Texas Register, Volume 30, Number 43, Pages 6973-7094, October 28, 2005 Page: 7,041
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Response: The department disagrees. The proposed rule
language is identical to the language that was repealed in
135.11(v). There is no evidence to support that the existing
rule has been ineffective in assuring that facilities properly
maintain their equipment. No change was made as a result of
this comment.
Comment: Regarding 135.11(b)(18), one commenter sug-
gested that changing the word "dismissed", which was not
defined in the rule, to "leaving the facility," would serve to clarify
the intent of the rule.
Response: Although the rule as proposed used the same lan-
guage as the existing rule, the department agrees with the com-
menter and has made the recommended change.
Comment: Regarding 135.11(b)(18), one commenter stated
that the word "physician" should be replaced with "operating sur-
geon."
Response: The department agrees and has made the recom-
mend change.
Comment: Regarding 135.11(b)(19), three commenters
expressed concerns related to this rule, and recommended
that the rule not be adopted. They believed it was not feasible
for all physicians that had privileges at an ASC to also have
staff privileges at local hospitals. The commenters pointed
out that some hospitals are refusing to grant privileges to
physicians who have an "interest" in an ASC. They also stated
that competitive market pressures could preclude a hospital
from entering into a transfer agreement with an ASC, which in
essence placed the ability of an ASC to open and operate in
the hands of the hospitals. Two commenters recommended that
hospitals be required to enter into transfer agreements with any
ASC licensed by the department.
Response: The department disagrees. Although the depart-
ment recognizes that some ASCs may experience challenges
in complying with this requirement, the rule as proposed con-
tains the same language that appears in the current rule under
135.4(c)(11) and repealed 135.11(aa). This same language is
also included in the Medicare Conditions of Participation under
42 CFR 418.41. The purpose of the requirement is to ensure
that the ASC maintains responsibility for assuring that the pa-
tient receives appropriate continuing care should complications
develop, and that the transfer to a higher level of care can be ef-
fected in an organized and timely manner. The department be-
lieves this existing requirement will require additional study and
stakeholder input before being removed or modified. In the in-
terim, facilities that are able to demonstrate a good faith effort to
comply with the requirement may request a waiver or exception
to the licensing rule, subject to the review and approval of the de-
partment; however, those facilities desiring to maintain Medicare
certification must recognize that the department cannot grant an
exception to the Medicare requirement. No changes were made
as a result of these comments.
Comment: Regarding 135.15(a)(2)(C), a commenter sug-
gested that the rule be modified to require that licensed
vocational nurses and surgical technicians assisting with
circulating duties be under the "direct" supervision of the RN
circulator.
Response: The department agrees. The rule has been revised
to clarify that the supervision by the RN circulator must be "direct"
supervision.Comment: Regarding 135.15(b), a commenter believed the
rule should require that all individuals who administer, supervise
and/or delegate anesthesia be trained in advanced cardiac life
support (ACLS).
Response: The department disagrees. Although the depart-
ment recognizes that this level of training would be the ideal, we
also believe this is a practice issue that should be addressed by
the medical staff, not mandated by the department. This section
of the rules seeks only to establish minimum qualifications re-
garding the staff that must be on duty in the facility. The facility is
free to decide which ACLS qualified personnel will fulfill this re-
quirement. No changes were made as a result of this comment.
Comment: Regarding 135.26(d), one commenter requested
clarification that the reporting requirement relating to the perfor-
mance of abortions was in addition to the other reporting require-
ments under 135.26(a).
Response: The department disagrees. Each rule under 135.26
is a separate reporting requirement that is clearly prescribed as
presented in the rule. No change was made as a result of this
comment.
The department is making the following change to eliminate du-
plication in the rules.
Change: Concerning 135.22(b)(1), subparagraphs (D) and (E)
are deleted to eliminate duplication because submission require-
ments for annual events reports and best practices reports are
provided in 135.27, relating to Patient Safety Program. There-
fore, 135.22(b)(1)(B) and (C) were corrected for grammar and
punctuation since (D) and (E) were deleted.
The department initially planned to accept only written com-
ments related to the proposed rules. However, one commenter
who submitted written testimony also requested, pursuant to
Government Code, 2001.29(B)(3), that the department hold a
public hearing before adopting the rule. The hearing was held
on August 25, 2005. All comments received during the public
hearing had previously been received by the department during
the 30 day written comment period. All comments have been
addressed in this preamble.
The commenters were the American Association of Oral and
Maxillofacial Surgeons, Austin Anesthesiology Group, the Board
of Nurse Examiners for the State of Texas, the Coalition for
Nurses in Advanced Practice, the Texas Ambulatory Surgery
Center Society, the Texas Association of Nurse Anesthetists,
the Texas Hospital Association, the Texas Medical Association,
the Texas Nurses Association, the Texas Society of Anesthe-
siologists, the law firm of Haynes and Boone, LLP, and the
Honorable Frank J. Corte, Jr. All commenters were not against
the rules in their entirety, however they expressed concerns,
asked questions and suggested recommendations for change
as discussed in the summary of comments.
LEGAL CERTIFICATION
The Department of State Health Services Deputy General Coun-
sel, Lisa Hernandez, certifies that the adoption has been re-
viewed by legal counsel and found to be within the state agen-
cies' authority to adopt.
SUBCHAPTER A. OPERATING REQUIRE-
MENTS FOR AMBULATORY SURGICAL
CENTERSADOPTED RULES October 28, 2005 30 TexReg 7041
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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/m1/67/?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.