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December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter


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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

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Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled



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Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

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Interpretive Guidelines

In January of 2011, The CMS released revised interpretive guidelines (IGs) to the Hospital Conditions of Participation. ASA secured significant revisions in these new interpretive guidelines that will positively impact ASA members. When the 2009 IGs were released, ASA developed a comprehensive regulatory lobbying strategy, involving comment letters, meetings and discussions with appropriate CMS officials, with the goal of making substantive changes to the IGs. ASA’s focus in all of its efforts was consistently on patient safety and quality of care coupled with emphasis on anesthesia as a continuum with no clear boundaries.  The strategy worked. 

Key Documents:  

2011 CMS Revised Interpretive Guidelines 

2011 Memo from CMS on Revised Interpretive Guidelines 

2011 CMS FAQs on Revised Interpretive Guidelines 


Major Positive Changes to the Interpretive Guidelines:

Labor Epidural Supervision

  • CMS has removed language specifically exempting labor epidurals from the physician supervision requirements.  Hospitals are now required to “establish policies and procedures, based on nationally recognized guidelines, that address whether specific clinical situations involved anesthesia versus analgesia,” as well as, “the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services.”   

Pre-Anesthesia Evaluation:

  • CMS loosened the timing of the various elements that comprise the pre-anesthesia evaluation.  There is now a requirement to complete and document a review of the medical history and interview (if possible given the patient’s condition) and examine the patient within 48 hours prior to surgery.  The remaining requirements (notation of anesthesia risk, identification of potential anesthesia problems, additional pre-anesthesia data or information and development of the anesthesia plan) can now be performed up to 30 days in advance of the surgery, as long as you review and update (as necessary) within 48 hours of surgery.

Post-Anesthesia Evaluation:

  • Same day surgery – CMS now explicitly permits completion of the post-anesthesia evaluations after patient discharge, as long as it is still within the 48 hour timeframe.
  • ICU/post-operative sedation patients – CMS now clarifies that documentation of the post-anesthesia evaluation must be made within 48 hours with a notation and reason documenting that the patient was unable to participate in the evaluation.
  • Long acting regional anesthesia patients – CMS now clarifies that the post-anesthesia evaluation is performed within 48 hours even if the intended affects of anesthesia have not worn off.

One Anesthesia Service: 

  • As the IGs state, the decision on who provides anesthesia care still rests with the hospital and the one anesthesia service.  The IGs actually further solidified the role of the one anesthesia service, which has authority over all sedation and anesthesia in a facility and must be led by the Director of Anesthesia Services.


Frequently Asked Questions

  • What does this language, “[ED] practitioners are uniquely qualified to provide all levels of analgesia/sedation and anesthesia (moderate to deep to general),” in the CMS released FAQs mean? 
    • It is important to remember that this is in the FAQ and NOT in the actual IGs. The interpretive guidelines, which will be relied upon by surveyors, state, “We encourage hospitals to address whether the sedation typically provided in the emergency department or procedure rooms involves anesthesia or analgesia.”  The language goes on to state that the skill set of the clinical staff providing the services must be taken into consideration in developing the policies.  ASA staff in coordination with the appropriate committees is working on developing resources for members to use to address this in their local institutions.