With 11 testing labs and 122 specimen collection centers in Ontario, Toronto-based LifeLabs used to spend plenty of time distributing copies of documents when there was an update, says Mary Costantino, MLT(CSMLS), ART, BA, training and education consultant for LifeLabs (Ontario). “We had a drive on our server that was only accessible by two people, so revisions to documents would be kept on the shared drive but were not accessible electronically.”
“You can imagine somebody sitting in front of the photocopier and sending up to 130 copies through the mail. That’s what we did until we phased in our Paradigm software.” Since the laboratory purchased a server, installed Paradigm II Work Management Process, and went fully electronic in September 2007, it now houses all its documents on the server and can send any Ontario employee online to read the latest standard operating procedures.
“We still have users who like to use paper, and we retain hard copies at the bench because we still like to actually flip through pages. But before using a particular procedure, staff can go online to print up forms and maintenance charts and have confidence that they’re using the most current documents.”
LifeLabs started looking for a software system because it is seeking ISO 15189 certification through the Ontario Laboratory Association. “They’re looking to see if the organization has a proper document management system, and we chose to go the electronic route because we thought in the long run it would be easier to develop,” Costantino says.
The system was particularly useful during the CAP accreditation in May, says Vanessa Lizano, HBSc, LifeLabs Paradigm administrator. “When the inspectors ask who approved this, when was the document released, who was notified, did the medical director sign off, in the past they would have had to go to the notebook and pull out all the signatures—it was all manual.” This time, if any employee was asked for a particular process or evidence for anything, they knew where to go in Paradigm and could show it to the inspector right away.
Paradigm controls even the job aids. “We don’t have handwritten Post-it notes anywhere,” Lizano says. “If a process requires a job aid, we develop and control it just as we would any of our SOPs.”
There was a certain adjustment period, Costantino says. “The change management piece was big. You have to appreciate the complexity of trying to get all those labs and specimen collection centers on board, when they’re used to having a nice package of documents delivered to them instead of retrieving them themselves.”
The Department of Pathology and Laboratory Medicine of Children’s Hospital of Los Angeles, like many other such departments, has been struggling with document control for years, says Clark B. Inderlied, PhD, director of microbiology and pathology informatics. “Of all the regulatory requirements we contend with, it’s the one that has resonated most with both administrative and technical staff.”
In Dr. Inderlied’s experience, just having a common server that makes documents available to everyone in the lab is not enough to carry out document control. “We looked at products such as MS Office’s Sharepoint, which is very attractive and is used at this institution for a variety of purposes, but it was missing an application specific to the needs of pathology and lab medicine.”
About a year and a half ago, Children’s Hospital chose SoftTech Health’s Quality Management System, an intranet-based system that resides on a server within the hospital. “Though it’s not Web-based, you actually access it using Internet Explorer on a local network, and it can be accessed from off site through VPN access.” In implementing the system, SoftTech Health performed a “bulk upload” of the laboratory’s documents and users, as well as the CAP checklists. “So we started out with a fairly robust database, rather than having to build that,” he says.
“We decided on this system because it is oriented to pathology. It includes document review and a revision process that not only meets but I think really exceeds ISO and CAP requirements, by allowing you to assign review dates for documents and then automatically notifying the appropriate people that the review date is coming up.” All the tracking of version changes and assigning of version numbers is automatic. “So for a large section like chemistry, which has many policies and procedures, this has become a godsend,” Dr. Inderlied says.
In line with document control standards, the system makes only current policies and procedures available. “But we did allow people to print them out. Not all of us are entirely comfortable with reading documents on a monitor.” To ensure that only the most recent policies and procedures are being distributed, “the software allows you to put a watermark on each page of documents, called an LTR number, basically an accession number, so you can immediately determine whether it’s current or not.”
Somewhat unexpectedly, once the system was implemented, laboratory staff started accessing the policies and procedures electronically more than they did when they were in printed format. “It was mostly because the printed versions tended to reside in notebooks on the shelves of supervisors or managers who were not on the bench. So they were readily available as CAP requires, but some of the staff indicated that, mistakenly, they didn’t ever realize they had access to some of this information on policies.”
The system’s archiving function turns out to be valuable, Dr. Inderlied says. “It allows you to maintain obsolete documents on the server but no longer make them available to the common user. Those with a high level of access, however, can look at archived documents, and even bring them up side by side with current versions, much as in the document comparison function within Microsoft Word.”
Dr. Inderlied actually created user names and passwords for the CAP inspectors who came in March, to allow them to access the laboratories’ documents electronically. “They seemed impressed that we were getting that part of our regulatory requirements under control. Of course, inspection teams always seem to find something—but in terms of our document control system, they found no deficiencies.”
There is some pain associated with implementing software like this, Dr. Inderlied notes. “It’s similar to what we and I would assume most labs have gone through in implementing an LIS. As with an LIS, the system has some aspects to it that are unforgiving.” The automatic notification feature, for example, “creates some stress because you’re aware you have to do something.” But in the end, he says “what you find is it’s really a way of forcing you, or coercing you, into complying with requirements.”
The UMassMemorial Laboratories in Worcester, Mass., had particularly daunting document control issues because of its huge size: more than 12 million tests per year in multiple locations; more than 2,000 documents, records, and forms; and more than 600 employees. Angela Nardella, BS, MT(ASCP), manager of regulatory affairs, began looking at software a couple of years ago, with an eye to implementing document control and to seeking ISO 15189 accreditation.
Her eventual choice, MasterControl Software, has been phased in gradually in hospital laboratories and anatomic pathology and at The Caitlin Raymond International Registry. “We’re trying to follow through on the whole life cycle of a document—the creation, the revision and archiving, and this just makes it so much easier.”
A medical technologist since 1975, Nardella remembers when changes to procedures would have been recorded using a bottle of White-Out and a typewriter—quite a contrast to MasterControl, which, like other currently available systems, is password-protected and menu-driven and has different levels of access. Those categorized as “users” are able to read current procedures, “power users” are managers who may make changes to their own SOPs, while “administrators” control security and passwords.
A feature she especially appreciates is that MasterControl hosts the entire system. “One of the barriers to putting new software on your own network is you have to make sure it is secure, back it up, and perform updates. With the company hosting the system for us, we pay a yearly subscription, we can log in from anywhere in the world, and they do all of the necessary maintenance and updates.” If the Internet is down, the information can be retrieved on a shared drive.
The training modules have many automatic features that make laboratory managers’ lives easier, she says. “The training modules are linked to the SOPs, so if a manager makes an edit, or wants to test yearly competency, it can be automatically e-mail-routed to staff, bringing them to a task in MasterControl. They will then read the SOP, take an exam (could be optional), and electronically sign off the course. Then the manager will get an e-mail and can verify that Mary read this SOP, took an exam, and passed it.” Certificates and reports are available also.
Small as well as large labs could benefit from a system like MasterControl, in Nardella’s view, because it offers an “a la carte” subscription to its services. “So you pay not for the total number of staff but the likely number of concurrent users. In our case we may buy five licenses, and five users would all have to start at the exact same minute before the system would knock anybody off.”
Nardella finds the standardized format helpful as well. “When I first looked at this software in 2007, every manager here wrote their SOPs differently. Using CLSI guidelines and MasterControl, we’ve standardized the numbering system, revisions and review, expiration dates, archiving, publishing features, routing, and collaboration. You can also link standards to your SOPs. This is the only way to keep up with the increasing complexity of complying with standards.”
“It’s still easier for people to take that hard-copy manual off the shelf, but from last December to now, staff are starting to realize this tool exists.” The electronic versions of the manuals are called “organizers,” which are separated by section, or “vault.” Each document is converted from the native file to a PDF . “You can also do a simple search to find out what you need,” Nardella says.
“I just went through this transformation with one of the more esoteric laboratories. They had more than 200 SOPs, forms, visual aids, and resource information scattered over multiple different electronic places. There was minimal control of review, revisions, authors, and owners. Now,” she says, “it is tough picturing lab life without it.”