CDC Rules on Multi-dose 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;
Based on the information that was presented from survey and certification group in last 2012. Here is a summary of the information:
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:
- 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.
- 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.
This is the lastest from SIG on the question of whether or not Physician Assitants may write post-operative notes:
The CMS COP guidelines 482.51(b)(6) stipulate that only the surgeon who is performing the surgery can sign the immediate post operative note. The PA signing the post operative note would not meet this requirement under federal CMS standards.
There is still a discrepancy between what Joint Commission requires and what CMS requires for post-operative documentation. Here are some points to consider:
1. There are two required documents: an operative REPORT and a p0st-operative NOTE. Be sure not to confuse these.
2. CMS only requires a operative REPORT immediately after surgery. There is no requirement for a short (brief) post-operative note. 24 hours is not in the CMS COP. Usually this document is completed by dictation. When the report returns to the medical record (transcription) and is authenticated is governed by hospital policy
3. Joint Commission DOES require a short (brief) post-operative note IF there is a delay in getting the operative report ON the medical record.
4. CMS requires that the operative report be completed IMMEDIATELY after surgery. Joint Commission (RC.02.01.03 EP 5, note #1) will allow a hospital to define what this time period would be if there is a brief operative note. Be aware, however, that CMS does not accept this type of delay for the operative report, holding the medical staff to getting it done immediately after surgery.
5. 24 Hours is in NO ONE’S standard. Immediately means before the patient is transferred to the next level of care (generally PACU to inpatient unit or ICU). So if a hospital is governed by Part A CMS COP, then they may not use 24 hours for anything.
6. The brief operative note must contain seven elements that are listed in the TJC standard. Estimated blood loss must be recorded if there is any. If there is none, it does not need to appear on the report.
I recently asked a question of SIG about what hospitals should do if they had no data to support OPPE. This generally occurs with low volume, or no volume. I had suspected this would be a problem in that no actual data would be available to support the conclusion of competency. I also asked for further details on their position on the “Good Standing” letters. Here is how the conversation went:
Question: If a physician does not complete his/her initial focused review because of lack of volume (or no volume), and the focused review period has been extended for two years, and still there is no volume, can the hospital depend on a “letter of good standing” as sufficient information to grant the physician reappointment (with no OPPE data either)? Thank you.
Answer: Based on your example, the letters would not be able to serve as a substitute for OPPE data or for low or no volume providers. There is also no FPPE completed so OPPE would not be able to be accomplished. It is not uncommon for organizations to simply inform the practitioner that they either need to find a way to meet/complete the FPPE requirements, or consider removing them from staff, or placing them in a status that does not require FPPE/OPPE – however, this would also mean that they would have no privileges to treat patients. The letter referenced that only states “in good standing “ for OPPE is not adequate. There needs to be evidence of privilege-specific competency.
FAQ: For practitioners who have been granted clinical privileges at an organization, every organization must collect data for the ongoing professional practice evaluation (OPPE) related to performance within its own organization. OPPE would not apply if the practitioner has membership only with no clinical privileges. Any information received from another organization can only be used as supplemental information and not in lieu of collecting organization specific data or evaluating performance within the organization.
Prior to sharing such information between organizations, even with the practitioner’s consent, organizations should obtain legal advice on whether such sharing would affect the protections provided by any applicable State peer review statute.
The OPPE standard will not fully address the issue of the low or no volume practitioner. Organizations must collect data, even data showing zero performance. At each review point, e.g. quarterly or every six months, the medical staff and governing body would use the data, however, limited, to determine whether to continue, limit, or revoke any existing privileges.
At the two year reappointment if the organization determines it has insufficient practitioner specific data, then per standard MS.07.01.03 EP 2 “Upon renewal of privileges, when insufficient practitioner-specific data are available, the medical staff obtains and evaluates peer recommendations.
Comment: Since peer recommendations are obtained for all providers, it would seem on the surface that organizations would love to just say that a peer recommendation could substitute for performance data. Stay tuned for more interpretations.
TJC has reversed its previous (years ago) opinion. Currently they REQUIRE that unauthenticated verbal and telephones that are unsigned at 30 days be included in the delinquent medical record count. Be aware that CMS does not allow for the luxurious “50%” delinquency rate, but actually mandates NO delinquent medical records.
Delinquencies have resulted in termination notices being issued.