for new lab directors
training time frame
CAP of legal problems
with poor PT scores
of staff inspectors
the CAP inspection process
The CAP Commission on Laboratory Accreditation
has been focusing on the following areas in recent months.
Unannounced inspections will start next year. The
College has always maintained that laboratories should be ready to be
inspected at any time. With unannounced inspections, some inspection
details will not be able to be arranged in advance, such as the location
of the summation conference, lunch arrangements, and scheduling
appointments with the team leader and members of the medical staff and
hospital administration. These arrangements will need to be made the day
the inspector arrives.
Inspections will take place within a 90-day
window around the accreditation anniversary date. Laboratories will be
allowed to select 10 black-out dates during this time.
Laboratories will receive more information about
unannounced inspections this fall.
Team leader checklist
The purpose of the new team leader checklist is
to give additional guidance to team leaders and to ensure that they are
asking the appropriate questions during the inspection. Some of the
questions in the checklist come from the laboratory general checklist and
others are new.
The checklist includes explanatory and
instructional information about interviews with the laboratory director,
hospital administrator, and representative of the medical staff. The
laboratory director's responsibilities, which are detailed in the
Standards for Laboratory Accreditation, are covered in the
checklist questions so the inspector will be able to understand how the
laboratory director ensures that these responsibilities are performed. The
team leader will also be evaluating the quality management plan, with
input from each of the team members who has reviewed each laboratory
section in detail.
Forms for new lab directors
The College will soon be sending out revised
forms that must be completed by an accredited laboratory when that
laboratory names a new director. The new director will be required to
attest on the form that he or she personally performs each of the 14
responsibilities from LAP standard I or delegates some of those
responsibilities, and if so, to whom, and monitors these functions. This
form will also be used when a new laboratory applies for inspection. In
addition to supplying a curriculum vitae, the laboratory director will be
asked how he or she meets the laboratory experience requirements of CLIA
Inspector training time
Beginning next year, all team leaders and team
members will be required to successfully complete inspector training, as
specified by the CLA, within two years prior to conducting an inspection.
In the past, such training was encouraged, and the recommended time frame
was three years prior to an inspection.
Laboratories and CAP inspectors will be receiving
more information about these requirements this fall.
Notifying CAP of legal
The CLA revised its policy that laboratories
notify the College when they receive adverse media attention or they are
being investigated by another agency. The commission added the requirement
that a laboratory notify the CAP when it discovers that an employee is
violating a federal, state, or local law that regulates laboratories.
Addressing patient safety
Laboratories will soon see new checklist
questions that address the CAP's national laboratory patient safety goals.
A question about patient safety goals will be added to the quality
management plan section of the laboratory general checklist to ensure that
patient safety within the laboratory is coordinated with other hospital
services and that safety problems are identified and corrected. The
question will specifically state:
Does the laboratory address the current CAP
national laboratory patient safety goals?
Note: The current CAP national laboratory
patient safety goals are: 1. improve patient and sample identification at
specimen collection, analysis, and resulting; 2. improve verification and
communication of life-threatening or life-altering information regarding
malignancies, HIV (and other serious infectious diseases), cytogenetic
abnormalities, and critical values; 3. improve identification,
communication, and correction of errors in a timely manner; 4. improve the
coordination of the laboratory's patient safety role within health care
organizations. The laboratory must document that these goals have been
addressed by evaluation and/or monitoring of the processes involved.
The last sentence of the checklist question notes
that there is no expectation that the lab necessarily monitor a key
indicator for each of the CAP patient safety goals. The lab should,
however, conduct a "mini-audit" to determine if its policies, processes,
and procedures are adequate in each of the four areas and to make any
necessary modifications and, if appropriate, monitor key indicators to
assess its performance.
A question has been added to the April 28, 2005,
edition of the anatomic pathology checklist to clarify that specimen
dissection is considered high-complexity testing under the CLIA
regulations and that all individuals performing this function must meet
the CLIA qualifications for high-complexity testing personnel. The phase
II question (ANP.11610) reads:
If specimens are dissected by individuals other
than a pathologist or pathology resident, do such individuals qualify as
high-complexity testing personnel under CLIA '88 regulations?
Note: The laboratory director may delegate
the dissection of specimens to non-pathologist individuals; these
individuals must be qualified as high-complexity testing personnel under
CLIA '88 regulations. The minimum training/experience required of such
personnel is: 1. an earned associate degree in a laboratory science or
medical laboratory technology obtained from an accredited institution, or
2. education/training equivalent to the above that includes at least 60
semester hours or equivalent from an accredited institution. This
education must include 24 semester hours of medical laboratory technology
courses or 24 semester hours of science courses that includes six semester
hours of chemistry, six semester hours of biology, and 12 semester hours
of chemistry, biology, or medical laboratory technology in any
combination. In addition, the individual must have laboratory training
including either completion of a clinical laboratory training program
approved or accredited by the ABHES, the CAHEA, or other organization
approved by HHS (note that this training may be included in the 60
semester hours listed above), or at least three months documented
laboratory training in each specialty in which the individual performs
In addition, the CLIA '88 regulations include
exceptions for grandfathered individuals; these regulations (42CFR493.1489
and 1491) may be found at www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1487.
This checklist question applies only to
laboratories subject to CLIA '88.
Increased use of online data collection and
review in lieu of an entirely manual, paper-based system has allowed the
commission to shorten the timeline from inspection to accreditation. The
goal is for the College to make accreditation decisions no later than 75
days after a laboratory is inspected, down from 120 days.
The team leader for inspections, including
histocompatibility, cytogenetics, and molecular pathology section
inspections, receives a list of qualified inspectors who have been
approved based on training, credentials, and experience. The CAP central
office has been contacting team leaders before inspections to ensure that
a qualified team member will be inspecting these areas. If the team leader
wants to take a member of his or her department who has not been approved
by the appropriate CAP scientific resource committee, the College must
approve that person prior to the inspection. This is another way to
increase the number of qualified inspectors for each area.
Team leaders are encouraged to introduce
pathology residents and fellows to the inspection process since they are
potential team leaders. The residents and fellows should inspect areas
consistent with their level of expertise and generally should not inspect
anatomic pathology, cytopathology, flow cytometry, cytogenetics, and
histocompatibility since special qualifications are required to inspect
these areas. Suggested areas for them to inspect include small hematology
laboratories, coagulation, urinalysis, and blood gas laboratories.
Labs with poor PT scores
If a laboratory has unsatisfactory performance,
meaning it scored less than 80 percent on a Survey with five challenges
(less than 100 percent in transfusion medicine), it is required to
investigate and document its corrective action. The laboratory must retain
this documentation so it can be reviewed during the next CAP on-site
inspector visit. If the laboratory is unsuccessful, meaning it scored less
than 80 percent on two out of three proficiency testing events, it must
send documentation of its investigation of the problem and corrective
action to the College. All tests, whether or not regulated by CMS, are
managed the same way.
If a laboratory has a critical proficiency
testing failure, meaning that three of four consecutive PT events have a
score of less than 80 percent, the laboratory will be required to cease
testing for this analyte and demonstrate acceptable performance on two
Additional explanatory material, with helpful
hints on how to conduct an inspection, will be added to each checklist
starting with the October edition.
Use of staff inspectors
Staff inspectors are helping with many more
inspections to provide consistency and additional information to team
leaders for nonroutine inspections, systems inspections, and certain
routine inspections where their expertise is helpful. They are also
inspecting small laboratories, especially if there is no pathologist
director and no anatomic pathology service.
CLA improvement projects
Laboratory Accreditation Program staff are
working on key projects to improve inspection and accreditation processes.
Among them are a video for laboratory personnel to view prior to an
inspection so they understand the inspection process, projects for
enhancing educational opportunities for inspection team leaders and team
members, and upgraded computer capabilities for tracking laboratory
performance. Additional information about these projects will be sent to
laboratories later this year.
New training modules
The College has introduced new inspector training
modules, including "Managing a Successful Inspection" and "Best Inspection
Techniques." Both modules emphasize the type of interaction and
communication that should occur during the inspection.
The CAP's education and communication services
divisions are preparing a video for laboratories involved in the
inspection process to explain what is expected during the inspection and
how the inspection process benefits the laboratory and patients.
Validating the CAP
Commissioners recently recommended that the
College set up its own quality management system for the Laboratory
Accreditation Program so the CAP can validate its own inspection
processes. Such a system might include spot checking certain areas by
conducting focused on-site validation inspections, having a staff member
accompany a team, or having the laboratory submit documentation for
certain checklist questions, even if it was not cited with a deficiency,
to evaluate its compliance.
Equivalent quality control
The Centers for Medicare and Medicaid Services
has decided not to implement proposed alternative quality control
requirements at this time. CMS has solicited more input from manufacturers
and accrediting organizations on the scientific basis of quality control
as it applies to single-use testing devices.
A conference to further review these issues will
be held in March 2006 under the aegis of the Clinical and Laboratory
Standards Institute, or CLSI.
Ed Finkel is a writer in Evanston, Ill.