: Briefings on Hospital Safety - hcpro. · PDF fileVolume 24 Issue No. 12 DECEMBER 2016 Briefings on Hospital Safety How surviving a disaster changes the disaster plan As the South recovers

DECEMBER 2016Volume 24 Issue No. 12

Briefings on Hospital Safety

How surviving a disaster changes the disaster planAs the South recovers from Hurricane Matthew, heed lessons from facilities that survived natural disasters

Changes to the HFAP standards manual

In this Q&A, learn how the new Life Safety Code® will affect standards you are used to following for compliance

Developing a crisis plan for disaster recovery

Contingency plans help manage the aftermath of disasters that impact facility operations

Disposable GI scopes will hit market in 2017

German company gets FDA approval for disposable device, but will hospitals benefit despite costs?

Drug diversion regulatory changes

This excerpt from a new HCPro book examines recent regulatory changes made to prevent drug diversion.

Healthcare Security Alert

In this month’s security insert, learn about how to put together a mobile hospital unit.

P6

P11

P12

P18

Putting a disaster plan in place is a critical step for a healthcare facility, but it becomes especially important for the facility operations depart-ment—without its proactive action, doctors and nurses will have nowhere to practice, and a community safe house could be lost. In reality, how-ever, it’s difficult to truly prepare for the chaos of a disaster. Each event teaches a lesson, and it’s the facility manager’s job to make sure this lesson isn’t learned at the expense of patient or staff lives.

An evolving plan

Few recent events have had the impact of Hurricane Katrina, not only on affected localities but also on building codes as a whole.

“Hurricane Katrina was an indescribable event that forced the hospital and the community to deal with issues that were not planned for,” recalls Ken McDowell, CHSP, CHEP, safety officer for Memorial Hospital at Gulfport (Mississippi).

Prior to the 2005 arrival of the largest hurricane ever to make landfall in

INSIDE THIS ISSUE

Copyright: Pixsooz. Image Source: istock.com

P15

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HCPRO.COM © 2016 HCPro, a division of BLR. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, contact the Copyright Clearance Center at copyright.com or 978-750-8400.

2 |Briefings on Hospital Safety December 2016

Briefings on Hospital Safety (ISSN: 1076-5972 [print]; 1535-6817 [online]) is published monthly by HCPro, a division of BLR®. Subscription rate: Regular $329/year or $592/two years; Platinum $549/year; back issues are available at $25 each. • Briefings on Hospital Safety, 100 Winners Circle, Suite 300, Brentwood, TN 37027. • Copyright © 2016 HCPro, a division of BLR®. All rights reserved. Printed in the USA. Except where specifically encouraged, no part of this publication may be reproduced, in any form or by any means, outside the subscriber’s facility without prior written consent of HCPro, a division of BLR., or the Copyright Clearance Center at 978-750-8400. Please notify us immediately if you have received an unauthorized copy. • For editorial comments or questions, call 781-639-1872 or fax 781-639-7857. For renewal or subscription information, call customer service at 800-650-6787, fax 800-785-9212, or email [email protected]. • Visit our website at www.hcpro.com. • Occasionally, we make our subscriber list available to selected companies/vendors. If you do not wish to be included on this mailing list, please write to the marketing department at the address above. • Opinions expressed are not necessarily those of BHS. Mention of products and services does not constitute endorsement. Advice given is general, and readers should consult professional counsel for specific legal, ethical, or clinical questions.

BHS STAFF MEMBERS EDITORIAL ADVISORY BOARDBarbara Bisset, PhD, MS, MPH, RNExecutive DirectorEmergency Services Institute/WakeMed Raleigh, North Carolina

Joseph Cocciardi, PhD, MS, CSP, CIHExecutive DirectorCocciardi & Associates Mechanicsburg, Pennsylvania

Leo J. DeBobes, MA (OS&H), CSP, CHCM, CPEA, CHEP, CHSP, CSC, EMTAssistant Administrator, Emergency Management/ Regulatory ComplianceStony Brook University Medical Center Stony Brook, New York

Elizabeth Di Giacomo-Geffers, RN, MPH, CSHAHealthcare ConsultantDi Giacomo-Geffers and Associates Orange County, California

Zachary Goldfarb, EMT-P, CHSP, CEM, CHEPPresidentIncident Management Solutions, Inc. East Meadow, New York

Ray W. Moughalian, BS, CHFRMPrincipalSaf-T-Man Methuen, Massachusetts

John L. Murray Jr., CHMM, CSP, CIHSafety DirectorBaystate Health Springfield, Massachusetts

Paul Penn, MS, CHEM, CHSPEnMagine/HAZMAT for Healthcare Diamond Springs, California

Lisa B. Pryse Terry, CHPA, CPPODS Security Solutions Richmond, Virginia

Dalton Sawyer, MS, CHEPDirector, Emergency Preparedness and Continu-ity PlanningUNC Health Care Chapel Hill, North Carolina

Steve SchultzCorp. E&O Safety DirectorCape Fear Valley Health System Fayetteville, North Carolina

Barry D. Watkins, MBA, MHA, CHSPSenior EC SpecialistCorporate Safety Carolinas HealthCare System Charlotte, North Carolina

Kenneth S. Weinberg, PhD, MScPresidentSafdoc Systems, LLC Stoughton, Massachusetts

Thomas A. Smith, CHPA, CPPPresidentHealthcare Security Consultants, Inc. Chapel Hill, North Carolina

This document contains privileged, copyrighted information. If you have not purchased it or are not otherwise entitled to it by agreement with HCPro, a division of BLR, any use, disclosure, forwarding, copying, or other communication of the contents is prohibited without permission.

involved fortifying major equipment to better protect it from future flooding. Katrina’s flooding was unprec-edented, putting nearly 80% of the city underwater when the levees broke, and the scale of the incident served as a lesson.

“We’d never experienced that type of flooding before, and after incurring that, we realized we needed to do a few things in case it ever happened again,” Hill says.

An initial survey of the damage

There is much to be done to prepare a facility as forecasters announce the potential arrival of a massive storm.

“Pre-landfall, the typical events for hurricane prepara-tion took place: boarding windows, securing missile objects, topping off fuel supplies, testing generators, ordering more food and water supplies, and so forth,” McDowell recalls.

Adequate preparation is crucial, since it’s impossible to predict just how your facility might be affected. Then, as McDowell says, “During landfall you are pretty much in a wait-and-respond mode.”

the United States, Memorial had a plan in place to help hospital staff prepare for nearly any disaster.

“Memorial Hospital at Gulfport adopted a National Incident Management System–compliant emergency operations plan (EOP), which is an all-hazards plan. There are incident-specific appendices for hurri-canes, tornadoes, loss of essential utilities, security, safety, etc. The engineering department also has procedures in place that support the hospital’s EOP,” McDowell says.

While Memorial was significantly affected by Katrina, it was not at the heart of the storm in the way that Ochsner Baptist Medical Center in New Orleans was. Thankfully, Ochsner Baptist was prepared too.

“We have a disaster plan, and we had one at the time of Hurricane Katrina. It worked out well,” says Wayne Hill, director of the physical plant at Ochsner Baptist Medical Center. “We did make some changes to it after going through such a terrible disaster. We made some changes to improve it in case we ever have to go through that again.”

For Hill and his team, many of those improvements

Erin CallahanVice President, Product Development & Content [email protected]

Managing EditorJohn [email protected]

Contributing EditorSteven MacArthurSafety Consultant The Greeley Company Danvers, Massachusetts

Follow Us! Follow and chat with us about all things healthcare com-

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Briefings on Hospital Safety | 3December 2016

It was immediately after Katrina that the real work, and learning, began. The first step was to assess the damage and determine what needed to be improved in the event of a future disaster. For Ochsner Baptist, there were several immediate problems that needed to be addressed. First, of course, was the flooding.

“The fuel systems that feed the generators were one of our weaker links,” Hill recalls. “We had our generators up high, but we had one electrical panel that fed the fuel tanks, and that was actually on the ground floor, so we weren’t able to get the fuel up to the generator.”

The second significant challenge was that the air conditioning system wasn’t original to the hospital building, which had been built in 1950. As the hospital grew over the years, air conditioning was added, but a backup power source for it was not.

“They never did put the air conditioning system on emergency power, so when the event happened in the summertime—as it does most of the time in the South—there was a big issue with not having the air conditioner working,” says Hill.

As a result, the facility management team determined flood elevations and raised much of its equipment on platforms, including a new backup power system. “If we do flood again, we will have air conditioning, and we’ve also added some additional generator power to supplement that,” Hill says.

Generators proved to be among Memorial’s biggest challenges as well.

“We had four emergency generators and three standby generators prior to Katrina, so the power was not as big of a concern until fuel started getting low,” McDowell says. The hospital housed two 12,500-gallon diesel tanks, but this turned out not to be enough. The facility managers had a plan in place to deal with low fuel levels, but then the unexpected happened. “Mutual aid agreements for fuel replenishment were in place, and the suppliers attempted to provide our fuel as scheduled, but some of the trucks were diverted to other facilities by the Mississippi Department of Transportation,” McDowell says.

That is why, he notes, it is extremely important to have a working relationship with your county emergency management agency. “We were able to get our diverted trucks back to us because of our working relation-ships,” he says.

A gathering place for the community

During Katrina, Memorial Hospital at Gulfport, with 278 operated beds, sustained damage to its roof and windows as a result of the hurricane’s high winds. Damages totaled roughly $8 million to $10 million, according to a news release issued shortly after the storm. Fortunately, the main facility was never without power and had no problems with its water supply. Memorial did, however, face a unique challenge: It was one of the only area hospitals to remain fully opera-tional. All but 40 beds were filled, and those 40 were empty only because they had been taken out of service due to water damage.

“Plan for mass amounts of victims with a wide array of injuries from mental injuries to broken bones, cuts, and more severe injuries,” McDowell says, looking back at that overflow.

He also notes that it’s important to plan not just for the living, but also for the dead. “Plan for fatality manage-ment: where will you store the deceased until the coroner can pick them up,” he advises.

According to the Memorial news release, management pre-purchased many supplies and pharmaceuticals before the hurricane struck, and normal deliveries of supplies quickly resumed. This helped the hospital become a gathering place for a community in need.

“Katrina changed our outlook on the community as a whole,” McDowell says. “The community turned to the hospital for assistance of all kinds. We provided addi-tional medications or medications that were destroyed in their homes. We were one of the few facilities on the Gulf Coast that had power and water after the storm. We deployed watering stations on the hospital grounds for the community to fill water coolers, and we shel-tered upward of 250 people at a time after discharge who were waiting for community shelters to open.”

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4 |Briefings on Hospital Safety December 2016

Learning curve

In some cases, a disaster can provide an opportunity for an organization to grow stronger. Mercy Hospital (formerly St. John’s Regional Medical Center) in Joplin, Missouri, is a facility that has taken a disaster and turned it into an opportunity for learning and growth.

Since the May 2011 tornado that destroyed the facility, John Farnen, executive director of strategic projects for Mercy Hospital, has overseen the installation of a number of innovative new products to better protect residents and staff in the event of future disasters.

“That was a historic storm that taught us many les-sons,” Farnen says.

In its new facility, opened last year, Mercy features a “tornado-proof” design with a concrete roof, fortified safe zones on each floor, and generators that are being half buried away from the main building. The hospital also employs a window system designed to withstand the 250-mile-per-hour winds of an EF-5 tornado.

Hill of Ochsner Baptist saw firsthand that today’s tough new windows, built to withstand high wind speeds and the impact of flying debris, work far better than older products. Following Katrina, he notes, “Some of the newer buildings fared a lot better than the older buildings, especially the windows. The newer buildings that were only about 10 years old, rather than 30 or 40 years old, had some windows that did stand up to [the storm].”

Following the historic hurricane, Ochsner Baptist installed new windows, and it continues to upgrade that critical part of the building shell. “In some of the buildings that we’re renovating, we’re putting in those big 200-mph-rated windows,” Hill says.

Neighboring problems

One of the problems faced by all windows is not just the pressure of strong winds, but the impact of small debris—often from neighboring rooftops.

“We had a lot of what they call ‘build up’ roofs, which they use in this area a lot,” Hill says. “They would put a tar roof on, and then they’d put rocks or gravel on top

of it. We had a lot of problems with that gravel flying around in the high winds.”

Memorial Hospital at Gulfport faced similar problems.

“Overall, the building fared well during Katrina,” says McDowell. “The damage was from the gravel ballast roof blowing off and knocking the windows out. Once the gravel ballast was gone, the leaking started from the wind-driven rain.”

Like Mercy Hospital, Memorial learned firsthand the important role that a strong building envelope system plays.

“A third of the wall surrounding our main communica-tions room was window wall,” McDowell says. “Once the windows were blown out, the wind from the storm removed most of the remaining wall, which exposed our communications equipment.”

Ultimately, Memorial Hospital had several rooms taken out of service due to the window damage inflicted by the gravel ballast roof. “We placed patients into the center core away from windows and extended utilities such as power and oxygen into the corridors to better protect the patients,” McDowell says. “Post-storm required specialty companies to come in and dry out a couple of the upper wings of the hospital due to the rain damage after the gravel ballast blew off.”

Since then, needless to say, Memorial has removed all of the gravel ballast from its roofs. McDowell advises other facility managers to review their roofing con-struction, no matter the makeup. “Is it the best option for the climate you are located in? Gravel ballast proved not to be a viable option in hurricane-prone areas,” he says.

What else is needed?

Once Ochsner Baptist’s immediate needs had been met following Hurricane Katrina, the hospital’s facility management team began to look further.

“We did put in an additional generator, not only to take care of the air conditioning system. It is a genera-tor large enough to supply normal power throughout

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Briefings on Hospital Safety | 5December 2016

the facility. Basically, we’ll be like a cruise ship on the ocean, where we can run normally without electricity,” Hill says. He adds that these projects are ongoing.

McDowell agrees that the generator and boiler rooms, main communications room, data/IT center, kitchen, and command center are among the elements most in need of protection. For hospitals that have limited budgets, though, he suggests the one system to rein-force now should be the hospital generator and its fuel capacity. His second choice: “Install a well if you don’t have one, and tie it in to your emergency power.”

For Memorial, recovering from the disaster meant changing some aspects of the layout and adopting newer products. “The communications room was reconstructed and no longer contains a window wall. The gravel ballast roof was removed and replaced without gravel. We are currently under construction, adding two floors and replacing the building brick skin with window wall. The window walls are hurricane-rated,” McDowell says.

Today’s plan

Having come through one of the country’s worst natural disasters, the Ochsner Baptist team takes its disaster planning very seriously. Hill explains that the facility has a thorough plan in place when a dangerous weather event is forecast.

“We’ll start out by cleaning off any loose materials on the roofs, and tie down anything that we can,” Hill says. “Then we go into the neighborhood streets and actually clean the drains and make sure they’re all free of debris. Then we come back into the facility and we check our sump pumps to make sure they’re opera-tional. We do preventive maintenance on them all the time, but we double-check that.

“We actually go through and clean the light wells to make sure there’s no debris and the drains are all free and clear. We also have little portable pumps and

generators, and we make sure they are fueled up, and then we run them to make sure we don’t have any mechanical problems with those. Then we go out and stockpile extra gasoline and diesel fuel and whatever is required for those pumps. Finally, we check our fuel levels in our generator and make sure we top those off, if there is the threat of a storm coming soon, and we make sure we have the maximum supply of fuel in the generators,” Hill adds.

Preparing for the worst

It is nearly impossible to be prepared for every eventu-ality that may result from the chaotic destruction brought by hurricanes, tornadoes, and other natural disasters. And as Hill knows firsthand, no disaster is without its challenges.

“The flooding [from Katrina] was really a big chal-lenge, and the fact that we did lose city water and natural gas,” he says. “It was difficult to overcome. You make provisions for the things that you feel like are going to go down, but every day it was just a little bit worse and a little bit worse.”

McDowell advises putting in place today the relation-ships that will ensure no hospital has to go through a disaster alone. “Build strong working relationships with your community agencies: city, county, and fellow hospitals,” McDowell says. He adds, “Always consider the worst-case scenario during your planning stages of projects.”

Having come out on the other side of such a devastat-ing event, these facility managers are able to emphasize the importance of having a disaster plan in place and regularly assessing the operation of vital equipment. H

EDITOR’S NOTE

Portions of this story originally appeared in Facility Care, a publica-

tion of Thompson Information Services.

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6 |Briefings on Hospital Safety December 2016

Editor’s note: The following is a Q&A excerpted from the Healthcare Facilities Accreditation Program (HFAP) and Accreditation Association for Hospitals/Health Systems (AAHHS) webinar, titled “Changes to Accreditation Requirements for Ambulatory Surgical Centers Chapter 5: Physical Environment.” The webi-nar covers how the adoption of the Life Safety Code® by CMS has changed the 2017 HFAP manual. Speaker Brad Keyes, CHSP, HFAP’s engineering advisor on all issues involving emergency management, physical environment, and life safety, provides the answers.

Q Can you explain the intent for the five-year private fire service mains?

Brad Keyes: I think you’re referring to the internal inspection of the sprinkler piping, and I don’t want to speak on behalf of the NFPA technical committee. But, my understanding of why they require that now is [because] the older systems are having foreign material in the pipes: gunk, slime, rocks, things that might cause an impairment to the sprinkler head.

Now it’s a requirement that once every five years we do a spot inspection looking for foreign material. Quite honestly, in some situations they’ve found rags and tools left in the pipes by the installers. That’s my understanding of why it’s a requirement now.

Q Is the fire watch for sprinkler impairment or fire alarm impairment?

BK: Fire watch is for both, and you’ve always had to have a fire watch. Under the 2000 Life Safety Code (LSC), you had to have a fire watch if you had a sprinkler impairment or a fire alarm impairment.

The difference now is that CMS is now defining what a fire watch is. Before it was never truly defined; no [hospital jurisdiction] was really putting in writing what it required. Hospitals were free to interpret it however they wanted.

CMS for the last three or four years have been saying in various opportunities that they wanted a continuous fire watch. So now they’ve finally put it in writing, it’s enforceable, and we have to comply with that.

Q What training is required for fire watch? Does the person have to be a certified

firefighter?

BK: No. NFPA 25—I think it’s Chapter 15 in the annex section—will tell you the details of what’s required.

But off the top of my head, you need to provide basic training as to the individual who’s doing it. That person needs to know what to look for, know where to go, and have the ability to communicate with the fire department. What that means is they carry a two-way radio with security or a switchboard. If they see something that [requires] the fire department there right away, they can communicate right away to the switchboard or security and they can call the fire department. That would be sufficient. But, it’s not like they have to be fire department–trained.

Q How should we document the sprinkler head inspection? Can they be grouped by

department or areas?

BK: The easiest way to do a sprinkler inspection is to use your life safety drawings. Identify the areas on the

Q&A: The new Life Safety Code brings changes to the HFAP standards manual

This Month’s Q&AQA&

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Briefings on Hospital Safety | 7December 2016

drawings that are sprinklers, and as you go through each room, put a checkmark for every room, closet, office, and corridor. As you finish one area, the inspector signs off and dates that. Then [the inspector moves on, and] maybe has another 11 x 17 page for another part of the hospital.

So you break up your hospital into many different levels and layers. That way if someone says, “Well, show me you got every sprinkler head,” you’ve got these drawings and they show that you’ve got every area. That’s truly the easiest and most effective way of doing that.

Q How many inches do fire extinguisher cabinets need to stick out into the corri-

dor to meet the standards for not needing the signs or identification?

BK: That’s not specified. So essentially, if it’s a 0.5-inch projection into the corridor, that would be sufficient.

I think if the cabinet was red and you could easily see the extinguisher, that helps, too.

Q Is there a requirement that the fire extin-guisher have a sign that protrudes into

the hallway and can be seen from a distance? Are there requirements for that sign?

BK: My recollection is no. This comes from NFPA 10; the requirement is that it just has to be marked. Some organizations will put a red dot on the ceiling, 1 inch in diameter, so when people walk by they can see it. Some will just paint the cabinet red. While signs are the most obvious [way of marking extinguisher locations], they aren’t required.

Q Is there a standard risk assessment to use, so we’re all kind of equal on those

things? In particular, for building assessment under the Healthcare Facilities Code.

BK: NFPA 99 doesn’t specify that you use a specific template for the risk assessment. However, they do identify multiple forms that are available that are considered to be acceptable. So you can go to NFPA 99 Chapter 4, and that has some references there to some risk assessments you can consider using.

Q How do we score if the local water au-thority fails to do the water testing over

the past 12 months? If they fail to do it, will that affect our score?

BK: Yes, a surveyor will cite the organization for not having documentation over the past calendar year that proves that the test was conducted. If the municipality doesn’t do it for you, you have to do it on your own.

Q Is there a standard for testing potable water?

BK: I’d be surprised if there wasn’t a standard on potable water, but there’s no HFAP or CMS standard as far as I know. It’s one of those things that’s not included as far as how that test should be done. We just say that has to be tested; we don’t say what those tests have to consist of.

Q And that can probably be coordinated with your municipality, correct?

BK: Yeah, if you’re getting your water from the muni-cipality]. Often the hospital gets a copy from the local municipality of the test report and that’s sufficient.

This Month’s Q&AQA&

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8 |Briefings on Hospital Safety December 2016

Q Speak to decorations hung from the ceil-ing grid. So let’s say we have some really

nice decorations that are hung from a drop ceiling—is that acceptable?

BK: It’s in the section of the LSC pertaining to combustible decorations. However, you still have to comply with the installation of the sprinkler standards that talks about distances that a ceiling-mounted object has to be away from a sprinkler head. So if you’re putting up ceiling mounted decorations and the area has sprinklers, then there is a standard.

Under the old Chapter 5 (maybe Chapter 8) of NFPA 13, it specifically states how far away any ceiling-mounted object can be from a sprinkler head. So you have to follow those particular rules; you can’t just put them up there willy-nilly. Somebody familiar with the NFPA standards should be consulted before any mounting of any decorations.

Q Is the five-year sprinkler obstruction investigation the same as the five-year in-

ternal inspection?

BK: No. There’s two different inspections; one is required, one is not.

The five-year internal inspection is required; the obstruction investigation is only required if the internal inspection warrants an investigation. I believe in Chapter 14 of NFPA 25, they go into detail about the circumstances where an investigation is required.

Off the top of my head, I remember one of them is very ambiguous. If the municipality has a breach in their water supply nearby, then you have to do an obstruction investigation. But they don’t define what “nearby” means; is it within 3 blocks, 3 miles, 30 miles? That’s not defined, so there are some ambiguous issues there that you need to be concerned about and be very

conservative when you apply those issues to your own application.

But no, they are not the same, and only one is required. The other is only required when you meet the conditions for an obstruction investigation.

Q For quarterly fire drills, do we still need to do three shifts? Currently we do a drill

“day,” “evening,” and “night,” which equals one drill each month. Is this still required, or just quarterly?

BK: Both: It’s still required, and it’s required quarterly. So if you have three shifts, you’re doing 12 drills per year minimum.

The requirement says once per shift, per quarter. That means if you have three shifts, then each quarter you’re going to have three drills. And there’s four quarters, and three times four is 12, so yes, it’s quarterly and each shift.

Q Are our existing smoke barrier doors re-quired to have the same annual fire door

inspections as the fire doors?

BK: No. If you look at Chapter 8 of the new LSC, they talk about doors in a smoke barrier that require inspection. But the way that standard is prefaced, it says it’s required by the occupancy chapter.

So if you go back to the occupancy chapter in health-care, it really doesn’t require smoke barrier doors to be inspected. Now NFPA 105 is the standard on smoke doors, and they do have provisions on how to inspect that door. But since the occupancy chapter does not require it, you are not required to inspect smoke barrier doors. [Now] if that door has a fire-rated label on it, that’s a totally different animal. [If] it’s a fire-rated door, you do have to test and inspect it.

This Month’s Q&AQA&

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Briefings on Hospital Safety | 9December 2016

Which leads to the next question that someone may have: “If we have a fire-rated door in a barrier that’s not a fire-rated barrier, do we still have to inspect the door?” And the answer is yes, because Chapter 7 talks about inspecting all fire-rated doors—it doesn’t say if it has to be in a fire barrier or not.

Q Does one need to still maintain a waiver for humidity levels for storage of sterile

items? I was told that CMS didn’t adopt amendments in NFPA 99.

BK: They did adopt. When CMS adopted the NFPA 99 2012 edition, they did adopt the change in humidity levels to 20%. I’ve not heard anything where they didn’t adopt the [American Society of Heating, Refrigerating and Air-Conditioning Engineers] ASHRAE 170 because that’s where the humidity requirements are derived from. I’ve not heard that they excluded that.

So there isn’t a requirement that you maintain a waiver on that, and you do have to maintain a risk assessment. That comes from a CMS [Survey & Certification] S&C memo that requires the healthcare organization conduct a risk assessment of the medical equipment and supplies that are in an environment that has a humidity of less than 30% to be evaluated to make sure that the medical equipment and supplies is suitable for that level of humidity. So yes, you do have to maintain a risk assessment, but not a waiver.

Q Do we have to maintain paper copies of all safety data sheet (SDS) forms, if we

can already retrieve those in an online data-base and an SDS emergency call center is available?

BK: Yes and no. HFAP requires that you have a backup, because if you have a retrieval system—fax, computers, electronic—you have to have a system

This Month’s Q&AQA&

available in case that backup system is down (i.e., the internet is down, fax is down, etc.).

Initially, HFAP was saying, “You’ve got to have paper copies.” Then somebody at a hospital contacted us saying, “We don’t have paper copies; is it okay if we have all the SDS mounted in a laptop and available?” And that serves that purpose, so yes, you don’t have to have paper copies.

But you have to have backups, and in this case it was on a laptop hard drive that they could access without using the internet. I think they had it on CDs or flash drive for a while, too, and those are fine so long as you have a battery-operated computer where you can retrieve that information.

So yes, originally we said you had to have paper copies, but now we’re backing off that and allowing other electronic formats, so long as there’s a retrievable backup in the facility.

Q Do we expect to see any alcohol-based hand sanitizer dispensers that will ex-

ceed the 4-inch projection into the corridor?

BK: I have seen that; some of the really older models did exceed the 4-inch. Though I haven’t seen a whole lot—they were older models, so they lost favor in a lot of organizations.

And as long as we’re talking about alcohol-based hand sanitizer dispensers, even though the standards are very clear that they are allowed in ambulatory healthcare occupancies, they aren’t allowed in corridors of business occupancies. Just so that people are aware.

Q Do we still need the categorical waiver for the Underwriters Laboratories–

approved power strips to be used in patient

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10 |Briefings on Hospital Safety December 2016

care areas? NFPA 99 Chapter 4 does not list any acceptable risk assessments.

BK: No, all categorical waivers are completed. All the categorical waivers did was allow hospitals to use either sections of the new LSC or the new NFPA 99. Now that these codes have been adopted, there’s no reason to continue those categorical waivers.

Just file those documents away in a file somewhere, but you don’t have to maintain them. The examples of the risk assessments aren’t in Chapter 4. They must be in the S&C memo from CMS or in the final rule.

Q Do you need to keep different types of compressed gases physically separated

from each other by type within smoke com-partments (i.e., oxygen, nitrous oxide)? And can you expound on separating full, empty, and partially full cylinders?

BK: You do have to separate oxidizing gases from flammable gases. Other than that, no. You can mix medical air and test gases (nitrous oxide with oxygen) in storage.

The NFPA 99 says you can’t store empty cylinders with full cylinders. There are other accreditation organiza-tions that have taken that further to say that you have to store partial cylinders separate from full and separate from empty. You can do that if you want, but we don’t require that you have three different categories for the oxygen cylinders.

Next question [is], “What constitutes an empty cylinder? What constitutes a full cylinder?” As long as a cylinder has its plastic cover tab on it from the supplier, then it’s considered full. Once that tag is

This Month’s Q&AQA&

removed, it’s no longer considered full. Even if no oxygen has been taken from it, it is now considered partial. And since it’s no longer “full,” you’d have to store it with the empties. Again, if you want to go to the trouble of creating a third designated spot, that’s perfectly fine. But you don’t have to.

“All the categorical waivers did was allow hospitals to use either sections of the new

LSC or the new NFPA 99. Now that these codes have been adopted, there’s no reason to

continue those categorical waivers.”

- Brad Keyes

Q So you can’t reseal the cylinders?

BK: If your people are qualified to seal the cylinders—those plastic caps that go around the port that the regulator hooks up to—I guess we would accept that if it looks like all the others. We’ll deal with that problem when we come to it. And that’s why we have trained surveyors; they get to make that decision.

Q For LS.13.03.12 (Cooking Hood Fire Sup-pression), who qualifies as the owner’s

representative?

BK: The owner’s representative is anyone who repre-0sents the owner. In general, that’s typically the facilities management department when you’re dealing with the NFPA. But, in this case it can be the food service department if it’s decided that they should be the ones to inspect it. So either one can inspect it; it doesn’t matter as long as they are trained in what to look for. H

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Briefings on Hospital Safety | 11December 2016

Developing a crisis plan for disaster recovery Contingency plans help manage the aftermath of disasters that impact facility operations

Even a short interruption in electrical power or heat-ing, ventilation, and air conditioning (HVAC) can put patients at risk, disrupt normal routines, and cause extensive physical damage. That’s why it’s important to have integrated hospital contingency plans specifically addressing power and HVAC interruptions.

Losing power or HVAC can have an immediate impact on hospital operations, the physical environment of care, and the hospital’s ability to meet community needs. The effects are even more severe if the outage lasts days or longer, eroding stakeholder confidence and impacting hospital finances by reducing revenue, distracting caregivers from their primary duties, and limiting use of expensive equipment.

To be effective, the power and HVAC recovery plan needs to be proactively developed, well-understood, updated frequently, and practiced regularly. An effective plan can reduce financial risk, protect the health and safety of building occupants, and increase peace of mind for the organization and its constituents. And in many cases, the time and money invested in contingency planning more than pays for itself the first time the plan is used.

Effective plans speed disaster recovery

Facility teams typically lead the effort to develop a power and HVAC disaster recovery plan. They often engage contingency service providers or HVAC rental service companies to develop a plan that meets their organization’s needs.

Here are some suggested steps for developing an effective disaster recovery plan:

• Take time to understand the financial, operation-al, and stakeholder impact of a power or HVAC service interruption. Qualified contingency ser-vice providers can help the organization deter-mine the true costs of unplanned downtime, which exceed the obvious expense of repairing or replacing damaged equipment.

• Address all the potential causes of system failure, including natural disasters, power outages, equip-ment failures, fires, and even sabotage. Consider each cause’s probability, potential to disrupt nor-mal operations, and financial cost. Include the equipment repair and replacement costs and the impact of the facility being out of commission for an extended period of time.

• Identify reliable, experienced contingency plan-ning consultants and temporary equipment pro-viders. These professionals have access to tools and templates to ensure the contingency plan is complete, effective, and practical.

• Arrange a critical system audit to identify mis-sion-essential power and HVAC systems and as-sess their current operating condition. Address performance problems and document potential failure points. Most organizations will seek a third-party expert to assist with an audit. They often choose to work with HVAC original equip-ment manufacturers because those entities are familiar with mechanical systems and their operation.

• Identify areas within the hospital for which an unplanned service interruption would have the greatest impact on mission-essential operations and the bottom line.

• Consider the need for rental power and HVAC equipment. An HVAC rental services company can help develop plans to meet power, heating, and cooling needs when permanent systems are not available or cannot handle the job.

• Develop and implement the power and HVAC contingency plan and ensure it is a living docu-ment. Review and update the plan each year or when there is a significant change in the facility, such as a building modification or expansion. Provide training, conduct drills, and make re-quired building modifications to accommodate temporary equipment.

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12 |Briefings on Hospital Safety December 2016

Rental companies provide temporary solutions

HVAC rental service companies can help facility teams develop and implement plans to meet heating, cooling, and power requirements when permanent building systems go down. Organizations need to establish a relationship with a rental equipment pro-vider that has the experience, inventory, and capabili-ties to meet their needs. By contracting with a service company in advance, facility teams can ensure the equipment they need will be available when disaster strikes and rental units are in high demand.

For example, a regional hospital in Louisiana was well prepared when Hurricane Isaac caused a major local power outage in 2012. The hospital already had a rental generator on-site to keep the lights on, the HVAC running, and the essential medical equipment operating. Because the hospital had a proactive power and HVAC recovery plan, the facility management team was able to work with its HVAC equipment partner and have the generator installed and ready to power the facility in about 24 hours.

Rental equipment is typically modified with special framing, piping, and electrical connections that make delivery, installation, and startup fast and efficient. The recovery plan should identify the best places to posi-tion temporary equipment and specify how the systems will be connected to the building. Electrical service

must be sufficient to operate temporary equipment, such as a chilled water system or supplementary HVAC units. When time is of the essence during an emergency, having the right connections for electrical, water, and air ducts is essential.

A hospital in North Carolina experienced a severe outage during a citywide power failure, convincing the facility team of the need to develop and implement an HVAC and power contingency plan. The hospital installed external power connections for a temporary generator and pipe connections to tie a temporary chilled water system into the existing system. These access points will streamline the installation of temporary equipment in the event of an unplanned system failure.

Facility leaders play a unique role in protecting their organization from the potential fallout of natural or man-made disasters. The severe weather conditions over the past several years should remind facility team members to be ready to take a leadership role in preparing their organization to respond quickly and efficiently in the event of a power or HVAC service interruption. H

EDITOR’S NOTE

This story originally appeared in Facility Care, a publication of

Thompson Information Services.

Disposable GI scopes will hit market in 2017German company gets FDA approval for disposable device, but will hospitals benefit despite costs?

Hospitals under fire to review and revamp their policies and procedures in the wake of dangers faced from deadly infections borne from improperly repro-cessed diagnostic scopes may soon have a new weapon in their arsenal. The FDA in September cleared the first ever single-use colonoscopy scope for use in endoscopy and endoscopic surgery.

The Invendoscope SC200, as the device is called, was created by Invendo Medical of Germany as part of the

company’s Invendoscopy E200 system. The new scope is being marketed as a safer alternative to reusable scopes; Invendo claims its use presents a lower risk of infection. The product was approved in September and will be released for sale in 2017 at a cost of around $200 per scope.

“Our one-of-a-kind technology provides a platform specifically tailored to address the need for device sterility during endoscopies, the importance of which

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Briefings on Hospital Safety | 13December 2016

Earlier in 2015, a lawsuit was also filed by patient Aaron Young, who became sick after undergoing procedures at The University of California’s Ronald Reagan Medical Center in Los Angeles. Young claims he was one of nearly 180 people exposed to an out-break of carbapenem-resistant Enterobacteriaceae (CRE), which is highly resistant to antibiotics and reportedly can kill up to 50% of infected patients. Two patients died in that outbreak. Also in 2015, officials at Cedars-Sinai Medical Center in Los Angeles discov-ered that four patients were infected with CRE and 67 other people may have been exposed.

The lawsuits led to recalls of Olympus’ TJF-Q180V duodenoscope model, in addition to the company reissuing proper procedures for cleaning and repro-cessing the instruments.

Scopes not easy to clean

In recent years, manufacturers have added more powerful tools to scopes, such as guide wires that can be used to carry stents and tubes to clear infections and blockages in the digestive tract. The drawback to the technology is that extra grooves and channels in the scopes can trap infection-causing bacteria that can be difficult to remove.

The scopes can be cleaned, disinfected, and ready for reuse in as little as two hours, but reprocessing instruc-tions need to be followed exactly as supplied by the manufacturer, and they usually involve several steps: pre-cleaning with special fluid, forcing air through the scopes to check for leaks, and intense brushing to remove residue before disinfection and drying proce-dures. In some hospitals, personnel dedicated to scope disinfection are specially certified, but safety experts say this certification is not required, and many smaller clinics don’t have the luxury of dedicated personnel.

“In addition to the clinical benefits associated with reducing potential cross-contamination, the ergonomic design of the Invendoscope SC200 offers a ScopeCon-troller that contours to the physician’s hand and can be used attached or detached to the endoscope,” says John Cifarelli, chief commercial officer of Invendo Medical. “This unique control body coupled with the

has been underscored by various recent ‘superbug’ outbreaks in multiple U.S. hospitals,” said Timo Herce-gfi, CEO of Invendo Medical, in a press statement.

“The FDA clearance of the Invendoscope E200 System continues its pathway of validation, enabling our company to now provide endoscopists in the U.S. with a revolutionary technology that will allow them to perform colonoscopies with a system that significantly improves medical staff and patient safety while enhancing physician comfort during procedures,” Hercegfi added.

While widespread use of the disposable devices is probably a long way off—the costs of storage and disposal for facilities that perform hundreds or thou-sands of procedures annually are among concerns cited—their invention represents a major breakthrough and alternative for facilities struggling to figure out how to keep patients safe from improperly disinfected scopes.

Colonoscopy scopes and other diagnostic scopes are some of the most frequently used medical devices in America—they are employed approximately 55 million times per year, including 14 million annual colorectal cancer screenings. Currently, all colonoscopy scopes are reusable and require high-level disinfection and controlled storage between uses. They usually cost around $40,000 each.

Because of the nature of their use—being inserted into the gastrointestinal (GI) tract of a patient—the danger of bacterial infections is very high if the scopes aren’t properly cleaned and disinfected, a routine known as reprocessing.

The topic of improperly sterilized endoscopes was highly publicized in 2015, when Virginia Mason Hospital in Seattle sued Olympus, Inc., which manu-factures about 85% of the scopes used in U.S. hospi-tals. The suit claimed that patients were put at risk because Olympus failed to disclose design flaws in its endoscopy scopes that, through scope contamination, led to superbug infections in patients between 2012 and 2014, ultimately causing 39 people at the hospital to contract infections from E. coli bacteria. Eleven of those patients died.

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14 |Briefings on Hospital Safety December 2016

light weight of the colonoscope provides a more comfortable and less tiring procedure for the health-care provider. The Invendoscope SC200 also includes a unique tip for full retroflection in various segments of the colon, enabling inspection behind colonic folds, which is key to a comprehensive diagnosis during colonoscopies.”

In a press release citing 2008 CDC data, Invendo Medical said patients are only placed at risk of endos-copy-associated infection at a rate of one in 276,000 GI procedures. This April, an FDA report found approxi-mately 350 patients at 41 medical facilities worldwide had been infected through dirty GI scopes between 2010 and 2015. The report comes on the heels of a Senate investigation that, in the same time span, identi-fied 250 infections in 25 U.S. and European hospitals.

There isn’t a single, simple solution to ensure scopes are correctly reprocessed, said William Rutala, MS, MPH, PhD, director of the hospital epidemiology, occupa-tional health and safety program at the University of North Carolina Health Care System in Chapel Hill, who was a guest speaker in an ECRI Institute webinar.

“We must do more or additional outbreaks will continue,” Rutala said. “I believe and we believe doing nothing is not an option.”

That said, disposable colonoscopy scopes could be a boon for treating immunocompromised patients or those who pose additional infection risks. This benefit could become a deciding factor for clinics, particularly those struggling to meet CMS and Joint Commission standards on minimizing infection risk.

Marge McFarlane, PhD, MT(ASCP), CHSP, CHFM, HEM, MEP, CHEP, principal of Superior Perform-ance in Eau Claire, Wisconsin, says she hasn’t had a chance to use the SC200 scope. “However, folks must ensure the disposable scopes are stored at the proper temp and humidity and that all manufacturer’s recommendations are followed,” she says.

“We must do more or additional outbreaks will continue. I believe and we believe

doing nothing is not an option.”

- William Rutala

Steve MacArthur, a safety consultant at The Greeley Company in Danvers, Massachusetts, says the idea of a single-use scope could really enhance patient safety. The current method of disinfection and reprocessing of scopes is fraught with peril, he adds. Still, there are economic factors to consider.

“I think the financial viability will depend a lot on the volume of procedures,” he says. “They can’t leave [reprocessable] scopes hanging around forever. I believe it’s seven days before they would need to reprocess. So there would certainly be a benefit of having some [disposable scopes] on hand in case there is an issue with the reprocessing process; maybe equipment-related, maybe staff-related. Depending on the shelf life of the disposables, using the product probably makes way more sense than not.” H

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Briefings on Hospital Safety | 15December 2016

Drug diversion: Regulatory requirements and best practicesDrug diversion in healthcare has been subject to increased focus from regulatory authorities in the past several years.

Editor’s note: The following is an excerpt from the new HCPro book, Drug Diversion in Healthcare, by author Kimberly New, BSN, JD, a consultant to healthcare institutions on the subject of drug security and diver-sion. The book will look at the serious issue of drug diversion in U.S. hospitals and provide a comprehen-sive guide for safety professionals looking to create and maintain a diversion program in their facility.

In many cases, the expectations of regulatory and accreditation authorities are not explicit in regulations, but come to light in the agreements reached, for example, between the DEA and facilities that make settlements for violations or poor practices. In general, the expectation of DEA and other authorities is that facilities adhere to the best available practices for patient safety and drug security, whether or not those practices are spelled out in published regulations.

Consequently, there is no real distinction in terms of DEA expectations between what is required and what is considered best practice. The technology and under-standing for dealing with drug diversion is evolving more quickly than regulations can be rewritten, and regulatory agencies expect facilities to keep abreast of the best practices available.

Most facilities have at least a core group of stakehold-ers that recognize the scope of the problem and risks associated with diversion. Unfortunately, even the existence of a diversion program within a facility is not explicitly mandated by regulation, so it may be difficult for committed people to gain support for some of the essential processes.

When I visit facilities in which administrators are resistant to my recommendations, an argument I hear often is, “Just show me the regulations that require it.” They are not usually content with best-practice guide-lines. There are several controlled substance– and

diversion-related requirements with which facilities must comply, which can support the diversion program effort. Some sources for requirements include CMS, DEA, FDA, EPA, survey agencies, and state profes-sional boards. There are also a number of best prac-tices and guidelines available to provide guidance and support. Sources for guidelines include ASHP, CDC, and ISMP, to name a few.

Finally, additional guidance and expectations can be gleaned from DEA settlement agreements with healthcare facilities. Some of the basic requirements and expectations are discussed below.

Patient safety

The pharmacy has ultimate responsibility for medica-tions throughout the hospital. The Interpretive Guide-lines for the Medicare Conditions of Participation (CoP) state, “The hospital’s pharmacy service must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication-related devices throughout the hospital, for both inpatient and outpatient services” (Interpretive Guidelines 42 CFR §482.25(a)).

Hospitals generally must provide safe environment of care for patients, one that is free from the threat of abuse or harm (42 CFR §482.13(c)(2)). The hospital must also ensure that the medical staff is accountable to the governing body for the quality of care provided to patients (42 CFR §482.12(a)(5) and 482.22(b)).

In order to comply with these patient safety–related requirements, hospitals must keep controlled sub-stances secure so as to prevent tampering and substitution. Nursing staff and anesthesia providers, particularly those in procedural and operative units, who fail to keep controlled substance injections secure

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16 |Briefings on Hospital Safety December 2016

impose a substantial risk to patient safety. Irrespective of whether the services are provided directly by hospi-tal employees or indirectly by contract, the hospital is responsible for requiring staff to comply with state and federal law (42 CFR §482.12(e)). This means that even if anesthesia staff are contracted, the hospital has responsibility for requiring them to comply with state and federal regulations and with relevant patient safety standards (42 CFR §482.12(e)(1)).

The hospital also has a responsibility to ensure that the care delivered by non-employed nursing staff meets hospital policies and procedures (42 CFR §482.23(b)(6)). This includes compliance with controlled sub-stance handling requirements.

Agency nurses are often implicated in drug diversion cases, so in order to comply with this requirement, they must be monitored closely. Due to the relatively short duration of their assignments, their controlled sub-stance transactions should be monitored more fre-quently than those of employed staff.

The CoPs require that hospitals have ongoing surveil-lance to identify “infectious risks or communicable disease problems” in any particular location (Inter-pretive Guidelines 42 CFR §482.42). This CoP requirement is meant, in part, to facilitate early identi-fication of an outbreak. In light of the many reported diversion cases that have resulted in bloodborne pathogen transmission to patients, and in conjunction with this responsibility, infection prevention depart-ments should be apprised of all confirmed drug diver-sion cases.

Patient privacy

Hospitals and other institutions are required to protect patient information and keep unauthorized individuals from accessing private healthcare-related data (42 CFR §482.13(c)(1) et seq and 42 CFR §164 et seq). Many times when diversion occurs, the diverting staff mem-ber has snooped in patient records to locate patient identities that would be ideal to divert under.

It is important to review each diversion case for the possibility of a privacy violation and work with the

institutional privacy officer to ensure that any viola-tions are appropriately addressed.

Security and medication handling requirements

The CoPs require that institutions have policies and procedures in place that prevent, to the extent possible, diversion of controlled substances (Interpretive Guide-lines 42 CFR §482.25(a)(3)). In order to comply with this directive, facilities must have specificity regarding controlled substance handling in their policies and procedures, and must insist on compliance with expected practices.

The CoPs require that all drugs and biologicals must be kept in a secure area, and locked when appropriate (42 CFR §482.25(b)(2)(i)). This means that controlled substances need to be stored in such a way as to prevent unauthorized access by anyone. Secure areas must be accessible only to authorized individuals (Interpretive Guidelines 42 CFR §482.25(b)(2)(iii)). “Authorized individuals” must be identified by job class in hospital policies and procedures, and those procedures must also indicate how unauthorized access is prevented.

Automated dispensing cabinets (ADC) are recognized in the CoPs as a secure option for controlled substance storage. If ADCs are used, it is important to consider the Institute for Safe Medication Practices (ISMP) guidelines for ADC use, including password security, unit-specific privileges, biometric access, locking storage in refrigerators, returning unused medications to a designated return bin, and implementing blind counts for controlled substances (ISMP Guidance).

The CoPs state that drugs can’t be administered without a valid order by a physician, and those drugs available on override must be strictly limited to those that might be needed immediately in emergency circumstances (42 CFR §482.23(c)(1) et seq and Inter-pretive Guidelines 42 CFR §482.25(b)).

This requirement is meant to ensure that appropriate safety checks are in place prior to administration, but it is also relevant to the diversion prevention effort. One popular method of diversion is to pull

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Briefings on Hospital Safety | 17December 2016

controlled substances via an override transaction. Hospitals should regularly review their list of overrid-able controlled substances, and keep that list as narrow as possible.

The CoPs require that quantities of medications dispensed must be limited to prevent diversion, and that patients must be assessed to ensure that medica-tions have their intended effects (Interpretive Guide-lines 42 CFR §482.25(b)(1)). Monitoring for the removal of excessively large doses is one way of pre-venting diversion, but limiting the dosage size available based on the needs of the patient population being served is also an effective preventive measure.

Although hospitals may permit patients to self-admin-ister their own medications, hospitals are required to keep self-administered medications safe and secure. Owing to the increased security requirements for controlled substances, hospitals should only allow self-administration of these drugs in very limited situations. In fact, the CoP Interpretive Guidelines state, “Hospitals… generally should not include such medications as part of a patient self-administration program (Interpretive Guidelines 258).

ISMP guidelines suggest that wasting of unneeded controlled substances happen at the time the medica-tion is removed from secure storage (ISMP Guidance, Core Process 2). As discussed in more detail in a subsequent chapter, the DEA, EPA, and FDA have all identified regulations or expectations regarding con-trolled substance waste disposal.

Local waste treatment regulations may also impact how a facility approaches controlled substance disposal. Because controlled substance waste is a common source for diversion, it is important to have a compliant process for disposal in place, one that doesn’t facilitate diversion.

Recordkeeping

The CoPs and DEA regulations require that current and accurate records must be kept of the receipt and disposition of all scheduled drugs (42 CFR §482.25(a)

(3) and 21 CFR §1304.04 et seq). This includes having complete records for all controlled substances from the time of procurement to administration, waste, or return via the reverse distributor. This also includes being able to track all controlled substances that leave the pharmacy and ensure that they are received into stock at the intended location, and also to track con-trolled substances that are removed from stock in remote locations to ensure they are received back into stock in the pharmacy.

All institutions should have a meaningful daily or per-shift reconciliation of drugs that leave or are expected to be returned to the pharmacy. This require-ment also applies to situations in which drugs are manually accounted for.

For instance, many facilities use manual records to track the administration and wasting of patient-specific controlled substances. Nursing documentation may not be sent to pharmacy as it should be, and pharmacy doesn’t follow up to be sure the documentation is received. This is a situation where complacency is not an option.

The CoPs require that all records demonstrating the movement of controlled drugs within the institution must be readily retrievable (21 CFR §1304.04 et seq). This means that facilities must be able to produce all records relating to controlled substances without delay, not just those records relating to procurement and inventories.

Discrepancies are required to be reconciled “promptly” (21 CFR §1304.04 et seq). The term “prompt” is explained in the CoPs by citing the Merriam-Webster online dictionary definition where “prompt” is described as being performed “readily or immediately” (Interpretive Guidelines 42 CFR §482.24(c)(2)).

This interpretation supports the policy that most facilities have requiring that discrepancies be resolved by the end of the shift. It also means that discrepancies cannot be left unresolved for extended periods of time, and discrepancy resolution must be consistently monitored. H

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18 |Briefings on Hospital Safety December 2016

Healthcare Security Alert!

Shortly after Hurricane Matthew hit the southeast-ern United States in early October, numerous field hospitals designed to aid storm- and flood-ravaged communities went into action.

One of them was Carolinas Healthcare System’s (CHS) MED-1 Mobile Hospital Unit. Headquar-tered in Charlotte, North Carolina, MED-1 is a flotilla consisting of two 53-foot, 18-wheel tractor-trailers and various support vehicles. It provides six critical care beds (including two isolated beds where surgical procedures can be performed), full trauma surgery and anesthetic capabilities, ED acute care beds, a dental/EENT chair, a shower/laundry truck, dormitory facilities, an SUV for staff transporta-tion, and 72 hours of self-sustaining power via generators or local shore power. In short, it’s an ED on wheels that can be used to temporarily replace or supplement a hospital ED.

MED-1’s mission? Deploy immediately to the nearby town of Lumberton and provide support to Southeastern Regional Medical Center, where rampant flooding and a patient surge had hobbled the facility.MAD For several days, MED-1 and its staff helped with hospital overflow, rendered treatment and emergency care to hundreds of patients, and even helped deliver a baby within the hospital unit.

“MED-1 is a first-of-its-kind advanced mobile hospital. As one of the few privately owned mobile hospital systems in the country, it is our job to assist communities in need and support hospitals during emergency events,” says David Callaway, director of operational and disaster medicine for CHS and MED-1’s medical director. “The ability to have a scalable response within the healthcare system and

support communities at risk is vital to our core mission. The MED-1 mobile hospital team puts service above self and can be mobilized within hours of a disaster to provide aid to an affected community.”

A shield in the field

Lisa Terry, CHPA, CPP, senior healthcare advisor for ODS Security Solutions in Whittier, North Carolina, can vouch for the impact and importance of mobile hospitals as well as the need for security during these field operations. She was part of the Police Emergency Response Team (PERT) from the WakeMed Health & Hospitals network in Raleigh that accompanied the North Carolina State Medical Assistance Teams to Waveland, Missis-sippi, in the wake of 2005’s Hurricane Katrina.

“Martial law had been declared due to the extreme state of emergency, but local law enforcement infrastructure had been destroyed along with the associated physical structures,” Terry says. “There was no force protection available in Waveland to protect the mobile field hospital there. These team members provided protection and support for the duration of the two-month field hospital and staff deployment.” She says PERT helped establish helicopter landing zones for patient transports, provided continuous security for pharmaceutical storage, and managed ground ambulance operation for patient support.

“Whenever you set up in a different setting outside a traditional healthcare facility, it’s really important to have strong security and safety protocols in place,” says Steve Seigel, a member of Cedars-Sinai Medical Center’s Board of Governors in Los

When your hospital facility hits the roadMobile hospitals are a trend on the rise, but security and safety have to still be ensured when considering this option

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Briefings on Hospital Safety | 19December 2016

Healthcare Security Alert!

Angeles and a veteran healthcare expert. “When people are in a situation like a disaster, it can sometimes influence them to act in negative ways when emotions are high. Additionally, it can be challenging to deliver quality care when you’re understaffed and overtaxed, so it’s important to implement safety measures as well.”

Mobile and multi-purpose

Dalton Sawyer, director of emergency management and business continuity for the UNC Health Care system in Chapel Hill, North Carolina, and its 14 campuses, says mobile hospitals can be leveraged for a variety of scenarios beyond emergency events and mass casualty incidents. This includes providing patient surge support for the hospital that operates the mobile unit and being ready during large-scale public congregations, like sporting events.

“It can serve as a means of shielding your main hospital from minor injuries during a pre-planned mass gathering,” says Sawyer.

But regardless of the reason, safety and security need to be emphasized.

“We deploy a mobile field unit in Chapel Hill every Halloween, when up to 80,000 people gather to party on Franklin Street,” says Sawyer, who notes that the field hospital is mobilized within a large lecture hall nearby that can accommodate up to 50 patient beds. “In this case, we are being proactive as opposed to responding to an emergency event. But we have to be on our guard—there are a lot of inebriated people on the street who can cause problems.”

Callaway, who is also the medical director for Team Rubicon USA, a veteran-focused disaster response organization, says mobile hospitals have to consider several potential threats to safety and security, including inclement weather, harassment or violence from displaced people, looting, theft of medical

equipment, pharmaceuticals or medical records, and injuries caused by damaged infrastructure.

“The healthcare organization that mobilizes a field hospital is responsible for its staff and patients, and they need to make sure that it’s a safe and secure place to work—not just, say, from violence and looting. The geography should also be safe from flooding, landslide, trees and debris falling on the mobile hospital, and more,” says Callaway. “Accountability is key, and there are preemptive security issues that need to be considered carefully well before deployment.”

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Healthcare Security Alert!

While Mother Nature can’t be controlled, your security presence can, says Terry. Following Hurricane Katrina, WakeMed Health & Hospitals created a mobile special/emergency response team, which includes existing security personnel as well as volunteer staff members. The team is trained to isolate, contain, and evacuate field hospitals and respond to heightened security situations on a hospital campus.

“This emergency response team should consist of a group of highly motivated, well-conditioned, specially equipped individuals trained to function under a variety of situations, including those that call for specialized security intervention,” Terry says. “Members of this special team should be selected based on important factors like physical fitness, intelligence, maturity, attitude, ability, and willingness to volunteer.”

Best practices for protection

To better ensure safety and security for everyone involved in a mobile hospital, consider these sugges-tions from the experts:

• Assemble the right planning team. Create a multidisciplinary team responsible for devising and improving your mobile hospital operations; include clinicians, nurses, administrators, facilities managers, engineers, leaders from various departments, and repre-sentatives from local authorities like police and fire departments.

• Create a mobile special emergency response team. “A specially trained and equipped secu-rity team can more effectively isolate and se-cure the inner perimeter of a mobile hospital, contain the outer perimeter, and evacuate if and when necessary,” says Terry. “The objec-tive of this team is to utilize the minimum amount of force necessary to achieve a suc-cessful conclusion of a security event, with

minimum hazard to the patients, public, staff, and officers involved.”

• Devise an emergency operations plan (EOP) that clearly addresses when and how a field hospital should be mobilized, including the circumstances, scope, and execution.

• Gather the necessary ingredients for an effec-tive mobile hospital, including automobiles, heavy machinery, tents and sandbags, beds, cots and linens, and medical devices and sup-plies. “Make sure you have a reputable and powerful generator you can rely on or another backup power source in the vicinity you can tap into,” says Seigel. Also, “aim to put up physical barriers around your field hospital,” adds Callaway.

• Determine the right location to mobilize a field hospital. If you’ll be providing support adjacent to your main hospital, is there a safe and suitable area, such as a nearby parking lot, where you can deploy? If you need to deploy elsewhere, “conduct a site assessment of the area, being careful not to set up too close to the event for which a mobile hospital is need-ed,” says Sawyer. “The chosen location should be a safe place with ingress and egress routes for vehicles and where environmental condi-tions can be better managed.”

• Select the right field hospital for the situa-tion. “Once you have picked your site, you need to determine the type of mobile hospital needed,” Sawyer notes. “Can you shelter with tents and sandbags, or do you need a building or facility that’s heated because it’s the middle of winter? The most important security and safety measure is effective situational aware-ness of factors like weather, environment, and social terrain.”

• Aim for efficiency. “It can be difficult to be a fast-moving operation within a mobile set-ting,” Seigel says. “Sometimes you see a bot-

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Briefings on Hospital Safety | 21December 2016

Healthcare Security Alert!

tleneck of support staff in a field hospital. In a traditional hospital setting, you have an idea of your patient flow, but that can be hard to gauge and manage in a remote operation. Try not to take on too much too quickly—work together with the health system in your local community, and assign a leader to man-age the logistics of operations within your mobile hospital.”

• Provide necessary support and relief for staff involved. Mobile hospital workers in-volved in an emergency event typically don’t want to relinquish their posts. That’s why it’s important for your healthcare organization to have extra staff ready to relieve your first re-sponders. “Create an A team and a B team that rotates shifts, and be selective about who you call in,” says Sawyer. In addition, have food, designated staff rest areas in or near the mobile hospital, and counseling support available for your staff. Remember that an overworked and overstressed staffer can make mistakes that can compromise safety and security.

• Choose your security presence wisely. Assign a sufficient number of security officers inside and surrounding your mobile hospital, and be prepared to call in extra help on a moment’s notice. “To help make the right security per-sonnel choices, ask important questions,” says Sawyer. “What is the status of the social climate in the area at the time? Are there protesters nearby, for example, which will

require extra security personnel? The security forces you need will depend on the nature of the event.”

• Train and drill properly. Conduct tabletop ex-ercises and mobile hospital deployment drills to test your organization’s ability to mobilize quickly and effectively. “We deploy our MED-1 Mobile Unit to support community service operations like charity marathons and cancer screenings at nearby clinics and use these events to train our staff and validate our oper-ational systems,” Callaway says.

Mobile hospitals will continue to matter

Healthcare organizations need to be proactive in developing their field hospital capabilities or risk being blindsided by a mass casualty incident, patient influx, or other event that could overwhelm a medi-cal facility’s resources and devastate its community.

“The issue isn’t going away—whether it’s a major weather event or other natural disasters, we have increasing need for mobile hospitals,” says Seigel. “Among the things we can control is readiness. We have the technology and the protocols in place to develop really great mobile hospital systems.”

What’s more, having an effective field hospital force that’s protected and able to provide quality care can add value to your organization and boost morale.

“The ability to support our communities builds camaraderie and a sense of purpose and service,” says Callaway.