This same, however, could be said of many hotels. A more compelling reason has made me loyal—so loyal that Kimpton tells me I’m the first person to have stayed at all 56 of their properties over the group’s first three decades. Hospitality. The Kimpton team exudes genuine hospitality.

As with anyone who stays fifteen nights in one year, Kimpton has granted me Inner Circle status, which, among other things means I will always find a lovely amenity in my room. I’ve also been given the direct phone number to the CEO. I understood the amenities but the CEO’s number?

A year and a half ago, after surgeons found glioblastoma in my brother’s brain, I determined to spend as many closing days with him as possible. This meant frequent trips to Novato, just north of San Francisco, during which I stayed at Kimpton’s Argonaut Hotel, not far from the city side of the Golden Gate Bridge.

On my second visit, before I said a word or handed over a credit card, the front desk people smiled and said, “Welcome back, Mr. Neuenschwander.” Early on, I realized I had found a home away from Bellevue. After several months, the Argonaut manager responded to one of my impersonal online reservations with a personal e-mail.

Mr. Neuenschwander,

So glad to see your reservation.  It will be good to have you back. How is your brother? We are praying for and thinking of you.

Antonio

Ugh. I had to inform him that Ed had passed away and that I was coming down to assist the family with arrangements. Antonio’s quick response was heartfelt, empathetic, comforting—brotherly. Upon arrival, they put me in the best corner suite overlooking the bay facing a majestic Northern California sunset behind the most beautiful bridge on the planet. On the table was a stunning Japanese flower arrangement with a sympathy card bearing kind thoughts, wishes, and prayers—handwritten by many of the staff who had lifted my spirits over the difficult months. I choked up.

Two weeks later, I enjoyed my inaugural visit to Kimpton’s new Palomar Hotel in the City of Brotherly Love. Again, I was upgraded to a beautiful suite, which had a gorgeous crystal vase filled with rare fresh flowers. I thought it a bit extravagant for a hotel. Soon a young lady arrived at my door, pushing a linen-covered cart carrying champagne, chocolate covered strawberries, and an envelope with my name on it. While opening the door, I opened the envelope and found sympathetic condolences from the staff. Ah, that’s why the flowers. I’m slow.

The young lady was tiny and shy, with hints that she may have known something of the harder side of life. When she saw the flowers, she smiled and dared to ask, “What are you celebrating?” When I told her my brother had died, she froze, looked me square in the eye with understanding, and gently asked, “Do you need a hug?” I did. She sincerely cared and gave me a hug that I feel to this day.

That’s when I knew what you do with the CEO’s number. After his secretary heard my name, she said,

“Of course, Mr. Depatie will take your call.”

“Hello, Mr. Neuenschwander.”

“Mike, I have to tell you what just happened to me in your Philadelphia hotel.”

“I’m eager to hear but would first like to say how sorry we are to hear about your brother.”

The CEO knew. The CEO cared. I was touched. But no more than he was by hearing about the young lady who delivered the hug. He said my call made his day and something about Kimpton’s commitment to genuine hospitality.

That evening I met the Palomar hotel manager and reran the hug episode. Nick teared up and said, “This is why I do what I do.” Then he told me how Sharnese had applied without experience—not even a resume. Though extremely timid, she came across as genuine and kind. “You can’t teach that; we can teach all the other stuff.” We both had tears.

Several months later, I was back in the Bay Area to be near my mother who had just entered hospice. Have you had experience with hospice? I’m a believer. Each person who cared for mom cared—was in it for all the right reasons. Their love for my mother as well as for her grieving husband and son was obvious.

Once again, the Argonaut was my home, and the staff was my extended family. Flowers, a sympathy card, kind words, and more hugs followed my mother’s passing.

I’m intrigued that in my desk dictionary, hospitality immediately rubs shoulders with hospice to its left and hospital to its right—a troika worth pondering.

Resumes and skills of physicians, nurses, pharmacists, and therapists are important. Safety, quality, state-of-the-art technology, lean process, and evidence-based medicine are vital. When patients don’t have to wait until hospice for caregivers to show hospitality, that’s priceless. That’s what I get from my hotel! And that’s what I got December 13 from the time I walked into my hospital to the moment I was wheeled out after having gone under the knife to repair a rotator cuff. Nice.

There is a great line from the back of those Gideon Bibles found in hotel nightstands everywhere, which says:

“Do not neglect to show hospitality to strangers, for by this some have entertained angels without knowing it.”[1]

I’m not sure I fully understand what that means. But I do know that when Sharnese hugged me in Philly, the city lived up to its name, and the membrane between heaven and earth seemed exceptionally thin.

I’m guessing that since you’ve stuck with me to this point, we’re resonating.

I commend you for genuinely caring for people where you work.

Mark Neuenschwander a.k.a. Noosh

Copyright 2012 The Neuenschwander Company

Presently, black-capped chickadees are having a free for all—two, then five, now ten at a time. Each stays a few seconds, grabs a seed or two, and moves on. Cooperative little tweets. Gladly each respects the queue.

Now and again a fat northern flicker, around ten times the body mass of a chickadee, lands and rules the dispenser while flicking massive quantities of seeds onto the ground beneath. That is unless a mountain blue jay is in the neighborhood. Toronto was onto something when they named their baseball team after these blue terrorists that send all our other feathered friends flying.

Then there are the resident squirrels. Pecking order exceeds the genera of beak-bearing critters. All creatures, great and small, flee when they show up—except for me. Squirrels make my adrenaline spike when they fail to differentiate between birdseed and peanuts. They have absolutely no respect for the concept of a bird feeder.

Admittedly, I take to squirrels chasing each other around the yard and up our trees. But when it comes to stealing birdseed, they are squirrels—rude, stubborn, intrusive rodents.

We have trimmed the branches of nearby trees and taken out bamboo stalks, but all we’ve done is raise the bar. Though they’re not the flying variety, these little beasts are world-class jumpers.

I don’t even want to waste a sentence on the rat that ransacks our feeder by night. Let’s just say he’s well-named.

I’ve tried attacking them with a golf club, but they are gone before I can get the window open. I think about wrapping the feeder with wire attached to a battery and fantasize switching on the juice while the rodents are snacking and watching how high the really can jump. My friend in Minnesota swears by the pellet gun. He’s a surgeon. I said, ”Yeah, but our feeder is too close to a window.” He said, “That’s OK. It’s worth it. There are few things in life as satisfying as seeing a squirrel on its back with a grand mal seizure.”

Most frustrating is that we have a hard time keeping our birdseed- dispensing device replenished for the chickadees.

Last week I was engaged with a hospital system preparing for bar-code-enabled medication administration. In the process, like so many hospitals, they have realized the value in revisiting their entire drug distribution and dispensing system, which includes using their automated dispensing cabinets (ADCs) more safely and efficiently.

Their issues made me think of mine with our bird feeder.

I’m sure there’s a manual out there for how to manage bird feeders in a way that controls access and keeps the rats, squirrels, and maybe even the jays away. I just haven’t taken the time to fetch and read it.

When it comes to ADCs, for starters, it is not uncommon for needed meds to unnecessarily go out of stock or for the wrong kind of users (if you know what I mean) to gain access to the drugs. Good news: There is a manual out there with almost everything you need to know about using ADCs safely and efficiently. It’s called
ISMP Medication Safety Self-Assessment for Automated Dispensing Cabinets.

The problem is that not enough hospitals use it, and many that do don’t use it often enough. ISMP recommends going through the assessment on a quarterly basis. Sounds about right to me. Perhaps it’s time for your organization to pull this trustworthy tool off the Internet shelf, dust it off, and use it. It’s an easy-to-follow checklist for an interdisciplinary team that covers all the bases.

I cherry-picked a few items from the assessment, which asks you to check A “no activity,” B “discussed but not implemented,” C “partially implemented in some areas,” D “fully implemented in some areas,” or E “fully implemented throughout the organization” for each item. For example:

• There is an interdisciplinary team that monitors, at least on a quarterly basis, the ongoing safe use of ADCs, (e.g., work-flow issues, location of cabinets, quantity, and service). A B D C E

• All staff with access to automated dispensing cabinets (ADCs) receive orientation and ongoing competency training on the safe and proper use of ADCs. A B D C E

• Sufficient numbers of automated dispensing cabinets (ADCs) are available throughout the organization to meet the needs of the medication- distribution system. A B D C E

• Pharmacy personnel are assigned to monitor par levels of ADCs for low critical values and to replenish stock when necessary. A B D C E

• Monitor for lines in front of the ADC to access medications. A B D C E

ADCs are sort of like golf. A good game has more to do with your swing than the brand of your clubs. It’s pretty hard to play golf without clubs. But my experience suggests that while the majority of hospitals have pretty good ADCs, most need to work on their swing.

I will let you draw your own parallels between the menagerie outside my window and the ADC users in your hospital.

I have to go—the squirrel’s back.

Mark Neuenschwander a.k.a. Noosh

The MRI, if not the nightly pain, prompted me to sign up for the rotator-cuff repair, a 70-minute procedure that was successfully completed on Tuesday afternoon (12/13). It was difficult to keep count, but before I went completely under, I recall being touched by nearly a dozen caregivers (e.g., nurses, technicians, anesthesiologists, and surgeons), to say nothing of the behind-the-scenes cast from pharmacy, housekeeping, engineering, admitting, administration, billing, parking, and security. Hospitals are villages.

During preop, two docs, with yen-and-yang precision, maneuvered a catheter into my neck. The portable pump on the other end took over where surgery left off—dripping Ropivacaine, a nerve-blocking agent, into to my beleaguered arm for the next 72 hours. A day, then two after surgery, nurses called for pain scales. They were pleased that all my answers were zero out of ten. I was elated.

After confirming my consent, the anesthesia started working its magic. But not before I heard someone call the team to order and walk them through a process I recognized from my reading. I said, “Atul Gawande!” to which one physician expressed pleasant surprise that I understood and appreciated what they were doing.

For a moment, I feared he might suspend the anesthesia to tell me how he and his colleagues had worked with Dan Boorman, the now famous Boeing engineer who helps other industries apply aviation-tested checklists to improve safety and accuracy—well before Brigham and Women’s surgeon Atul Gawande’s Checklist Manifesto became a New York Times best-seller two Decembers ago.

So, I’m a week out. The pain pump is gone but with Ibuprofen and a bit of Percocet, the pain is manageable. The trick is learning to live without my left arm for a few months. Anyone remember Jim Abbott, the one-handed pitcher? It was amazing to behold his windup. Jim would put his glove pocket-down atop his right arm, pitch the ball, and place his left hand into the glove, hopefully before the batter hit the ball his direction. When he caught the ball (fielding or, much more commonly, getting the toss back from the catcher), he’d move the glove under his right arm, quickly extract his hand, grab the ball out of the glove, and make his throw or get ready for the next pitch.

NPR interviewed a handball champion a few years ago who had only one hand. The reporter asked what I thought was a stupid question. “Do you find having just one hand a disadvantage?” To my surprise, he said he found it to be an advantage. “Each play, my opponent has to decide which hand he will use. I’ve already decided.”

Regardless of our stations in life, they say we all put our trousers on one leg at a time. But I’ve discovered a new slant to that playing field. Even though I’ve decided which arm I will use when getting dressed (which happens to be on my strong side), it’s far south of amazing. I’ll spare you the details. Enough to say that I hadn’t realized how important both hands were to even the little things in life. Though we admire the heroics of a Jim Abbott, I’d wager even he would say that two are better than one. The handball guy is definitely an outlier.

A few thousand years ago, Paul, an apostle of Christ, used the human body as a metaphor for the church. I think it works just as well for a hospital. He argued that each person/part is needed and that the less attractive parts may be the most important. “The eye cannot say to the hand, “I don’t need you!” And the head cannot say to the feet, “I don’t need you!” On the contrary, those parts of the body that seem to be weaker [for me my left shoulder, arm, hand] are indispensable.”[1]

It’s obvious that the staff at my hospital not only play their roles, but they also work at understanding, appreciating, and honoring their colleagues’ roles regardless of gender, age, or degrees. They call it Virginia Mason Team Medicine.

As we prepare for the seventh unSUMMIT for Bedside Barcoding, I’m thinking about the unique members of our excellent team and their essential roles.[2] Then, there are our enthusiastic alliance and media partners and, of course, your hospital peers who are not only doing a quality job of bar coding at the point of care (BPOC) in their hospitals, but also are willing to give their time to share what they are learning with others.

But wait, there’s more. Hospitals cannot say to technology providers, “I have no need for you.” Nor visa versa. Have you ever heard one hand clapping? Hospitals could not scan at the bedside were it not for the legion of good products and supportive services. Similarly, software companies can’t say what they provide is any more important than what the printer, cart, or scanner companies provide. Each plays a critical role, even if some are tempted to deem their offerings more important than others. A million-dollar electronic medication administration system cannot accomplish its objectives if the lowly bar codes on patient wristbands are unreadable.

And how about the journals and magazines that publish the BPOC literature, print the case studies, and run the ads for required products and services?

BPOC requires a tribe.

Finally, part of the “un” in unSUMMIT is the unconventional (we think ingenious) path we committed to take at our inception, namely that caregivers and vendors would sit shoulder to shoulder in our educational sessions. And, that nurses and pharmacists, safety, risk, and information managers would blend in one conference (rare) to learn from each other.

This team approach has resulted in better products from the vendors and better processes from the end users.

Wherever your role in the enterprise, I hope you will get to experience the team approach to BPOC with us this May 2-4 in Anaheim.

I love the scene in A League of Their Own, when the Rockville Peaches’ Coach Dugan (Tom Hanks) is awakened on the team bus. When they told him the bus wasn’t moving, he barked a question for which the pretty little left fielder, Betty ‘Spaghetti’ Horn, has the answer:

Dugan: Why are we stopped?

Horne: Lou quit.

Dugan: Who’s Lou?

Horne: (Pointing to the steering wheel) The driver.

Grateful for the part you play in BPOC’s league of its own.

Mark

Well, I went in for an MRI, and the diagnosis was not good: Claustrophobia. But I’m getting ahead myself.

While studying x-rays of my shoulder, my doc ordered an MRI. I told him we were nearing eight on the pain scale and pressed for the earliest appointment.

Seven o’clock the next morning, after being scanned for metal, a rad tech strapped me to the transport board and pushed a button. Moving into the magnetic abyss, I felt like dead man walking. Except, I couldn’t walk. But I could talk. It took about two seconds to find my authoritative voice: “I NEED OUT NOW.” She got the hint, and I was pardoned.

I asked her not to tell anyone, throwing in HIPPA. She kindly assured me it happens all the time. Okay, I didn’t pass. But, she says I didn’t fail. We’re calling it an incomplete.

She said something about rescheduling so we can get those shoulder pictures. I said, “What shoulder?” She mentioned the sedation option. I relented.

So, I determined to take my mulligan. The plan was to put me under while stepping up to the tee the following week.

While it felt like I left the building wearing a scarlet C, I experienced more shudders than shame. I couldn’t shake the hemmed-in feeling. On the drive home, I entertained stopping by the dealership and buying a bigger Audi.

Truthfully, I was blindsided. I was looking forward to a horizontal half hour. Looking back, though, clues were available. As a kid at camp, I couldn’t zip up a sleeping bag. Not if I was in it. Still can’t.

While watching news of the Peruvian miners who had to Houdini their bodies into a narrow capsule to be lifted to light and life, I recall thinking I’d probably stay in the hole. Just thinking about it begs for Clonazepam.

I surmised that either Rumsfeld and Cheney aren’t claustrophobic or they’d never had a closed MRI, else they would not have settled for water boarding.

Before I got home, I flashed back on how up to her last April 14, my mother reminded me that on that day in 1948 I refused to deliver. My head came out, but my shoulders (yes, my shoulders) wouldn’t. They were too broad to negotiate the passage. Not to minimize mom’s trauma, but apparently I didn’t appreciate the delivery myself. I’ve got forceps marks on my head to prove it.

Finally, I remembered Jesus’ words, “Unless a man is born again, he cannot enter the kingdom of heaven,” and the puzzled listener who rhetorically asked, “Can a man enter a second time into his mother’s womb and be born again?” Good thing Jesus was talking metaphorically because I don’t know if there’d be any hope for me if one had to be born again physically.

Perhaps that’s what I was feeling at the entrance to the MRI. Been there. Done that. Not interested.

Did I say I asked to have “MRI” added to the “allergies” field in my EHR?

I got my second chance last week. They put me under before strapping me down. No problem. However, as the Capital One commercial suggests, it pays to ask, What’s in your wallet? The magnetic strips on all five credit cards in my jeans got fried.

Today, we looked at the digital images. My left rotator cuff, though photogenic, is torn. Surgery? Hmm. Decisions.

On this Thanksgiving eve, I’m grateful for sedation and MRIs—In that order.

I’m thankful for Virginia Mason Hospital and Medical Center (VM), my health-care provider, whose groundbreaking efforts have applied Toyota’s lean principles to increase quality and reduce the cost of healthcare. From top to bottom, VM lives up to its mantra: Team Medicine.[1] All this, when most people in our world will never be touched by a qualified physician or treated in a hospital that could pass a Joint Commission audit.

I’m also thinking about the wide swath of nurses, pharmacists, physicians, informaticists, technology developers, healthcare writers, and journalists (among others) who drop by my column now and again while helping hospitals move from good to great. As one of your many beneficiaries, this Thursday I’ll be giving thanks for you.

Happy holidays,

Noosh

Not so for the Phoenix lady last October who ended up in an ER because she reached for eye drops and mistakenly picked up Super Glue. One responder suggested the lady was crazy for not observing the differences in size, shape, and color of the containers. What is crazy is that the error seems to occur periodically. Like this October, when a 69-year-old Maryland man said, it felt “just like I lost my eye” when he made the same mistake.

I know a very sane person who mistook contact lens cleaner for eye lubricant. At that time, the bottles were similar in appearance—to say nothing that both had to do with eye care. The episode was insanely painful and injured her eyes—temporarily, thank God. The industry has since changed the packaging.

Last month, an ISMP Medication Safety Alert brought yet another pair of sound-alike, look-alike (SALA) drug names to our attention: DUREZOL and DURASAL. In the long list of SALA’s, it’s hard to find two that could be more easily confused.

Granted the containers do not look alike. DUREZOL is in a white plastic squeeze bottle containing corticosteroid eye drops to reduce inflammation and pain following ocular surgery. DURASAL is in a brown glass bottle with a brush applicator for spreading the caustic liquid on warts for removal.

Though ineffective, my guess is it wouldn’t be that big a deal to apply eye drops to a wart. But applying wart-removal fluid to your eyes? Do eyes get warts?

The first DUREZOL/DURASAL mix-up reported involved a pharmacist misreading a doctor’s prescription for the eye drops and dispensing the wart remover instead. The patient brushed [1] the acid in his eyes, suffered “grievous personal injury,” and filed a $1 million lawsuit against the pharmacy.

When confronted with SALAs, ISMP says some drug companies simply “respond with a letter stating, ‘Reading the label is Nursing 101,’ implying that labeling, packaging, and nomenclature problems lie solely with the practitioner who did not read the label correctly.”

Similar sentiments were expressed during an ASHP LinkedIn Discussion of the DUREZOL/DURASAL debacle. After a number of reasonable fixes were suggested, one discussant added, “Still, nothing takes the place of good-old fashioned reading.”

Okay, that might be a helpful word for the practitioner, but what about the patient? Granted, “Wart Remover” is spelled out beneath the drug name in good-sized print. And the instructions are unambiguous: “Using the brush applicator supplied, apply twice to entire wart surface.” Shouldn’t patients read too? Of course—if they can.

It’s too easy to assume. Like the billboard I saw on a Florida highway a few years ago that read: “Have a literacy problem? Call 800-READ-NOW.” Yeah, right.

I’m thinking about the 14 percent of our U.S. adult population who can’t read. This year, the National Institute for Literacy estimated that 47 percent of adults in Detroit are “functionally illiterate.”

I’m grateful for ISMP’s persistence in collecting and reporting SALAs and for their unrelenting appeal that we all do our part to keep preventable errors from being repeated. So I’m wondering if there’s more we could do to communicate critical drug information to nonreading patients.

Here’s an idea: Briggs and Stratton is putting 2D bar codes that they call Power Codes (it’s a guy thing) on their motors, which when scanned with smart phones link lawnmower users to an array of important information like FAQs about operation and maintenance in English and Spanish. More reading you say. Not necessarily. Scanning QR or DataMatrix [2] codes on DUREZOL and DURASAL containers could link patients to videos pronouncing the name of the drug, stating what it is for, showing how to squeeze drops into an eye or brush fluid on a wart, and issuing warnings.

Of course, I’m assuming that people who can’t read will have smart phones. I realize some don’t. But many do and are fairly skilled with them. I’ve seen preschoolers use them to view pictures and play games. DataMatrix codes aren’t going away, and QR codes are showing up in more and more magazine ads as well as on products.

Vintners are using QR codes on bottles to link sophisticated connoisseurs to video clips, touting their wines’ vintage, aromas, and flavors and suggesting perfect pairings. If it’s good for lawnmowers and wine, why not drugs?

What do you think?

Mark Neuenschwander a.k.a. Noosh

BTW: I’m sad to report that my grandchildren’s Sunday schools do not offer edible paste. I hope the kids turn out all right.

Copyright 2011 The Neuenschwander Company

SUMMARY: The Food and Drug Administration (FDA) is announcing a review of the “Bar Code Final Rule,” under Executive Order 13563, “Improving Regulation and Regulatory Review.” The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified.

DATES: FDA will accept both initial comments and reply comments in response to this notice. Initial comments must be received on or before January 9, 2012 and reply comments on or before February 23, 2012. (See the “Comments” section of this document for more information.)

ADDRESSES: Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: On February 2, 2011, President Barack Obama issued Executive Order (E.O.) 13563, “Improving Regulation and Regulatory Review” (76 FR 3821). One of the provisions in the new Executive order is the affirmation of retrospective reviews of existing significant regulations. As one step in implementing the new Executive order, FDA published a notice in the Federal Register on April 27, 2011 (76 FR 23520), entitled “Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563.” In that document, FDA announced that it is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation that have occurred since those regulations took effect. Under E.O. 13563, and under the Department of Health and Human Services’ Plan for Retrospective Review of Existing Rules, FDA will consider strengthening, complementing, or modernizing rules where necessary or appropriate.

As FDA conducts its retrospective review of regulations, the Agency will take into account the following factors: /1/

FOOTNOTE 1 Department of Health and Human Services, ” Plan for Retrospective Review of Existing Rules, ” pp. 21-22 (August 22, 2011). END FOOTNOTE

* Whether an action will have a positive impact on innovation in an area of public health, safety, or delivery of or access to care;

* Whether the public health benefits of an action have been realized;

* Whether the public or regulated community view modification or revocation of a regulation as important and have offered useful comments and suggestions for change;

* Whether the impact and effectiveness of a regulation has changed or been superseded by changes in conditions or advances in scientific or technological information;

* Whether there are significant, unresolved issues with implementation or enforcement; and

* How long the regulation has been in effect and whether it has been subject to prior reviews.

The first rule FDA is reviewing under E.O. 13563 is the Bar Code Final Rule. The Agency plans to reassess its costs and benefits and to determine if the Bar Code Final Rule should be modified to take into account changes in technology that have occurred since the rule went into effect in 2004.

I. Background

In the Federal Register of March 14, 2003 (68 FR 12500), FDA published a proposed rule (Bar Code Proposed Rule) that would require certain human drug product labels and biological product labels to have a linear bar code that would contain, at a minimum, the drug’s National Drug Code (NDC) number. In the Federal Register of February 26, 2004 (69 FR 9120), the Agency finalized the proposed rule (SUBSEC 201.25 and 610.67 (21 CFR 201.25 and 610.67)). As discussed in the preamble to the Bar Code Proposed Rule, the rule was intended to help reduce the number of medication errors that occur in hospitals and other health care settings (68 FR 12500 at 12501 through 12502). FDA envisioned that bar codes would be part of a system, along with bar code scanners and computerized databases, that would enable health care professionals to check whether they are giving the right drug (in the right dose and via the right route of administration) to the right patient at the right time (Id. at 12501).

The events that led FDA to propose requiring bar codes are described in the preamble to the Bar Code Proposed Rule. In brief, medication errors are known to be a serious public health problem and can occur at several points from the time a health care provider prescribes the drug to a patient to the time when the patient receives the drug. The use of bar codes on drug products was expected to significantly reduce medication errors. Bar codes also can complement other efforts to reduce medication errors, such as computer physician order entry (CPOE) systems (where a physician enters orders electronically into a computer instead of writing the order on paper, and subsequently the order can be checked against the patient’s electronic records for possible drug interactions, overdoses, and patient allergies) and retail pharmacy-based computer systems that use a bar-coded NDC number to verify that a consumer’s prescription is being dispensed with the correct drug. FDA refers readers to the preamble to the Bar Code Proposed Rule should they wish to obtain details on the events, recommendations, meetings, and literature that shaped the proposed rule.

In the preamble to the Bar Code Proposed Rule, the Agency discussed in detail the challenge of requiring the use of linear bar codes, which, while enabling hospitals to buy scanning equipment with the confidence that their purchased equipment would not be rendered obsolete by new technology, could affect future technological innovation (68 FR 12500 at 12508 through 12510). Comments received related to a public meeting on bar coding, presented an array of differing opinions on the issue of whether to require a specific technology (68 FR 12500 at 12508). Given the complexity of the issues, FDA requested in the Bar Code Proposed Rule comment concerning alternatives that could replace or be used in conjunction with the linear bar code such as another symbol, standard, or technology (Id. at 12510 and 12529).

In response to the Bar Code Proposed Rule, FDA received comments including those opposing the use of linear bar codes or asking the Agency to consider other technologies or to eliminate any reference to linear bar codes in the final rule. Such comments primarily argued that selecting a symbology or standard would inhibit technological innovation. Comments opposed to a linear bar code requirement generally advocated the following alternatives: (1) Two-dimensional symbologies, (2) the European Article Number/Uniform Code Council (EAN/UCC) system generally, (3) radio frequency identification (RFID) chips, or (4) no standard or symbology at all (69 FR 9120 at 9136).

Ultimately, FDA determined that, based on data and public comment, a linear bar code requirement was appropriate (Id. at 9137 through 9138). In the preamble to the Bar Code Final Rule, the Agency addressed comments concerning alternatives to the linear bar code and stated that, while it believed that linear bar codes were an established, cost-effective, widely used and easily recognized technology, it also acknowledged that linear bar codes have several disadvantages. For example, linear bar codes may take up more label space than alternative technologies and may encode less data compared to other technologies. Thus, if more data need to be encoded on the packaging or labeling for any other reason (such as to allow tracking and tracing of drug products through the drug distribution system), a linear bar code might prove too limiting (Id. at 9137). FDA also stated that, although it had decided to preserve the linear bar code requirement, it would consider revising the rule to accommodate newer technologies as they become more mature and established (Id. at 9137 through 9138).

Since FDA issued the Bar Code Final Rule, advances in alternative technologies have occurred. In addition, it has become increasingly clear from industry, health care providers, and other FDA initiatives, that certain FDA-regulated products present unique bar coding concerns. For example, the Agency has since learned that certain vaccines present unique challenges in the bar coding context, particularly with respect to compliance with recordkeeping and mandatory adverse event reporting requirements that are specific to the administration of childhood vaccines. /2/

FOOTNOTE 2 The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660) (42 U.S.C. 300aa-25(a)) requires health care providers to report certain adverse events related to identified childhood vaccines to the Vaccine Adverse Event Reporting System (42 U.S.C. 300aa-25(b)). Although health care providers are encouraged to report adverse events related to other drugs and biological products to FDA, they are not required to do so. END FOOTNOTE

–This is a summary of a Federal Register article originally published on the page number listed below–

Notice; request for comments.

CFR Part: “21 CFR Parts 201 and 610″

Citation: “76 FR 66235″

Document Number: “Docket No. FDA-2011-N-0719″

Federal Register Page Number: “66235″

We will be submitting comments to the FDA on the Barcode Final Rule. The 2004 rule is open for review at this time. Attached is the notice from the Federal Register. I have attached a word document with 13 specific questions that the Agency would like to have answered during this public comment period.

Initial comments are due on January 9, 2012. With this deadline in light of the Holidays and the Midyear Clinical Meeting, we should aim getting our final comments together by the middle of December.

If you are interested in helping ASHP provide comments, please record your comments on the attached word document under each question. Obviously, you may not have a response for all the questions.

ASHP has the following policies that include barcoding:

ASHP Statement on Bar-Code-Enabled Medication Administration Technology: http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCMA.aspx

ASHP Statement on Bar-Code Verification during Inventory, Preparation, and Dispensing of Medications: http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCVerif.aspx

1003        FDA AUTHORITY ON RECALLS – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos1003

0920        STANDARDIZED CLINICAL DRUG NOMENCLATURE – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos0920

9919        MANAGEMENT OF BLOOD PRODUCTS AND DERIVATIVES – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos9919

Please respond by November 11, 2011with any comments. If we need to discuss further, we can schedule a follow-up conference call. You may be receiving this e-mail for a variety of reasons: SAG member, frequent poster on ASHP Connect/old Listserv, or a reviewer of one of the above statements. If you are not interested or do not have time to provide comments, that is fine. If there is someone within your institution better able to provide comments, please feel free to forward this e-mail to him/her.

Thanks for your continued support of ASHP and the Section.

Karl

Karl F. Gumpper, RPh, BCPS, FASHP
Director, Section of Pharmacy Informatics & Technology
American Society of Health-System Pharmacists®
7272 Wisconsin Avenue
Bethesda, MD 20814
Tel: 301-664-8723
Fax: 301-634-5823
kgumpper@ashp.org

You bet I clicked on that one. However, because my display window was not opened wide enough, part of the final word was missing—it was demonstration not demons. Darn. I thought I might have stumbled upon a resource for nurses who swear their bar-code scanners are possessed.

Admittedly, some old scanners out there are awfully slow readers. However, unreadable bar codes are generally the result of poor printing. To prevent slow-reads and no-reads, let’s tackle a few of the devils in the details—the three R’s.

Reading

Unreadable and slow-read bar codes undermine nurses’ confidence in BCMA and ultimately provoke high-risk work-arounds. Enough said.

Righting

Wristbands should be scanned to verify their bar codes are right before they leave admitting. This is important for two reasons. First, to ensure the bar codes are readable; second, to affirm that when the bar codes are scanned, the right patient records appear. Furthermore, bar codes must retain their readability throughout the patient’s stay. If not, look for better printers and/or wristband stock until you get it right. Both are readily available.

In pharmacy receiving, bar codes on manufacturer medications should also be verified. Find and fix unreadable bar codes and confirm that all accurately map to your pharmacy’s drug data base before putting them into your hospital’s supply chain.

When you encounter drugs with unreadable codes, and you will, send ’em back with a piece of your mind. Should a manufacturer’s bar codes consistently prove unreadable, report the problem to the FDA here and copy ASHP here. Because you’ll still need these drugs, if possible, find another manufacturer whose “unit-dose” packages have bar codes that are readable. If not possible, you’ll either have to outsource them to a reputable contract repackager or purchase these NDCs in bulk and repackage them in-house.

Finally, all bar codes on patient-specific labels generated from your pharmacy information system must be validated as readable and accurately mapped to the correct patient order. Equally important, I believe your IV preparation processes should force the function of bar-code scanning all ingredients to validate that right doses of the right drugs are being admixed. Neither the most conscientious nurse nor any state-of-the-art BCMA system is capable of intercepting admixing errors made upstream.

For heaven’s sake, let’s get it right.

Rithmatic

Research the above packaging options, and you will discover that some cost more than others. Do the math. Weigh cost against potential safety gains and losses. Remember, those unreadable bar codes that encourage nurse work-arounds subtract from BCMA’s safety value and add up to costly, indeed hellish, medication errors. Sometimes, as Jon Arbuckle said, “You get what you pay for.” Other times you pay dearly for what you get.

Exorcising these wrongs helps protect our patients’ rights and provide our caregivers with peace of mind.

What do you think?

Mark Neuenschwander a.k.a. Noosh

P.S. An hour ago, on a device invented by Steve Jobs, I learned of his death. I’m sad. I’m also grateful for how I have benefitted from his genius and life work. Pecking out these thoughts on a MacBook Pro, I confess, I lean hopelessly on the side of the brain that can’t remember which side is creative. Jobs opened the technology door for my kind of brain to enter and flourish. Yes, I am grateful.

Copyright 2011 The Neuenschwander Company

Generally, I issued such warnings to protect my kids. However, back in the day when my other daughter, saw a half-eaten cotton candy under our seats at Safeco Field and went for it, my, “Don’t touch!” was issued to protect my shirt. They say cleanliness is next to godliness. With Sandra, it was next to impossible. Though she outgrew it, she has a little peach that didn’t fall too far from her tree.

So tell me, are we supposed to saniwipe the handles on our shopping carts so we won’t get other peoples’ crud or wipe our hands so other shoppers won’t get ours? Yes.

Preventing people in hospitals from spreading and collecting pathogens and reducing hospital-acquired infections require both: faithful surface disinfection and proper hand hygiene.

I’ve been wondering about hands and handheld computing devices involved with administering medications. From my many hospital visits, it seems that caregivers conscientiously disinfect their hands between patients. I’m not so sure, however, about handhelds, scanners, and carts employed in retrieving electronic medication administration records and scanning bar codes at the point of care.

In the original academy award-winning movie True Grit, 14-year Mattie finds herself alone with Tom Chaney, her father’s murderer.

Tom Chaney: What are you doin’?
Mattie Ross: I’m getting some water so I can wash my hands.
Tom Chaney: A little smut won’t hurt you.
Mattie Ross: That’s true—or else you and your chums would surely be dead.

I remember complying with the manufacturer’s instructions for our first baby’s mouth held comforting device. We submerged the binkie under boiling water for five minutes. Then, upon first use, he spit it out. I quickly fetched it from the dirty floor, wiped it on my sleeve, and stuck it back in his mouth. A little dirt won’t hurt you.

But the five-second rule doesn’t satisfy The Joint Commission. A little staph on a medical device, and a patient could surely be dead.

In a recent press release from McKesson, Clorox Professional Products general manager, Craig Stevenson, said, “In working closely with hospitals, we’ve found that explicit protocols for disinfection are very important to ensuring compliance and reducing the risk of infection” (italics are mine). Like godliness, cleanliness is no accident.

Does your hospital have “explicit” protocols related to surface disinfection of medication-administration devices? If so, would you be willing to send me a PDF that I could share with my readers so they can benefit from your good work?

What do you think?

Mark Neuenschwander a.k.a. Noosh

Speaking of True Grit, I’m happy to announce that next year’s unSUMMIT for Bedside Barcoding attendees will be flying in to Orange County’s John Wayne Airport—May 2-4. If you are not on our emailing list, send me your address so we can be sure our nitty-gritty lands in your hands.

BTW Yesterday, the nurse searching electronic records for my periodic melanoma screenings said “There it is—Neueuschwander. Can’t be another one of those.” Wrong. Not only are there other Neuenschwanders, there are other Mark Neuenschwanders. Thank you Joint Commission for requiring two identifiers.

Copyright 2011 The Neuenschwander Company

Geriatrics
Haberman died last month at age eighty-one in Newton-Wellesley Hospital, which utilizes bar-code medication-administration technology and, as a result, has demonstrated significant reduction in transcription, administration, and total medication errors of 56 percent, 53 percent, and 56 percent respectively. Haberman’s work unwittingly helped pave the way to a safer point of care for himself and his family. Yours and mine too. Thanks Alan.

Two weeks ago, I visited two geriatric patients (two days apart) in a Northern California Kaiser hospital—one in critical care, the other in emergency. I was pleased to observe nurses scanning bar codes on their wristbands and medications to ensure a match. Pleased, because the first patient, Juanita, was my eighty-nine-year old mother. The second, Edgar, was my ninety-year-old father.

Unfortunately, Mom was sent home to hospice. Fortunately, Dad escaped death and was able to return to mom’s side. It was an honor to watch him tenderly support her through her final days as he had for 68 years of marriage. Of course, bar coding could not have prevented my mother nor Alan Haberman from dying. Their time had come.

Such was not the case earlier this year for an elderly woman in a UK hospital who was given a tenfold overdose of potassium chloride, an error which bedside bar coding could have prevented.

Pediatrics
A few days after Mom changed addresses (her words), my niece gave birth to Edgar and Juanita’s ninth great-grandchild. The little guy was immediately tagged with a bar-coded ankle band not only to prevent medication administration errors, but also to make sure he was not breast fed by or sent home with someone else’s mother.^[1]

Over the past few years, we’ve heard too many reports of infants whose lives were lost because of preventable medical errors. The landmark episodes involved the infamous heparin errors of 2008 in Indianapolis and Texas. Adult doses of heparin (10,000 units/mL) were given to neonates instead of 10-units/mL doses used to flush pediatric intravenous lines. It turns out that adult-dose vials were mistakenly placed in automated dispensing cabinets located in pediatric care units. Bar coding at the bassinette could have intercepted the dispensing errors. Bar-code scanning at the point of stocking the machines could have prevented the high-risk drugs from reaching the infants in the first place.

Bar Coding
While we’ve made significant progress, still more than half the hospital beds in our country are without bar-code scanning. And we are not doing as well with our vulnerable infants as we are with adults. This is mainly because most medication packaging and delivery systems are designed for adult populations.

Manufacturers failing to respond to requests for producing more pediatric-sized doses and hospitals lagging in the standardization of pediatric dosing require too much dose preparation and labeling in pharmacies. Meanwhile, though hospitals will never reach cGMP^[2] precision, bar-code and scale-assisted technologies can go a long way in reducing errors in pediatric dose preparation.

When infusions are involved, bar coding not only matches infants with the right drugs but some systems also trigger auto-programming of pumps, which helps prevent giving the right drug the wrong way. With manual entry there is greater potential for missed decimals, double bumping of numbers, and extra zeros.

Beyond patients and their families, we are also concerned about the dedicated, conscientious caregivers whose careers are often lost after committing errors that technology could have prevented. I’m thinking of the nurse in Seattle whose life-taking error this year at Seattle Children’s sent her on a downward spiral that ended in taking her own life.

There is so much more to understand about pediatric medication safety than I’ve briefly brushed above.Thus, I am honored to be the host of Talyst’s Pediatric Safety Summit this September here in my neck of the woods—beautiful Bellevue, Washington. Would you consider joining us? It’s hard to beat Pacific Northwest weather in September.

Meanwhile, I will continue to unrelentingly work to persuade drug manufacturers, technology companies, and healthcare institutions to do their part in assuring that Owen Edgar Neuenschwander will grow up in a world where he will be protected by bar-code point-of-care safety systems whenever and wherever he is hospitalized throughout his life.

What do you think?

Mark Neuenschwander a.k.a. Noosh

BTW. Each time nurses scanned my dad’s wristband in the ER, they got his electronic medication administration record. However, when a care coordinator attempted to pull up Dad’s medical record using her keypad, she unknowingly pulled up my brother’s medical record. Good thing I was there. My brother (who passed away in April) and my dad are both named Edgar Herman Neuenschwander. I knew which was Edgar the second and which was Edgar the third.

Briefs: A few years ago, an elderly woman who shared a hospital room with my mom told me that she asked a old guy if he preferred boxers or briefs. He said, “Depends.”

Copyright 2011 The Neuenschwander Company