The Joint Commission has been evaluating and accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995. Today, The Joint Commission accredits almost 2,000 organizations providing laboratory services. This represents almost 3,000 Clinical Laboratory Improvement Amendment-certified laboratories, including freestanding laboratories, such as reference labs and in vitro fertilization labs, and those connected with other health care organizations such as ambulatory surgical centers and long term care facilities. Laboratories eligible for accreditation include:
- Laboratories in hospitals, clinics, long term care facilities, home care organizations, behavioral health care organizations, ambulatory sites and physician offices.
- Reference labs.
- Freestanding laboratories, such as assisted reproductive technology labs.
- Blood transfusion and donor centers.
- Public health laboratories, including Indian Health Service laboratories.
- Laboratories in federal facilities, such as the Department of Veteran’s Affairs and the Department of Defense.
- Point-of-care test sites which include blood gas labs providing services to patients in emergency rooms, surgical suites, cardiac catheterization labs, as well as in other patient care areas.
Standards
The survey is conducted using the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB). The standards emphasize the results a laboratory should achieve, instead of the specific methods of compliance, and were developed with input from professional laboratory organizations. In compliance with CLIA regulations, Joint Commission standards address processes that follow laboratory specimens through the laboratory from specimen collection to result reporting, focusing on the provision of high quality, safe laboratory services. These standards highlight the essential nature of laboratory services on the actual care and service delivery processes that contribute to and support the overall health care delivery system.
Survey process
Joint Commission accreditation concentrates on operational systems critical to the safety and quality of patient care. The objective of the survey is not only to evaluate the laboratory, but to provide education and “good practice” guidance that will help staff continually improve the laboratory’s performance. The survey process evaluates actual care processes by tracing patients through the care, treatment and services they receive and also analyzes key operational systems that directly affect the quality and safety of resident care.
Surveys are conducted by Joint Commission-employed medical technologists with at least a bachelor’s degree (a master’s degree is preferred). They must have clinical experience working in three or more technical specialty areas of laboratory medicine and at least five years of laboratory management experience. Surveyors complete a two-week training course and preceptorship with a veteran surveyor and must pass a core certification exam and a laboratory-specific exam. Comprehensive, continuing education is provided throughout each annual period. A full time surveyor conducts 50 to 75 laboratory surveys annually.
Deemed status
The Centers for Medicare & Medicaid officially recognize the Joint Commission Laboratory Accreditation Program as meeting the requirements of CLIA ‘88. CLIA regulations require that all laboratories be surveyed on a two-year cycle. CLIA regulations also require that there be an on-site survey or inspection by an approved agency such as the Joint Commission, for all tests of moderate or high complexity. The main categories of laboratory testing, as defined by CLIA regulation, are:
- Waived tests — simple procedures with little chance of negative outcomes if performed inaccurately.
- Moderately complex tests — more complex than waived testing but usually automated, such as blood counts or routine chemistries.
- Provider-performed microscopy (PPM) — a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services.
- Highly complex tests — usually non-automated or complicated tests requiring considerable judgment, such as microbiology or crossmatching of blood.
Performance measurement requirements and proficiency testing
The Joint Commission accepts the use of proficiency testing for meeting the ORYX ® performance measurement requirements for accredited laboratories. Joint Commission standards and CLIA regulations require that a laboratory be enrolled in a CMS-approved proficiency testing program for all regulated tests conducted by the lab. Annually, laboratories must report verification of annual enrollment in a PT program to the Joint Commission. CLIA requires that a laboratory’s PT results be monitored on an ongoing basis by the Joint Commission.
Upon notification by the Joint Commission of an unsuccessful proficiency testing status, the laboratory must submit a plan of action within 10 calendar days. The laboratory must cease testing when there is documented unsuccessful proficiency testing and:
- The laboratory has failed to submit a written plan of action after two requests from the Joint Commission.
- The plan of action has not been found acceptable after three opportunities to provide an acceptable plan.
- The laboratory fails to achieve satisfactory performance on the next two consecutive testing events or other situations as warranted by the nature, scope, severity and duration of the underlying issue, e.g. non-sequential, but repeated unsuccessful proficiency testing events in immunohematology.
The laboratory must cease testing for at least the six months after the notice is issued for the testing specified. The laboratory may not resume testing until the criteria for reinstatement are met and the laboratory receives from the Joint Commission written confirmation to resume testing.
Lab Advantageä
To meet proficiency testing and education requirements, laboratories can participate in Lab Advantageä, a collaboration between the Joint Commission, the American Proficiency Institute (a CMS-approved PT provider), and the American Society for Clinical Pathology. Lab Advantage offers web-based API proficiency testing and ASCP technological and scientific educational programs. Lab Advantage customers receive a 5 percent discount off Joint Commission survey fees for each year of the accreditation cycle. For more information, call (800) 333-0958, ext. 3013.
Cost of accreditation
The 2008 base fee begins at $530 for a small lab and is adjusted based on the number of CLIA specialties and subspecialties for which testing is performed. A laboratory’s on-site survey fee is based on the type of services provided, volume, and the sites to be included in the organization’s laboratory accreditation. The fee begins at $2,050.
Laboratory information available to the public
Information about the safety and quality of accredited laboratories is available to the public on Quality Check®, www.qualitycheck.org. This comprehensive listing includes detailed information about a lab’s performance and how it compares to similar organizations.
For more information about the Joint Commission’s Laboratory Accreditation Program, call
(630) 792-5287, or visit the website at www.jointcommission.org.
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