DAR File No. 40243

Health, Family Health and Preparedness, Licensing

Rule R432-550

Birthing Centers

Notice of Proposed Rule

(Amendment)

DAR File No.: 40243
Filed: 03/04/2016 08:39:19 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule amendment is to remove certain requirements that conflict with current statutes governing midwives and other licensed maternity practitioners. This amendment will update the entire rule and remove old clinical requirements that due, to age of the rule, no longer apply to birthing centers. Also, this amendment amends the rule's content and numbering that needs clarification, so they can be easily understood and consistently applied by providers and the Department of Health. The Health Facility Committee reviewed and approved these rule amendments on 02/24/2016.

Summary of the rule or change:

The rule amendment removes the requirement for a transfer agreement or admitting privileges with a hospital. It allows for all providers licensed through the Division of Occupational and Professional Licensing to provide maternity, midwifery, or obstetric care in a birthing center. It also corrects many outdated references and corrects numbering errors.

State statutory or constitutional authorization for this rule:

• Title 26, Chapter 21

Anticipated cost or savings to:

the state budget:

The state budget will be impacted due to the licensing of birthing centers that was not previously possible. For each 2-room birthing center applying for licensure, there will be an initial licensing fee of $1,527.50 for the first year and a renewal fee of $1,560 every 2 years thereafter. The Department anticipates two centers licensing in FY2016 which will result in fees of $3,055 to state revenues. The Department also anticipated two birthing centers applying for licensure per year for the next three years.

local governments:

There is no impact to local governments because they are not involved with this process.

small businesses:

There is a cost to small businesses. The birthing centers will be considered small businesses, so the licensing fees will apply as stated above.

persons other than small businesses, businesses, or local governmental entities:

There is no impact to businesses, individuals, local governments, and persons that are not small businesses because the changes in this rule will not affect them.

Compliance costs for affected persons:

There is a change for birthing centers that wish to be licensed. For a 2-room birthing center, there is an initial licensing fee of $1,527.50 for the first year, and a fee of $1,560 for license renewal every 2 years after.

Comments by the department head on the fiscal impact the rule may have on businesses:

There will be a fiscal impact on business in that birthing centers will be subject to licensing fees of approximately $1,500; however, the change in the rule will enable the licensing of birthing centers, which were unable to obtain a license under the existing rule.

Joseph Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Family Health and Preparedness, Licensing
3760 S HIGHLAND DR
SALT LAKE CITY, UT 84106

Direct questions regarding this rule to:

• Joel Hoffman at the above address, by phone at 801-273-2804, by FAX at 801-274-0658, or by Internet E-mail at jhoffman@utah.gov
• Carmen Richins at the above address, by phone at 801-273-2802, by FAX at 801-274-0658, or by Internet E-mail at carmenrichins@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/02/2016

This rule may become effective on:

05/09/2016

Authorized by:

Joseph Miner, Executive Director

R432. Health, Family Health and Preparedness, Licensing.

R432-550. Birthing Centers.

R432-550-1. Legal Authority.

This rule is adopted pursuant to Title 26, Chapter 21.

 

R432-550-2. Purpose.

This rule provides health and safety standards for the organization, physical plant, maintenance and operation of birthing centers.

(1) Birthing centers shall consist of [at least two,]one to [but not more than] five birth[ing] rooms. Licensure is not required for birthing centers with only one birth room.

(2) Birthing centers provide quality care and services in a pleasing and safe environment to a select low risk population of healthy maternal patients who choose a safe and cost-effective alternative to the traditional hospital childbirth experience.

(3) Birthing center clinical staff assess the maternal patient's risk for obstetric complications through careful review of the patient's records for prenatal screening [for]of potential problems[throughout pregnancy].

(4) Birthing centers recognize the individual needs of, and provide service to, low risk maternal patients expected to have an uncomplicated [pregnancy, ]labor and delivery.

 

R432-550-3. Time for Compliance.

Facilities governed by these rules shall be in full compliance with these rules at the time of licensure.

 

R432-550-4. Definitions.

(1) Common definitions R432-1-3.

(2) Special Definitions:

(a) "Birth room" means a room and environment designed, equipped and arranged to provide for the care of a maternal patient and newborn and to accommodate a maternal patient's support person during the process of vaginal birth and recovery. "Birth room" does not include rooms intended for pre-admittance or post-discharge accommodations of maternal patients and their newborns.

(b) "Birthing center" means a freestanding facility, receiving maternal patients and providing care during [pregnancy]labor, delivery and immediately after delivery.

(c) "Patient" means a woman or newborn receiving care and services provided by a birthing center during [pregnancy]labor, childbirth and recovery.

(d) "Clinical staff" means [the physicians, certified nurse-midwives and other licensed health care practitioners ]a licensed maternity care practitioner appointed by the governing authority to practice within the birthing center and governed by rules approved by the governing body.

(e) "Support person" means the individual or individuals selected or chosen by a patient to provide emotional support and to assist her during the process of labor and childbirth.

(f) "Vaginal birth" means the three stages of labor.

(g) "Licensed maternity care practitioner" means a person licensed to provide maternity care services including physicians licensed under Title 58, Chapters 67 and 68, Certified Nurse-Midwives licensed under Title 58, Chapter 44a, Naturopathic Physicians licensed under Title 58, Chapter 71, Licensed Direct-Entry Midwives licensed under Title 58, chapter 77, and others licensed to provide maternity, midwifery, or obstetric care under Title 58.

 

[ R432-550-5. Licensure.

License Required. See R432-2.]

 

R432-550-[6]5 . General Construction Rules.

See R432-14 Birthing Center Construction Rules.

 

R432-550-[7]6 . Governing Body.

(1) The licensee shall appoint in writing an individual or group to constitute the facility's governing body.[

(2)] The governing body shall:

(a) comply with federal, state and local laws, rules and regulations;

(b) adopt written policies and procedures which describe the functions and services of the birthing center and protect patient rights;

(c) adopt a policy prohibiting discrimination because of race, color, sex, religion, ancestry, or national origin in accordance with Title 13, Chapter 7, Sections [13-7-]1 through 4.

(d) develop an organizational structure establishing lines of authority and responsibility;

(e) when the governing body is more than one individual, conduct meetings in accordance with facility policy, but at least annually, and maintain written minutes of the meetings;

(f) appoint by name and in writing a qualified administrator;

(g) appoint by name and in writing a qualified director of the clinical staff;

[(h) notify the licensing agency in writing no later than five days after a change of administrator, identifying the name of the new administrator and the effective date of the change;]

([i]h) appoint members of the clinical staff and delineate their clinical privileges;

([j]i) review and approve at least annually a quality assurance program for birthing center operation and patient care provided.[R432-550-12.]

([k]j) establish a system for financial management and accountability;

([l]k) provide for resources and equipment to provide a safe working environment for personnel;

([m]l) act on findings and recommendations of facility-created committees relevant to compliance with these birthing center rules;

([n]m) ensure that facility patient admission eligibility criteria are strictly applied by clinical staff and are evaluated through quality assurance review in accordance with R432-550-1[2]1.

([3]2) Written policies and procedures shall:

(a) clearly, accurately and comprehensively define the methods by which the facility will be operated to protect the health and safety of patients;

(b) provide for meeting the patient's needs;

(c) provide for continuous compliance with federal, state and local laws, rules and regulations.

(d) Written policies and procedures shall include:

(i) defining the term "low risk maternal patient" which shall include eligibility criteria for birth services offered in the birthing center;

(ii) defining specific criteria, which shall in normally anticipated circumstances render a maternal patient ineligible for birth services or continued care at the birthing center;

(iii) identifying and outlining methods for transferring patients who, during the course of[pregnancy,] labor or recovery, are determined to be ineligible for birthing center services or continued care at the birthing center, including;

(A) information required for proper care and treatment of the individual(s) transferred, including patient records; and

(B) security and accountability of the personal effects of the individual being transferred.

(iv) planning for consultation, back-up services, transfer and transport of a newborn and maternal patient to a hospital where necessary care is available;

(v) documenting the maternal patient has been informed of the [benefits, risks and ]eligibility requirements of an out-of-hospital birthing center labor and birth;

(vi) providing[for the education of patients, family and support persons]instructions in postpartum and newborn care to the patient and any other family or support person designated by the patient;[

(vii) planning for post-discharge follow-up of patients;]

(vii[i]) registering birth, fetal death or death certificates in accordance with Title 26, Chapter 2, Sections [26-2-]5, [26-2-]13, [26-2-]14, [26-2-]23 and rules promulgated pursuant thereto in R436.

( viii[ix]) prescribing and instilling a prophylactic solution approved by the Department of Health in the eyes of the newborn in accordance with R386-702-[7]8, Special Measures for the Control of Ophthalmia Neonatorum;

( ix) performing phenylketonuria (PKU) and other[metabolic] disease tests in accordance with Department of Health Laboratory rules developed pursuant to Section [26-10-]6;

(x[i]) [providing for]verifying prenatal laboratory screening to include:

(A) blood type and Rh Factor and provision for appropriate use of Rh immunoglobulin;

(B) hematocrit or hemoglobin;

(C) antibody screen;

(D) rubella; and

(E) syphilis;

[(F) urine glucose and protein.]

(xi[i]) providing for infection control to include :

(A) housekeeping;

(B) cleaning, sterilization, sanitization and storage of supplies and equipment; and

(C) prevention of transmission of infection in personnel, patients and visitors.

 

R432-550-[8]7 . Administrator.

(1) Direction.

(a) The administrator shall be responsible for the overall management and operation of the birthing center.

(b) The administrator shall designate in writing a competent employee to act as administrator in the temporary absence of the administrator.

(c) The administrator's designee shall have authority and responsibility to:

(i) act in the best interests of patient safety and well-being;

(ii) operate the facility in a manner which ensures compliance with these birthing center rules.

(2) Qualifications.

The administrator and administrator's designee shall be knowledgeable:

(a) by education, training or experience in administration and supervision of personnel and qualified as required by facility policy;

(b) in birthing center protocols;

(c) in applicable federal, state and local laws, rules and regulations.

(3) The administrator's responsibilities shall be included in a written job description available for Department review. The administrator shall:

(a) complete, submit and file records and reports required by the Department;

(b) develop and implement facility policies and procedures;

(c) review facility policies and procedures at least annually and report to the governing body on the review;

(d) employ or contract with competent personnel whose qualifications are commensurate with job responsibilities and authority and who have the appropriate Utah license or certificate of completion;

(e) develop, for all employee positions, job descriptions that delineate functional responsibilities and authority; and

(f) review and act on incident or accident reports.

 

R432-550-[9]8 . Clinical Director.

(1) The clinical director shall be responsible for implementing, coordinating and assuring the quality of patient care services.

(2) The clinical director shall:

(a) be currently licensed to practice medicine or midwifery in Utah;

(b) have training and expertise in obstetric and newborn services offered to ensure adequate supervision of patient care services.

(3) The clinical director's responsibilities shall be included in a written job description available for Department review. The clinical director shall:

(a) review and update facility protocols;

(b) review and evaluate clinical staff privileges and revise them as necessary;

(c) recommend, to the governing body, names of qualified licensed health care practitioners to perform approved procedures and the corresponding clinical staff privileges to be granted;

(d) coordinate, direct and evaluate clinical operations of the facility;

(e) evaluate and recommend to the administrator the type and amount of equipment needed in the facility;

(f) ensure that qualified staff are on the premises [when]while patients are [in]admitted to the facility;

(g) ensure clinical staff documentation is recorded immediately and reflects a description of care given;

(h) ensure that planned birthing center services are within the scope of privileges granted to the clinical staff; and

(i) recommend to the administrator appropriate remedial action and disciplinary action, when necessary, to correct violations of clinical protocols.

 

R432-550-[10]9 . Personnel.

(1) The administrator shall employ a sufficient number of qualified professional and support staff who are competent to perform their respective duties, services and functions.

(2) The facility shall maintain written personnel policies and procedures which shall be available to personnel and shall address the following:

(a) content of personnel records;

(b) job descriptions, qualifications and validation of licensure or certificates of completion as appropriate for the position held;

(c) conditions of employment; and

(d) management of employees.

(3) The facility shall maintain personnel records for employees and shall retain personnel records for terminated employees for a minimum of one year following termination of employment.

(4) The facility shall establish a personnel health program through written personnel health policies and procedures which shall protect the health and safety of personnel and patients commensurate with the services offered.

(5) An employee placement health evaluation shall include at a health inventory which shall be completed when an employee is hired. The health inventory shall obtain the employee's history of the following:

(a) conditions that predispose the employee to acquiring or transmitting infectious diseases; and

(b) conditions which may prevent the employee from performing certain assigned duties satisfactorily.

(6) Employee health screening and immunization components of personnel health programs shall be developed in accordance with R386-702, Code of Communicable Disease Rules.

(7) Employee skin testing by the Mantoux method or other FDA approved in-vitro serologic test and follow-up for tuberculosis shall be done in accordance with R388-804, Special Measures for the Control of Tuberculosis.

(a) The licensee shall ensure that all employees are skin-tested for tuberculosis within two weeks of:

(i) initial hiring;

(ii) suspected exposure to a person with active tuberculosis; and

(iii) development of symptoms of tuberculosis.

(b) Skin testing shall be exempted for all employees with known positive reaction to skin tests.

(8) [The birthing center shall provide staff development programs to include at least documented orientation for new staff and ongoing in-service training for personnel.

(a) Facility policy shall define an orientation program, standardized for employee categories of responsibility, and shall specify the time for completion.

(b) The in-service training program shall define the frequency and content of training to include:

(i) an annual review of facility policies and procedures;

(ii) infection control, personal hygiene and each employee's responsibility in the personnel health program.

(c) Personnel shall have ready access to the facility's policy and procedure manuals when on duty.]The birthing center personnel must receive documented orientation to the facility and the job for which they are hired.

(9) The birthing center personnel must receive documented ongoing in-service training to include:

(a) an annual review of facility policies and procedures; and

(b) infection control, personal hygiene and each employee's responsibility in the personnel health program.

(10) The birthing center Personnel shall have access to the facility's policy and procedure manuals when on duty.

(11) Personnel shall maintain current licensing, certification or registration appropriate for the work performed and as required by the Utah Department of Commerce.

(a) Personnel shall provide evidence of current licensure, registration or certification to the Department upon request.

(b) Failure to ensure personnel are licensed, certified or registered may result in sanctions to the facility license.

 

R432-550-1[1]0 . Contracts[and Agreements].

(1) [The licensee shall secure a written contract or agreement for services not provided directly by the facility. Contracts or agreements shall include a statement that contract personnel shall]The licensee shall provide a written contract for any birthing center services that are not provided directly by the facility. The licensee shall ensure that the contracted entity:

(a) perform s according to facility policies and procedures;

(b) conform s to standards required by laws, rules and regulations;

(c) provide s services that meet professional standards and are timely.

(2) Contracts[or transfer agreements] shall be available for Department review.[

(3) The licensee shall maintain transfer agreements for one or both of the following:

(a) admitting privileges for clinical staff at a general hospital within 30 minutes travel distance of the birthing center;

(b) a written transfer agreement with one or more general hospitals located within 30 minutes travel distance of the birthing center.

(4) The general hospital transfer agreement shall include provisions for:

(a) transfer of information needed for proper care and treatment of the individual transferred;

(b) security and accountability of the personal effects of the individual being transferred.]

 

R432-550-1[2]1 . Quality Assurance.

(1) The administrator shall establish a [program to ensure quality in the operation of the birthing center and the services provided]quality assurance committee and program. This committee shall review regularly clinic operations, protocols, policies and procedures, incident reports, infection control, patient care policies and safety.

(2) The quality assurance [program shall include a written organizational plan to identify and resolve problems]committee shall initiate action to resolve identified quality assurance problems by filing a written report of findings and recommendations with the licensee.

(3) [The quality of services offered by the facility shall be monitored by a quality assurance committee:

(a) The quality assurance committee shall include at least representatives from facility administration and clinical services and a knowledgeable person who is not an owner or employee of the birthing center.

(b) ]The quality assurance committee shall meet as prescribed in facility policy or at least quarterly and shall keep written minutes available for department review.

[(c) The quality assurance committee shall initiate action to resolve identified quality assurance problems by filing a written report of findings and recommendations with the governing body and with the administrator and clinical director as necessary to produce desired results.

](4) The quality assurance program shall include surveillance, prevention and control of infection.

 

R432-550-1[3]2 . Emergency and Disaster.

(1) The administrator shall make provisions to maintain a safe environment in the event of an emergency or disaster. An emergency or disaster includes but is not limited to utility interruption, explosion, fire, earthquake, bomb threat, flood, windstorm, epidemic and injury.

(2) The administrator shall educate, train and drill staff to respond appropriately in an emergency in accordance with NFPA 101[-31-4], Life Safety Code [1991]2009.

(3) The administrator shall review the written emergency procedures at least annually and update them as appropriate.

(4) Personnel shall have ready access to written emergency and disaster plans when on duty.

(5) The administrator shall review the disaster plan with local disaster agencies as appropriate.

(6) The smoking policy shall comply with Title 26, Chapter 38, the "Utah Clean Air Act" and Section [31-4.4]20.7.4 of the Life Safety Code, [1991]2009 edition.

 

R432-550-1[4]3 . Patients' Rights.

(1) Written patients' rights shall be established and made available to the patient as determined by facility policy which shall include the following:

([1]a) to be fully informed, prior to or at the time of admission, and during stay, of these rights and of facility rules that pertain to the patient;

([2]b) to be fully informed, prior to admission, of the treatment to be received, potential complications and expected outcomes;

([3]c) to refuse treatment to the extent permitted by law and to be informed of the medical consequences of such refusal;

([4]d) to be informed, prior to or at the time of admission and during stay, of services available in the facility and of any expected charges for which the patient may be liable;

([5]e) to be afforded the opportunity to participate in decisions involving personal health care, except when contraindicated;

([6]f) to refuse to participate in experimental research;

([7]g) to be ensured confidential treatment of personal and medical records and to approve or refuse release to any individual outside the facility, except in the case of transfer to another health facility, or as required by law or third party payment contract;

([8]h) to be treated with consideration, respect and full recognition of personal dignity and individuality, including privacy in treatment and in care for personal needs.

 

R432-550-1[5]4 . Clinical Staff and Personnel.

(1) [A physician applying for privileges at the birthing center must maintain admitting privileges at a general hospital within 30 minutes travel distance of the birthing center.

(2) A certified nurse-midwife applying for privileges must provide evidence of, and maintain, a collaborative relationship with a back-up physician to include at least a written and signed agreement approved by the clinical director. Written agreements a certified nurse-midwife establishes with a back-up physician shall include at least the following:

(a) documentation that the back-up physician agrees to accept consultation calls and referrals from the certified nurse-midwife 24 hours a day;

(b) documentation that the back-up physician has admitting privileges at a general acute hospital within 30 minutes travel distance of the birthing center;

(c) provisions to ensure adequate and timely services by the back-up physician.

(3) ]Information identifying current clinical staff[, back-up physicians] and on-call and emergency telephone numbers shall be readily available to birthing center personnel.

([4]2) Clinical staff and licensed personnel of the birthing center shall be trained in emergency and resuscitation measures for infants and adults, including but not limited to, cardiopulmonary resuscitation certification through an American Heart Association or American Red Cross approved course.

([5]3) A [physician or certified nurse-midwife ]licensed maternity care practitioner shall be present at each birth and remain until the maternal patient and newborn are stable postpartum.

([6]4) A second [employee]member of the birthing center staff who is licensed or certified to give cardiopulmonary resuscitation shall be present at each birth.

([7]5) Clinical staff, licensed personnel and support staff shall be provided to meet patients' needs, to ensure patients' safety and to ensure that patients in active labor are attended.

 

R432-550-1[6]5 . Clinical Staff.

(1) The attending member of the clinical staff shall ensure the supervision of, and quality of, care delivered to the patient admitted to the facility.

(2) Each patient shall be under the care of a member of the clinical staff.

(3) Clinical staff members shall comply with applicable professional practice laws and written birthing center protocols approved by the clinical director.

(4) The attending member of the clinical staff shall verify in writing that the patient conforms to facility eligibility criteria.

(5) The attending member of the clinical staff shall decide when transfer of a patient to a hospital is necessary and document in writing the conditions warranting the decision.

 

[ R432-550-17. Nursing Services.

(1) The birthing center shall provide nursing care services to meet the needs of the patients served.

(2) Licensed nursing service personnel shall plan and deliver nursing care as defined in written facility policy and in accordance with Title 58, Chapters 31b and 44a; and R156-31b and R156-44a; and other applicable laws and rules.

(3) The administrator shall employ sufficient licensed and auxiliary nursing staff to meet the total nursing needs of the patients.]

 

R432-550-1[8]6 . Equipment and Supplies.

(1) The administrator shall provide necessary equipment in good working order to meet the patient's needs.

(2) The type and amount of equipment shall be indicated in facility policy and approved by the clinical director.

(3) An emergency cart or tray equipped to allow completion of emergency procedures defined by facility policy shall be readily available.

(a) The facility shall safely store the emergency cart or tray in a designated area that is accessible to authorized personnel.

(b) The facility shall maintain a written log of all upkeep of the emergency cart or tray.

(4) The inventory of supplies shall be sufficient to care for the number of patients registered for care.

(5) Properly maintained equipment and supplies for the maternal patient and the newborn shall include at least the following:

(a) furnishings suitable for labor, birth and recovery;

(b) oxygen with flow meters and masks or equivalent;

(c) [mechanical suction and ]bulb suction;

(d) resuscitation equipment to include resuscitation bags, [laryngoscopes, endotracheal tubes]laryngeal mask airways and oral airways;

(e) firm surfaces suitable for use in resuscitating patients;

(f) emergency medications[, intravenous fluids] and related supplies and equipment;

(g) fetal monitoring equipment, minimally to include a fetoscope or [doptone]doppler;

(h) equipment to monitor and maintain the optimum body temperature of the newborn;

(i) a clock indicating hours, minutes and seconds;

(j) sterile suturing equipment and supplies;

(k) adjustable examination light;

(l) infant scale;

(m) a telephone or equivalent two-way communication device capable of reaching other facilities or emergency agencies; and

(n) a delivery log for recording birth data.

 

R432-550-1[9]7 . [Pharmacy Service]Medications.

(1)[The administrator shall provide documentation that facility pharmacy services comply with R156-17a, Board of Pharmacy Rules; Section 58-17a, Pharmacy Practice Act; Section 58-37, Controlled Substances Act; and with other applicable state and federal laws, rules and regulations.

(2)] Licensed personnel shall prescribe , order and administer medication in accordance with applicable professional practice acts, pharmacy and controlled substances laws.

 

R432-550-[20]18 . Anesthesia Services.

(1) The birthing center shall provide facilities and equipment for the provision of anesthesia services commensurate with the obstetric procedures planned for the facility.

(2) The clinical director shall ensure the safety of anesthesia services administered to patients by clinical staff through written policies and protocols approved by the clinical staff for anesthetic agents, delivery of anesthesia and potential hazards of anesthesia.

[(a) Protocols for administration of anesthesia by a certified nurse-midwife shall be in accordance with R156-44a-102 and R156-44a-601.

]([b]3) A clinical staff member shall monitor patients who receive anesthesia or analgesics.

 

R432-550-[2]1 9 . Laboratory[and Radiology] Services.

(1) The birthing center shall provide direct or contract laboratory[, radiology] and associated services according to facility policy and to meet the needs of patients.

(2) Laboratory[and radiology] reports or results shall be reported promptly to the attending clinical staff member and documented in the patient's medical record.

(3) Laboratory services shall be provided [by a]according to CLIA[approved laboratory which meets] requirements[of R432-100-22. In-house laboratory facilities shall meet the requirements for laboratories in the construction portion of this rule].

[(4) Radiology services shall comply with applicable sections of R313-16 Radiation Control and R432-100-21.]

 

R432-550-2[2]0 . Medical Records.

(1) Medical records shall be complete, accurately documented and systematically organized to facilitate retrieval and compilation of information.

(2) An employee designated by the administrator shall be responsible and accountable for the processing of medical records.

(3) The medical record and its contents shall be safeguarded from loss, defacement, tampering, fires and floods.

(4) Medical records shall be protected against access by unauthorized individuals.

(a) Medical record information shall be confidential.

(b) The birthing center may disclose medical record information only to authorized persons in accordance with federal, state and local laws.

(c) The birthing center shall obtain consent from the patient before releasing client information identifying the client, including photographs, unless release is otherwise allowed or required by law.

(5) Medical records shall be retained for at least five years after the last date of patient care. Records of minors, including records of newborn infants, shall be retained for three years after the minor reaches legal age under Utah law, but in no case less than five years.

(6) The birthing center shall maintain an individual medical record for each patient which shall include but is not limited to written documentation of the following:

(a) admission record with demographic information and patient identification data;

(b) history and physical examination which shall be up-to-date upon the patient's admission;

(c) written and signed informed consent;

(d) orders by a clinical staff member;

(e) record of assessments, plan of care and services provided;

(f) record of medications and treatments administered;

(g) laboratory and radiology reports;

(h) discharge summary for mother and newborn to include a note of condition, instructions given and referral as appropriate;

(i) prenatal care record containing at least prenatal blood serology, Rh factor determination, past obstetrical history and physical examination and documentation of fetal status;

(j) monitoring of progress in labor with assessment of maternal and newborn reaction to the process of labor;

(k) fetal monitoring record;

(l) labor and delivery record, including type of delivery, record of anesthesia and operative procedures if any; and

(m)[record of administration of Rh immune globulin;

(n)] documentation that the patient is informed of the statement of patient rights.

(7) The records of newborn infants shall include the following:

(a) date and hour of birth, birth weight and length, period of gestation, [sex ]gender and condition of infant on delivery including Apgar scores and resuscitative measures;

(b) mother's name or unique identification;

(c) record of ophthalmic prophylaxis; and

(d) the identification number of the screening kit used to screen for metabolic diseases, documentation that metabolic screening , [was done and the ]genetic screening, PKU or other metabolic disorders reports were completed or refused by the client.

 

R432-550-2[3]1 . Housekeeping Services.

(1) The facility shall provide adequate housekeeping services to maintain a clean and sanitary environment.

(2) The facility shall develop and implement written housekeeping policies and procedures.

 

R432-550-2[4]2 . Laundry Services.

(1) The facility shall develop and implement written policies and procedures for storage and processing of clean and soiled linen.

(2) Clean linen shall be stored, handled and transported to prevent contamination. Linens shall be maintained in good repair[ and shall not be threadbare].

(3) Soiled linen shall be handled, transported, stored and processed in a manner to prevent both leakage and the spread of infection.

 

R432-550-2[5]3 . Maintenance, Physical Environment, and Safety.

(1) The facility shall provide adequate maintenance service to ensure that facility equipment and grounds are maintained in a clean and sanitary condition and in good repair.

(2) The facility shall develop and implement a written maintenance program which shall include a preventive maintenance schedule for major equipment and physical plant systems.

 

R432-550-2[6]4 . General Maintenance.

(1) The facility shall maintain facility buildings, fixtures, equipment and spaces in operable condition.

(2) The facility shall provide a safe, clean and sanitary environment.

(3) The facility shall conduct a pest-control program that ensures the facility is free from vermin.

(4) Direct or contract pest-control programs shall comply with Title 4, Chapter 14.

(5) Documentation shall be maintained for Department review.

 

R432-550-2[7]5 . Waste Processing Service.

Facilities and equipment shall be provided for the sanitary storage and treatment or disposal of all categories of waste, including hazardous and infectious wastes if applicable, using techniques acceptable to the Department of Environmental Quality, and the local health department having jurisdiction.

 

R432-550-2[8]6 . Lighting.

The facility shall provide adequate and comfortable lighting to meet the needs of patients and personnel.

 

R432-550-2[9]7 . Limitations of Services.

(1) [Birthing center maternal patients shall be limited to women initially determined to be at low maternity risk and evaluated regularly throughout pregnancy to ensure they remain at low risk for a poor pregnancy outcome.

(2) ]Birthing center policy shall establish a written risk assessment system to assess the individual risk for each maternal patient.

([3]2) A clinical staff member shall perform and document a risk assessment for each maternal patient[, which shall include evaluating the maternal patient for the criteria in R432-550-29(4) and facility policy.] to ensure the patient needs:

(a) fall within the scope of practice and standards of care included in the clinical staff member's professional practice act and within facility policy; and

(b) meet the eligibility requirements for a low risk maternal patient.

([4]3) [In order to be given care in a birth center a patient shall exhibit no evidence of the following]Clients shall become ineligible for birthing center care upon development of:

(a) [severe anemia or blood dyscrasia;

(b) insulin dependent diabetes mellitus;

(c) symptomatic cardiovascular disease, including active thrombophlebitis;

(d) compromised renal function;

(e) substance abuse;

(f) pregnancy-induced hypertension to include moderate to severe hypertension, preeclampsia and toxemia;

(g) known or suspected active herpes genitalis;

(h) viral infections during pregnancy known to adversely affect fetal well-being;

(i) previous caesarean section, major uterine wall surgery or obstetrical complications likely to recur;

(j) multiple gestation;

(k) pre-term labor (37 weeks or less) or post-term gestation (43 weeks or greater);

(l) prolonged rupture of membranes;

(m) intrauterine growth retardation or macrosomia;

(n) suspected serious congenital anomaly;

(o) fetal presentation other than vertex;

(p) oligohydramnios, polyhydramnios or chorioamnionitis;

(q) abruptio placenta or placenta previa;

(r) fetal distress which will be likely to adversely affect the infant in labor or at birth, including moderate to heavy meconium stained amniotic fluid;

(s) ]a clinical need for anesthesia or analgesia other than those used in a setting where anesthesia and analgesia are limited in accordance with the facility's written protocols; or

[(t) a desire for transfer from birthing center care;

]([u]b) any condition identified intrapartum or postpartum which will be likely to adversely affect the health of the maternal patient or infant and will require management in a general hospital.

 

R432-550-[30]28 . Penalties.

Any person who violates any provision of this rule may be subject to the penalties enumerated in Title 26, [-]Chapter 21, [-]Section 11 and R432-3-[6]7 and be punished for violation of a class A misdemeanor as provided in Title 26, [-]Chapter 21, [-]Section 16.

 

KEY: health care facilities

Date of Enactment or Last Substantive Amendment: [October 1, 2011]2016

Notice of Continuation: November 9, 2015

Authorizing, and Implemented or Interpreted Law: 26-21-5; 26-21-16