By Jennifer Schraag
Medical errors arise in many unspoken areas. Risk managementand patient safety initiatives must begin within the materials management arenaand follow all the way through to delivery to the patient. ICT examines what is being done in todays healthcaresystem to ensure patient safety as items journey through the supply chain.
According to a national research study conducted in April byHarris Interactive, researchers found 72 percent of frontline registered nurses(RNs) surveyed believe that medication safety has improved in their hospitalover the last five years. Eighty percent of those nurses identified technologyas a major contributor to that improvement. However, 94 percent of therespondents polled reported seeing one or more serious medication errors withinthat same timeframe.
A 1999 Institute of Medicine (IOM) report estimated as many as100,000 Americans die each year as a result of medical errors a projectedrank of the eighth place in the leading causes of death in the United States,according to the report. These errors can take shape in many forms. Attention to detailcan play a major role in guarding against errors. Carol Petersen, RN, BSN, MAOM,CNOR, perioperative nursing consultant with the Association of periOperativeRegistered Nurses (AORN), referenced an incident discussed in the December 2004Clinical Issues section of the AORN Journal (www.aorn.org/journal/2004/decci.htm).
A potential error with compressed medical gases (CMGs) wasnarrowly avoided during a laparoscopic cholecystectomy procedure. During the procedure, the healthcare team ran out of carbondioxide (CO2) gas and had to switch tanks. When I was switching tanks, Idiscovered that someone had inadvertently placed an unlabeled tank on the cartinstead of the appropriate backup CO2 tank required for the procedure, the healthcare worker wrote, asking for guidance on the issue.The tank appeared to have been repainted a faded bluish-gray color and had nosymbols, markings, or inspection stickers to indicate its contents, according tothe worker.
Packaging and labeling controls include materials examinationand usage procedures, offers Petersen. The labels and container must be examinedand tested upon receipt by the supplier and before they are refilled andrelabeled.
If a tank is not labeled or is mislabeled, the tank should not be used and the manufacturer, distributor,filling company, and the FDA [the U.S. Food and Drug Administration] should benotified immediately, Petersen wrote in her reply. The tank should belabeled do not use and isolated so it will not be put back into inventory.It is important that all facility employees who handle medical gases be educatedregarding potential hazards associated with their use.
Fortunately, the problem was discovered before the tank wasconnected to the laparoscopy machine.
CMGs need to be treated just like a medication that comesthrough the door, and special attention must be paid to items donning colorcodes. I dont think everyone knows what those color codes should be orknow how to do it, Petersen points out.
She said the best practices are to follow the good standardsof practice set forth by AORN and the Association for the Advancement of MedicalInstrumentation (AAMI).
Moreover, Don Gordon, CRCST, FCS, president of theInternational Association of Healthcare Central Service Material Management(IAHCSMM), and network director of central service (CS) for the North BronxHealthcare Network, in Bronx, N.Y., offers the following advice: Cliniciansshould carefully check the label of the packaging, making sure the item iscorrect, the item has a valid expiration date and that the integrity of thepackaging is not compromised, and is free from dust thus ensuring that thecontents are safe to use.
Teamwork and education can nip potential problems as well.
We must not ever hesitate in educating our staff towardwhat we perceive to be the goal which is quality patient care, with qualityproducts, at the lowest cost that can be obtained, says Dianne Gantt, RN,FCSP, president-elect and chairwoman of the regulatory committee of AmericanSociety for Healthcare Central Service Professionals (ASHCSP), and director ofsupply chain contract management services with Premiere, Inc.
I think getting clinical input in making product choices isessential, offers Petersen. The key is communication working together to solve theproblems to identify what the issue is, she says.
Another aspect tying teamwork, communication, and educationincludes such practices as rotating employees through different divisionsthroughout the healthcare facility to impart on them what the other positionsand departments require and how each one helps the other to function properly.
Gantt says educating staff is imperative, and rotation servesthat purpose. I found it very useful to rotate folks through variousdepartments within a division, she says. Even if its just for half a day so that they have abetter understanding of what they do and how that affects the product later ondown the road.
The shipping, transporting, and handling of medical suppliesrequire special care. Petersen says items need to be shipped in as clean anenvironment as possible, and points out that multiple handling of a package willbreak down the package. She also said dropping it on the floor is an issue andcan compromise the products safety even if it is still enclosed.
Transport is an issue, storage is an issue, and presentingthem onto the sterile field in an appropriate manner to maintain the sterilityis another issue, she adds.
A few key points related to storage include ensuring suppliesare stored in a well-ventilated, controlled environment, Petersen says. Moisture and airborne contaminants are real threats, she says,and she advises the humidity level in storage areas be kept between 30 percentand 60 percent.
Another key point, Petersen adds, is once it gets to us,they need to be taken out of those shipping boxes. We do not recommend usingthose shipping boxes to store items in the operating room.
Lori Patterson, CRCST, FEL, sterile processing department(SPD) manager of Morton Plant Mease Countryside Hospital and a member of theFlorida Central Service Committee of IAHCSMM, says her biggest concern is makingsure inventory is regularly rotated.
Thats a huge issue, she says. You have toinventory. With this time and age, you have to take the time and you have tomake it a pattern to inventory. You have to establish patterns to keep yoursupplies in check.
Proper inventory steps will help to ensure everything is notoutdated and that they are correctly sterilized, she says. Keeping inventorydocumented, rotated, and fresh is important, but Patterson strongly suggestsproper management of lot numbers as well.
You have to keep your lot numbers matched up, she warns.I think that is something that is often overlooked. Lot numbers are a bigthing and I think people tend to forget them. There are certain things that youneed to keep and you have to be able to track them for patient safety. Sheremarks on recalls and how lot numbers will aid in ensuring proper trackingthroughout the supply chain. She references the hydraulic fluid incident thatoccurred when two surgeons at several North Carolina hospitals used surgicalinstruments that were cleaned with hydraulic fluid instead of detergent, amistake that affected approximately 3,800 patients.
How close could we be to something like that because of ourinventory and our supplies? asks Patterson. Its very easy to leave something, nothave it, its not where it is supposed to be, and then all of sudden you findout wait a minute, what have I done? How have I jeopardized somebody?
Patterson recommends a few avenues that may lower some aspectsof the confusion. I think you need to bring up supplies when you are not onpeak business hours, she offers.
Pick a time when you have more time; when you have time tobe more thorough. She also says implementation and use of certain inventorytracking systems are beneficial.
She says Morton Plant Mease Countryside Hospital recentlyimplemented a new approach. I think this system is going to be a real assetto us because it is going to control so much more, she says. We will knowexactly what were using. I really feel like this is going to help getinventory issues under control, so you dont have supplies sitting and yourenot cross contaminating.
One inventory concern generally universal withinhealthcare facilities is the issue with people hoarding supplies,according to Patterson. She said this raises many concerns due to thepossibility of compromising expiration dates, inhibiting proper tracking of thematerials, and it also may compromise sterility.
You hear back order so much anymore when youreordering supplies that you kind of start hoarding them, she says.
Just-in-time inventory can be a solution, but it also canincrease the problem, she says.
When you go into just-in-time, you have to establishguidelines as to what just-in-time is, Patterson recommends. Are you really going to get it in 24hours? Twelve hours? Six hours? What is your just-in-time limit and where is it coming from?Just-in-time comes back to hoarding because youre not confident in thesystem, she adds.
Tracking materials through the supply chain is an age-oldissue. Governmental agencies have recognized the challenges and the dangers thatmay arise, and are working to offer solutions.
The FDA finalized a ruling on Feb. 25, 2004 requiring the useof bar codes on human drugs and biological products.
Were encouraging widespread use of technologies that canhelp healthcare providers avoid hundreds of thousands of medication errors,FDA Commissioner Mark B. McClellan, MD, PhD, said in a press release.
Bar coding systems have proved their dependability andeffectiveness by ensuring the accuracy of a myriad of actions in commerce andindustry. Were now advancing the adoption of these systems in settings wherethey can help save lives.
The FDA estimates that when the bar code rule is fullyimplemented, it will help to prevent nearly 500,000 adverse events andtransfusion errors during a 20-year period.
The rule calls for the inclusion of linear bar codes on allprescription drug products, including biological products and vaccines (exceptfor physician samples), and over the counter (OTC) drugs that are commonly usedand dispensed in hospitals. Each bar code for a drug will have to contain, at aminimum, the drugs National Drug Code number. This information will beencoded within the bar code on the label of the product. Companies also mayinclude information about lot number and product expiration dates.
The bar code rule is designed to support and encouragewidespread adoption of advanced information systems that, in some hospitals,have reduced medication error rates by as much as 85 percent, according to theFDA Web site.
Hospital groups are jumping at this chance for safer linkswithin the supply chain and requested in a May 9 letter to FDA that swiftaction be taken to include required bar codes on medical devices a step that would promote publichealth and welfare, the letter reads.
The hospital groups which include the American HospitalAssociation (AHA), the Federation of American Hospitals (FAH), and Premier,Inc., wrote that bar coding medical devices is a common sense next stepin our shared goal of promoting patient safety, improving quality of care, andencouraging cost-effectiveness and supply chain efficiency.
The letter points out that bar coding medical devices has vastpotential for improved clinical product and service innovation.
Comprehensive data on and that ability to conduct rigorouscomparisons of emerging health practices, products, and services isessential for both clinical and economic decision-making.
Bar coding is understandably gaining much attention in thehealthcare materials management arena.
Thats a hot topic right now, says Gantt. I know Premiere is currently working and contributinginformation with regard to that arena. You know, anything we can do to make thepatient safer, Im all for, but by the same token, I think we need to not benaive of what its going to cost us to do some of those things. When itstime to do the budgeting process, we need to make sure we are cognizant of thatfact. If it will provide a safer environment, certainly we need to work towardsthat end.
Sterile Inventory Issues
Every employee in a hospital setting is obligated to takespecial care in ensuring patient safety through maintaining the sterility ofmedical and surgical supplies. It is absolutely imperative such supplies remainintact, and this task goes much farther than the sterile processing field.
Protecting sterile inventory begins with the simplest offundamentals in any healthcare setting. Education, for example, is key. Continuous education, positive reinforcement, andcross-training all can be building blocks to a smoother sterile path.
If youve not been in an OR environment and you work in awarehouse situation or a storage situation, and its not a clean storage suchas sterile processing or a sterile storage area, then you really dont have agood frame of reference, says Gantt. I think some of it has to do withlack of cross-training or education and going that next step to ensure thatpeople understand how great an impact their handling and storage practices haveon a product.
One basic fundamental often overlooked within the supply chainis the basic task of handwashing. Even in storage areas, the lack of handwashingcompromises patient safety.
I think a lot of people dont go back to the basics ofhandwashing, says Gantt. Especially if youre not involved in patient care and itsnot highly emphasized to you, I dont think people who do distribution, andwho transport, and who do all of those kinds of functions, feel like that maybehandwashing is just as important for them as it is for someone who wears greenscrub attire in a sterile environment.
Periodic reminders of the risks are imperative, according toGantt. You get that in most hospital orientations, but for people in anon-sterile environment, thats usually the last time you hear of it, unlessits included in annual retraining. But, if your manager doesnt take thetime to say Heres a reminder ... or think back to How many timeshave you washed your hands today? and that sort of thing, I think it tends toget overlooked.
In addition to handwashing, another commonly overlooked aspectof compromising sterility can be whittled all the way down to the wheels of thetransportation cart.
I think materials management departments must be verycognizant of the fact that their vehicles that they transport items on whetherthey are carts or pallet jacks or whatever it is they use they sometimesforget to clean the carts and the wheels, Gantt points out.
You may say, Well, thats kind of silly, that doesntmatter, but it does. I think sometimes that isnt thought of as somethingextremely important. But as we move around the facilities and are in and out ofplaces, I think it could be very important. And its not that hard to partnerup with a sterile processing department that might have a cart washer, or asteam gun to periodically, on a schedule, get that done, she offers.
Petersen also points out that supplies must be transported tothe OR in covered containers to protect the integrity of the packaging.
Handling and storage are two very important aspects inensuring receipt of sterile supplies. As Gantt says, Handling and storage impact infectioncontrol issues more than people imagine.
We are so used to handling and when I say we, Imean the whole SPD/OR environment we are so used to handling sterile items,that I think we tend to sometimes not be as careful as we should be in handlingthem. Whether it is a weighted instrument tray or whether its a disposablepackage of some kind, whether its a sterile gown, or a package of steriletowels or a disposable procedure tray. We tend to be rough with them and I think probably wecompromise the integrity of the packaging more than we know unintentionally,of course.
Sterilized items need to be stored in a manner that protectsthem, says Petersen. They need to be stored in a clean supply room within theOR in a restricted area, she adds.
Gantt agrees. Ive been in a lot of institutions wherethe sterile storage conditions are less than ideal and people do the best theycan with what they have, but they are certainly not always kept in a cleanenvironment. It may be an environment where the door to the warehouse, to theoutside is left open, or maybe the tops of the box is not re-closed so that dustor any other matter might fall on those items and then we turn around and takethem into SPD and take them into the OR environment. I think as a whole entity,we sometimes are not as careful as we should be, even though our intentions aregood.
Gordon offers a few key points:
Patterson elaborates on the importance of expiration dates andhow it highlights the imperativeness of rotating stock. She uses the analogy ofemergency situations when time is critical in caring for a patient.
You would like to think they look at it before it goes inthe field, she says, but if you are faced with an emergency at 2 a.m., arethey really going to take the time to look at the date?
Just-in-time inventory can aid in reducing possiblecompromises as a product travels through the supply chain. The use ofjust-intime inventory has taken on a new slant for inventory management ashospitals are working with vendors where the vendor becomes responsible for thedaily restocking of the hospital, according to Gordon.
In the OR, this just-in-time inventory management systemhas worked very well with the use of surgical packs, he says. The CS staffpicks the pack and not multiple supplies for the case cart system. Theadvantage is that CS staff does not have to pick multiple items, and storagespace for supplies becomes a non-issue.
In addition to storage space issues and rotating the stock,further inventory steps are critical. Sterilized items need to have a lotcontrol number to identify the sterilizer used if they sterilized in-house, anda lot control number if they are coming from the outside, for example, accordingto Petersen. So you can identify if there is a recall or something so youwill know which ones to pull, she says.
Aside from recalls, compromised packs are a very seriousconcern. When in doubt, throw it out, advises Patterson. Once itsopen, or once it is compromised or that it could be, its not even thatyou did if there is that doubt in your mind that you could have compromised,you have to ask yourself: Is it really worth it to save the dollar?
Gordon agrees. In my opinion, any single-usemedical/surgical supply item that is compromised should be discarded, hesays. Gordon adds the North Bronx Healthcare Network would notattempt to reprocess the item due to departmental policy.
Theyre either sterile or theyre not, declares Gantt. Theyre not almost sterile or almost unsterile.This is an area where there is no grey. Period. End of story, she says.