Texas Register, Volume 30, Number 43, Pages 6973-7094, October 28, 2005 Page: 7,038
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plan within 30 days. The amendment to 135.52 updates
language to reflect current terminology used in other guidelines
and standards and updates references for patient spaces.
The sections for repeal address anesthesia and surgical
services, nursing services, and reporting of incidents. New
135.11, 135.15 and 135.26 reflect reorganization of existing
sections and contain new language to clarify the requirements
for providing anesthesia and surgical services, nursing services,
and reporting requirements. New 135.11 identifies anesthesia
that a hospital's governing body may approve for use in the ASC
including the equipment and supply needs for each; requires
the facility to develop policies and guidelines related to the
administration of anesthesia; names the practitioners who may
administer anesthesia or sedation; and requires that a physician
shall be on call and able to respond physically or by telephone
within 30 minutes until all patients have been discharged. New
135.15 requires a registered nurse with certification in basic
cardiac life support to be on duty and on the premises whenever
patients are in the facility, and establishes staffing requirements
for the particular anesthesia to be administered. New 135.26
establishes specific incidents that must be reported to the
department within 10 business days, and data that the ASC
must provide annually on a form prescribed by the department.
New 135.29 provides time periods for processing applications
for initial and renewal licenses.
COMMENTS
The following comments were received concerning the proposed
sections. Following each comment is the department's response
and any resulting change(s).
Comment: Concerning 135.2, one commenter requested that
anesthesiologist's assistant be added to the definitions and in-
cluded in the list of those authorized to administer anesthesia.
Response: The department disagrees with the commenter. This
would be considered a substantive change from the current rules
as well as the proposed rules, requiring further research by the
department, and an opportunity for additional stakeholder input;
therefore, this change will not be incorporated at this time. This
recommendation may be revisited during future reviews of the
ASC rules. No changes were made as a result of this comment.
Comment: Concerning 135.2(4), one commenter requested
that the definition of Advanced Practice Nurse include a refer-
ence to the multi-state licensure privilege from another compact
state.
Response: The department agrees and has added the re-
quested language to the definition.
Comment: Concerning 135.2(6), one commenter opposed al-
lowing planned stays of up to 23 hours. The commenter rec-
ommended that ASCs be required to discharge patients no later
than 1:00 a.m. local time, and discharges past 1:00 a.m. should
be allowed only in those cases where additional time for post-sur-
gical recovery could not be anticipated prior to surgery. The com-
menter also referenced the Medicare policy which states there
should be no planned overnight stays in Medicare certified facil-
ities.
Response: The department disagrees. In developing the pro-
posed definition, the department conducted research of rules
and enforcement practices in other states. This research re-
vealed that the majority of states that had licensing rules or state
policies addressing length of stay used the 23-hour limit. The de-
partment also considered the Medicare policy. The Centers forMedicare and Medicaid Services (CMS) was contacted for clar-
ification since their policy does not define the term "overnight".
The response from CMS was that, in terms of enforcement of the
policy, a stay of less than 24 hours was not considered overnight.
The department has included in the rules a requirement that all
patient stays greater than 23 hours be reported to the depart-
ment so that any quality of care and patient safety concerns re-
lated to extended stays can be evaluated. No change was made
to the rule as a result of this comment.
Comment: Concerning 135.4(k), one commenter supported
the proposed rule, stating that they believed that some ASCs, in
competing for patients, might inappropriately steer patients away
from contracted inpatient facilities. Another commenter opposed
the proposed rule, and provided extensive legal citations to sup-
port their assertion that the rule exceeded the department's gen-
eral and specific rule-making authority.
Response: The department agrees with the commenter who as-
serted that the rule as proposed exceeded our general and spe-
cific rule-making authority. The rule has been revised to include
a general requirement that the governing body is responsible for
ensuring compliance with applicable state laws.
Comment: Concerning 135.9(j)(11), a commenter suggested
that changing the words "was dismissed", which was not defined
in the rule, to "leaving the facility," would serve to clarify the intent
of the rule.
Response: The department agrees and the term "was dis-
missed" has been replaced by "left the facility" to be consistent
with changes to 135.11(b)(18).
Comment: Regarding the proposed deletion of 135.10(a)(4)
from the existing rules, one commenter was concerned that the
department was proposing to eliminate the requirement that the
ASC have staff trained in cardiopulmonary resuscitation (CPR)
and the use of emergency equipment on duty during all hours of
operation.
Response: The department disagrees with the commenter, as
we have not proposed the elimination of this requirement. To the
contrary, staffing and training requirements have been strength-
ened in 135.15. The rules require that there be a minimum of
two individuals on duty on the premises at all times who are cer-
tified in CPR. One of the individuals required to be on duty at
all times is a registered nurse who is certified in CPR. The rules
add additional requirements for staff certified in advanced car-
diac life support to be on duty, based on the type of anesthesia
being administered. No change was made to the rule as a result
of this comment.
Comment: Regarding 135.11(a)(1)(A) - (G), one commenter
recommended adopting the American Society of Anesthesiol-
ogists (ASA) document "Continuum of Sedation--Definition of
General Anesthesia and Levels of Sedation/Anesthesia."
Response: The department disagrees. Although the depart-
ment did not adopt the ASA document, the definitions and de-
scriptions of the types of anesthesia that may be administered in
an ASC were taken directly from the referenced document. No
change was made to the rule as a result of this comment.
Comment: Regarding 135.11(a)(2), two commenters re-
quested the rule be clarified to indicate that the physician was
supervising the anesthesia "department," not the individual
administration of anesthesia. Another commenter requested
that the rule be clarified by adding the word "medical" before30 TexReg 7038 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/m1/64/?q=%22%22~1&rotate=90: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.