Matthew D. Krasowski, MD., PhD.
A. About This Course
The Clinical Laboratory Improvement Act of 1988 (CLIA '88) has
drastically altered the management and use of the physician's office
laboratory. Physicians who had managed a clinical laboratory as part
of their practice for one year before the implementation of the law
are effectively "grandfathered in" meeting the qualifications to be a
director of a moderately complex laboratory. Those physicians who
completed resident training after September 1, 1993 or have no
previous experience as laboratory directors need 20 hours of
continuing medical education credit in clinical laboratory practice
in order to qualify as a laboratory director of a moderately complex
laboratory.
This course utilizes linked information to present pertinent information about a topic. Many of the links are to the Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. This document contains the regulations as published in the Federal Register as well as guidelines for inspectors to determine if the laboratory is in compliance with the regulations. We must state that this is not an official version of the manual to satisfy the people at Center for Medicare & Medicaid Services (CMS). It is imperative that you read all the links of a particular module since some of the questions are only covered in the links.
The rules are specific as to what this training must entail. It cannot consist only of how to order and interpret laboratory tests. The training must include preanalytic, analytic, and postanalytic phases of testing and provide the physician with training equivalent to the one year of laboratory directorship.
System requirements for completing this CME course
To complete this course, you need access to the Internet and a browser. Be sure that your browser is set so that graphics are viewable.
CME privacy and confidentiality policy
The Roy J. and Lucille A. Carver College of Medicine at the University of Iowa respects and values your privacy and the confidentiality of the information you choose to share with us. We are committed to protection of this information and will assure your privacy when participating in CME activities on our Website. When you enroll in any of our course offerings, personal information is collected only for the purpose of processing your registration and awarding credit. This information is not routinely shared with persons outside of the UI Carver College of Medicine. For questions regarding our Internet privacy policy, please contact the college's Continuing Medical Education Division.
Copyright Compliance
This CME activity complies with U.S. copyright law.
B. Intended Audience
This course offers up to 20.0 hours of AMA category 1 credit that
will qualify physicians to be directors of moderately complex
laboratories. The course will also be of value to those physicians
and other laboratory personnel who wish to gain additional knowledge
and new skills in the practice of laboratory medicine.
C. Educational Objectives
Objectives accompany each module.
D. Continuing Medical Education.
The University of Iowa Roy J. and Lucille A. Carver College of
Medicine is accredited by the Accreditation Council for Continuing
Medical Education (ACCME) to provide continuing medical education for
physicians.
The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this Enduring Material for a maximum of 20.0 credits. AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
E. Disclosure
Faculty for this activity have no significant financial
relationships to disclose relative to commercial entities, nor are there
pharmaceuticals or medical procedures and devices discussed that are
investigational or unapproved for use by the U.S. Food and Drug
Administration (FDA).
F. Instructions
This course at present contains 20 educational modules. Each module
carries 1.0 AMA category 1 credit. An exception is the module on
Urinalysis, which offers 2.0 credits. All told, 20.0 credits are
possible. Quizzes following each of the educational modules may be
taken directly online and forwarded via electronic mail. Effective September 1, 2012, all 20 modules must be completed within two years of the date of registration. If the entire course is not completed within the two years, you will be required to repeat all 20 modules. (Additional fees may apply.)
In the spaces provided at the beginning of each quiz, please enter your full name, academic degree, medical specialty, complete address (including Zip), and e-mail address. Participation in this activity is confidential. To earn the AMA category 1 credit, a check in the amount of $425.00 made payable to the University of Iowa College of Medicine, should be sent to:
Continuing Medical Education Division
University of Iowa College of Medicine
100 Administration Building
Iowa City, IA 52242-1101
To register on line click on this link. on line registration
It is also possible to register using VISA or Master Card by calling the College's CME Division at 319-335-8599.
Payment is required before credit can be awarded. Once payment is received and confirmed, you may work through the various educational modules at your leisure.
A module quiz score of at least 70% must be attained in order to receive credit. Questions left unanswered will be counted as incorrect. Participants who achieve a score of 70% or above will receive by e-mail a copy of the quiz with an explanation of the correct answers. After completing a quiz on content, an evaluation of each module must also be completed in order to receive credit. This evaluation can also be accomplished online and forwarded automatically via e-mail.
As indicated earlier, instructions are included online with each module. Shortly after the College of Medicine's CME Division receives notification that you have successfully completed a module or group of modules, certificates awarding 1.0 hour of AMA category 1 credit per module will be sent. Category 1 credit may be applied toward the Physician's Recognition Award of the American Medical Association. It should be noted that a number of states require category 1 credit as a condition of licensure.
Questions on matters relating to continuing medical education credit may be directed toMolly James in the College of Medicine's CME Division. Phone 319-335-8599, or via e-mail at molly-james@uiowa.edu
Other questions may be directed to the course director: Dr. Matthew Krasowski. Phone 319-384-9380, or via e-mail to mkrasows@healthcare.uiowa.edu
G. Completion Time and Review Schedule
This educational activity was planned and produced in accordance
with ACCME Essentials and Standards for CME Enduring Materials. Time
required to complete this educational activity is estimated to be 20
hours.
Date of Original Release for CME Credit:
December 1995
Date of Most Recent Reviews:
December 1998, November 2001, November 2004, December 2006, December 2007, January 2008, January 2010, January, 2011, January, 2012.
Date of Next Scheduled Review:
January, 2013
Termination Date: Content is reviewed and updated continuously. It is not acticipated that this activity will be terminated prior to 2020 at the earliest.
H. FAQ File
Persons who register for the course will be allowed to submit
questions either via electronic or regular mail. Please address
questions to: Dr. Matthew Krasowski.
The regular mail address is:
Dr. Matthew Krasowski
University of Iowa Hospitals and Clinics
Department of Pathology
200 Hawkins Drive, 6233 RCP
Iowa City, IA 52242
Answers to the questions will be posted in a FAQ (Frequently Asked Questions) file on the computer. Each module will be updated as new regulations or information becomes available. These changes will be posted in an Updates file in the Main Menu. We hope this course will be beneficial and welcome any suggestions for improvement.
I. The History of CLIA '88
The Clinical Laboratory Improvement Act of 1988 was not the first
foray of the Federal Government into the regulation of the clinical
laboratory. CLIA '67 regulated laboratories that engaged in
interstate commerce. This law pertained to approximately 12,000,
mainly commercial and hospital, laboratories. Except for a few
states, laboratories located in physicians' offices or other small
health care facilities were largely unregulated prior to CLIA '88.
One impetus for CLIA '88 was a series of articles that appeared in the Wall Street Journal in the late 1980s. These articles exposed "PAP smear mills" and called into question the quality of laboratories in general. Congress held hearings at which people who had been harmed by laboratory errors testified. As Congress frequently does when encountering a problem, they attempted to solve the problem with increased regulation.
CLIA '88, passed in October of 1988, greatly broadened the definition of a laboratory. For the first time, federal laboratory regulation was site neutral. The level of regulation was determined by the complexity of the tests performed rather than performance site. Physicians' office laboratories, dialysis units, health fairs, and nursing homes were all covered under the new law along with other previously exempt and non-exempt laboratories.
It is not surprising that the new law dramatically increased the number of laboratories falling under the regulatory umbrella. During the 1980s, advancements in technology and information processing greatly increased the number and complexities of tests that could be performed in a small laboratory. Through increased regulation, Congress hoped to increase the quality of laboratory testing regardless of where it was performed. Incompetent and dangerous laboratories would be weeded out and further tragedies like those presented in testimony would be minimized.
J. An Overview of CLIA '88
While the final regulations of CLIA '88 which were published in the
February 28, 1992 Federal Register are written in "bureaucratese",
there are some broad themes that can be gleaned from the fine print.
The first of these is the complexity model for laboratory testing. As
discussed earlier, in order to make the regulations site neutral, a
complexity model was developed to categorize laboratories. Testing
was divided into three broad categories - waived, moderate and
high-complexity. Since the original regulations were published, a new
category of provider performed microscopy has been added.
Waived tests are defined as simple tests which have little risk of an erroneous result and also pose no reasonable risk of patient harm if performed incorrectly. With a definition like that, one wonders why anyone would want the test in the first place. Examples of waived tests are fecal occult blood and dipstick urinalysis.
The remaining tests are categorized as moderate and high-complexity tests by a scoring model that includes knowledge, training and experience, reagent preparation, manual vs. automated, availability of controls, calibrators and proficiency testing, troubleshooting, and interpretation and judgment as criteria. Lists of test classified by complexity were first published in the June 26, 1995 issue of the Federal Register. There is a mechanism in place to categorize new tests as they are developed. An updated set of links to waived, provider-performed microscopy, and non-waived testing is available as pdf downloads at the CMS website (http://www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPage).
Laboratories performing only waived tests require only a certificate of waiver, and are exempt from most of the other regulations covering personnel, proficiency testing and inspection. They must apply for a certificate of waiver which is renewable every two years. Laboratories performing moderate or high-complexity testing must apply for a license also renewable at two-year intervals. The fee to obtain a license is dependent on the number of tests performed. Laboratories performing only a single moderate or high-complexity test are so classified and subject to all of the regulations of that category. For instance, a laboratory performing only moderately complex tests except for the manual white cell differential, which is categorized as highly complex, must follow the regulations for a highly complex laboratory.
Personnel requirements for moderate and high-complexity laboratories fall into four categories: laboratory director, technical consultant, clinical consultant, and testing personnel. Again, physicians completing residency training after Sept. 1, 1993, or who have not previously had a year of directing a laboratory need 20 hours of laboratory directed continuing medical education in order to qualify as the laboratory director of a moderately complex laboratory. There are special personnel requirements for laboratories performing cytopathology and histocompatibility testing. Individual requirements for each category will be discussed more fully in a later section.
Proficiency testing lies at the heart of the regulations' intent to ensure quality. Proficiency testing is mandated as a tool, along with inspection. Basically, proficiency testing consists of five challenges three times a year. Different passing scores are determined and set depending on the laboratory area being tested. Cytopathology proficiency tests individual personnel rather than the entire laboratory. Several organizations have obtained deemed status from CMS in order to offer proficiency testing programs for all or part of the laboratories. (see http://www.cms.hhs.gov/CLIA/downloads/ptlist.pdf). There are specific sanctions outlined in the regulations for those laboratories which do not pass proficiency testing challenges. These can range from increased proficiency testing to loss of the license. There are many problems and limitations with proficiency testing which will be discussed later. Proficiency testing is not offered for all analytes.
Inspection is another key part of the regulations' tools to ensure quality. Several organizations including the College of American Pathologists (CAP) and American Association of Blood Banks (AABB) have obtained deemed status to perform inspections (see http://www.cms.hhs.gov/CLIA/downloads/AO.List.pdf for a complete list of organizations with deemed status) have obtained deemed status to perform inspections. Inspection is every two years. Laboratories performing only waived tests will not be inspected unless there is cause or a need to assess the effectiveness of the regulations. Laboratories not inspected by one of these organizations will be inspected by state personnel working under contract to CMS. Currently, New York and Washington are the only two states exempt from CLIA (see http://www.cms.hhs.gov/CLIA/downloads/Exempt.States.List.pdf).
Quality control and quality assurance appear to be two areas where many laboratories are being cited. Appropriate quality control and documentation plus a quality assurance program which monitors and evaluates the total quality of the laboratory are key areas for inspection. Further sections of this course will explore these and other areas in detail to help you meet proficiency testing goals and successfully complete a laboratory inspection.
Most Cited Deficiencies According to CMS (formerly HCFA) CLIA-88 Inspection Statistics
| Deficiency |
Total # |
% |
|---|---|---|
| D4006 - General Quality Control-not performed | 8,443 | 29.4% (documented) |
| D7001 - QA Establish and Follow Written Policies | 7,567 | 26.3% |
| D4001 - Follow Manufacturer's Instructions | 7,118 | 24.8% |
| D6032 - Lab Director Assigns Written Duties | 5,026 | 17.5% |
| D4002 - Procedure Manual | 3,934 | 13.7% |
| D3056 - Test Reports-Indicate Lab Location | 3,362 | 11.7% |
| D3042 - Test Records-Include the Identity of Testing Personnel | 3,030 | 10.5% |
| D6031 - Lab Dir Ensures Availability of a Procedure Manual To | 2,851 | 9.9% |
| D2000 - PT Enrollment-Approved PT Program | 2,300 | 8.0% |
| D3039 - Test Records Include The Time of Specimen Receipt into The Lab | 2,239 | 7.8% |
Total Number of Surveyed Labs Entered into Data Bank as of 5/17/95: 28,752