Clinical Imperatives in Healthcare Materials Management
By Jennifer Schraag
Medical errors arise in many unspoken areas. Risk management and patient safety initiatives must begin within the materials management arena and follow all the way through to delivery to the patient. ICT examines what is being done in todays healthcare system to ensure patient safety as items journey through the supply chain.
According to a national research study conducted in April by Harris Interactive, researchers found 72 percent of frontline registered nurses (RNs) surveyed believe that medication safety has improved in their hospital over the last five years. Eighty percent of those nurses identified technology as a major contributor to that improvement. However, 94 percent of the respondents polled reported seeing one or more serious medication errors within that same timeframe.
A 1999 Institute of Medicine (IOM) report estimated as many as 100,000 Americans die each year as a result of medical errors a projected rank 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 detail can play a major role in guarding against errors. Carol Petersen, RN, BSN, MAOM, CNOR, perioperative nursing consultant with the Association of periOperative Registered Nurses (AORN), referenced an incident discussed in the December 2004 Clinical Issues section of the AORN Journal (www.aorn.org/journal/2004/decci.htm).
A potential error with compressed medical gases (CMGs) was narrowly avoided during a laparoscopic cholecystectomy procedure. During the procedure, the healthcare team ran out of carbon dioxide (CO2) gas and had to switch tanks. When I was switching tanks, I discovered that someone had inadvertently placed an unlabeled tank on the cart instead 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 no symbols, markings, or inspection stickers to indicate its contents, according to the worker.
Packaging and labeling controls include materials examination and usage procedures, offers Petersen. The labels and container must be examined and tested upon receipt by the supplier and before they are refilled and relabeled.
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 be notified immediately, Petersen wrote in her reply. The tank should be labeled 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 educated regarding potential hazards associated with their use.
Fortunately, the problem was discovered before the tank was connected to the laparoscopy machine.
CMGs need to be treated just like a medication that comes through the door, and special attention must be paid to items donning color codes. I dont think everyone knows what those color codes should be or know how to do it, Petersen points out.
She said the best practices are to follow the good standards of practice set forth by AORN and the Association for the Advancement of Medical Instrumentation (AAMI).
Moreover, Don Gordon, CRCST, FCS, president of the International Association of Healthcare Central Service Material Management (IAHCSMM), and network director of central service (CS) for the North Bronx Healthcare Network, in Bronx, N.Y., offers the following advice: Clinicians should carefully check the label of the packaging, making sure the item is correct, the item has a valid expiration date and that the integrity of the packaging is not compromised, and is free from dust thus ensuring that the contents are safe to use.
Teamwork and education can nip potential problems as well.
We must not ever hesitate in educating our staff toward what we perceive to be the goal which is quality patient care, with quality products, at the lowest cost that can be obtained, says Dianne Gantt, RN, FCSP, president-elect and chairwoman of the regulatory committee of American Society for Healthcare Central Service Professionals (ASHCSP), and director of supply chain contract management services with Premiere, Inc.
I think getting clinical input in making product choices is essential, offers Petersen. The key is communication working together to solve the problems to identify what the issue is, she says.
Another aspect tying teamwork, communication, and education includes such practices as rotating employees through different divisions throughout the healthcare facility to impart on them what the other positions and departments require and how each one helps the other to function properly.
Gantt says educating staff is imperative, and rotation serves that purpose. I found it very useful to rotate folks through various departments within a division, she says. Even if its just for half a day so that they have a better understanding of what they do and how that affects the product later on down the road.
The shipping, transporting, and handling of medical supplies require special care. Petersen says items need to be shipped in as clean an environment as possible, and points out that multiple handling of a package will break down the package. She also said dropping it on the floor is an issue and can compromise the products safety even if it is still enclosed.
Transport is an issue, storage is an issue, and presenting them onto the sterile field in an appropriate manner to maintain the sterility is another issue, she adds.
A few key points related to storage include ensuring supplies are 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 percent and 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 using those 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 the Florida Central Service Committee of IAHCSMM, says her biggest concern is making sure inventory is regularly rotated.
Thats a huge issue, she says. You have to inventory. With this time and age, you have to take the time and you have to make it a pattern to inventory. You have to establish patterns to keep your supplies in check.
Proper inventory steps will help to ensure everything is not outdated and that they are correctly sterilized, she says. Keeping inventory documented, rotated, and fresh is important, but Patterson strongly suggests proper 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 big thing and I think people tend to forget them. There are certain things that you need to keep and you have to be able to track them for patient safety. She remarks on recalls and how lot numbers will aid in ensuring proper tracking throughout the supply chain. She references the hydraulic fluid incident that occurred when two surgeons at several North Carolina hospitals used surgical instruments that were cleaned with hydraulic fluid instead of detergent, a mistake that affected approximately 3,800 patients.
How close could we be to something like that because of our inventory and our supplies? asks Patterson. Its very easy to leave something, not have it, its not where it is supposed to be, and then all of sudden you find out wait a minute, what have I done? How have I jeopardized somebody?
Patterson recommends a few avenues that may lower some aspects of the confusion. I think you need to bring up supplies when you are not on peak business hours, she offers.
Pick a time when you have more time; when you have time to be more thorough. She also says implementation and use of certain inventory tracking systems are beneficial.
She says Morton Plant Mease Countryside Hospital recently implemented a new approach. I think this system is going to be a real asset to us because it is going to control so much more, she says. We will know exactly what were using. I really feel like this is going to help get inventory issues under control, so you dont have supplies sitting and youre not cross contaminating.
One inventory concern generally universal within healthcare facilities is the issue with people hoarding supplies, according to Patterson. She said this raises many concerns due to the possibility of compromising expiration dates, inhibiting proper tracking of the materials, and it also may compromise sterility.
You hear back order so much anymore when youre ordering supplies that you kind of start hoarding them, she says.
Just-in-time inventory can be a solution, but it also can increase the problem, she says.
When you go into just-in-time, you have to establish guidelines as to what just-in-time is, Patterson recommends. Are you really going to get it in 24 hours? 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 the system, she adds.
Tracking materials through the supply chain is an age-old issue. Governmental agencies have recognized the challenges and the dangers that may arise, and are working to offer solutions.
The FDA finalized a ruling on Feb. 25, 2004 requiring the use of bar codes on human drugs and biological products.
Were encouraging widespread use of technologies that can help 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 and effectiveness by ensuring the accuracy of a myriad of actions in commerce and industry. Were now advancing the adoption of these systems in settings where they can help save lives.
The FDA estimates that when the bar code rule is fully implemented, it will help to prevent nearly 500,000 adverse events and transfusion errors during a 20-year period.
The rule calls for the inclusion of linear bar codes on all prescription drug products, including biological products and vaccines (except for physician samples), and over the counter (OTC) drugs that are commonly used and dispensed in hospitals. Each bar code for a drug will have to contain, at a minimum, the drugs National Drug Code number. This information will be encoded within the bar code on the label of the product. Companies also may include information about lot number and product expiration dates.
The bar code rule is designed to support and encourage widespread adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85 percent, according to the FDA Web site.
Hospital groups are jumping at this chance for safer links within the supply chain and requested in a May 9 letter to FDA that swift action be taken to include required bar codes on medical devices a step that would promote public health and welfare, the letter reads.
The hospital groups which include the American Hospital Association (AHA), the Federation of American Hospitals (FAH), and Premier, Inc., wrote that bar coding medical devices is a common sense next step in our shared goal of promoting patient safety, improving quality of care, and encouraging cost-effectiveness and supply chain efficiency.
The letter points out that bar coding medical devices has vast potential for improved clinical product and service innovation.
Comprehensive data on and that ability to conduct rigorous comparisons of emerging health practices, products, and services is essential for both clinical and economic decision-making.
Bar coding is understandably gaining much attention in the healthcare materials management arena.
Thats a hot topic right now, says Gantt. I know Premiere is currently working and contributing information with regard to that arena. You know, anything we can do to make the patient safer, Im all for, but by the same token, I think we need to not be naive of what its going to cost us to do some of those things. When its time to do the budgeting process, we need to make sure we are cognizant of that fact. If it will provide a safer environment, certainly we need to work towards that end.
Sterile Inventory Issues
Every employee in a hospital setting is obligated to take special care in ensuring patient safety through maintaining the sterility of medical and surgical supplies. It is absolutely imperative such supplies remain intact, and this task goes much farther than the sterile processing field.
Protecting sterile inventory begins with the simplest of fundamentals in any healthcare setting. Education, for example, is key. Continuous education, positive reinforcement, and cross-training all can be building blocks to a smoother sterile path.
If youve not been in an OR environment and you work in a warehouse situation or a storage situation, and its not a clean storage such as sterile processing or a sterile storage area, then you really dont have a good frame of reference, says Gantt. I think some of it has to do with lack of cross-training or education and going that next step to ensure that people understand how great an impact their handling and storage practices have on a product.
One basic fundamental often overlooked within the supply chain is the basic task of handwashing. Even in storage areas, the lack of handwashing compromises patient safety.
I think a lot of people dont go back to the basics of handwashing, says Gantt. Especially if youre not involved in patient care and its not highly emphasized to you, I dont think people who do distribution, and who transport, and who do all of those kinds of functions, feel like that maybe handwashing is just as important for them as it is for someone who wears green scrub attire in a sterile environment.
Periodic reminders of the risks are imperative, according to Gantt. You get that in most hospital orientations, but for people in a non-sterile environment, thats usually the last time you hear of it, unless its included in annual retraining. But, if your manager doesnt take the time to say Heres a reminder ... or think back to How many times have you washed your hands today? and that sort of thing, I think it tends to get overlooked.
In addition to handwashing, another commonly overlooked aspect of compromising sterility can be whittled all the way down to the wheels of the transportation cart.
I think materials management departments must be very cognizant of the fact that their vehicles that they transport items on whether they are carts or pallet jacks or whatever it is they use they sometimes forget to clean the carts and the wheels, Gantt points out.
You may say, Well, thats kind of silly, that doesnt matter, but it does. I think sometimes that isnt thought of as something extremely important. But as we move around the facilities and are in and out of places, I think it could be very important. And its not that hard to partner up with a sterile processing department that might have a cart washer, or a steam gun to periodically, on a schedule, get that done, she offers.
Petersen also points out that supplies must be transported to the OR in covered containers to protect the integrity of the packaging.
Handling and storage are two very important aspects in ensuring receipt of sterile supplies. As Gantt says, Handling and storage impact infection control issues more than people imagine.
We are so used to handling and when I say we, I mean 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 handling them. Whether it is a weighted instrument tray or whether its a disposable package of some kind, whether its a sterile gown, or a package of sterile towels or a disposable procedure tray. We tend to be rough with them and I think probably we compromise the integrity of the packaging more than we know unintentionally, of course.
Sterilized items need to be stored in a manner that protects them, says Petersen. They need to be stored in a clean supply room within the OR in a restricted area, she adds.
Gantt agrees. Ive been in a lot of institutions where the sterile storage conditions are less than ideal and people do the best they can with what they have, but they are certainly not always kept in a clean environment. It may be an environment where the door to the warehouse, to the outside is left open, or maybe the tops of the box is not re-closed so that dust or any other matter might fall on those items and then we turn around and take them 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 are good.
Gordon offers a few key points:
- Supplies should be removed from the outside carton before transporting to the OR.
- Check the outside carton for wet spots or dried wet spots. This could indicate that the outside carton was subjected to moisture of some kind which could affect the packaged items contained within.
- The packaging should not be compromised (e.g., cuts, tears, punctures, etc.).
- The packaging should be checked for dust to be sure the items were stored in a clean area free from contaminants.
- Storage areas for items should be located away from areas of heavy traffic and the access to these areas should be restricted.
- Authorized staff should be properly attired and follow good health and personal hygiene. The expiration date on the packaging should be checked.
Patterson elaborates on the importance of expiration dates and how it highlights the imperativeness of rotating stock. She uses the analogy of emergency situations when time is critical in caring for a patient.
You would like to think they look at it before it goes in the field, she says, but if you are faced with an emergency at 2 a.m., are they really going to take the time to look at the date?
Just-in-time inventory can aid in reducing possible compromises as a product travels through the supply chain. The use of just-intime inventory has taken on a new slant for inventory management as hospitals are working with vendors where the vendor becomes responsible for the daily restocking of the hospital, according to Gordon.
In the OR, this just-in-time inventory management system has worked very well with the use of surgical packs, he says. The CS staff picks the pack and not multiple supplies for the case cart system. The advantage is that CS staff does not have to pick multiple items, and storage space 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 lot control number to identify the sterilizer used if they sterilized in-house, and a lot control number if they are coming from the outside, for example, according to Petersen. So you can identify if there is a recall or something so you will know which ones to pull, she says.
Aside from recalls, compromised packs are a very serious concern. When in doubt, throw it out, advises Patterson. Once its open, or once it is compromised or that it could be, its not even that you 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-use medical/surgical supply item that is compromised should be discarded, he says. Gordon adds the North Bronx Healthcare Network would not attempt 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.