The Texas Health and Human Services Commission (THHSC), on behalf of the Department of State Health Services, has adopted new Ambulatory Surgical Center (ASC) regulations, effective June 18, 2009. The new rules update, reorganize and clarify existing rules and implement the 2007 Texas legislation, Consumer Access to Health Care Information.
The new rules require a preanesthesia evaluation by an individual qualified to administer anesthesia be included in a patient’s medical record. The individual may be a qualified Registered Nurse (RN) in connection with the administration of topical anesthesia, local anesthesia, minimal sedation and moderate sedation. This preanesthesia evaluation does not necessarily need to be performed immediately before the surgical procedure, as compared to the operating surgeon’s risk assessment of the anesthesia and procedure required immediately before the procedure. 25 TAC 135.9(j)(5).
Consumer Access to Health Information
This 2007 law (Texas Health and Safety Code, Chapter 324) requires ASC governing bodies (as well as hospitals and birthing centers) to develop, implement and enforce written policies for the billing of health care services and supplies, including:
- any discounting of charges to an uninsured consumer, subject to the Texas Insurance Code, Chapter 552, Illegal Pricing Practices;
- any discounting of charges to a financially or medically indigent consumer qualifying for services based on a sliding fee scale or a written charity care policy;
- the provision of itemized statements;
- the interest rate, if any, to be applied to billed services not covered by a third party payor;
- the ASC’s complaint procedure;
- written disclosure at admission whether the ASC, surgeon and anesthesia practitioner are participating providers in the consumer’s third-party payor coverage;
- conspicuous posting of a notice in the general and business office/registration waiting area of the availability of the policies;
- provision of an estimate on request and before the scheduling of the surgical procedure with information on financial responsibility and factors affecting a variance between the estimate and actual charges; and
- refunds of consumer overpayments. 25 TAC 135.4(j).
Responding to comments from the Texas Council of PeriOperative Registered Nurses, HHSC now prohibits surgical technicians and licensed vocational nurses from serving as circulating nurses in ASC operating rooms under any circumstances. Such personnel may assist in circulatory duties under the direct supervision of a qualified RN. 25 TAC 135.15(a)(2)(C).
Patient Safety Program/General Safety
The patient safety program reporting requirements for an annual events report and a best practices report have been repealed and no longer need be submitted. New general safety requirements were added including appointment of a safety officer, establishment of an incident reporting system, development of departmental and facility safety manuals and provision of a self-sufficient emergency communication system. 25 TAC 135.27; 25 TAC 135.42.
The new rules change the ASC license term from one year to two years. The HHSC rules additionally require ASCs to:
- Document all approvals or delegations of anesthesia services, including the training, experience and qualifications of the individual providing anesthesia services;
- Provide specific background information on the ASC license applicant’s owners, affiliates and managers; and
- Construct new ASCs and additions to existing ASCs located in a designated 100-year flood plain one foot above the set base flood plain elevation.
Text of New Rules
New ASC licensing rules adopted with changes to the proposed text, as published in the December 5, 2008 issue of the Texas Register, were published in the June 12, 2009 issue. Rules adopted without change to the proposed text were not republished and may be found in the December 5, 2008 issue. The complete text of the new rules should be available on the Department’s web site under the “Certifications, Licenses & Permits” tab and the Texas Administrative Code web site on or about June 18, 2009, the effective date.
In addition to the new Texas operating, fire prevention and safety and physical plant and construction requirements, new Medicare conditions for coverage were effective on May 18, 2009.