Starting January 1, 2010, the Joint Commission standards for the laboratory accreditation program will have the new six-digit numbers. This change is part of the Standards Improvement Initiative (SII) launched by The Joint Commission last year when the standards for the hospital accreditation program were changed. SII involved revisions to the format, structure, numbering, and wording of standards and elements of performance (EP). Redundant or nonessential standards and EPs were deleted, and similar standards and EPs were consolidated. Some EPs were split into separate requirements, and scoring categories were changed. 

This article will provide an overview of where the requirements for the two main laboratory equipment standards (EC.6.10 and EC.6.20) and some of the related EPs of EC.9.10 have been moved. Figure 1 provides a cross reference between the 2009 standards EC.6.10, EC.6.20, and EC.9.10 (EPs 1, 3, 4, and 5); the corresponding new 2010 standards; and the specific Joint Commission requirement.

Figure 1: A cross reference between the 2009 standards EC.6.10, EC.6.20, and EC.9.10 (EPs 1, 3, 4, and 5); the corresponding new standards; and the specific JC requirement.

 

Overview of the 2010 Requirements and Changes

EC.02.04.01 EP 1: Selection and acquisition of laboratory equipment. For 2010 it now requires that the laboratory solicit input from those who operate and service equipment when it selects and acquires laboratory equipment.

Joint Commission standards for the laboratory accreditation program now have the new six-digit numbers.

EC.02.04.01 EP 2: Requires keeping a written inventory and incident history of laboratory equipment. It also requires evaluation of new types of equipment before initial use to find if they need to be included in the inventory.

EC.02.04.01 EP 3 and EP 4: Maintenance of laboratory equipment. It states that the laboratory identify in writing the frequencies of testing and maintenance based on risks, manufacturer recommendations, and Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) guidelines, and history and experience with the laboratory equipment. For more details about CLIA, see the May 2009 24×7 CCE Prep article, “JC Laboratory Accreditation Program.”

EC.02.04.01 EP 5: It requires incident reporting and monitoring as required by the Safe Medical Devices Act (SMDA) of 1990.

EC.02.04.03 EP 4: It requires performance testing and maintenance of all sterilizers.

EC.02.04.03 EP 6: This requires documenting major repairs and parts replacement for all equipment for the life of the equipment.

EC.02.04.03 EP 7: This requires documented maintenance and testing of each piece of equipment.

EC.02.04.03 EP 8: This requires documented evaluation of analytical measuring equipment for all operating characteristics.

EC.02.04.03 EP 9: This requires documented evaluation of volumetric equipment.

EC.02.04.03 EP 10: This states that the temperature-controlled spaces and equipment are monitored at established frequencies, and the temperature is documented.

EC.02.04.03 EP 11: This requires retaining documentation of periodic testing and functional checks of equipment for at least 2 years.

For more details, check The Joint Commission laboratory accreditation standards available at www.jointcommission.org/Standards/SII/sii_lab.htm.

Arif Subhan, MS, CCE, is the chief biomedical engineer, VA Nebraska-Western Iowa Health Care System, Omaha, Neb; adjunct assistant professor, biomedical engineering, University of Connecticut; and a member of 24×7’s editorial advisory board. For more information, contact .

Review Questions

  1. The Joint Commission’s laboratory standards require that the documentation for periodic testing and functional checks of equipment should be retained for at least ____ years.
    1. 2
    2. 5
    3. 10
    4. None of the above

    2. See the answer

  2. Starting January 1, 2010, The Joint Commission laboratory standards will have the new ____-digit numbers.
    1. Two
    2. Three
    3. Four
    4. Six

    3. See the answer

  3. The Joint Commission’s laboratory standards will require that the laboratory seek input from those who ____ equipment when it selects and acquires laboratory equipment.
    1. Operate
    2. Service
    3. Operate and service
    4. Design

    4. See the answer

  4. The Joint Commission’s laboratory standards require that the frequency of testing and maintenance should be based on ____.
    1. Risks
    2. Manufacturer recommendations
    3. Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)
    4. All of the above

    5. See the answer

  5. The Joint Commission’s laboratory standards require keeping the documentation of major repairs and parts replacement for all equipment for ____.
    1. 5 years
    2. 7 years
    3. 10 years
    4. The life of the equipment

    6. See the answer