(a) Anesthesia services. If the hospital furnishes anesthesia services, these services shall be provided in a well-organized manner under the direction of a qualified physician. The anesthesia service is responsible for all anesthesia administered in the hospital.
  (1) Organization and staffing. The organization of anesthesia services shall be appropriate to the scope of the services offered. Anesthesia shall be administered only by:
    (A) a qualified anesthesiologist;
    (B) a physician (other than an anesthesiologist);
    (C) a dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law; or
    (D) a certified registered nurse anesthetist who is under the supervision, as set forth in the Medical Practice Act, Texas Occupations Code, Title 3, Subtitle B, and the Nursing Practice Act, Texas Occupations Code, Chapter 301, of the operating physician or of an anesthesiologist who is immediately available if needed.
  (2) Delivery of services. Anesthesia services shall be consistent with needs and resources. Policies on anesthesia procedures shall include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies shall ensure that the following are provided for each patient.
    (A) A pre-anesthesia evaluation by an individual qualified to administer anesthesia under paragraph (1) of this subsection shall be performed within 48 hours prior to the procedure.
    (B) An intraoperative anesthesia record shall be provided. The record shall include any complications or problems occurring during the anesthesia including time, description of symptoms, review of affected systems, and treatments rendered. The record shall correlate with the controlled substance administration record.
    (C) A post-anesthesia follow-up report shall be written by the person administering the anesthesia before transferring the patient from the recovery room and shall include evaluation for recovery from anesthesia, level of activity, respiration, blood pressure, level of consciousness, and patient color.
      (i) With respect to inpatients, a post-anesthesia evaluation for proper anesthesia recovery shall be performed after transfer from recovery and within 48 hours after the procedure by the person administering the anesthesia, registered nurse (RN), or physician in accordance with policies and procedures approved by the medical staff.
      (ii) With respect to outpatients, immediately prior to discharge, a post-anesthesia evaluation for proper anesthesia recovery shall be performed by the person administering the anesthesia, RN, or physician in accordance with policies and procedures approved by the medical staff.
(b) Dietary services. The facility shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a facility that has a contract with an outside food management company or an arrangement with another facility may meet this requirement if the company or other facility has a dietitian who serves the facility on a full-time, part-time, or consultant basis, and if the company or other facility maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the facility medical staff for recommendations of dietetic policies affecting patient treatment. The facility shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.
  (1) Organization.
    (A) A facility shall have an employee who is qualified by experience or training to serve as director of the food and dietetic service, and be responsible for the daily management of the dietary services. This employee shall be full-time in a hospital; the crisis stabilization unit employee does not have to be full-time.
    (B) There shall be a qualified dietitian who works full-time, part-time, or on a consultant basis. If by consultation, such services shall occur at least once per month for not less than eight hours. The dietitian shall:
      (i) be currently licensed under the laws of this state to use the titles of licensed dietitian or provisional licensed dietitian, or be a registered dietitian;
      (ii) maintain standards for professional practice;
      (iii) supervise the nutritional aspects of patient care;
      (iv) make an assessment of the nutritional status and adequacy of nutritional regimen, as appropriate;
      (v) provide diet counseling and teaching, as appropriate;
      (vi) document nutritional status and pertinent information in patient medical records, as appropriate;
      (vii) approve menus; and
      (viii) approve menu substitutions.
    (C) There shall be administrative and technical personnel competent in their respective duties. The administrative and technical personnel shall:
      (i) participate in established departmental or facility training pertinent to assigned duties;
      (ii) conform to food handling techniques in accordance with paragraph (2)(E)(vii) of this subsection;
      (iii) adhere to clearly defined work schedules and assignment sheets; and
      (iv) comply with position descriptions which are job specific.
  (2) Director. The director shall:
    (A) comply with a position description which is job specific;
    (B) clearly delineate responsibility and authority;
    (C) participate in conferences with administration and department heads;
    (D) establish, implement, and enforce policies and procedures for the overall operational components of the department to include, but not be limited to:
      (i) quality assurance;
      (ii) frequency of meals served;
      (iii) non-routine occurrences; and
      (iv) identification of patient trays;
    (E) maintain authority and responsibility for the following, but not be limited to:
      (i) orientation and training;
      (ii) performance evaluations;
      (iii) work assignments;
      (iv) supervision of work and food handling techniques;
      (v) procurement of food, paper, chemical, and other supplies, to include implementation of first-in first-out rotation system for all food items;
      (vi) menu planning; and
      (vii) ensuring compliance with Chapter 228 of this title (relating to Retail Food).
  (3) Diets. Menus shall meet the needs of the patients.
    (A) Therapeutic diets shall be prescribed by the physician(s) responsible for the care of the patients. The dietary department of the facility shall:
      (i) establish procedures for the processing of therapeutic diets to include, but not be limited to:
        (I) accurate patient identification;
        (II) transcription from nursing to dietary services;
        (III) diet planning by a dietitian;
        (IV) regular review and updating of diet when necessary; and
        (V) written and verbal instruction to patient and family. It shall be in the patient's primary language, if practicable, prior to discharge. What is or would have been practicable shall be determined by the facts and circumstances of each case;
      (ii) ensure that therapeutic diets are planned in writing by a qualified dietitian;
      (iii) ensure that menu substitutions are approved by a qualified dietitian;
      (iv) document pertinent information about the patient's response to a therapeutic diet in the medical record; and
      (v) evaluate therapeutic diets for nutritional adequacy.
    (B) Nutritional needs shall be met in accordance with recognized dietary practices and in accordance with orders of the physician(s) responsible for the care of the patients. The following requirements shall be met.
      (i) Menus shall provide a sufficient variety of foods served in adequate amounts at each meal according to the guidance provided in the Recommended Dietary Allowances, as published by the Food and Nutrition Board, National Academy of Sciences, National Research Council, Tenth edition, 1989, which may be obtained by writing the National Academy Press, 2101 Constitution Avenue, Box 285, Washington, D.C. 20055, telephone (888) 624-8373.
      (ii) A maximum of 15 hours shall not be exceeded between the last meal of the day (i.e. supper) and the breakfast meal, unless a substantial snack is provided. The facility shall adopt, implement, and enforce a policy on the definition of "substantial" to meet each patient's varied nutritional needs.
Cont'd...
(C) A current therapeutic diet manual approved by the dietitian and medical staff shall be readily available to all medical, nursing, and food service personnel. The therapeutic manual shall:
      (i) be revised as needed, not to exceed 5 years;
      (ii) be appropriate for the diets routinely ordered in the facility;
      (iii) have standards in compliance with the RDA;
      (iv) contain specific diets which are not in compliance with RDA; and
      (v) be used as a guide for ordering and serving diets.
(c) Governing body.
  (1) Legal responsibility. There shall be a governing body responsible for the organization, management, control, and operation of the facility, including appointment of the medical staff. For facilities owned and operated by an individual or by partners, the individual or partners shall be considered the governing body.
  (2) Organization. The governing body shall be formally organized in accordance with a written constitution or bylaws which clearly set forth the organizational structure and responsibilities.
  (3) Meeting records. Records of governing body meetings shall be maintained.
  (4) Responsibilities relating to the medical staff. The governing body shall:
    (A) ensure that the medical staff has current bylaws, rules, and regulations which are implemented and enforced;
    (B) approve medical staff bylaws and other medical staff rules and regulations;
    (C) determine, in accordance with state law and with the advice of the medical staff, which categories of practitioners are eligible candidates for appointment to the medical staff;
    (D) ensure that criteria for selection include individual character, competence, training, experience, and judgment;
    (E) ensure that under no circumstances is the accordance of staff membership or professional privileges in the facility dependent solely upon certification, fellowship or membership in a specialty body or society;
    (F) ensure the process for considering applications for medical staff membership and privileges affords each candidate for appointment procedural due process;
    (G) ensure in granting or refusing medical staff membership or privileges, the facility does not differentiate on the basis of the academic medical degree;
    (H) ensure that equal recognition is given to training programs accredited by the Accreditation Council on Graduate Medical Education and by the American Osteopathic Association if graduate medical education is used as a standard or qualification for medical staff membership or privileges for a physician;
    (I) ensure that equal recognition is given to certification programs approved by the American Board of Medical Specialties and the Bureau of Osteopathic Specialists if board certification is used as a standard or qualification for medical staff membership or privileges for a physician;
    (J) ensure that the medical staff is accountable to the governing body for the quality of care provided to patients;
    (K) ensure that a facility's credentials committee acts expeditiously and without unnecessary delay when a candidate for appointment submits a completed application, as defined by each hospital, for medical staff membership or privileges, in accordance with the following:
      (i) The credentials committee shall take action on the completed application not later than the 90th day after the date on which the application is received;
      (ii) The governing body shall take final action on the application for medical staff membership or privileges not later than the 60th day after the date on which the recommendation of the credentials committee is received; and
      (iii) The facility must notify the applicant in writing of the facility's final action, including a reason for denial or restriction of privileges, not later than the 20th day after the date on which final action is taken;
    (L) ensure the facility complies with the requirements for reporting to the Texas Medical Board the results and circumstances of any professional review action in accordance with the Medical Practice Act, Occupations Code, §160.002 and §160.003.
  (5) Facility administration. The governing body shall appoint a chief executive officer or administrator who is responsible for managing the facility.
   (6) Patient care. In accordance with facility policy, the governing body shall ensure that:
    (A) every patient is under the care of a physician. This provision is not to be construed to limit the authority of a physician to delegate tasks to other qualified health care personnel to the extent recognized under state law;
    (B) patients are admitted to the facility only by members of the medical staff who have been granted admitting privileges; and
    (C) a physician is on duty or on-call at all times.
  (7) Contracted services. The governing body shall be responsible for services furnished in the facility whether or not they are furnished directly or under contracts. The governing body shall ensure that a contractor of services (including one for shared services and joint ventures) furnishes services in a safe and effective manner that permits the facility to comply with all applicable rules and standards for contracted services.
  (8) Nurse staffing. The governing body shall adopt, implement and enforce a written nurse staffing policy to ensure that an adequate number and skill mix of nurses are available to meet the level of patient care needed. The governing body policy shall require that hospital administration adopt, implement and enforce a nurse staffing plan and policies that:
    (A) require significant consideration be given to the nurse staffing plan recommended by the hospital's nurse staffing committee and the committee's evaluation of any existing plan;
    (B) are based on the needs of each patient care unit and shift and on evidence relating to patient care needs;
    (C) ensure that all nursing assignments consider client safety, and are commensurate with the nurse's educational preparation, experience, knowledge, and physical and emotional ability;
    (D) require use of the official nurse services staffing plan as a component in setting the nurse staffing budget;
    (E) encourage nurses to provide input to the nurse staffing committee relating to nurse staffing concerns;
    (F) protect from retaliation nurses who provide input to the nurse staffing committee; and
    (G) comply with subsection (j) of this section.
(d) Infection control. The facility shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There shall be an active program for the prevention, control, and investigation of infections and communicable diseases.
  (1) Organization and policies. A person shall be designated as infection control coordinator. The facility shall ensure that policies governing prevention, control and surveillance of infections and communicable diseases are developed, implemented and enforced.
    (A) There shall be a system for identifying, reporting, investigating, and controlling nosocomial infections and communicable diseases between patients and personnel.
    (B) The infection control coordinator shall maintain a log of all reportable diseases and nosocomial infections designated as epidemiologically significant according to the facility's infection control policies.
    (C) There shall be a written policy for reporting all reportable diseases to the local health authority or the Infectious Disease Epidemiology and Surveillance Division, Department of State Health Services, Mail Code 2822, P.O. Box 149347, Austin, TX 78714-9347, in accordance with Chapter 97 of this title (relating to Communicable Diseases).
  (2) Responsibilities of the chief executive officer (CEO), medical staff, and chief nursing officer (CNO). The CEO, the medical staff, and the CNO shall be responsible for the following.
    (A) The facility-wide quality assurance program and training programs shall address problems identified by the infection control coordinator.
    (B) Successful corrective action plans in affected problem areas shall be implemented.
  (3) Universal precautions. The facility shall adopt, implement, and enforce a written policy to monitor compliance of the facility and its personnel and medical staff with universal precautions in accordance with Health and Safety Code, Chapter 85, Subchapter I (relating to the Prevention of Transmission of HIV and Hepatitis B Virus by Infected Health Care Workers).
(e) Laboratory services. The facility shall provide directly, or have available adequate laboratory services to meet the needs of its patients.
Cont'd...
(1) Facility laboratory services. A facility that provides laboratory services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in 42 Code of Federal Regulations (CFR), §§493.1 - 493.1780. CLIA 1988 applies to all facilities with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
  (2) Contracted laboratory services. The facility shall ensure that all laboratory services provided to its patients through a contractual agreement are performed in a facility certified in the appropriate specialties and subspecialties of service in accordance with the requirements specified in 42 CFR Part 493 to comply with CLIA 1988.
  (3) Adequacy of laboratory services. The facility shall ensure the following.
    (A) Emergency laboratory services shall be available 24 hours a day.
    (B) A written description of services provided shall be available to the medical staff.
    (C) The laboratory shall make provision for proper receipt and reporting of tissue specimens.
  (4) Chemical hygiene. A facility that provides laboratory services directly shall adopt, implement, and enforce written policies and procedures to manage, minimize, or eliminate the risks to laboratory personnel of exposure to potentially hazardous chemicals in the laboratory which may occur during the normal course of job performance.
(f) Linen and laundry services. The facility shall provide sufficient clean linen to ensure the comfort of the patient. The facility, whether it operates its own laundry or uses commercial service, shall ensure the following.
  (1) Employees of a facility involved in transporting, processing, or otherwise handling clean or soiled linen shall be given initial and follow-up inservice training to ensure a safe product for patients and to safeguard employees in their work.
  (2) Clean linen shall be handled, transported, and stored by methods that will ensure its cleanliness.
  (3) All contaminated linen shall be placed and transported in bags or containers labeled or color-coded.
  (4) Employees who have contact with contaminated linen shall wear gloves and other appropriate personal protective equipment.
  (5) Contaminated linen shall be handled as little as possible and with minimum agitation. Contaminated linen shall not be sorted or rinsed in patient care areas.
  (6) All contaminated linen shall be bagged or put into carts at the location where it was used.
    (A) Bags containing contaminated linen shall be closed prior to transport to the laundry.
    (B) Whenever contaminated linen is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the linen shall be deposited and transported in bags that prevent leakage of fluids to the exterior.
    (C) All linen placed in chutes shall be bagged.
    (D) If chutes are not used to convey linen to a central receiving or sorting room, then adequate space shall be allocated on the various nursing units for holding the bagged contaminated linen.
  (7) Linen shall be processed as follows:
    (A) If hot water is used, linen shall be washed with detergent in water with a temperature of at least 71 degrees Centigrade (160 degrees Fahrenheit) for 25 minutes. Hot water requirements specified in Table 5 of §134.131(e) of this title (relating to Tables) shall be met.
    (B) If low temperature (less than or equal to 70 degrees Centigrade) (158 degrees Fahrenheit) laundry cycles are used, chemicals suitable for low-temperature washing at proper use concentration shall be used.
    (C) Commercial dry cleaning of fabrics soiled with blood also renders these items free of the risk of pathogen transmission.
  (8) Flammable liquids shall not be used in the laundry.
(g) Medical record services. The facility shall have a medical record service that has administrative responsibility for medical records. A medical record shall be maintained for every individual who presents to the hospital for evaluation or treatment.
  (1) The organization of the medical record service shall be appropriate to the scope and complexity of the services performed. The facility shall employ adequate personnel to ensure prompt completion, filing, and retrieval of records.
  (2) The facility shall have a system of coding and indexing medical records. The system shall allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.
  (3) The facility shall adopt, implement, and enforce a policy to ensure that the facility complies with Health and Safety Code, §576.005 (relating to Confidentiality of Records) and Chapter 611, (relating to Mental Health Records).
  (4) The medical record shall contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services. Medical records shall be accurately written, promptly completed, properly filed and retained, and accessible.
  (5) The facility shall use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all entries to the records.
    (A) The author of each entry shall be identified and shall authenticate his or her entry.
    (B) Authentication shall include signatures, written initials, or computer entry.
    (C) Use of signature stamps by physicians may be allowed in facilities when the signature stamp is authorized by the individual whose signature the stamp represents. The administrative offices of the facility shall have on file a signed statement to the effect that he or she is the only one who has the stamp and uses it. Delegation of use to another individual shall not be acceptable.
    (D) A list of computer codes and written signatures shall be readily available and shall be maintained under adequate safeguards.
    (E) Signatures by facsimile shall be acceptable. If received on a thermal machine, the facsimile document shall be copied onto regular paper.
  (6) Medical records (reports and printouts) shall be retained by the facility in their original or legally reproduced form for a period of at least ten years. Films, scans, and other image records shall be retained for a period of at least five years. For retention purposes, medical records that shall be preserved for ten years include:
    (A) identification data;
    (B) the medical history of the patient;
    (C) evidence of a physical examination and psychiatric evaluation;
    (D) admitting diagnosis;
    (E) diagnostic and therapeutic orders;
    (F) properly executed informed consent forms for procedures and treatments specified by the medical staff, or by federal or state laws if applicable, to require written patient consent;
    (G) treatment plans;
    (H) clinical observations, including the results of therapy and treatment, all orders, nursing notes, medication records, vital signs, and other information necessary to monitor the patient's condition;
    (I) reports of procedures, tests, and their results, including laboratory, pathology, and radiology reports;
    (J) results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient;
    (K) discharge summary with outcome of hospitalization, disposition of care, and provisions for follow-up care; and
    (L) final diagnosis with completion of medical records within 30 calendar days following discharge.
  (7) If a patient was less than 18 years of age at the time he was last treated, the facility may authorize the disposal of those medical records relating to the patient on or after the date of his 20th birthday or on or after the 10th anniversary of the date on which he was last treated, whichever date is later.
  (8) The facility shall not destroy medical records that relate to any matter that is involved in litigation if the facility knows the litigation has not been finally resolved.
  (9) If a licensed facility should close, the facility shall notify the department at the time of closure the disposition of the medical records, including the location of where the medical records will be stored and the identity and telephone number of the custodian of the records.
(h) Medical staff.
  (1) The medical staff shall be composed of physicians and may also be composed of podiatrists, dentists and other practitioners appointed by the governing body.
Cont'd...
(A) The medical staff shall periodically conduct appraisals of its members according to medical staff bylaws.
    (B) The medical staff shall examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidate.
  (2) The medical staff shall be well-organized and accountable to the governing body for the quality of the medical care provided to patients.
    (A) The medical staff shall be organized in a manner approved by the governing body.
    (B) If the medical staff has an executive committee, a majority of the members of the committee shall be doctors of medicine or osteopathy.
    (C) Records of medical staff meetings shall be maintained.
    (D) The responsibility for organization and conduct of the medical staff shall be assigned only to an individual physician.
    (E) Each medical staff member shall sign a statement signifying they will abide by medical staff and hospital policies.
  (3) The medical staff shall adopt, implement, and enforce bylaws, rules, and regulations to carry out its responsibilities. The bylaws shall:
    (A) be approved by the governing body;
    (B) include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, consultant);
    (C) describe the organization of the medical staff;
    (D) describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body; and
    (E) include criteria for determining the privileges to be granted and a procedure for applying the criteria to individuals requesting privileges.
(i) Mobile, transportable, and relocatable units. If the facility provides diagnostic procedures or treatments in mobile, transportable, or relocatable units, the facility shall adopt, implement and enforce procedures which address the potential emergency needs for those inpatients who are taken to mobile units on the facility premises for diagnostic procedures or treatment.
(j) Nurse staffing.
  (1) The hospital shall establish a nurse staffing committee as a standing committee of the hospital. As used in this subsection, "committee" or "staffing committee" means a nurse staffing committee established under this paragraph.
    (A) The committee shall be composed of:
      (i) at least 60% registered nurses who are involved in direct patient care at least 50% of their work time and selected by their peers who provide direct care during at least 50% of their work time;
      (ii) members who are representative of the types of nursing services provided at the hospital; and
      (iii) the chief nursing officer of the hospital who is a voting member.
    (B) Participation on the committee by a hospital employee as a committee member shall be part of the employee's work time and the hospital shall compensate that member for that time accordingly. The hospital shall relieve the committee member of other work duties during committee meetings.
     (C) The committee shall meet at least quarterly.
     (D) The responsibilities of the committee shall be to:
      (i) develop and recommend to the hospital's governing body a nurse staffing plan that meets the requirements of paragraph (2) of this subsection;
      (ii) review, assess and respond to staffing concerns expressed to the committee;
       (iii) identify the nurse-sensitive outcome measures the committee will use to evaluate the effectiveness of the official nurse services staffing plan;
      (iv) evaluate, at least semiannually, the effectiveness of the official nurse services staffing plan and variations between the plan and the actual staffing; and
      (v) submit to the hospital's governing body, at least semiannually, a report on nurse staffing and patient care outcomes, including the committee's evaluation of the effectiveness of the official nurse services staffing plan and aggregate variations between the staffing plan and actual staffing.
  (2) The hospital shall adopt, implement and enforce a written official nurse services staffing plan. As used in this subsection, "patient care unit" means a unit or area of a hospital in which registered nurses provide patient care.
    (A) The official nurse services staffing plan and policies shall:
      (i) require significant consideration be given to the nurse staffing plan recommended by the hospital's nurse staffing committee and the committee's evaluation of any existing plan;
      (ii) be based on the needs of each patient care unit and shift and on evidence relating to patient care needs;
      (iii) require use of the official nurse services staffing plan as a component in setting the nurse staffing budget;
       (iv) encourage nurses to provide input to the nurse staffing committee relating to nurse staffing concerns;
      (v) protect nurses who provide input to the nurse staffing committee from retaliation; and
      (vi) comply with this subsection.
     (B) The plan shall:
      (i) set minimum staffing levels for patient care units that are:
        (I) based on multiple nurse and patient considerations; an
        (II) determined by the nursing assessment and in accordance with evidence-based safe nursing standards; and
      (ii) include a method for adjusting the staffing plan shift to shift for each patient care unit to provide staffing flexibility to meet patient needs;
      (iii) include a contingency plan when patient care needs unexpectedly exceed direct patient care staff resources;
      (iv) include how on-call time will be used;
      (v) reflect current standards established by private accreditation organizations, governmental entities, national nursing professional associations, and other health professional organizations;
      (vi) include a mechanism for evaluating the effectiveness of the official nurse services staffing plan based on patient needs, nursing-sensitive quality indicators, nurse satisfaction measures collected by the hospital, and evidence based nurse staffing standards; and
      (vii) be used by the hospital as a component in setting the nurse staffing budget and guiding the hospital in assigning nurses hospital wide.
    (C) The hospital shall make readily available to nurses on each patient care unit at the beginning of each shift the official nurse services staffing plan levels and current staffing levels for that unit and that shift.
  (3) The hospital shall annually report to the department on:
    (A) whether the hospital's governing body has adopted a nurse staffing policy;
    (B) whether the hospital has established a nurse staffing committee that meets the membership requirements of paragraph (1) of this subsection;
    (C) whether the nurse staffing committee has evaluated the hospital's official nurse services staffing plan and has reported the results of the evaluation to the hospital's governing body; and
    (D) the nurse-sensitive outcome measures the committee adopted for use in evaluating the hospital's official nurse services staffing plan.
  (4) Mandatory overtime. The hospital shall adopt, implement and enforce policies on use of mandatory overtime.
    (A) As used in this subsection:
      (i) "on-call time" means time spent by a nurse who is not working but who is compensated for availability; and
      (ii) "mandatory overtime" means a requirement that a nurse work hours or days that are in addition to the hours or days scheduled, regardless of the length of a scheduled shift or the number of scheduled shifts each week. Mandatory overtime does not include prescheduled on-call time or time immediately before or after a scheduled shift necessary to document or communicate patient status to ensure patient safety.
    (B) A hospital may not require a nurse to work mandatory overtime, and a nurse may refuse to work mandatory overtime.
    (C) This section does not prohibit a nurse from volunteering to work overtime.
    (D) A hospital may not use on-call time as a substitute for mandatory overtime.
    (E) The prohibitions on mandatory overtime do not apply if:
      (i) a health care disaster, such as a natural or other type of disaster that increases the need for health care personnel, unexpectedly affects the county in which the nurse is employed or affects a contiguous county;
Cont'd...
(ii) a federal, state, or county declaration of emergency is in effect in the county in which the nurse is employed or is in effect in a contiguous county;
      (iii) there is an emergency or unforeseen event of a kind that:
        (I) does not regularly occur
        (II) increases the need for health care personnel at the hospital to provide safe patient care; and
        (III) could not prudently be anticipated by the hospital; or
      (iv) the nurse is actively engaged in an ongoing medical or surgical procedure and the continued presence of the nurse through the completion of the procedure is necessary to ensure the health and safety of the patient. The nurse staffing committee shall ensure that scheduling a nurse for a procedure that could be anticipated to require the nurse to stay beyond the end of his or her scheduled shift does not constitute mandatory overtime.
    (F) If a hospital determines that an exception exists under subparagraph (E) of this paragraph, the hospital shall, to the extent possible, make and document a good faith effort to meet the staffing need through voluntary overtime, including calling per diems and agency nurses, assigning floats, or requesting an additional day of work from off-duty employees.
    (G) A hospital may not suspend, terminate, or otherwise discipline or discriminate against a nurse who refuses to work mandatory overtime.
(k) Outpatient services. If the facility provides outpatient services within the facility, written policies and procedures describing the operation of the services shall be adopted, implemented and enforced.
(l) Pharmacy services. The facility shall provide pharmaceutical services that meet the needs of the patients.
  (1) License. A facility that stores and dispenses prescription drugs for administration to a patient by a person authorized by law to administer the drug, shall be licensed, as required, by the Texas State Board of Pharmacy.
  (2) Organization. The facility shall have a pharmacy directed by a licensed pharmacist.
  (3) Medical staff. The medical staff shall be responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the facility's organized pharmaceutical services.
  (4) Pharmacy management and administration. The pharmacy or drug storage area shall be administered in accordance with accepted professional principles.
    (A) Standards of practice as defined by state law shall be followed regarding the provision of pharmacy services.
    (B) The pharmaceutical services shall have an adequate number of personnel to ensure quality pharmaceutical services including emergency services.
      (i) The staff shall be sufficient in number and training to respond to the pharmaceutical needs of the patient population being served. There shall be an arrangement for emergency services.
      (ii) Employees shall provide pharmaceutical services within the scope of their license and education.
    (C) Drugs and biologicals shall be properly stored to ensure ventilation, light, security, and temperature controls.
    (D) Records shall have sufficient detail to follow the flow of drugs from entry through dispensation.
    (E) There shall be adequate controls over all drugs and medications including floor stock. Drug storage areas shall be approved by the pharmacist, and floor stock lists shall be established.
    (F) Inspections of drug storage areas shall be conducted throughout the hospital under pharmacist supervision.
    (G) There shall be a drug recall procedure.
    (H) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
      (i) Direction of pharmaceutical services may not require on premises supervision but may be accomplished through regularly scheduled visits in accordance with state law.
      (ii) A job description or other written agreement shall clearly define the responsibilities of the pharmacist.
    (I) Current and accurate records shall be kept of the receipt and disposition of all scheduled drugs.
      (i) There shall be a record system in place that provides the information on controlled substances in a readily retrievable manner which is separate from the patient record.
      (ii) Records shall trace the movement of scheduled drugs throughout the services, documenting utilization or wastage.
      (iii) The pharmacist shall be responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled with written orders.
  (5) Delivery of services. In order to provide patient safety, drugs and biologicals shall be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state laws.
    (A) All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with federal and state laws.
    (B) Drugs and biologicals shall be kept in a locked storage area.
      (i) A policy shall be adopted, implemented, and enforced to ensure the safeguarding, transferring, and availability of keys to the locked storage area.
      (ii) Dangerous drugs as well as controlled substances shall be secure from unauthorized use.
    (C) Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use.
    (D) When a pharmacist is not available, drugs and biologicals shall be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with federal and state laws.
      (i) There shall be a current list of individuals identified by name and qualifications who are designated to remove drugs from the pharmacy.
      (ii) Only amounts sufficient for immediate therapeutic needs shall be removed.
    (E) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a reasonable time that is predetermined by the medical staff.
      (i) Stop order policies and procedures shall be consistent with those of the nursing staff and the medical staff rules and regulations.
      (ii) A protocol shall be established by the medical staff for the implementation of the stop order policy, in order that drugs shall be reviewed and renewed, or automatically stopped.
      (iii) A system shall be in place to determine compliance with the stop order policy.
    (F) Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician and, if appropriate, to the facility-wide quality assurance program. There shall be a mechanism in place for capturing, reviewing, and tracking medication errors and adverse drug reactions.
    (G) Abuses and losses of controlled substances shall be reported, in accordance with applicable federal and state laws, to the individual responsible for the pharmaceutical services, and to the chief executive officer, as appropriate.
    (H) Information relating to drug interactions and information on drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration shall be immediately available to the professional staff.
      (i) A pharmacist shall be readily available by telephone or other means to discuss drug therapy, interactions, side effects, dosage, assist in drug selection, and assist in the identification of drug induced problems.
      (ii) There shall be staff development programs on drug therapy available to facility staff to cover such topics as new drugs added to the formulary, how to resolve drug therapy problems, and other general information as the need arises.
    (I) A formulary system shall be established by the medical staff to ensure quality pharmaceuticals at reasonable costs.
(m) Quality assurance. The governing body shall ensure that there is an effective, ongoing, facility-wide, data-driven quality assurance (QA) program to evaluate the provision of patient care.
  (1) Implementation plan. The facility-wide QA program shall be on-going and have a written plan of implementation.
    (A) All organized services related to patient care, including services furnished by contract, shall be evaluated.
    (B) Nosocomial infections and medication therapy shall be evaluated.
Cont'd...
(C) All medical services performed in the facility shall be evaluated as they relate to appropriateness of diagnosis and treatment.
  (2) Implementation. The facility shall take and document appropriate remedial action to address deficiencies found through the QA program. The facility shall document the outcome of the remedial action.
  (3) Discharge planning. The facility shall have an effective, ongoing discharge planning program that facilitates the provision of follow-up care.
    (A) Discharge planning shall be completed prior to discharge.
    (B) Patients, along with necessary medical information, shall be transferred or referred to appropriate facilities, agencies, or outpatient services, as needed for follow-up or ancillary care.
    (C) Screening and evaluation before patient discharge from facility. In accordance with 42 Code of Federal Regulations (CFR), Part 483, Subpart C (relating to Requirements for Long Term Care Facilities) and the rules of the Department of Aging and Disability Services (DADS) set forth in 40 TAC Chapter 17, (relating to Preadmission Screening and Resident Review (PASRR)), all patients who are being considered for discharge from the facility to a nursing facility shall be screened, and if appropriate, evaluated, prior to discharge by the facility and admission to the nursing facility to determine whether the patient may have a mental illness, intellectual disability or developmental disability. If the screening indicates that the patient has a mental illness, intellectual disability or developmental disability, the facility shall contact and arrange for the local mental health authority designated pursuant to Texas Health and Safety Code, §533.035, to conduct prior to facility discharge an evaluation of the patient in accordance with the applicable provisions of the PASRR rules. The purpose of PASRR is:
      (i) to ensure that placement of the patient in a nursing facility is necessary;
      (ii) to identify alternate placement options when applicable; and
      (iii) to identify specialized services that may benefit the person with a diagnosis of mental illness, intellectual disability, or developmental disability.
(n) Radiology services. When radiology services are provided, written policies and procedures shall be adopted, implemented and enforced which describe the radiology services provided in the facility and how employee and patient safety will be maintained.
  (1) Proper safety precautions shall be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities.
  (2) Inspection of equipment shall be made periodically. Defective equipment shall be promptly repaired or replaced.
  (3) Radiation workers shall be checked, by the use of exposure meters or badge tests, for amount of radiation exposure. Exposure reports and documentation shall be available for review.
  (4) Radiology services shall be provided only on the order of individuals with privileges granted by the medical staff and of other physicians or practitioners authorized by the medical staff and governing body to order such services.
   (5) Personnel.
    (A) A qualified full-time, part-time, or consulting radiologist shall supervise the ionizing radiology services and shall interpret only those radiology tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section a radiologist is a physician who is qualified by education and experience in radiology in accordance with medical staff bylaws.
    (B) Only personnel designated as qualified by the medical staff shall use the radiology equipment and administer procedures.
  (6) Records. Records of radiology services shall be maintained. The radiologist or other individuals who have been granted privileges to perform radiology services shall sign reports of his or her interpretations.
(o) Respiratory care services. When respiratory care services are provided, written policies and procedures shall be adopted, implemented, and enforced which describe the provision of respiratory care services in the facility. Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures shall be designated in writing.
(p) Waste and waste disposal.
  (1) Special waste and liquid/sewage waste management.
    (A) The hospital shall comply with the requirements set forth by the department in §§1.131 - 1.137 of this title (relating to Definition, Treatment, and Disposition of Special Waste from Health Care Related Facilities) and the Texas Commission on Environmental Quality (TCEQ) requirements in 30 TAC §330.1207 (relating to Generators of Medical Waste).
    (B) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).
  (2) Waste receptacles.
    (A) Waste receptacles shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location(s) into closed containers.
    (B) Waste receptacles shall be properly cleaned with soap and hot water, followed by treatment of inside surfaces of the receptacles with a germicidal agent.
    (C) All containers for other municipal solid waste shall be leak-resistant, have tight-fitting covers, and be rodent-proof.
    (D) Non-reusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations.

Source Note: The provisions of this §510.41 adopted to be effective January 1, 2004, 28 TexReg 5154; amended to be effective December 9, 2010, 35 TexReg 10746; amended to be effective May 24, 2013, 38 TexReg 3027; amended to be effective February 18, 2018, 43 TexReg 576; transferred effective June 1, 2019, as published in the Texas Register May 17, 2019, 44 TexReg 2469