HOME    SEARCH    ABOUT US    CONTACT US    HELP   
           
Montana Administrative Register Notice 37-637 No. 11   06/06/2013    
Prev Next

 

 BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rules I through XI pertaining to licensure requirements for outpatient centers for surgical services

)

)

)

)

NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION

 

 

TO: All Concerned Persons

 

            1. On June 26, 2013, at 10:00 a.m., the Department of Public Health and Human Services will hold a public hearing in Room 207 of the Department of Public Health and Human Services Building, 111 North Sanders, at Helena, Montana, to consider the proposed adoption of the above-stated rules.

 

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on June 19, 2013, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

3. The rules as proposed to be adopted provide as follows:

 

NEW RULE I PURPOSE (1) The purpose of these rules is to establish the minimum licensing requirements for the licensure of outpatient centers for surgical services.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

NEW RULE II SCOPE (1) For purposes of this subchapter, outpatient centers for surgical services include facilities described at 50-5-101(42), MCA.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE III DEFINITIONS (1) "Accreditation Association for Ambulatory Health Care (AAAHC)" means the organization nationally recognized by that name and surveys outpatient centers for surgical services upon their request and grants accreditation status to the outpatient center for surgical services that it finds meets its standards and requirements.

            (2) "Medical director" means a physician licensed under Title 37, chapter 3 MCA, who oversees the services provided in an outpatient center for surgical services. The medical director may also serve in the outpatient center as a licensed health care professional. The medical director can also serve as the outpatient center administrator.

            (3) "Outpatient center" for purposes of this subchapter, refers to an outpatient center for surgical services. Outpatient centers are limited to provide care for periods of less than 24 hours.

(4) "Safe manner" means that physicians and other clinical staff must follow acceptable surgical standards of practice in all phases of a surgical procedure, beginning with the preoperative preparation of the patient, through to the postoperative recovery and discharge.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE IV MINIMUM STANDARDS FOR OUTPATIENT CENTERS FOR SURGICAL SERVICES (1) An outpatient center must:

            (a) meet the requirements of ARM Title 37, chapter 106, subchapter 3 relating to the minimum standards for all health care facilities;

            (b) to the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the rules in this subchapter will apply;

            (c) have a written policy and procedure manual as described in [NEW RULE V] available to, and followed by, all personnel;

(d) establish a coordinated transfer of care for patients who require services longer than 24 hours or for patients requiring care beyond the capabilities of the outpatient center. This coordinated transfer of care must include one of the following:

            (i) a written transfer agreement with the receiving hospital;

            (ii) one or more physicians with surgical privileges in the outpatient center must have admitting privileges at the receiving hospital and are present in the outpatient center during any surgical procedure; or

            (iii) the receiving hospital writes a coordinated transfer policy and specifies the respective roles and responsibilities of the outpatient center upon arrival at the receiving hospital; and

            (e) in transferring patients, the outpatient center must:

            (i) coordinate and provide notice to the receiving hospital, including the reason for the transfer prior to the patient's transfer; and

            (ii) provide the patient's medical records to the receiving hospital during the transfer.

            (2) An outpatient center may:

            (a) show written evidence of current accreditation by the Accreditation Association for Ambulatory Health Care (AAAHC) including recommendations for future compliance as a condition of licensure; or

(b) meet the standards as specified in [NEW RULE V through XI].

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE V WRITTEN POLICIES AND PROCEDURES (1) Each outpatient center must maintain a policy and procedure manual. The policy and procedure manual must be reviewed by the medical director or administrator and updated as necessary, but at least annually. The manual must contain policies and procedures for:

                     (a) preadmission;

            (b) patient education;

            (c) preoperative assessment;

            (d) postoperative assessment;

            (e) observation and recovery;

            (f) discharge planning;

            (g) emergency procedures of the outpatient center to include information on the transfer agreement with the receiving hospital;

            (h) anesthesia policies as described in [NEW RULE X];

            (i) business practices; and

            (j) patient and staff security.

            (2) The policy and procedure manual must include a current organizational chart delineating the lines of authority, responsibility, and accountability for the administration and provision of all outpatient center patient services.

            (3) Each outpatient center must have policies and procedures that address the criteria for clinical staff privileges and the process the governing body uses when reviewing physician credentials and determining whether to grant privileges.

(4)   The outpatient center must implement a policy and a process which addresses the Food and Drug Administration (FDA) or manufacturer recall of drugs, vaccines, blood and blood products, medical devices, equipment, and supplies. The policy must address:

            (a) the sources of information;

            (b) methods for notifying staff;

            (c) methods to determine if the recalled product is present at the facility;

            (d) documentation of response to the recalled product;

            (e) disposition or return of the recalled product; and

(f) patient notification as appropriate.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE VI  OPERATIONAL STANDARDS FOR OUTPATIENT CENTERS FOR SURGICAL SERVICES (1) An outpatient center is organized under a governing body that sets policy and is responsible for the organization. This governing body must meet regularly, but at least quarterly.

            (2) The outpatient center administration must:

            (a) operate under clearly defined mission, goals, and objectives for the organization;

            (b) employ qualified personnel, both medical and managerial;

            (c) adopt policies and procedures necessary for the orderly conduct of the organization, including the scope of clinical and surgical activities;

            (d) ensure that the quality of care is evaluated and that identified problems are appropriately addressed;

            (e) maintain effective communication throughout the organization, including ensuring a correlation between quality management and improvement activities and other management functions of the organization; and

            (f) follow generally accepted accounting principles.

            (3) Facility requirements for an outpatient center include:

            (a) compliance with regulations established in the local jurisdiction, including applicable local and state codes for construction, fire prevention, public safety and access, and annual inspections by the fire department; and

            (b) an emergency plan for use in the event of fire or natural disaster and documents exercise of the plan on an annual basis.  The "exercise" may involve a functional review of the process. That review must be documented accordingly.

            (4) Each outpatient center for surgical services will have a quality management and improvement plan which must include:

            (a) a peer review process that includes:

            (i) at least two licensed health care professionals one of whom is a physician, and operating within their scope of practice; and

            (ii) that the results of the peer review are reported to the governing body.

            (b) a credentialing process that provides a monitoring function to ensure the continued maintenance of licensure and certification, or both, of professional personnel who provide health care services at the outpatient center;

            (c) a quality improvement program that:

            (i) is ongoing;

            (ii) is data-driven;

            (iii) is broad in scope;

            (iv) addresses clinical and administrative issues as well as actual patient outcomes;

            (v) has a defined set of quality improvement goals and objectives;

            (vi) actively seeks patient feedback, evaluates complaints and suggestions, and works to improve patient satisfaction;

            (vii) includes the active participation of the medical staff;

            (viii) respects the health care rights of all patients, including the right to privacy;

            (ix) at least annually conducts evaluation of outpatient center effectiveness;        (x) describes to the outpatient center's governing board the reports, findings, and activities relating to quality improvement; and

            (xi) analyzes ongoing comprehensive self-assessment of the quality of care, including medical necessity of care or procedures performed and appropriateness of care. The findings from this process should be used to update facility policies and procedures.

            (d) a risk management plan that:

            (i) has a designated individual or committee that is responsible for the risk management program; and

            (ii) addresses safety of patients and other important issues including:

            (A) consistent application of the risk management program throughout the organization;

            (B) review of all deaths, trauma, or other adverse incidents including reactions to drugs and materials;

            (C) review and analysis of all actual and potential infection control occurrences and breaches, surgical site infections, and other health care acquired infections;

            (D) review of patient complaints;

            (E) impaired health care professionals;

            (F) establishment and documentation of coverage after normal working hours;

            (G) methods for prevention of unauthorized prescribing; and

(H) periodic review of clinical records and clinical record policies.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE VII STAFFING AND PERSONNEL REQUIREMENTS

            (1) Staffing and personnel requirements for an outpatient center for surgical services include:

            (a) professional staff who are licensed under Title 37, MCA, to practice in their profession and have the knowledge and skills required to provide the services offered by the outpatient center;

            (b) all personnel assisting in the provision of health care services are appropriately trained, qualified, and supervised according to the policies and procedures of the outpatient center; and

(c) the outpatient center must keep a schedule for clinical staff, to make sure all shifts are adequately covered.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE VIII MEDICAL, CLINICAL, AND HEALTH RECORD INFORMATION (1) An individual clinical record must be established for each person receiving care. Each record must be accurate, legible, and promptly completed. The record must include at least the following:

            (a) patient identification;

            (b) significant medical history and results of physical examination;

            (c) preoperative diagnostic studies, if performed;

            (d) findings and techniques of the operation including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body;

            (e) any allergies and abnormal drug reactions;

            (f) entries related to anesthesia administration;

            (g) documentation of properly executed informed patient consent which includes notice of transfer when deemed appropriate;

            (h) discharge diagnosis; and

            (i) discharge recommendations and instructions given to the patient.

            (2) To ensure confidentiality, security, and physical safety of a patient's medical record, the outpatient center must designate a person to oversee and manage the clinical records.

(3) The outpatient center must have policies concerning clinical records. The policies must include:

            (a) the retention of active records;

            (b) the retirement of inactive records;

            (c) the timely entry of data in records; and

(d) the release of information contained in records.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE IX INFECTION PREVENTION, CONTROL, AND SAFETY

            (1) The outpatient center must maintain an infection control program that seeks to minimize infections and communicable diseases. The outpatient center is responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases, and for immediately implementing corrective and preventive measures that result in improvement.

            (a) The infection prevention and control program must include documentation that the outpatient center has considered, selected, and implemented nationally recognized infection control guidelines.

            (b) The infection prevention and control program is under the direction of a designated and qualified infection control officer who is a licensed health care professional and has training in infection control.

            (2) The outpatient center must have written policies that also address cleaning of patient treatment and care areas to include:

            (a) cleaning before use; and

            (b) cleaning between patients.

            (3) The outpatient center will have policies and processes in place for:

            (a) the monitoring and documentation of the cleaning, high level disinfection, and sterilization of medical equipment, accessories, instruments, and implants; and

            (b) minimizing the sources and transmission of infections, including adequate surveillance techniques.

            (4) The outpatient center must designate a safety officer who is responsible for the facility's safety plan.

            (5)  The outpatient center must have a safety program which addresses the organization's environment of care and safety for all patients, staff, and others. The elements of the safety program include:

            (a) a process for identifying hazards, potential threats, near misses, and other safety concerns;

            (b) a process for reporting known adverse incidents to proper authorities;

            (c) a process for reducing and avoiding medication errors; and

            (d) prevention of falls or physical injuries involving patients, staff, and others.

            (6) The outpatient center must have a written emergency and disaster preparedness plan.  The plan must address both internal and external emergencies and must also address provision for the safe evacuation of individuals during an emergency, especially for individuals who are at greater risk.

            (a) The outpatient center must complete a written evaluation of each drill and promptly implement any corrections identified during the drill. This documentation must be on site at the facility for the period of licensure.

            (7) The outpatient center must have a policy concerning the training of outpatient center staff in terms of the emergency and disaster plan.

            (8) Products, including medications, reagents, and solutions that carry an expiration date are monitored and disposed of accordingly.

            (9) Prior to use, appropriate education is provided to intended operators of newly acquired devices or products to be used in the care of patients.

(10) A system must exist for the proper identification, management, handling, transport, storage, and disposal of biohazardous materials and wastes, whether solid, liquid, or gas.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE X ANESTHESIA RISK AND EVALUATION (1) The outpatient center must:

            (a) prohibit the use of flammable anesthesia;

            (b) have a policy which defines the types of anesthesia that will be used within the facility. Similarly, the outpatient center must address in this policy the level of American Society of Anesthesiologists (ASA) Physical Status Classification System level appropriate to receive surgical services in these types of facilities;

            (c) conduct an assessment prior to the patient's admission as well as prior to surgery to evaluate the risk of anesthesia and of the procedure to be performed; and

            (d) have policies that address the basis or criteria used in conducting the assessments.

            (2) Supplies and exhaust systems for windowless anesthetizing locations must be arranged to automatically vent smoke and products of combustion.

            (a) Ventilating systems for anesthetizing locations using general anesthesia must be provided that automatically:

            (i)  prevent recirculation of smoke originating within the surgical suite; and

            (ii)  prevent the circulation of smoke entering the system intake, without, in either case, interfering with the exhaust function of the system.

            (3) Anesthesia must be administered only by:

            (a) a qualified anesthesiologist;

            (b) a physician qualified to administer anesthesia;

            (c) a certified registered nurse anesthetist (CRNA);

            (d) an anesthesiologist assistant is a person who:

(i)  works under the direction of an anesthesiologist;

(ii)  is in compliance with all applicable requirements of Montana state law, including any licensure requirements the state of Montana imposes on nonphysician anesthetists; and

(iii)  is a graduate of a medical school-based anesthesiologist's assistant educational program that:

(A)  is accredited by the Committee on Allied Health Education and Accreditation; and

(B)  includes approximately two years of specialized basic science and clinical education in anesthesia at a level that builds on a premedical undergraduate science background.

            (e) an anesthesiologist assistant may administer anesthesia when under the direct supervision of an anesthesiologist. The anesthesiologist must be immediately available if needed, meaning:

            (i) the supervising anesthesiologist is physically present in the facility; and

            (ii) is prepared to immediately conduct hands on intervention if needed.

            (f) a supervised trainee in an approved educational program under the supervision of a licensed anesthesiologist; or

            (g) a trainee who is a physician in training to be an anesthesiologist in a recognized graduate medical education program, or a student in a recognized nurse anesthesia or anesthesiologist assistance education program may administer anesthesia when supervised by the physician performing the operation.

            (4) Before discharge, each patient must be evaluated by a physician or by an anesthetist in accordance with applicable state health and safety laws, standards of practice, and facility policy. This postanesthesia assessment must include evaluation of:

            (a) respiratory function, including respiratory rate, airway patency, and oxygen saturation;

            (b) cardiovascular function, including pulse rate and blood pressure;

            (c) mental status and level of consciousness, or both;

            (d) temperature;

            (e) pain;

            (f) nausea and vomiting; and

(g) postoperative hydration.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            NEW RULE XI SURGICAL AND RELATED SERVICES (1) Surgical procedures must be performed in a safe manner by qualified physicians functioning within their scope of practice and who limit the surgical procedures to those that are approved by the governing body in accordance to the facility policies and procedures.

            (2) The outpatient center uses acceptable standards of practice to ensure proper identification of the patient and the surgical site in order to avoid wrong site/wrong person/wrong procedure errors. Generally accepted procedures to avoid such errors include:

            (a) a preprocedure verification process to make sure all relevant documents and related information are available, are correctly identified, match the patient, and are consistent with the procedure the patient and the surgical staff are expecting to perform;

            (b) marking of the intended procedure site by the physician who will be performing the procedure so that is it is clear where the procedure is to be performed on the patient's body;

            (c) verification that a current health history is complete which includes a list of current prescription and nonprescription medications and dosages, physical examination, and pertinent preoperative diagnostic studies have been completed; and

            (d) a recheck of the procedures listed in (a) through (c).

            (3) Each operating or procedure room is designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and ensures the physical safety of all persons in the area. Only nonflammable agents are to be present in the operating or procedure room.

            (4) All personnel with direct patient contact will maintain skills in basic cardiac life support and are available whenever there is a patient in the facility.

            (5) A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross-infection, is ensured through the provision of adequate space, equipment, supplies, and personnel including:

            (a) all persons entering the operating or procedure room are properly attired as defined by the governing body;

            (b) acceptable aseptic techniques are used by all persons in the surgical area;

            (c) only authorized persons are allowed in the surgical or treatment areas; and

            (d) measures are implemented to prevent skin and tissue injury from chemicals, cleaning solutions, and other hazardous exposure.

            (6) The outpatient center has established protocols for instructing patients in self-care following surgery.

            (7) The outpatient center has a procedure to address when sponge, sharps, and instrument counts will occur.

            (8) Suitable equipment for rapid and routine sterilization is available to ensure the operating room materials are sterile. Sterilized materials are packaged, labeled, and stored in a manner to maintain sterility and identify sterility dates. Sterility requirements also include:

            (a) processes for cleaning and sterilization of supplies and equipment must comply with manufacturer's instructions and recommendations; and

            (b) internal and external indicators are used to demonstrate the safe processing of items undergoing high level disinfection and sterilization.

            (9) Periodic calibration and preventive maintenance, or both of equipment is provided.

            (10)  An alternate source of power must be available in the event of power shortages, surges, or loss of utility.

(a)  In accordance to National Fire Protection Association (NFPA) 110 Standard the outpatient center must have a generator which automatically starts within 10 seconds of loss of the utility. An Uninterrupted Power Supply (UPS) system is not acceptable as a substitute in any location using general anesthesia.

(b)  UPS systems are permitted in settings where a patient is not under general anesthesia.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, MCA

 

            4. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (the department) is proposing the adoption of New Rules I through XI pertaining to the licensure of Outpatient Centers for Surgical Services. In establishing these rules the department has outlined a set of requirements specific to the outpatient facility; in addition, the department is exercising its authority to accept American Association for Ambulatory Health Care (AAAHC) accreditation as outlined in 50-5-103(7), MCA for purposes of licensing. If the latter is the facility's chosen course, the department will license the outpatient center for surgical services based upon its accreditation in the same manner as the department does with hospitals and other health care facilities.

 

The department has, in the past, had one primary rule, ARM 37.106.1001, that pertained to all outpatient facilities. When the department adopted rules for the Outpatient Centers for Primary Care found in ARM 37.106.1008 through 37.106.1016, the language of ARM 37.106.1001 was inadvertently struck, thus leaving the department with no rule to govern the licensure of outpatient surgical facilities; therefore, the need for this new set of proposed rules.

 

New Rules I and II

 

These rules are being proposed under the authority of 50-5-103, MCA to establish the minimum licensing requirements for outpatient centers for surgical services.

 

New Rule III

 

This rule is being proposed to identify the various terms used throughout the rule.

 

New Rule IV

 

The department is proposing a set of minimum standards that any outpatient center for surgical services must meet. In this set of minimums, the department proposes that the center shows evidence of accreditation by the AAAHC or alternatively meet the set of standards set out in New Rules V through XI.

 

This proposed rule provides a basic tool for measuring the overall health and safety of the patient receiving services in the surgical center. The requirement for accreditation is proposed because as a national "designation of approval" accredited programs generally meet or exceed the minimum requirements proposed through a licensing process. In other areas of health care facility licensure, the department has acknowledged accreditation as a basis for licensure. New Rule V establishes an equivalent set of health and safety requirements in the event that a surgical center chooses to not become accredited.

 

Outpatient centers are limited to provide care for periods of less than 24 hours. If a patient needs care beyond the 24-hour care limitation or needs care beyond what the outpatient center can provide, the department requires in New Rule IV(1)(d) and (e) that the center has formal arrangements for the immediate transfer of the patient to a hospital. The rule requires the facility to indicate the process and the records to be sent with the patient for a coordinated transfer of care.

 

New Rule V

 

All health care facilities are required to develop, implement, and maintain a policy and procedure manual for the overall operation of the facility. Outpatient centers for surgical services are included in the definition of a health care facility under 50-5-101(23), MCA and must have established policies and procedures for their operation.

 

New Rule VI

 

Like other health care facilities, a surgical center must have a designated governing body that exercises oversight for all surgical center activities. The governing body is responsible for establishing the facility policies, making sure that the policies are implemented and monitoring internal compliance. They also review policies at least annually to determine if revisions to policies are needed. Ultimately, it is the governing body's responsibility to create a safe environment where patients can receive quality health care. The rules as proposed will make such a process mandatory for governing boards of outpatient surgical centers. Research and current standards of practice show that facilities that create an active, integrated, peer-based program of quality management and improvement, including a risk management process, improve the quality of care to patients.

 

New Rule VII

 

Surgical and related services in an outpatient center for surgical services must be performed in a safe manner by health care professionals who have the proper training, are operating within the scope of their particular occupational license, and have been granted privileges to perform those procedures by the governing board. To do anything less would mean inadequate care for patients. The proposed regulations outlined in New Rule VII describe the staffing requirements and specifies the necessity of proper training for all professionals within the surgical setting.

 

New Rule VIII

 

The proposed text in (1) requires that the surgical center have a complete, comprehensive, and accurate medical record for each patient. This information is necessary to assure that adequate care is delivered to each patient. The core objective of this regulation is to ensure the patient can tolerate the surgical experience, the anesthesia risk and recovery have been properly assessed, the postoperative care and recovery are adequately evaluated, and the patient has received proper discharge planning. Each medical record must contain the elements defined in New Rule VIII. Additionally, this proposed language helps to determine whether there is anything in the patient's overall condition that would affect the planned surgical procedure or related service such as a medication allergy or a new or existing condition that requires additional interventions to reduce risk to the patient or which may even indicate that the surgical center setting might not be an appropriate setting for the patient's surgery. In order to ensure confidentiality, security, and physical safety of a patient's medical record, there should be a designated person who oversees the medical records. The most important reason for keeping medical records is to provide information on a patient's care to other health care professionals. Another major rationale is that a medical record that is well documented provides support for the physician's defense in the event of a medical malpractice action. Without the medical record, the physician might not be able to show that the care he or she provided was appropriate and met the standard of care. The regulation, as proposed, allows surgical centers to define this process by policy.

 

New Rule IX

 

This proposed rule requires the outpatient center to maintain an active program for the minimization of infectious and communicable diseases. The outpatient center setting presents a unique challenge for infection control because:  patients remain in common areas, often for prolonged periods of time; surgical prep, recovery rooms, and operating rooms (ORs) are turned around quickly; patients with infections or communicable diseases may not be identified; and there is a risk of infection at the surgical site. Due to these reasons, it is critical that the outpatient center have a comprehensive and effective infection control program.

 

Also critical to the overall infection control program, is the designation of a qualified individual who has training in infection control. This individual is responsible to lead the outpatient center's infection control program and to ensure that plans of action for preventing, identifying, and managing infections and communicable disease are properly implemented. New Rule IX is designed to specify the importance of a program focused on minimizing facility acquired infections in the outpatient setting.

 

New Rule X

 

The purpose for this proposed rule is to define the types of anesthesia to be used in the outpatient center as well as outline who can administer that anesthesia. Certain procedures require certain types and levels of anesthesia; which may or may not be a procedure offered by the specific outpatient center. The purpose of the assessment as indicated in (1)(b) prior to surgery is to evaluate whether the risks associated with the anesthesia fall within those ranges for a patient to have the procedure performed within the outpatient setting. While the proposed regulation in (1)(c) does not specify the content or methodology to be employed in conducting the assessment, it is critical that the outpatient center have policies around the patient assessment. Such policies and subsequent classification systems serve the purpose of predicting operative risks, and are useful in predicting morbidity and mortality.

 

New Rule XI

 

The purpose of this new rule is to make certain that procedures performed in outpatient centers must be performed in a safe manner. New Rule III(4) provided a definition for "safe manner." The other requirements contained within this new rule are important components of the provision of services being provided in a "safe manner." Additionally, acceptable standards of practice include the use of a standard procedure to ensure proper identification of the patient and the surgical site, in order to avoid wrong site/wrong person/wrong procedure errors.

 

Conducting surgery in a "safe manner" also requires appropriate use of liquid germicides in the operating room. It is estimated that approximately 100 surgical fires occur each year in the United States (US) resulting in roughly 20 serious patient injuries. New Rule XI(3) is specifically written to address this issue.

 

            5. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., July 5, 2013.

 

6. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

7. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices.  Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 5 above or may be made by completing a request form at any rules hearing held by the department.

 

8. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

9. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

 

 

/s/ Kurt R. Moser                                           /s/ Richard H. Opper                                   

Kurt R. Moser                                                Richard H. Opper, Director

Rule Reviewer                                             Public Health and Human Services

           

Certified to the Secretary of State May 28, 2013.

 

 

Home  |   Search  |   About Us  |   Contact Us  |   Help  |   Disclaimer  |   Privacy & Security