The Joint Commission has several different accreditation programs in addition to the one for hospital accreditation that we are most familiar with. It offers accreditation programs for ambulatory care, behavioral health care, critical access hospitals, home care, hospitals, laboratory services, long-term care and office-based surgery. Many hospitals seek only hospital accreditation; however, others may seek other accreditation based on the special services they provide. Clinical engineers and BMETs should first determine which specific accreditation programs their hospital has selected.

Lab Accreditation Standards

The Joint Commission laboratory accreditation standard has some medical equipment-related requirements that are different from those contained in The Joint Commission hospital accreditation standards. The previous “CCE Prep” articles discussed the medical equipment standards for the hospital accreditation program.

The Centers for Medicare & Medicaid Services (CMS)1 officially recognizes The Joint Commission Laboratory Accreditation Program2 as conforming to the requirements of Clinical Laboratory Improvement Amendments (CLIA). The Joint Commission laboratory accreditation standards refer to CLIA regulations.

CLIA

According to the CLIA Web site,3 the US Congress passed the CLIA in 1988 as Public Law 100-578 to ensure the accuracy and reliability of all laboratory testing. CLIA establishes uniform quality standards for laboratories and applies to all entities that perform tests on human specimens. The tests commonly performed in laboratories regulated under CLIA are tests on blood, urine, and other samples to detect cancer, HIV, diabetes, and other diseases.

The CMS regulates all human laboratory testing (except research) performed in the United States through CLIA. CLIA covers about 200,000 laboratory entities. The CMS is responsible for implementation of CLIA, including surveys, enforcement, and approvals of accrediting organizations and exempt states.

CLIA has established three categories of tests: waived tests, moderate complexity tests, and high complexity tests. Waived tests are simple tests that have a small chance of error or risk, and they are exempt from virtually all CLIA rules as long as testing is performed in strict compliance with the manufacturers’ instructions.

Moderate complexity tests are more complicated than waived tests but they are usually automated, such as blood counts or routine chemistries. Highly complex tests are usually nonautomated or complicated tests requiring considerable judgment, such as microbiology or crossmatching of blood.

Moderate and high complexity tests are subject to regulations setting minimum qualifications for all persons performing or supervising these tests. These laboratories are also required to participate successfully in approved proficiency testing programs, which provide an external evaluation of the accuracy of the laboratory’s test results. The moderate and high complexity laboratories must have systems and processes for monitoring testing equipment, procedures to ensure proper test performance and accurate results, and a plan to monitor the quality of all aspects of the laboratory’s operation.

Moderate and high complexity laboratories must undergo on-site surveys at least every 2 years. These surveys may be conducted by the Federal CLIA program; a state survey agency under contract with CMS; or private CMS-approved agencies such as AABB, COLA, The Joint Commission, or the College of American Pathologists. States like Washington and New York are exempted from the CLIA program as they have established laboratory quality standards at least as stringent as CLIA. The CLIA medical equipment regulations can be found in title 42 CFR, part 493.

The primary 2009 Joint Commission Standards for laboratory equipment are EC.6.10 and EC.6.20 in the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing. Following are two specific maintenance requirements for laboratory equipment.

The FAQ section on The Joint Commission Web site explains the requirement for blood warmers

EC.6.20 EP12

“The organization inspects, tests, and maintains equipment, including evaluating automated volumetric equipment, using maintenance protocols and frequencies of at least those established by the manufacturer.”

EC.6.20 EP14

“The organization documents monitoring of temperature-controlled spaces and equipment.” The note to this EP states that for blood warmers and blood bank storage alarms, the activation temperature should be recorded and remedial action should be taken when the results are outside the acceptable range.

The frequently asked question section on The Joint Commission Web site explains this requirement for blood warmers4 as follows:

Blood Warmers—Alarm Check Documentation. Question: “Is Pass/Fail documentation acceptable for recording blood warmer alarm checks?”

Answer: “No. While Pass/Fail documentation is commonly used for other biomedical equipment, it is not acceptable for blood warmer alarm checks. As required by standard EC.6.20 in the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing, the actual temperature of the plates or effluent at which the alarm sounds should be recorded.”

Laboratory Surveys

CLIA regulations require that laboratory surveys be conducted every 2 years. The Joint Commission conducts unannounced surveys for laboratories within 18 to 24 months after its previous unannounced survey. If the laboratory is part of another Joint Commission-accredited health care organization, the survey will not ordinarily take place at the same time as the health care organization’s triennial survey. For example, if the last Joint Commission laboratory survey date was June 15, 2007, then the next survey window would be December 15, 2008, to June 15, 2009.

Additionally, the CMS performs routine validation surveys to monitor the effectiveness of surveys by accrediting agencies.


Arif Subhan, MS, CCE, is a senior clinical engineer, Masterplan, Chatsworth, Calif; adjunct assistant professor, biomedical engineering, University of Connecticut; and a member of 24×7’s editorial advisory board. For more information, contact 24x7Editor.

References

  1. The Centers for Medicare & Medicaid Services (CMS). www.cms.hhs.gov/manuals/iom/list.asp?listpage=1. Accessed April 20, 2009.
  2. From The Joint Commission, The 2009 Laboratory Accreditation Standards. www.jcrinc.com/Accreditation-Manuals/2009-LABORATORY-ACCREDITATION-STANDARDS/1323/. Accessed April 20, 2009.
  3. CLIA program Web site. www.cms.hhs.gov/clia/. Accessed April 20, 2009.
  4. The frequently asked question section on The Joint Commission Web site explains the requirement for blood warmers. www.jointcommission.org/AccreditationPrograms/LaboratoryServices/Standards/09_FAQs/EC/Blood_Warmers.htm. Accessed April 20, 2009

Review Questions

  1. The Joint Commission offers accreditation programs for ____.
    1. Home Care
    2. Hospitals
    3. Laboratory Services
    4. Ambulatory Care
    5. All of the above

    See the answer

  2. Moderate and high complexity laboratories must undergo on-site surveys at least every ____ year(s).
    1. Two
    2. Three
    3. One
    4. Four
    5. None of the above

    See the answer

  3. The CLIA surveys may be conducted by ____.
    1. A State survey agency under contract with CMS
    2. The Joint Commission
    3. College of American Pathologists
    4. COLA
    5. All of the above

    See the answer

  4. ____ regulates all laboratory testing (except research) performed on humans in the United States.
    1. The Centers for Medicare & Medicaid Services (CMS)
    2. The Joint Commission
    3. College of American Pathologists
    4. COLA
    5. None of the above

    See the answer

  5. The Joint Commission conducts unannounced surveys for laboratories within ____ months after its previous unannounced survey.
    1. 18 to 24
    2. 18 to 39
    3. 18 to 30
    4. 24 to 30
    5. None of the above

    See the answer