It is perhaps the least conspicuous certificate among the many pathological and dermatological accreditations that adorn the offices of Pinkus Dermatopathology Laboratory, yet, the effort to attain this small ISO 9001 certificate will be remembered as one of the most challenging and beneficial projects in company history.Already a highly disciplined working environment, Pinkus Dermatopathology was no longer satisfied to merely comply with the myriad of healthcare and medical accreditations. It wanted its operational practices to be judged against a set of requirements transcendingindustry, size and operational demographics ISO 9001.Everyone knows the frustration of sitting in a doctor's waiting room 30 minutes after a scheduled appointment time or being informed that test results had not come in as expected or worse yet, that they had been lost. "We knew how we compared to other labs and physician's offices, and you can shout it from the rooftops that you're great and wonderful, but unless somebody independent comes in and tells you you're doing everything you say you're doing, and will certify it, it really doesn't mean a thing," says Dr Darius Mehregan, laboratory director and pathologist of Pinkus.Now when Pinkus shouts, there is something tangible to back up its claims. The process has been a long one for the Monroe Michigan based dermatopathology laboratory, with an occasional bump along the way. "We were a little bit naive about exactly what the commitment was going to require," says Suzie Altiere, office administrator and management representative. "We developed an attitude: We'll do these things, but not to fly a flag out front that says ISO 9001. We want to make sure through the measurement techniques that we've embodied here over the last 60 years that the payback is there, that we're not doing it just to keep up with the Joneses."Adds Altiere, "There are always a lot of people outside the company and inside the company that are going to be detractors, who say [the certification] doesn't necessarily impact the accuracy of the diagnosis. That is true. You can write procedures that wouldn't mandate that you come out with a good service or a good product." That was something the company kept in mind during its implementation. "When all was said and done, this project wasn't to create paperwork... this project was to create efficiencies and accountability," Altiere says. The toughest aspect was convincing the company's own personnel that the changes were not intended to create additional work but to improve the services provided to physicians and clients.From a company perspective, the entire process has been approached with an eye on the bottom line, observes Mehregan. "The critical part of our ISO implementation was not to market it, the critical part was to make our company more efficient - to continue to control costs and resources and continue to make our referring physicians happy." As it went through the ISO process, Pinkus focused on a number of avenues to check quality, productivity and efficiency. One measure of nonconformance was the internal rate for clerical, technical and critical errors. While the error rate was never considered high, Pinkus has been able to improve its results even further since starting its ISO 9001 implementation in October."The whole concept of ISO 9001 is continuous improvement," Altiere says. "That is the overriding umbrella for ISO 9001. Every time the registrar comes in here, if we were doing everything exactly the way we were doing it six months ago, they may say to us 'that's a nonconformance, you haven't continued to improve.''Every error (no matter how small or insignificant) is identified and tracked and assigned to a responsible department so that everybody knows exactly how they're doing and how they compare to peers within the company. This also helps the company better focus its training and continual improvement efforts. "That's changed the way Pinkus directors and management filters information down to its employees", adds David Mehregan, director and pathologist. Ã¢€˜We've taken subjectivity out of measuring bad news. We don't try to belittle people that are continuously making the same errors, but we do make them aware of it. We measure by department as well." In addition, Pinkus is benchmarked through an external peer review and has consistently achieved a higher level of agreement from its peers than the standard, he says.At times, however, ISO 9001 was not an easy fit. One example concerns the way raw materials are received and how they impact Pinkus activities. "Many materials we purchase are catalogue items," says Michelle Martin, lab manager "No matter which way you look at it, we just don't have a complicated purchasing and vendor control process." Instead Pinkus chose to focus on incoming specimens from referring physician offices. In some cases specimens are missing, bottles are mislabeled with respect to the area of biopsy, patient name or other important information. In other instances there may be more than one specimen in a bottle or a specimen that somehow doesn't fit the distinguishing information provided.We targeted this process in particular with the ISO 9000 implementation because we knew we could have positive significant impact on the company's operations. As with any receiving process in a manufacturing environment, missing or incorrect information can be a huge problem. In the case of Pinkus, it affected the company's ability to process biopsies, prepare and read slides and ultimately report the diagnosis to referring physicians. By putting in place stronger control mechanisms we reduced nonconforming material (biopsies and accompanying information) and educated the referring physician offices on how the accuracy of the information they provide strongly affects the speed and accuracy of the diagnosis they get back. This required all Pinkus personnel to have a consistent understanding of acceptable and unacceptable biopsies and distinguishing information." With all that we implemented, we knew we had a strong program, but until the registration audit we didn't know just how strong," acknowledges Altiere. "The system controls and feedback mechanisms were so integrated it took the auditor no time at all to go through every element of the ISO 9001 standard. In fact, at times it was hard for the auditor to fill their time. In some instances they were forced to look at much larger sample sizes of objective evidence than is usual".Pinkus not only passed its registration audit, but did so with zero findings. ...read more