News and Views for Healthcare Accreditation Professionals

Well folks, the world has changed.  After many discussions (or arguments) it has now happened:
TJC has now cited a hospital under an IMMEDIATE THREAT (and SITUATION DECISION) when a nurse administers agents of deep sedation.  The nurse was at the head of the table, administering the anesthesia agent and monitoring the agent.  The only other person in the room was the physician who was performing the procedure.  Hope everyone will stop arguing about this and just do the right thing.

CDC Rules on Multi-dose Vials

cdc on multidose vials

Interpretive Guidelines §482.24(c)(2)(vii)
All patient medical records must contain a discharge summary. A discharge summary discusses the outcome of the hospitalization, the disposition of the patient, and provisions for follow-up care. Follow-up care provisions include any post hospital appointments, how post hospital patient care needs are to be met, and any plans for post-hospital care by providers such as home health, hospice, nursing homes, or assisted living.

The MD/DO or other qualified practitioner with admitting privileges in accordance with State law and hospital policy, who admitted the patient is responsible for the patient during the patient’s stay in the hospital. This responsibility would include developing and entering the discharge summary.
Note:  While others may perform this function, it is clear that they should have participated in the care of the patient AND be recognized to perform this function under the state licensing act.  What if the state is silent?  Then it probably cannot be done by them.

There is an age old dilemma about who qualifies to be privileged by the medical staff.  Traditionally it had been those to provide a “medical level of care”.  In the most recent release of the Condition of Participation the following is noted:

§482.12(a)(1) Determine, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the medical staff;

Physician assistant;
Nurse practitioner;
Clinical nurse specialist (Section 1861(aa)(5) of the Act) (master level);
Certified registered nurse anesthetist (Section 1861(bb)(2) of the Act);
Certified nurse midwife (Section 1861(gg)(2) of the Act);
Clinical social worker (Section 1861(hh)(1) of the Act;
Clinical psychologist (42 CFR 410.71for purposes of Section 1861(ii) of theAct)
Registered dietician or nutrition professional
So the rest are a “NO GO” and organizations must apply the Human Resources standards to others such as: rounding RNs, all other RNs, surgical technicians, surgical assistants, perfusionists.

Based on the information that was presented from survey and certification group in last 2012.  Here is a summary of the information:

1.  Humidity and Temperature MUST be monitored either by automated systems from a central location OR it must be logged, but not both.  There is no other way to know that the parameters are “out of bounds.”  What these bounds are depends on whether the state requires FGI guideline compliance or NFPA 99.  But if its anesthesia or deep sedation, then NFPA 99 is mandatory.
2.  Emergency power and lighting must be present in all surgical suites including endoscopy.  THIS IS A BIG ONE.. Few endoscopy rooms have back up LIGHTING.
3.  The air pressure differential, positive versus negative really depends on:
      a.  If this is an anesthetizing or deep sedation location (then POSITIVE).
      b.  State Law (California requires negative).
      c.  Hospital states decision depends on law or cited reference, or if required to comply with FGI by state.

I recently browsed the CDC website and found this.  I will be recommending that multi-dose vials not be opened and used
for multiple patients inside an operating room, such as on an anesthesia cart:

  1. Can multi-dose vials be used for more than one patient?  How?
    Multi-dose vials should be dedicated to a single patient whenever possible.
    If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area.  This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients.  If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use.
  2. What are examples of the “immediate patient treatment area”?
    Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms.

I get a lot of questions concerning the ability of nurses to administer agents of deep sedation.  I have put together my conclusion based on the following citations from CMS.  Be aware that some states have written into the nurse practice act that RNs may not administer agents of deep sedation, or “non-reversable” agents for sedation purposes.  My conclusion is, based on the actual CMS COP, that nurses may not administer these agents for the purpose of sedation.  Actually, based on CMS, one would wonder if RNs could even MONITOR patients.  By the way, supervision of nurses is not even addressed by CMS, so therefore the “supervision” aspect would be irrelevant.  Be aware that whether something is Deep Sedation or MAC depends on the manufacturer’s definition of the drug.

482.52 Condition of Participation: Anesthesia Services

Monitored anesthesia care (MAC): anesthesia care that includes the monitoring of the patient by a practitioner who is qualified to administer anesthesia as defined by the regulations at §482.52(a). Indications for MAC depend on the nature of the procedure, the patient’s clinical condition, and/or the potential need to convert to a general or regional anesthetic. Deep sedation/analgesia is included in MAC.

§482.52(a) Standard: Organization and Staffing

Anesthesia must be administered only by –
(1) A qualified anesthesiologist;
(2) A doctor of medicine or osteopathy (other than an anesthesiologist);
(3) A dentist, oral surgeon, or podiatrist who is qualified to administer
anesthesia under State law;
(4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c) of this
section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or
(5) An anesthesiologist’s assistant, as defined in Sec. 410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed.

Based on the above, it would also appear that Nurse Practitioners or Physician Assistants may also not administer deep sedation.

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