CEOSUMMARY: Here is the lab industry’s first report from a laboratory which has under gone an unannounced inspection under the College of American Pathologist’s new accreditation program. Lab management at Kern Medical Center say the process went smoothly—but that effective preparation and a detailed contingency plan are “musts.” Once the inspection starts, conventional procedures are followed.
THIS IS THE YEAR that unannounced inspections commence for laboratories accredited by the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations(JCAHO).
CAP is wrapping up its pilot program for unannounced inspections. In mid-April, it expects to begin unannounced routine inspections for laboratories reapplying for CAP accreditation.
Kern Medical Center (KMC) in Bakersfield, California, participated in the pilot program. Its unannounced inspection was conducted on January 3, 2006, making it among the first laboratories to undergo CAP’s new inspection process. KMC is a county-owned, 244-bed teaching hospital with level II trauma center. The laboratory performs about 650,000 billable tests annually.
“In October 2005, CAP called our Chairman of Pathology at KMC to ask if we would like to participate in the pilot program,” stated James Pusavat, MT(ASCP)SM, Supervisor of the Microbiology Section at Kern Medical Center. “CAP needed to do some trial runs before the beginning of the unannounced inspections.
“We immediately formed a team to develop a contingency plan,” recalled Pusavat, who was a member of this team. “In this group were the chairman and key members of the leadership team. Representation included both day and night shifts and every section of the lab, such as hematology, urinanalysis, point of care testing, chemistry, microbiology, coagulation, blood bank, etc. We met almost every week until early December to put together a contingency plan.
Preparing For Inspectors
“We organized our contingency plan around three major areas: personnel, paper, and place,” he explained. “Under personnel, we needed to develop a list of staff members who would be available and willing to work on short notice in the event of an inspection. This was challenging for our lab, because we operate our laboratory with a very lean staff on all shifts.
“As it turned out, most everybody asked was cooperative,” continued Pusavat. “In the event of an unannounced inspection, they all agreed to come in on their days off. By asking them in advance, it helped us to sustain good morale levels in the laboratory. We also identified the executive staff who would need to be notified immediately in the event of an inspection.”
The second area involved the laboratory’s written communications tools, including checklists and task lists. “I’ve kept annotated checklists in my microbiology section for nearly 10 years,” noted Pusavat. “These checklists cover four things that are critical during an inspection: 1) what it is; 2) where it is; 3) what it looks like; and, 4) how to retrieve it. We keep the checklists and all relevant documents in binders marked with a green fluorescent dot, so they can be located quickly and easily.
“Prior to the unannounced inspection pilot program, no one in Microbiology was required to read the CAP checklists,” he added. “As part of our preparation, I made copies of the checklists for each staff member in my section. Everyone was required to read the checklists and be able to locate every document named in the checklists.
Organized in Binders
“I know these binders are a point of differentiation compared to some laboratories,” stated Pusavat. “Some labs are poorly organized with these documents. As a result, it may take a long time to locate a specific document. This can slow down an inspection process. It also wastes valuable personnel time.
“Our binder organization did not go unnoticed by the CAP inspector. It took less than one minute to locate any document when asked by the inspector,” he recalled. “All materials in the binders are clearly labeled and are listed in a master table of contents. We store the microbiology binders on 20 feet of overhead shelves along the wall of the microbiology section. Only the instrument print-outs are not in binders. We store these print-outs in boxes.
“Another key area of our preparation for an unannounced inspection concerned the checklists in the binder” added Pusavat. “Like most laboratories, we make and revise annotations to our checklists annually. Upon review, we realized that some of these annotations may have been a little cryptic, and thus unclear to someone responding to an inspector’s inquiry.
“We updated the notations to be sure they were written clearly and legibly,” he noted. Our goal was to have checklists that met my “Rule of 4,” allowing anyone looking at them to determine: 1) what it is; 2) where it is; 3) what it looks like; and, 4) how to retrieve it.
Giving Inspectors A Place
“Our third area of preparation involved a place where the inspectors could do their work,” said Pusavat. “Our lab has a conference room. Part of our contingency plan is for the secretary to call and cancel all appointments scheduled for the conference room the day of the inspection. During our pilot program inspection, some inspectors preferred to sit within the department, rather than in the conference room.”
Contingency planning by the laboratory team at Kern Medical Center was done by the middle of December, 2005. As it turned out, the timing of KMC’s unannounced inspection came on the heels of the holiday season.
“On January 3, 2006, we were surprised at around 7:45 a.m. by a CAP inspection team,” recalled Pusavat. “It was a total surprise. Many people were just returning from the holidays. The chairman of the pathology department and one of the supervisors were out with the flu! But everyone in the lab knew exactly what to do. We simply followed our checklist and our contingency plans.”
Good Preparation Pays Off
Once the unannounced inspection commenced, it proceeded along in a conventional manner. “Essentially, this inspection process was the same as it used to be during announced inspections,” observed Pusavat. “The key is to have a detailed contingency plan that everyone in the lab understands—whom to contact, where to locate and how to retrieve documents and records. Good preparation paid dividends for us.”
Pusavat has several recommendations about how other laboratories can better prepare for an unannounced inspection. “The first place to start is the CAP Web site, which is www.cap.org. It has all the information anyone needs to prepare for an unannounced inspection,” he said.
“Another useful resource is the information the CAP presented during its audioconference on the unannounced inspection process in Nov- ember 2005,” stated Pusavat. “This information is available on the CAP web site. There is also a useful page on frequently asked questions (FAQs) and a tips page, which was probably compiled based on feedback from the unannounced inspections pilot program.”
Getting Good Information
“In addition to the customized checklists sent to the lab on a CD-ROM, CAP has also posted checklists with different formats on-line,” he added. “In our microbiology section, I have a copy of our annotated checklists in Adobe PDF format at each workstation in Microbiology. This is useful for the techs on a routine basis, in addition to being convenient for inspectors.
“Using the ‘find’ feature in searching the PDFs of checklists, it becomes easy and quick to access specific information by checklist number or keywords,” said Pusavat. “This saves time for busy techs. If Adobe software is not available to create PDF files, it is also possible to use security-protected MSWord files. The password protects against unauthorized editing.
“In summary, good advance contingency planning, a well-organized storage system, and following the CAP tips are the most effective ways to assure a successful unannounced laboratory inspection experience,” advised Pusavat.
Using CAP’s Resources To Prepare the Laboratory
HAVING DONE WELL with its unannounced inspection last month, the laboratory at Kern Medical Center (KMC) in Bakersfield, California has several lessons to share.
“My main advice is to establish a good contingency planning team and give it the time and resources to do a good job,” said James Pusavat, MT (ASCP)SM, Supervisor of the Microbiology Section at KMC. “The contingency plan is what guides your laboratory staff when inspectors do show up—at the most unexpected moment.
“Second, you’ll find lots of useful and detailed information on the Web site of the College of American Pathologists (CAP), located at www.cap.org,” noted Pusavat. “This information provides a good roadmap to prepare for the unannounced inspection.
“Third, remember that continuous improvement follow-up is now part of the inspection program,” Pusavat explained. “The contingency plan your lab develops will form the basis for ongoing improvements that fulfill this part of the CAP accreditation process”