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, and 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 and certification by the American Society for Clinical Pathology (A.S.C.P.). 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. Surveyors receive comprehensive, continuing education throughout the year. A full time surveyor conducts 50 to 75 laboratory surveys annually.
Adverse laboratory decisions no longer affects hospital accreditation decision
Beginning January 1, 2009, adverse laboratory accreditation decisions will no longer impact hospital accreditation decisions. A new policy establishes equivalence in the way that a laboratory with an adverse accreditation decision — whether that decision is rendered by The Joint Commission, the College of American Pathologists (CAP) or COLA — impacts the hospital with which the laboratory is affiliated.
The new policy establishes a “related impact requirement” for the laboratory and the hospital. “Related impact requirement” means that any adverse laboratory accreditation decision — whether a result of a Joint Commission, CAP or COLA survey — will be integrated into the Priority Focus Process (PFP). An adverse laboratory accreditation decision will serve as an information point in the PFP, along with other data, to prioritize and customize the hospital’s or other organization’s next survey, which, as a result, could occur earlier within the organization’s 18 to 39 month survey window.
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 tests but usually automated, such as blood counts or routine chemistry tests.
- 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 clinical judgment, such as microbiology tests or crossmatching of blood.
Performance measurement requirements and proficiency testing
The Joint Commission accepts the use of proficiency testing to meet 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 proficiency testing program to the Joint Commission. CLIA requires that a laboratory’s proficiency testing results be monitored on an ongoing basis by the Joint Commission.
Lab Advantage
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 proficiency testing 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 2009 annual fee starts 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 on-site survey fee starts at $2,050 for one surveyor per day. For an estimate of accreditation fees, please contact the Pricing Unit at (630) 792-5115.
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, call (630) 792-5866.