your lab focus 284 CE Update [generalist compliance/regulation management/administration and training] COLA Accreditation An Educational Experience Jennifer L. Rivers, Catherine M. Johnson, MT(ASCP) COLA, Columbia, MD DOI: 10.1309/X8WJYBVUJ2664LQP After reading this article, the reader should understand the education process in COLA s accreditation program. Generalist exam 90301 questions and corresponding answer form are located after the Your Lab Focus section on p. 317. COLA accreditation is a multi-step educational process promoting excellence in the operation of clinical laboratories. COLA enrollment normally leads to more accurate patient test results as specific problems are addressed and overall laboratory operations are improved. COLA s technical professionals are available throughout the process to answer technical and administrative questions. COLA s roots run to the heart of the medical community. COLA was incorporated as a non-profit organization in 1988 and is sponsored by the American Academy of Family Physicians (AAFP), the American Medical Association (AMA), the American Osteopathic Association (AOA), the American Society of Internal Medicine (ACP-ASIM), and the College of American Pathologists (CAP). Several other national medical groups endorse the COLA accreditation program, including the American Academy of Clinical Endocrinologists, the American Academy of Neurology, the American College of Rheumatologists, and the Endocrine Society. Since 1993, COLA has been deemed by the Centers for Medicare and Medicaid Services (CMS) to accredit laboratories under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. After its 1997 re-approval with CMS, COLA added transfusion services to the testing specialties it is authorized to accredit. Laboratories that enroll with COLA receive COLA s educational resources, including the laboratory self-assessment, technical assistance as needed through the COLA information resource center, a subscription to the bi-monthly COLA Insights newsletter, proficiency test monitoring and feedback, members only Web site, and a biennial on-site survey. One of the unique aspects of COLA accreditation is its educational nature. The COLA accreditation criteria are the centerpiece of this interactive process. These criteria guide a quality-conscious laboratory to take all appropriate steps to ensure accurate results from tests performed in the laboratory. Study of these criteria can be used to improve the operation of any laboratory. Another unique component of COLA s educational process features the survey staff. COLA employs a dedicated staff of clinical laboratory scientists to perform the laboratory on-site surveys. They are trained to provide consistent application of COLA s standards. An important focus in the education process is the COLA self-assessment. COLA has developed a questionnaire that is used to assess the operation of a laboratory and to determine if the laboratory is taking steps to ensure continuing accurate test results. These questions, used by laboratories to determine if they are in compliance with COLA s accreditation criteria, are intended to educate laboratory staff in the operation of a qualityoriented laboratory. Once the laboratory staff has answered these questions, they are returned to COLA where they are reviewed for deficiencies. If any problem areas are found, COLA sends the laboratory recommendations that address these problems. The selfassessment questions are the same questions used by COLA surveyors during the laboratory s on-site survey. At the end of the self-assessment process, laboratory personnel should be able to predict how the laboratory will perform during the COLA on-site survey. If necessary, laboratory staff still has the opportunity to make additional changes to
Types of Laboratories Eligible for COLA Accreditation Physician Office Laboratories Point-of-Care Laboratories Community Hospital/ Independent Laboratories Reference Laboratories laboratory policies and procedures, thereby improving laboratory performance and reducing problems that would have been identified at the time of survey. If the physician participates fully in the self-assessment process, he or she will receive up to 15 hours of AMA Category 2 CME credit. Of course, the COLA on-site survey has also been designed to be educational rather than punitive. Our staff is trained to help COLA participants understand where their laboratory operation needs improvement and how to make those improvements. COLA accredits a variety of laboratories [T1], including those laboratories that are part of a group practice, HMO, clinic, residency program, Indian Health Service clinic, public health clinic (or similar patient care facility), student health service clinic, or other practice arrangement. COLA expects that a fully licensed physician be responsible for the operation of the laboratory in accordance with COLA standards and in the best interests of the patients served by the laboratory. COLA-accredited laboratories meet CLIA requirements and are recognized by the Joint Commission on Accreditation of Healthcare Organizations. COLA s fees for physician office laboratories are based on the number of physicians using the laboratory and the number of laboratory specialties tested [T2]. Fees for community hospital and independent laboratories are based on the number of tests performed annually and the number of laboratory specialties tested. T1 A clinical laboratory used by a fully licensed physician to test specimens collected primarily from patients of the practice. It is usually located at the physician s principal site of care. Include ancillary testing sites, ambulatory surgery clinics, community clinics, home health agencies, hospices, mobile units, skilled nursing facilities, renal dialysis units, and similar facilities. Includes all clinical specialties including immunohematology and transfusion services. If the laboratory tests specialties for which COLA is not approved under CLIA (ie, surgical pathology), it must obtain alternate accreditation for these specialties. This certification may include accreditation by another CMS-approved accrediting organization. A laboratory that receives more than 50% of its specimens from sources outside the practice. Preparing for the Survey With each COLA laboratory, including those experiencing high turnover of personnel, COLA assists the laboratory in the process of preparing for the survey. The best way to prepare for a COLA survey is to complete the questions for selfassessment. These questions are the same questions that COLA surveyors use to survey laboratories, so there should be no surprises during the on-site visit. COLA has found that the laboratories that complete the questions for self-assessment have done better, as a whole, on their surveys. The laboratory director should be available during the day of the survey. However, the director s presence is not necessary for a survey to be conducted. If the director cannot be present, he or she should designate the laboratory supervisor to be present as the laboratory s representative. Consultants are encouraged to be present to observe the survey. COLA advises laboratory personnel on the necessary documentation that should be available for review by the surveyor, such as: Procedure manual Safety manual (if separate from procedure manual) Specimen collection and handling manual (if separate from procedure manual) Quality control records (corrective action logs, etc) Instrument maintenance records Daily function checks/activities (cleaning, temperature records, etc) Quality assurance documentation Calibration documentation Proficiency testing records Personnel records Patient test management records such as specimen rejection logs, panic value notification logs, and daily patient tracking logs or equivalent records Complaints and communication records As part of its preparation for the survey, the laboratory should ensure that it meets the COLA standards detailed here. Overall Laboratory Operation The laboratory must have sufficient space for safe and efficient testing. The director must be sure that the staff follows written procedures for the collection, labeling, testing, and reporting of test specimens. Quality Assurance Periodically, the laboratory director and staff should review all laboratory processes according to the written quality assurance plan. This plan evaluates such things as patient preparation, specimen collection, testing procedures, reporting results, proficiency testing results, and identifying and correcting errors. Quality Control The laboratory needs a quality control program for all tests performed. The laboratory director is responsible for ensuring that the laboratory staff follows the quality control plan. COLA strongly urges laboratories to include waived tests in their laboratory quality control program because it is good laboratory practice. When performing testing in the waived category, laboratories must follow the manufacturer s instructions in order for those tests to be considered waived. Proficiency Testing A laboratory must enroll in proficiency testing (PT) for all regulated analytes they perform. Although it is not required by CLIA regulations, COLA strongly recommends that laboratories participate in a PT program or perform split sample testing for non-regulated and 285
waived tests. Proficiency testing is an important aspect of the laboratory s quality assurance program. COLA monitors each laboratory s performance through our PT tracking system for each analyte and specialty, and will contact the laboratory in the event of PT failure with information on corrective action and troubleshooting tips. CMS-Approved Specialties Chemistry - including endocrinology, toxicology, and methods utilizing radioimunoassay (RIA). Hematology - including coagulation Microbiology - including bacteriology, mycology, parasitology, and virology Immunology - including syphilis serology Immunohematology/transfusion services Compatibility testing Mycobacteriology T2 286 Personnel Training Federal personnel requirements are very specific about the qualifications of the laboratory director, technical consultants, supervisors, and testing personnel. Most physicians and their staffs should be able to qualify for moderate complexity laboratory testing without difficulty. Instrument Maintenance Every instrument in the laboratory should be maintained according to the manufacturer s recommendations. Instruments in top condition are critical to providing accurate test results. Safety It is important for the physician and laboratory workers to be aware of the local, state, and federal safety regulations that apply to the laboratory. These regulations include precautions that must be taken when handling and disposing patient specimens, among other safety concerns. Documentation In addition to documentation of actual patient test results, the laboratory should have a procedure manual that contains the information about the testing procedure. The manual should contain step-by-step directions for each test as well as for specimen collection and handling, instrument maintenance, and quality control procedures. This material supplies the specific details of testing, acts as a guide for troubleshooting, provides consistency and continuity in the event of personnel turnover, and provides a permanent record of laboratory activities. Other documents in the laboratory should include personnel records, quality control records, duplicate test results, instrument maintenance records, results of proficiency testing, and corrective actions taken when results are unacceptable. COLA On-Site Survey An on-site survey is performed sometime between the first 3 to 11 months of enrollment with COLA. Future surveys are usually scheduled 18 to 24 months after the initial survey. One of the major distinctions of the COLA accreditation program is its emphasis on the educational aspect of the on-site survey. COLA s mission is to assist laboratories in establishing a qualityoriented laboratory that meets applicable regulations. The on-site survey is required for accreditation and is used to confirm the laboratory s compliance with COLA standards and accreditation criteria, and to verify the demographic information sent to COLA earlier in the accreditation process. A COLA survey is also designed to educate the laboratory director and staff in the operation of an efficient and accurate laboratory. This aspect is especially important when deficiencies are found in testing procedures followed by the laboratory. COLA surveyors are specially trained to assist the laboratories they survey. COLA surveyors are clinical laboratory scientists experienced with testing facilities of various sizes and complexities. The surveyor evaluates the laboratory s compliance with the specific performance measures and will take time to answer questions and educate laboratory staff about good laboratory practices. After introductions, the surveyor takes a tour of the laboratory. During this tour, the laboratory s instrumentation is checked against data the laboratory previously submitted to COLA on the laboratory information forms. After the tour, the surveyor requests to review the laboratory s documentation. The surveyor uses this documentation to verify the test menu and complexity of testing performed at the laboratory. These records are also instrumental in evaluating personnel for their ability and qualifications to perform the level of testing performed at the laboratory. Patient test results are compared to worksheets and/or instrument printouts. After the paperwork review, the laboratory is checked for other criteria that reveal laboratory conditions. The surveyor will refer the laboratory to any relevant educational materials available from COLA. If the surveyor has any questions about a particular laboratory worker s ability to perform a given test, the surveyor may ask the laboratory worker to perform the test and observe whether it is done properly. Summary Conference The final phase of the on-site survey is the summary conference, which is held between the COLA surveyor and the laboratory director, staff, consultants, and any other staff the laboratory director indicates. The purpose of the summary conference is to provide a general overview of the survey findings to all interested parties. During the summary conference, the surveyor emphasizes the educational resources available to help the laboratory staff resolve any problems or areas requiring attention. This is also an opportunity for the surveyor to congratulate the laboratory director and staff when the laboratory is found to be in compliance with COLA criteria. The surveyor stresses that written notification of the laboratory s status will
follow, explains the remaining steps in the accreditation process, and gives the laboratory director an estimate of when he or she can expect to be notified of the laboratory s accreditation status. The laboratory director is asked to complete a survey evaluation form and return it to COLA. The overwhelming majority of laboratories report the on-site survey to be a helpful, educational process. Most laboratories are already quality-oriented, and therefore look forward to suggestions that will help them run an accurate and efficient laboratory. Processing Data From the Survey After the on-site survey, COLA makes the laboratory aware of any deficiencies it may have and provides a plan of required improvement (PRI) to address the deficiencies noted. The PRI contains detailed instructions concerning the following: necessary improvements, documentation required for the laboratory to prove completion of the plan, whether the laboratory is subject to probation, whether the laboratory is subject to resurvey, the cost of this resurvey, and whether the laboratory director must forward documentation to COLA. The laboratory director normally has 14 days to agree to the PRI or to appeal to COLA. If the laboratory director agrees to correct deficiencies in a timely manner, the laboratory is approved for accreditation. When the laboratory receives its PRI, a laboratory performance report will also be included. The laboratory performance report is a valuable tool that provides an indication of how the laboratory is performing in comparison with other laboratories in its peer group. Peer groups are determined by the size of the facility, with the number of physicians using the facility as a determining factor. Additional Support While COLA is not a proficiency testing provider, it does monitor the laboratory s proficiency testing performance and offer guidance to help the laboratory achieve successful results. So that the laboratory complies with CLIA, COLA uses the same proficiency testing enrollment requirements and grading criteria as the federal government. If the laboratory has adequate instrument maintenance, personnel training, and quality control procedures, proficiency testing should be successful. Unsuccessful proficiency testing is an indication of possible problems in these areas. COLA is sensitive to the need that laboratories have in demonstrating superior performance. Therefore, COLA created the laboratory excellence award that is earned by COLA laboratories that show exemplary performance. COLA laboratories are eligible if they complete an on-site survey; are compliant with COLA essential and required criteria; document successful performance in proficiency testing for the preceding 3 events and have no valid complaints against the laboratory. Each laboratory receiving this award receives a congratulatory letter and a special COLA laboratory excellence plaque. Educational Resources COLA encourages participants to access our information resource center and speak with our technical staff who are capable of answering questions about instrumentation, record keeping, quality assurance, and a host of other topics. The COLA Insights newsletter, published 6 times a year, provides current information on laboratory regulations, COLA program news, technical information, and other important topics. In addition to COLA Insights, COLA provides a number of other educational opportunities, including: Laboratory Quality Assurance: A Plan for Implementation, a turnkey publication which includes a working template of a QA plan for any laboratory to implement immediately; OSHA Self-Assessment: The COLA Guide to Complying with the OSHA Bloodborne Pathogen Regulations, provides a complete overview of the bloodborne pathogen regulations and requirements; CLIA Fact Sheets, user-friendly, 1- and 2-page sheets relating to quality assurance, quality control, OSHA, personnel standards, and proficiency testing; and COLA Web Site (www.cola.org), includes the following sections: special members-only extranet site, shopping cart system, on-line forms, healthcare/cola news, and the e- learning program offering CME and CEU credits. e-learning Endeavors COLA s newest on-line education program located on the web at www.labuniversity.org offers on-line courses that help physicians and laboratory staff meet continuing education, certification, and licensing requirements. Through the joint sponsorship of the University of Wisconsin Medical School and COLA, physicians can earn 3 to 4 hours of Category 1 CME credit for successfully completing each course. In addition, COLA is approved to award ASCLS P.A.C.E. (CEU) credits for LabUniversity courses. Offered through LabUniversity, the laboratory director program is a subscription series of on-line courses available to physicians at a discounted rate. The courses in this package are designed to offer 20 combined hours of CME activity that meets CMS-CLIA requirements for designation as a laboratory director of a moderate complexity laboratory. Course topics include quality control, quality assurance, CLIA, OSHA, laboratory personnel requirements, and proficiency testing. In response to government and industry concerns regarding the quality and accuracy in which waived testing is presently being conducted, COLA has also produced a cost-effective, web-based education certification product. The product consists of 2 categories. The first category is a course on best laboratory practices. The second is a library of courses on specific manufacturers waived test products. The program is designed to complement the instructions provided in the manufacturer s package insert. COLA s objective with this initiative is to provide cost-effective on-line courses to educate the health care staff 287
who performs waived testing. COLA s waived test training certification will assist staff in fully understanding the general aspects of quality laboratory testing and provide specific training on the waived laboratory tests they perform in their office. The goal of this educational program is to improve compliance and address regulatory concerns for waived testing. As we move forward, COLA is committed to continuing to provide laboratories with exceptional educational experiences through the survey process and other educational endeavors. COLA strongly believes that education leads to quality laboratory services and outstanding patient care. This is the third in a series of CE Updates on Laboratory Inspections. Next issue will feature the view from the CAP. For a brochure with a complete list of COLA educational publications, call COLA at (800) 981-9883 or visit the COLA Web site at www.cola.org for more information. 288