Texas Register, Volume 30, Number 43, Pages 6973-7094, October 28, 2005 Page: 7,040
This periodical is part of the collection entitled: Texas Register and was provided to The Portal to Texas History by the UNT Libraries Government Documents Department.
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clarifying language was added to indicate that sedation would
be provided in accordance with the orders of the operating sur-
geon or anesthesiologist. It is already an established practice
for qualified RN's who are not CRNAs, practicing in accordance
with the guidelines issued by the BNE, to provide both minimal
and moderate sedation under a physician's order in ASCs and
office-based practices. The rule requires that the facility share
responsibility for ensuring that certain safeguards are in place if
RNs are allowed to administer minimal and moderate sedation
under a physician's order.
Comment: Regarding 135.11(a)(6), one commenter requested
that the term "operating physician" be replaced with "operating
surgeon" to address other types of surgeons who may practice
in an ASC.
Response: The department concurs, and has made the re-
quested change.
Comment: Regarding 135.11(a)(6), two commenters recom-
mended that the term "discharged" be clarified by adding the
word "medically" to indicate that the provider is clearing the pa-
tient for discharge, even though the patient may not be leaving
the facility.
Response: The department disagrees that the rule requires clar-
ification. In 135.11(a)(7), it is clear that the patient can only be
discharged from the post-anesthesia care unit (PACU) after the
surgeon or person administering the anesthesia has made the
determination that the patient has recovered from the anesthesia
and can be discharged from the PACU. This is a medical evalu-
ation. No changes were made as a result of these comments.
Comment: Regarding 135.11(a)(7), one commenter recom-
mended that a physician be required to evaluate all patients
for proper anesthesia recovery, and requested clarification of
the conflict between the proposed state rules and the Medicare
and Joint Commission on the Accreditation of Healthcare Or-
ganizations (JCAHO) standards, which require that a physician
complete this evaluation.
Response: The department disagrees with the commenter. The
department recognizes that the Medicare regulations and JC-
AHO standards do require that a physician complete the evalu-
ation for proper anesthesia recovery. However, these are state
rules that establish minimum requirements, and they must re-
flect what is allowed under Texas state law. Under state law and
BNE rules and regulations, it is within the scope of practice of the
CRNA to complete this evaluation. Participation in Medicare is
voluntary, as is JCAHO accreditation. Ambulatory surgical cen-
ters which desire to be Medicare certified or accredited by JC-
AHO will need to be cognizant of the differences between state,
federal and JCAHO requirements. No changes were made as a
result of this comment.
Comment: Regarding 135.11(a)(8), one commenter believed
that the rule appeared to require an RN, who was not an ad-
vanced practice nurse, to exercise independent medical judg-
ment, which would be beyond the scope of the RN's license.
Response: The department disagrees. The rule as proposed
does not require an RN to make an "independent medical judg-
ment." The surgeon or the person administering the anesthesia
must have already evaluated the patient and determined that the
patient had recovered from anesthesia and was stable for dis-
charge from the PACU, but the patient remained in the facility
for some extended period of time for additional observation or
comfort measures. The rule allows the medical staff to developpolicies and procedures that predefine the criteria for final dis-
charge, usually in the form of standing orders or protocols. The
department did revise the language in the final rule to clarify the
intent of the evaluation to be completed by the RN.
Comment: Regarding 135.11 (a)(10)(B)(ii), one commenter re-
quested that "laryngeal mask airways" be added to the list of
required equipment.
Response: The department disagrees. The purpose of these
rules is to establish minimum requirements for equipment that
must be maintained on the premises. The department has no in-
formation to support the absolute necessity of this piece of equip-
ment. The decision as to whether this piece of equipment will be
maintained on the premises will be left to the discretion of the
facility's medical staff. No changes were made as a result of this
comment.
Comment: Regarding 135.11(a)(10)(B)(v), two commenters
recommended changing the term "cardiac defibrillator" to
"cardioverter-defibrillator" in accordance with ACLS protocols,
and adding a requirement for Pediatric Advanced Life Support
(PALS) guidelines if surgery is performed on pediatric patients.
Response: The department agrees with these recommen-
dations. The change to "cardioverter-defibrillator" was
incorporated into this section. The recommendation to include
a requirement for PALS certification was incorporated into
135.15(b)(2)(B) and 135.15(b)(3)(B), relating to Facility
Staffing and Training.
Comment: Regarding 135.11(a)(10)(B)(vi), a commenter re-
quested that the phrase "drugs, including" be added before the
word "pharmacologic."
Response: The department disagrees that the addition of these
words will change the interpretation of, or add value to, the rule. It
is understood that there will be a variety of drugs available in the
ASC, as recommended by the medical staff based on the types of
procedures performed and the types of anesthesia administered.
The intent of the rules in this section is to establish only minimum
standards for the emergency equipment and supplies that must
be available. Medical staff has the discretion to require additional
equipment and supplies. No change was made to rule as a result
of this comment.
Comment: Regarding 135.11(b)(9), one commenter ques-
tioned why the department would allow exceptions for the
pathology review of surgical tissues. The commenter recom-
mended that the allowance of this exception be removed from
the rule.
Response: The department disagrees. The rule language as
proposed is the same as existing rule 135.9(j)(7), and has been
standard practice for many years. The intent is to allow the med-
ical staff and governing body to designate certain types of tis-
sues that do not need to be subjected to pathology analysis.
This will help to prevent unnecessary costs to both patients and
third party insurers. The medical staff may only exempt tissues
known to be without potential abnormality or pathology. An ex-
ample would be normal fatty tissue removed during an elective
cosmetic procedure. No change was made to the rule as a result
of this comment.
Comment: Regarding 135.11(b)(14), one commenter re-
quested that the rule include more specific maintenance
requirements, including a requirement that only qualified
bio-medical personnel complete the equipment service, and
that a separate maintenance log be maintained by the facility.30 TexReg 7040 October 28, 2005 Texas Register
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Texas. Secretary of State. Texas Register, Volume 30, Number 43, Pages 6973-7094, October 28, 2005, periodical, October 28, 2005; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth97316/m1/66/?q=%22%22~1: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.