By Arif Subhan, MS, CCE, FACCE
In a December 2013 memo (S&C 14-07-Hospitals), the Centers for Medicare & Medicaid Services (CMS) relaxed its restrictive policies on preventive maintenance of medical equipment. The CMS now allows alternatives to manufacturer recommended PM intervals for many types of devices.1,2
In response to this clarification, The Joint Commission has added a new element of performance (EP) for deemed-status hospitals. This EP is added to the primary medical equipment standard EC.02.04.03. It is a Category A EP, and will be effective July 1, 2014.3
“Interpretation of Codes and Standards” is a topic in the section “Technology Management,” which makes up 25% of the CCE examination.4,5 One of the important roles of a clinical engineer is a good understanding of the codes, standards, and regulations that relate to the use of medical equipment in the hospital. The Joint Commission is a primary voluntary standards-setting organization that has a direct impact on clinical engineering. Familiarity with Joint Commission standards is clearly critical for anyone taking the CCE exam.
With that in mind, consider the new text added by The Joint Commission for Standard EC.02.04.03 (“The hospital inspects, tests, and maintains medical equipment”):
Elements of Performance (EP) 24.
For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital inspects, tests, and maintains the following in accordance with manufacturers’ recommendations:
• Medical lasers
• Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes)
• New medical equipment with insufficient maintenance history to support the use of alternative
(See also EC.02.04.01, EPs 3 and 4)
Note: Maintenance history includes any of the following documented evidence:
• Records provided by the hospital’s contractors
• Information made public by nationally recognized sources
• Records of the hospital’s experience over time3
It should be noted that this EP is for hospitals that have “deemed status.” For a healthcare organization to partake in and get payment from the Medicare or Medicaid programs, it must be certified as complying with the Conditions of Participation (CoP), or standards, stated in the federal regulations. In order to obtain this certification, a site survey is conducted by a state agency on behalf of the CMS.
There are alternatives to the state agency site survey. One of the national accrediting organizations, including, for example, The Joint Commission, the American Osteopathic Association (AOA), and Det Norske Veritas (DNV), also has and implements standards that meet the federal Conditions of Participation. CMS may grant an accrediting organization “deeming” authority. The healthcare organization therefore would have “deemed status” if it is surveyed by one of these “deeming” national accrediting organizations. The healthcare organization in this case will not be subject to the Medicare survey and certification process.6
Maintenance of Imaging and Radiologic Equipment
The CMS memo requires adherence to manufacturer’s recommendation for maintenance for medical lasers, imaging and radiologic equipment, and new medical equipment.2 The memo cites Title 42 of the Code of Federal Regulations 482.26(b)(2), which states “Periodic inspection of equipment must be made and hazards identified must be promptly corrected.” According to the Interpretive Guidelines in the State Operations Manual, the hospital must ensure that equipment is inspected in accordance with manufacturer’s instructions.7
1) A new element of performance (EP) which requires manufacturer recommended PM intervals for certain types of medical equipment was added to the Joint Commission standard _____________.
d) None of the above
2) According to the new Joint Commission standard EC.02.04.03 EP24, all of the following medical equipment should be maintained according to manufacturer recommendations except:
a) Medical lasers
b) Imaging and radiologic equipment
c) New medical equipment with insufficient maintenance history
d) Anesthesia machines
3) The new Joint Commission standard EC.02.04.03 EP24 is a category _________ Element of Performance
4) The new Joint Commission standard EC.02.04.03 EP24 will be effective on what date?
a) January 1, 2014
b) July 1, 2014
c) April 1, 2014
d) January 1, 2015
5) The healthcare organization would have “deemed status” if it is surveyed by one if the national accrediting organization except:
a) The Joint Commission
b) The American Osteopathic Association (AOA)
c) Det Norske Veritas (DNV)
d) American National Standards Institute (ANSI)
See answers below.
1. Biomeds Cheer CMS Change of Mind on Maintenance, December 27, 2013. Accessed April 4, 2014.
2. Hospital Equipment Maintenance Requirements, CMS Memo dated December 20, 2013. Accessed April 4, 2014.
3. Revised Requirements for the Environment of Care (EC) Chapter. Accessed April 4, 2014.
4. Healthcare Technology Certification Commission (HTCC). 2013 Candidate Handbook for Certification in Clinical Engineering by the HTCC. Accessed April 4, 2014.
5. American College of Clinical Engineering (ACCE), Clinical Engineering Certification Study Guide, V3.0, available in pdf format only online through ACCE.
6. The American Society for Healthcare Engineering, Deemed Status. Accessed April 4, 2014.
7. State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. Accessed April 8, 2014.
Answers: 1—A, 2—D, 3—A, 4—B, 5—D
Arif Subhan, MS, CCE, FACCE, is the chief biomedical engineer at VA Greater Los Angeles Healthcare System and a member of 24×7’s editorial advisory board. The suggestions and views expressed in this article are of the author. They do not represent the views of the Department of Veterans Affairs. For more information, contact [email protected]