Gearing up for unannounced inspections

In 2004, deficiencies at Maryland General Hospital (MGH) in Baltimore brought oversight attention to the process of laboratory accreditation and inspections. The title of a resulting Government Accountability Office (GAO) report, published in June 2006, summarizes the result: “Clinical Labs: CMS and Survey Organization Oversight Is Not Sufficient to Ensure Lab Quality.” Something had to change. Congressmen called for a switch to unannounced inspections.

At the same time, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Oakbrook Terrace, Ill, was in the process of altering its accreditation process, implementing a plan named Shared Visions—New Pathways, which became effective January 1, 2004.

“In 2004, JCAHO announced its intent to implement unannounced surveys in 2006 as part of our Shared Vision—New Pathways effort,” says Margaret Peck, MS, MT(ASCP), the organization’s director of the lab accreditation program. The goal was to provide a more accurate picture of a laboratory’s day-to-day function. “It would allow our accreditation process to be used as a systems improvement tool,” Peck says.

College of American Pathologists (CAP) followed suit, influenced, says R. Bruce (RB) Williams, MD, pathologist and head of CAP’s accreditation committee, by the concern of the GAO and Congress. “We are continually improving our lab accreditation process, and we underwent a systemic review following MGH,” he says. A subsequent bill—HR 686: Clinical Laboratory Compliance Improvement Act of 2005, introduced by Rep Elijah Cummings (D-Md)—aims to make unannounced inspections a requirement if passed.

The bill is still in its first stage and could undergo significant changes. Not everyone thinks unannounced inspections are a good idea; the Commission on Office Laboratory Accreditation (COLA), Columbia, Md, has not changed its process, says Max (M) Williams, its director of policy and external affairs. “I believe it’s mostly a political reaction and does not really get to the root quality problems in laboratories,” M Williams says.

But whether or not one supports the change, unannounced inspections are a new reality, having begun this year. The result has been some anxiety: What should laboratories expect? How can they prepare? CLP spoke with three accrediting organizations to examine how laboratories can prepare.

The Rules
Unannounced inspections are not completely new to the industry. The method had already been employed in certain instances, such as following up on complaints. And “unannounced” does not mean anytime between now and forever; there are some restrictions that assist laboratories in planning.

CAP laboratories can expect an inspection within a 90-day window of the anniversary of their last inspection (45 days before or after). Lab management is given the opportunity to indicate 10 “blackout” days during this period that would create tight scheduling conflicts for the institution.

JCAHO-accredited laboratories can expect an unannounced survey up to 6 months prior to their biennial resurvey date. These laboratories will also have the opportunity to note 10 days during that period that would not work.

Even though COLA has not implemented standard unannounced inspections, through its agreement with JCAHO, the organization will conduct unannounced surveys for certain facilities, such as JCAHO-affiliated laboratories new to COLA or those with a testing volume greater than 25,000 specimens. “We accredit 7,300 labs and this affects a few hundred,” M Williams says.

The Impact
The impact of an unannounced inspection on a laboratory’s function should not be much different than the planned survey; the actual survey processes of the accrediting organizations have not changed much. Reporting and follow-up methods have not been significantly altered, either.

However, with the lack of advance notice, the first hour is usually a bit chaotic. During its pilot program, CAP conducted interviews, both before and after unannounced inspections, to determine the impact on a lab. Facilities were concerned with having the right personnel and documentation on-site, as well as providing space and food for the inspection team. The first hour is typically spent handling such details.

“During that first hour, people are sent to retrieve documentation, calls are made to staff, food is arranged, and space is made,” RB Williams says. To ease this process, CAP inspectors will arrive a half-hour to an hour earlier.

“As far as room goes, there is rarely a problem. Even if something else was formerly scheduled, laboratories undergoing inspection have been able to get auditorium space for summation conferences. And the vast majority of laboratories are introducing survey teams to their cafeterias or the local fast food restaurant nearby,” RB Williams says.

Labs have also not shown many deficiencies regarding staff or documentation. “Occasionally the lab director or manager is not there, but this has generally been handled with no problems. The lab director should have a partner or backup who could even be interviewed by phone,” RB Williams says.

Laboratories may decide during that first hour to bring in additional staff to ensure that laboratory functions are not disrupted.

M Williams notes concerns about the potential for disruption to patient care, particularly in smaller practices. “We have gotten a lot of feedback that indicates many laboratories have the home and cell phone numbers of employees, which they use to call these personnel and ask to come in at the start of an inspection. Generally, they’ve been successful bringing staff in,” RB Williams says. However, he notes that additional staff may not always be necessary.

JCAHO’s Peck stresses that laboratories should expect a process that sharpens the focus of the survey on care systems. “We will conduct multiple tracers throughout the continuum of care, looking at communications, critical reporting processes, and such,” Peck says. Tracer methodology permits surveyors to evaluate an organization’s systems and compliance as they follow a selected record throughout the health care organization. An individual’s experience is “retraced” and assessed for quality and safety.

In general, the unannounced inspections have gone like the planned ones.

The Prep
Besides assigning dust duty, how can labs prepare for these inspections? Peck suggests they start by developing a team of people who meet on a regular basis to educate staff about inspection-related items, such as documentation. “A team can educate staff about the location of important documents,” Peck says.

“Backup personnel is a key issue for anyone involved in the inspection process. So it is important to identify other individuals who would be available and capable of helping with an inspection,” RB Williams says. He also suggests that laboratorians know their areas. “The entire lab ought to know that the inspection does not focus on one individual but that anyone in the lab is subject to questioning, so they should be familiar with relevant policies and procedures,” RB Williams says.

A notebook in which necessary documentation is stored can be a tool for the inspection team and laboratory personnel. CAP’s RB Williams suggests an annotated checklist that identifies the answers to all inspection items, including maintenance, quality control, policies, and documentation. Formats can range from the printed to the digital. This does three things: ensures the labs they are meeting the intent of the questions, allows the inspection process to occur even if the normal individuals are not present, and decreases the time needed.

RB Williams notes that it is easy for a lab to conduct a self-inspection and think it is meeting a requirement. However, actually documenting it ensures it is becoming more knowledgeable about the topic. Peck agrees that mock surveys can be an excellent tool to help a laboratory stay prepared.

An inspection action plan can also help to ease laboratory anxiety and improve preparedness. “When the inspection team arrives in the morning, there ought to be a preorganized action plan with steps for notifying the administration and chief of staff as well as designated individuals for gathering documentation or calling in extra staff,” RB Williams says. Laboratories with action plans in place have experienced less confusion in the first hour than those without.

COLA’s M Williams thinks that in addition to notebooks and plans, a new culture may be necessary as well. “Laboratories need to shift to being continually operating at a high level, meaning you are following policies and procedures not because you may be inspected that day but because the lab has an internal commitment to customers, whether patients or clinicians,” he says. This means that when problems are identified, the lab does not seek to hide them but instead views them as an opportunity to improve. “A problem, like a misidentified specimen, is an opportunity for the entire lab to determine what happened, make quality improvements, and move on rather than try to place blame or hide the event during an inspection,” he says.

The Effect
Anxiety is both an advantage and a disadvantage to the unannounced inspection process. COLA’s M Williams believes it adds fear to the process, with anxious laboratories canceling employee vacations to have necessary staff on hand if needed. “The idea that an unannounced inspection is more likely to catch a laboratory doing something wrong produces a perpetual state of fear and runs contrary to the idea of quality improvement,” he says.

James O. Westgard of Westgard QC, Madison, Wis, suggests that fear inspires secrecy rather than openness and does not necessarily contribute to improvements.1 Drawing associations to the Sago Mine fatalities in West Virginia, he suggests that cost pressures and insufficient follow-up activity resulted in the MGH incident and suggests flawed enforcement might be a greater issue than inadequate inspections.1

Follow-up procedures have not been altered, though all organizations cited the importance of trained inspectors who can perform on-site education in addition to conducting the survey. “The accreditor can stay in touch and work with the lab to ensure the plan of required improvement is completed properly and not given lip service,” COLA’s M Williams says.

JCAHO’s Peck agrees that the surveyor should educate the lab to provide examples of good practices that may assist the lab in preparing an action plan to address any deficiencies. She notes that if unannounced surveys work as planned, stakeholders will be more confident and will offer proof of the highest degree of testimony regarding laboratory performance.

Reference
1. Westgard JO (MD). Unannounced inspections: unlikely to improve quality. Westgard QC, A Word from JW. Available at www.westgard.com/essay88.htm Accessed October 2, 2006.

Renee DiIulio is a contributing writer for Clinical Lab Products.
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