Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D., CLDir(NCA), John D. Olson, M.D., Ph.D.
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 HCFA. 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.
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.
Objectives will accompany each module.
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 Carver College of Medicine designates this educational activity for a maximum of 20.0 AMA PRA Category 1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
CME System Requirements and Privacy Policy>
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).
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.
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:
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 to Katie Coleman in the College of Medicine's CME Division. Phone 319-335-8599, or via e-mail at kathleen-coleman@uiowa.edu.
Other questions may be directed to either of the course directors: Dr. Ronald Feld at 319-356-1759.
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:
Date of Most Recent Reviews:
Date of Next Scheduled Review:
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. Ronald Feld.
The regular mail address is:
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.
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 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. The same principle was used by your third grade teacher who kept the entire class after school because only a few people were talking. Incidentally, I was one of the people who was not talking; and if you were one of the people who was, I hope you have become lactase deficient and cannot enjoy ice cream any more!
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 greatly 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.
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. A list of moderate and high-complexity tests, which include the following:
was 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.
Laboratories performing only waived tests require only a certificate of waiver, they 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 leaving 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. 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. Based on the premise that the way to judge if children have learned their spelling list is to give them a spelling test, proficiency testing (PT) is mandated as a tool, along with inspection, which will weed out the bad labs from the good. Basically PT 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 comparing to a peer group for a passing score. Several organizations have obtained deemed status from HCFA in order to offer proficiency testing programs for all or part of the laboratories. 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 with proficiency testing which will be discussed later.
Inspection is another key part of the regulations' tools to ensure quality. Several organizations 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 HCFA.
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.
| Accutest | (800) 356-6788 |
| American Academy of Family Physicians | (800) 274-2237 |
| American Academy of Pediatrics | (800) 433-9016 |
| American Association for Bioanalysts | (800) 234-5315 |
| American Proficiency Institute | (800) 333-0958 |
| American Society of Internal Medicine | (800) 338-2746 |
| American Thoracic Society | (212) 315-8789 |
| California Thoracic Society | (714) 730-1944 |
| College of American Pathologists/Excel | (800) 323-4040 |
| College of American Pathologists/Surveys | (800) 323-4040 |
| Commonwealth of Pennsylvania | (610) 280-3464. |
| Commonwealth of Puerto Rico | (809) 764-6945 |
| Pacific Biometrics Research Foundation | (206) 233-9151 |
| Solomon Park Research Institute | (206) 821-7005 |
| State of Idaho | (208) 334-2235 |
| State of New Jersey | (609) 530-6172 |
| State of New York | (518) 474-8739 |
| State of Ohio | (614) 466-2278 |
| Wisconsin State Laboratory of Hygiene | (800) 462-5261 |
(The American Osteopathic Association did not reapply for provider status in 1996.) Not all programs offer PT for all analytes.
| College of American Pathologists (CAP) | (312) 446-8800 |
| Joint Commission on Accreditation of Healthcare Organizations (JCAHO) | (708) 916-5600 |
| COLA | (800) 298-8044 |
| Deficiency | Total # | % |
|---|---|---|
| D4006 - General Quality Control-not performed | 8,443 | 29.4% (documented) |
| D7001 - QA Establish and Follow Written Pol | 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