Harnessing Automation to Give Your QA Process the White Glove Test


Automating quality assurance (QA) represents a cornerstone to effective sterile processing and infection prevention, two necessary healthcare functions in caring for patients. Patricia Koncur, corporate director of central sterile processing at Detroit Medical Center (DMC), recognizes the need for accurate, effective and efficient QA processes.

“I think today the physicians and [operating rooms] are playing a big role in pushing central sterile (CS) departments to tighten up on their QA,” Koncur says. “Many of our managers do take quality very seriously but, like anything else, there is a small percentage that [believe] standards that are reviewed by an outside agency will be needed to bring the others into compliance.” She cites the ANSI/AAMI ST 79 standard as an example.

But Koncur decided to elevate the QA process of her CS department in the DMC healthcare system to the next level by adopting and implementing BlackTie Medical’s ProFormanceQA Web-based quality assurance management software for chronicling key quality indicators. She and her team began using ProFormanceQA in October 2008.

What Koncur needed to achieve was real-time updates of equipment status and the ability to keep track of each facility, something that ProFormanceQA delivered from the start. “We receive warning notices whenever a test was not logged as complete in the assigned time, as well as an alert when test results were not what was expected,” she says.

Pam Bittner, manager of materials resources at DMC’s Surgery Hospital, relishes the ability to be “kept informed about equipment failures and tests that aren’t done on time,” she indicates. In addition, she likes the efficiency. “We were logging all of the data on log sheets and this has eliminated the need for paper,” she adds.

In fact, the ProFormanceQA software creates test-specific documents with color-coded screens that match the test strips, according to Koncur, which is a tremendous administrative advantage. And the CS department can monitor this system-wide at each facility.

“In the past, I did not get test results until at the specific facility,” Koncur says. “Staff did not always run tests at times specified and no tests were run as required with results waiting when I came into the office.” Now she receives weekly documentation when tests are run, which helps her spot trends to plan repairs before equipment might fail, leading to downtime, she adds.

“ProFormanceQA alerts the manager as to equipment test failures so repairs can be called in quicker,” Bittner notes.

ProFormanceQA solved at least two challenges with which Koncur grappled. “The use of ProFormanceQA assisted in determining the cause of a long-term intermittent problem with one of our washers,” she says. “With the test results the issue was located and repaired, and a seven-month frustrating issue was resolved.”

Another benefit Koncur welcomed was improved communications. “The ability of inter-facility review has opened more of a dialog between hospitals with the management team, reviewing results, scheduling maintenance, etc.”

Bittner agrees. “Once all of the off-site facilities are on the program it will benefit management by being able to report what’s happening at all sites,” she says. “It’s a QA reporting tool for CS and it eliminates space and time for storage of data.”

Koncur acknowledges that ProFormanceQA has facilitated more efficient equipment management and operations. “Clinically we are able to trend results and watch for areas where there is a slow decline in test results,” she says. “Financially, it has helped us identify downward trends in equipment function before equipment has expensive breakdowns. Operationally, we have the ability to schedule repairs during department downtime so the instrument turnaround process is not affected.”

Both Koncur and Bittner indicate that training to use ProFormanceQA has been virtually pain-free. “This system is very, very easy to utilize,” Koncur adds. In fact, it takes roughly a half-hour to an hour to learn and very little to no staff downtime, they note.

Col. Thomas G. Winthrop, chief of perioperative services at Washington, D.C.-based Walter Reed Army Medical Center, logged similar outcomes after implementing ProFormanceQA last year in its central processing department as a means of documenting and verifying test runs and results.

“The paper filing system was a mess, and we wanted a way to pull up data immediately as well as present data,” Winthrop explains. Because Walter Reed maintains a very detailed documentation testing program, they mentioned their need for testing documentation in a computer format to one of their vendors, Healthmark Industries Co., which referred Winthop’s team to BlackTie Medical and its ProFormanceQA product

“The system was very easy to implement, and most of our staff are now trained on it,” Winthrop adds. “We plan to extend our license to tie in other metrics from not only our department but also from those areas doing high-level disinfection and sterilization such as urology, endoscopy, clinics and even microbiology in the clinical lab.”

Winthrop appreciates the capability to gain “a complete view of what is going on in the department from your desk.” It’s particularly helpful for when Winthrop’s team works with the hospital infection control committee because all sterilization QA issues have documentation. For example, ProFormanceQA enables a department to document all aspects required by the Joint Commission in establishing that decontamination and sterilization standards are met, according to Winthrop. “Its versatility in adding metrics enables the user to tailor the program to its needs,” he adds.

Winthrop highlights two success stories notched with ProFormanceQA. “We have one person assigned to review all the data in the program on a daily basis,” he says. “He has already identified the failure to document a [biological indicator] and was able to rectify it immediately. Also, he has visibility into the flash sterilization cycles in the [operating room] and is now able to generate a monthly report for the OR.”

Like Detroit Medical Center, Walter Reed also plans to expand ProFormanceQA’s reach into the OR.

While the inherent dangers of an inadequate or substandard paper-based QA process might be obvious, the benefits from a software-based QA process are equally overt.

“In the long run it affects patient care,” Bittner says. “If machine failures aren’t detected and reported or other QA measures aren’t performed, the sterilization process could be compromised and ultimately the patient could be harmed.”

Acknowledges Koncur, “Patient issues are the biggest danger. Instruments that have not been properly cleaned or decontaminated can always be an issue. Being able to monitor and trend tests helps identify potential problems before they become real issues.”

Charles Hancock, RAC, founder and principal of Charles O. Hancock Associates Inc. in Fairport, N.Y., sees the “ultimate danger as the compromising of patient safety. “An inadequate or ineffectual QA system will yield a false sense of security with respect to patient safety,” Hancock notes. “Such a system will be a hindrance in dealing with an infection control issue and may actually inhibit the practice of good and effective procedures.”

Winthrop couldn’t agree more. “Thinking things are done right is a far cry from knowing things are done right,” he says. “Having the tools to test parameters and not doing it is negligent. The cost of a hospital-acquired infection is enormous not to mention the harm done to the patient. Documentation is the key to providing validation of the processes.”

Bittner cites a quartet of gains offered by automation that are limited by paper. The data are easy to read, paper records are eliminated and data can be stored indefinitely and can be transmitted across all of the system, she says.

Data from all sites can be reviewed, reported and stored versus one site collecting data and integrating the information with all the sites,” Bittner says. “There is a benchmarking reporting capability for all sites and possibly across other hospital systems.”

Winthrop acknowledges automation’s advantages over paper, too. “Paper-based QA is a nightmare as it involves an accumulation of documentation that in many instances is damaged or lost or misplaced,” he says. “It is also time-consuming if information is needed quickly. The computer provides a quick access-based data recall and gives the department a professional demeanor.”

Automation can be the ticket to keep operations honest and improving, according to Ralph Basile, vice president of marketing for Healthmark Industries Co. in Fraser, Mich.

“We improve what we measure,” Basile says. “If a department focuses on a given area, say improving instrument tray quality, there will almost certainly be improvement in the short term. But if a feedback loop is not created and utilized – that is a periodic, standardized practice of auditing instrument trays, quality improvements will be lost. The virtue of an automated system is that the computer can play ‘nanny’ reminding staff and managers alike that testing needs to be done and recorded.”

ProFormanceQA’s capabilities motivated Healthmark to work with BlackTie Medical because the company’s software product satisfied a fundamental need in the industry.

“We were seeking a more powerful method for our customers to log and then mine all the data they collect on their decontamination process utilizing our ProFormance monitoring products,” Basile says. “We had evaluated other Web-based solutions but had not found the right business partner until we met BlackTie Medical. They brought not only the technical expertise, but an understanding and commitment to the healthcare market.”

Hancock emphasizes that QA software offers a variety of clinical, financial and operational benefits. “Clinically such systems may be easier to use in training personnel and maintaining competence in accepted practice,” Hancock says. “Financially, the costs of such systems are well-defined and predictable. Operationally such systems may operate as part of the established work place environment and routine procedures. As such they may be perceived to be less intrusive in time, place and motivation for use.”

Basile pointed to a noteworthy operational benefit in that the online feature of ProFormanceQA allows the manager to monitor the performance of staff and equipment alike.

“The system e-mails them when a test fails, or when a test is not conducted,” he says. “The manager is better able to analyze the clinical performance of their department over a period of time. This may lead to conclusions such as that one sterilizer is being used too frequently, or a sonic cleaner is frequently down and needs to be replaced. This information can be used for making the financial case for new equipment, or more rational use of existing equipment.”

Stephen Kovach, Healthmark’s director of education, says that the ProFormanceQA software meets the intent of a true QA program, based on the simple principles of FOCUS-PDCA, or Plan, Do, Check, Act. That includes monitoring the cleaning process with products that are based on sound scientific principles that actually help a hospital better understand their process, he indicated, and recording the results and reporting on them in a way that is easy to understand and respond if there is a highlighted concern.

“No other cleaning verification product line can offer such simple solutions to understanding the cleaning process,” Kovach continues. “That is the bottom line; getting the staff to understand their process better, and if there is a variance from the standard of practice, it is documented and responded to in the proper manner.”  

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