# 25 Tex. Admin. Code § 133.41: 25 TAC § 133.41. Hospital Functions and Services

> Texas · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C133_S133_41

## Section

- **Citation:** 25 Tex. Admin. Code § 133.41
- **Heading:** 25 TAC § 133.41. Hospital Functions and Services
- **Jurisdiction:** Texas
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Texas Administrative Code / Title 25 HEALTH SERVICES / Part 1 DEPARTMENT OF STATE HEALTH SERVICES / Chapter 133 HOSPITAL LICENSING / 25 TAC § 133.41

## Text

(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 in accordance with the Texas Occupations Code Subtitle B and the Texas Occupations Code Chapter 301. The hospital is responsible for and shall document all anesthesia services administered in the hospital.
(1) Organization and staffing. The organization of anesthesia services shall be appropriate to the scope of the services offered. Only personnel who have been approved by the facility to provide anesthesia services shall administer anesthesia. All approvals or delegations of anesthesia services as authorized by law shall be documented and include the training, experience, and qualifications of the person who provided the service.
(2) Delivery of services. Anesthesia services shall be consistent with needs and resources. Policies on anesthesia procedure 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 before surgery.
(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 post-anesthesia care unit and shall include evaluation for recovery from anesthesia, level of activity, respiration, blood pressure, level of consciousness, and patient's oxygen saturation level.
(i) With respect to inpatients, a post-anesthesia evaluation for proper anesthesia recovery shall be performed after transfer from the post-anesthesia care unit and within 48 hours after surgery by the person administering the anesthesia, registered nurse (RN), or physician in accordance with policies and procedures approved by the medical staff and using criteria written in the medical staff bylaws for postoperative monitoring of anesthesia.
(ii) With respect to outpatients, immediately before 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 and using criteria written in the medical staff bylaws for postoperative monitoring of anesthesia.
(b) Chemical dependency services.
(1) Chemical dependency unit. A hospital may not admit patients to a chemical dependency services unit unless the unit is approved by the Texas Health and Human Services Commission (HHSC) as meeting the requirements of §133.163(q) of this title (relating to Spatial Requirements for New Construction).
(2) Admission criteria. A hospital providing chemical dependency services shall have written admission criteria that are applied uniformly to all patients who are admitted to the chemical dependency unit.
(A) The hospital's admission criteria shall include procedures to prevent the admission of minors for a condition which is not generally recognized as responsive to treatment in an inpatient setting for chemical dependency services.
(i) The following conditions are not generally recognized as responsive to treatment in a treatment facility for chemical dependency unless the minor to be admitted is qualified because of other disabilities, such as:
(I) cognitive disabilities due to intellectual disability;
(II) learning disabilities; or
(III) psychiatric disorders.
(ii) A minor may be qualified for admission based on other disabilities which would be responsive to chemical dependency services.
(iii) A minor patient shall be separated from adult patients.
(B) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.
(C) A voluntarily admitted patient shall sign an admission consent form before admission to a chemical dependency unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.
(3) Compliance. A hospital providing chemical dependency services in an identifiable unit within the hospital shall comply with Chapter 448, Subchapter B of this title (relating to Standard of Care Applicable to All Providers).
(c) Comprehensive medical rehabilitation services.
(1) Rehabilitation units. A hospital may not admit patients to a comprehensive medical rehabilitation services unit unless the unit is approved by HHSC as meeting the requirements of §133.163(z) of this title.
(2) Equipment and space. The hospital shall have the necessary equipment and sufficient space to implement the treatment plan described in paragraph (7)(C) of this subsection and allow for adequate care. Necessary equipment is all equipment necessary to comply with all parts of the written treatment plan. The equipment shall be on-site or available through an arrangement with another provider. Sufficient space is the physical area of a hospital which in the aggregate, constitutes the total amount of the space necessary to comply with the written treatment plan.
(3) Emergency requirements. Emergency personnel, equipment, supplies and medications for hospitals providing comprehensive medical rehabilitation services shall be as follows.
(A) A hospital that provides comprehensive medical rehabilitation services shall have emergency equipment, supplies, medications, and designated personnel assigned for providing emergency care to patients and visitors.
(B) The emergency equipment, supplies, and medications shall be properly maintained and immediately accessible to all areas of the hospital. The emergency equipment shall be periodically tested according to the policy adopted, implemented, and enforced by the hospital.
(C) At a minimum, the emergency equipment and supplies shall include those specified in subsection (e)(4) of this section.
(D) The personnel providing emergency care in accordance with this subsection shall be staffed for 24-hour coverage and accessible to all patients receiving comprehensive medical rehabilitation services. At least one person who is qualified by training to perform advanced cardiac life support and administer emergency drugs shall be on duty each shift.
(E) All direct patient care licensed personnel shall maintain current certification in cardiopulmonary resuscitation (CPR).
(4) Medications. A rehabilitation hospital's governing body shall adopt, implement, and enforce policies and procedures that require all medications to be administered by licensed nurses, physicians, or other licensed professionals authorized by law to administer medications.
(5) Organization and Staffing.
(A) A hospital providing comprehensive medical rehabilitation services shall be organized and staffed to ensure the health and safety of the patients.
(i) All provided services shall be consistent with accepted professional standards and practice.
(ii) The organization of the services shall be appropriate to the scope of the services offered.
(iii) The hospital shall adopt, implement, and enforce written patient care policies that govern the services it furnishes.
(B) The provision of comprehensive medical rehabilitation services in a hospital shall be under the medical supervision of a physician who is on duty and available, or who is on-call 24 hours each day.
(C) A hospital providing comprehensive medical rehabilitation services shall have a medical director or clinical director who supervises and administers the provision of comprehensive medical rehabilitation services.
(i) The medical director or clinical director shall be a physician who is board certified or eligible for board certification in physical medicine and rehabilitation, orthopedics, neurology, neurosurgery, internal medicine, or rheumatology as appropriate for the rehabilitation program.
(ii) The medical director or clinical director shall be qualified by training or at least two years training and experience to serve as medical director or clinical director. A person is qualified under this subsection if the person has training and experience in the treatment of rehabilitation patients in a rehabilitation setting.
(6) Admission criteria. A hospital providing comprehensive medical rehabilitation services shall have written admission criteria that are applied uniformly to all patients who are admitted to the comprehensive medical rehabilitation unit.
(A) The hospital's admission criteria shall include procedures to prevent the admission of a minor for a condition which is not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services.
(i) The following conditions are not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services unless the minor to be admitted is qualified because of other disabilities, such as:
(I) cognitive disabilities due to intellectual disability;
(II) learning disabilities; or
(III) psychiatric disorders.
(ii) A minor may be qualified for admission based on other disabilities which would be responsive to comprehensive medical rehabilitation services.
(B) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.
(7) Care and services.
(A) A hospital providing comprehensive medical rehabilitation services shall use a coordinated interdisciplinary team which is directed by a physician and which works in collaboration to develop and implement the patient's treatment plan.
(i) The interdisciplinary team for comprehensive medical rehabilitation services shall have available to it, at the hospital at which the services are provided or by contract, members of the following professions as necessary to meet the treatment needs of the patient:
(I) physical therapy;
(II) occupational therapy;
(III) speech-language pathology;
(IV) therapeutic recreation;
(V) social services and case management;
(VI) dietetics;
(VII) psychology;
(VIII) respiratory therapy;
(IX) rehabilitative nursing;
(X) certified orthotics;
(XI) certified prosthetics;
(XII) pharmaceutical care; and
(XIII) in the case of a minor patient, persons who have specialized education and training in emotional, mental health, or chemical dependency problems, as well as the treatment of minors.
(ii) The coordinated interdisciplinary team approach used in the rehabilitation of each patient shall be documented by periodic entries made in the patient's medical record to denote:
(I) the patient's status in relationship to goal attainment; and
(II) that team conferences are held at least every two weeks to determine the appropriateness of treatment.
(B) An initial assessment and preliminary treatment plan shall be performed or established by the physician within 24 hours of admission.
(C) The physician in coordination with the interdisciplinary team shall establish a written treatment plan for the patient within seven working days of the date of admission.
(i) Comprehensive medical rehabilitation services shall be provided in accordance with the written treatment plan.
(ii) The treatment provided under the written treatment plan shall be provided by staff who are qualified to provide services under state law. The hospital shall establish written qualifications for services provided by each discipline for which there is no applicable state statute for professional licensure or certification.
(iii) Services provided under the written treatment plan shall be given in accordance with the orders of physicians, dentists, podiatrists, or practitioners who are authorized by the governing body, hospital administration, and medical staff to order the services, and the orders shall be incorporated in the patient's record.
(iv) The written treatment plan shall delineate anticipated goals and specify the type, amount, frequency, and anticipated duration of service to be provided.
(v) Within 10 working days after the date of admission, the written treatment plan shall be provided. It shall be in the person's primary language, if practicable. What is or would have been practicable shall be determined by the facts and circumstances of each case. The written treatment plan shall be provided to:
(I) the patient;
(II) a person designated by the patient; and
(III) upon request, a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.
(vi) The written treatment plan shall be reviewed by the interdisciplinary team at least every two weeks.
(vii) The written treatment plan shall be revised by the interdisciplinary team if a comprehensive reassessment of the patient's status or the results of a patient case review conference indicates the need for revision.
(viii) The revision shall be incorporated into the patient's record within seven working days after the revision.
(ix) The revised treatment plan shall be reduced to writing in the person's primary language, if practicable, and provided to:
(I) the patient;
(II) a person designated by the patient; and
(III) upon request, a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.
(8) Discharge and continuing care plan. The patient's interdisciplinary team shall prepare a written continuing care plan that addresses the patient's needs for care after discharge.
(A) The continuing care plan for the patient shall include recommendations for treatment and care and information about the availability of resources for treatment or care.
(B) If the patient's interdisciplinary team deems it impracticable to provide a written continuing care plan before discharge, the patient's interdisciplinary team shall provide the written continuing care plan to the patient within two working days after the date of discharge.
(C) Before discharge or within two working days after the date of discharge, the written continuing care plan shall be provided in the person's primary language, if practicable, to:
(i) the patient;
(ii) a person designated by the patient; and
(iii) upon request, to a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.
(d) Dietary services. The hospital shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company or an arrangement with another hospital may meet this requirement if the company or other hospital has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company or other hospital maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the hospital medical staff for recommendations of dietetic policies affecting patient treatment. The hospital shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.
(1) Organization.
(A) The hospital shall have a full-time 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.
(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 hospital training pertinent to assigned duties;
(ii) conform to food handling techniques in accordance with paragraph (2)(E)(viii) 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:
(i) quality assessment and performance improvement program;
(ii) frequency of meals served;
(iii) nonroutine occurrences; and
(iv) identification of patient trays; and
(E) maintain authority and responsibility for the following:
(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) ensuring there is a four-day food supply on hand at all times;
(vii) menu planning; and
(viii) ensuring compliance with Chapter 228 of this title (relating to Retail Food Establishments).
(3) Diets. Menus shall meet the needs of the patients.
(A) Therapeutic diets shall be prescribed by the physicians responsible for the care of the patients. The dietary department of the hospital shall:
(i) establish procedures for the processing of therapeutic diets to include:
(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, before discharge. What is or would be 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 physicians or appropriately credentialed practitioners 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 (RDA), as published by the Food and Nutrition Board, Commission on Life Sciences, National Research Council, Tenth edition, 1989.
(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 hospital shall adopt, implement, and enforce a policy on the definition of "substantial" to meet each patient's varied nutritional needs.
(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 hospital;
(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.
(e) Emergency services. All licensed hospital locations, including multiple-location sites, shall have an emergency suite that complies with §133.161(a)(1)(A) of this chapter (relating to Requirements for Buildings in Which Existing Licensed Hospitals Are Located) or §133.163(f) of this title, and the following.
(1) Organization. The organization of the emergency services shall be appropriate to the scope of the services offered.
(A) The services shall be organized under the direction of a qualified member of the medical staff who is the medical director or clinical director.
(B) The services shall be integrated with other departments of the hospital.
(C) The policies and procedures governing medical care provided in the emergency suite shall be established by and shall be a continuing responsibility of the medical staff.
(D) Medical records indicating patient identification, complaint, physician, nurse, time admitted to the emergency suite, treatment, time discharged, and disposition shall be maintained for all emergency patients.
(E) Each freestanding emergency medical care facility shall advertise as an emergency room. The facility shall display notice that it functions as an emergency room.
(i) The notice shall explain that patients who receive medical services will be billed according to comparable rates for hospital emergency room services in the same region.
(ii) The notice shall be prominently and conspicuously posted for display in a public area of the facility that is readily available to each patient, managing conservator, or guardian. The postings shall be easily readable and consumer-friendly. The notice shall be in English and in a second language appropriate to the demographic makeup of the community served.
(2) Personnel.
(A) There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the hospital.
(B) Except for comprehensive medical rehabilitation hospitals and pediatric and adolescent hospitals that generally provide care that is not administered for or in expectation of compensation:
(i) there shall be on duty and available at all times at least one person qualified as determined by the medical staff to initiate immediate appropriate lifesaving measures; and
(ii) in general hospitals where the emergency treatment area is not contiguous with other areas of the hospital that maintain 24-hour staffing by qualified staff (including separation by one or more floors in multiple-occupancy buildings), qualified personnel must be physically present in the emergency treatment area at all times.
(C) Except for comprehensive medical rehabilitation hospitals and pediatric and adolescent hospitals that generally provide care that is not administered for or in expectation of compensation, the hospital shall provide that one or more physicians shall be available at all times for emergencies, as follows.
(i) General hospitals, except for hospitals designated as critical access hospitals (CAHs) by the Centers for Medicare & Medicaid Services (CMS), located in counties with a population of 100,000 or more shall have a physician qualified to provide emergency medical care on duty in the emergency treatment area at all times.
(ii) Special hospitals, hospitals designated as CAHs by the CMS, and general hospitals located in counties with a population of less than 100,000 shall have a physician on-call and able to respond in person, or by radio or telephone within 30 minutes.
(D) Schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates, shall be maintained. Schedules shall be retained for no less than one year.
(3) Supplies and equipment. Adequate age-appropriate supplies and equipment shall be available and in readiness for use. Equipment and supplies shall be available for the administration of intravenous medications as well as facilities for the control of bleeding and emergency splinting of fractures. Provision shall be made for the storage of blood and blood products as needed. The emergency equipment shall be periodically tested according to the policy adopted, implemented, and enforced by the hospital.
(4) Required emergency equipment. At a minimum, the age-appropriate emergency equipment and supplies shall include the following:
(A) emergency call system;
(B) oxygen;
(C) mechanical ventilatory assistance equipment, including airways, manual breathing bag, and mask;
(D) cardiac defibrillator;
(E) cardiac monitoring equipment;
(F) laryngoscopes and endotracheal tubes;
(G) suction equipment;
(H) emergency drugs and supplies specified by the medical staff;
(I) stabilization devices for cervical injuries;
(J) blood pressure monitoring equipment; and
(K) pulse oximeter or similar medical device to measure blood oxygenation.
(5) Participation in local emergency medical service (EMS) system.
(A) General hospitals shall participate in the local EMS system, based on the hospital's capabilities and capacity, and the locale's existing EMS plan and protocols.
(B) The provisions of subparagraph (A) of this paragraph do not apply to a comprehensive medical rehabilitation hospital or a pediatric and adolescent hospital that generally provides care that is not administered for or in expectation of compensation.
(6) Emergency services for sexual assault survivors. This section does not affect the duty of a health care facility to comply with the requirements of the federal Emergency Medical Treatment and Active Labor Act of 1986 (
42 U.S.C. §1395dd
) that are applicable to the facility. The hospital shall develop, implement, and enforce policies and procedures to ensure that after a sexual assault survivor presents to the hospital following a sexual assault, the hospital shall provide the care specified under Texas Health and Safety Code (HSC) Chapter 323.
(f) Governing body.
(1) Legal responsibility. There shall be a governing body responsible for the organization, management, control, and operation of the hospital, including appointment of the medical staff. For hospitals 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 and 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.
(A) The governing body shall ensure that the medical staff has current bylaws, rules, and regulations which are implemented and enforced.
(B) The governing body shall approve medical staff bylaws and other medical staff rules and regulations.
(C) In hospitals that provide obstetrical services, the governing body shall ensure that the hospital collaborates with physicians providing services at the hospital to develop quality initiatives, through the adoption, implementation, and enforcement of appropriate hospital policies and procedures, to reduce the number of elective or nonmedically indicated induced deliveries or cesarean sections performed at the hospital on a woman before the 39th week of gestation.
(D) In hospitals that provide obstetrical services, the governing body shall ensure that the hospital implements a newborn audiological screening program, consistent with the requirements of HSC Chapter 47, and performs, either directly or through a referral to another program, audiological screenings for the identification of hearing loss on each newborn or infant born at the facility before the newborn or infant is discharged. These audiological screenings are required to be performed on all newborns or infants before discharge from the facility unless:
(i) a parent or legal guardian of the newborn or infant declines the screening;
(ii) the newborn or infant requires emergency transfer to a tertiary care facility before the completion of the screening;
(iii) the screening previously has been completed; or
(iv) the newborn was discharged from the facility not more than 10 hours after birth and a referral for the newborn was made to another program.
(E) In hospitals that provide obstetrical services, the governing body shall adopt, implement, and enforce policies and procedures related to the testing of any newborn for critical congenital heart disease (CCHD) that may present themselves at birth. The facility shall implement testing programs for all infants born at the facility for CCHD. In the event that a newborn is presented at the emergency room following delivery at a birthing center or a home birth that may or may not have been assisted by a midwife, the facility shall ascertain if any testing for CCHD had occurred and, if not, shall provide the testing necessary to make such determination. The rules concerning the CCHD procedures and requirements are described in Chapter 37, Subchapter E of this title (relating to Newborn Screening for Critical Congenital Heart Disease).
(F) The governing body shall 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.
(i) In considering applications for medical staff membership and privileges or the renewal, modification, or revocation of medical staff membership and privileges, the governing body must ensure that each physician, podiatrist, and dentist is afforded procedural due process.
(I) If a hospital's credentials committee has failed to take action on a completed application as required by subclause (VIII) of this clause, or a physician, podiatrist, or dentist is subject to a professional review action that may adversely affect his medical staff membership or privileges, and the physician, podiatrist, or dentist believes that mediation of the dispute is desirable, the physician, podiatrist, or dentist may require the hospital to participate in mediation as provided in Texas Civil Practice and Remedies Code (CPRC) Chapter 154. The mediation shall be conducted by a person meeting the qualifications required by CPRC §154.052 and within a reasonable period of time.
(II) Subclause (I) of this clause does not authorize a cause of action by a physician, podiatrist, or dentist against the hospital other than an action to require a hospital to participate in mediation.
(III) An applicant for medical staff membership or privileges may not be denied membership or privileges on any ground that is otherwise prohibited by law.
(IV) A hospital's bylaw requirements for staff privileges may require a physician, podiatrist, or dentist to document the person's current clinical competency and professional training and experience in the medical procedures for which privileges are requested.
(V) In granting or refusing medical staff membership or privileges, a hospital may not differentiate on the basis of the academic medical degree held by a physician.
(VI) Graduate medical education may be used as a standard or qualification for medical staff membership or privileges for a physician, if that equal recognition is given to training programs accredited by the Accreditation Council for Graduate Medical Education and by the American Osteopathic Association.
(VII) Board certification may be used as a standard or qualification for medical staff membership or privileges for a physician, provided that equal recognition is given to certification programs approved by the American Board of Medical Specialties and the Bureau of Osteopathic Specialists.
(VIII) A hospital's credentials committee shall act expeditiously and without unnecessary delay when a licensed physician, podiatrist, or dentist submits a completed application for medical staff membership or privileges. The hospital's credentials committee shall take action on the completed application not later than the 90th day after the date on which the application is received. The governing body of the hospital 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. The hospital must notify the applicant in writing of the hospital'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.
(ii) The governing body is authorized to adopt, implement and enforce policies concerning the granting of clinical privileges to advanced practice registered nurses (APRNs) and physician assistants, including policies relating to the application process, reasonable qualifications for privileges, and the process for renewal, modification, or revocation of privileges.
(I) If the governing body of a hospital has adopted, implemented and enforced a policy of granting clinical privileges to APRNs or physician assistants, an individual APRN or physician assistant who qualifies for privileges under that policy shall be entitled to certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, when an application for privileges is submitted to the hospital. At a minimum, any policy adopted shall specify a reasonable period for the processing and consideration of the application and shall provide for written notification to the applicant of any final action on the application by the hospital, including any reason for denial or restriction of the privileges requested.
(II) If an APRN or physician assistant has been granted clinical privileges by a hospital, the hospital may not modify or revoke those privileges without providing certain procedural rights to provide fairness of process, as determined by the governing body of the hospital, to the APRN or physician assistant. At a minimum, the hospital shall provide the APRN or physician assistant written reasons for the modification or revocation of privileges and a mechanism for appeal to the appropriate committee or body within the hospital, as determined by the governing body of the hospital.
(III) If a hospital extends clinical privileges to an APRN or physician assistant conditioned on the APRN or physician assistant having a sponsoring or collaborating relationship with a physician and that relationship ceases to exist, the APRN or physician assistant and the physician shall provide written notification to the hospital that the relationship no longer exists. Once the hospital receives such notice from an APRN or physician assistant and the physician, the hospital shall be deemed to have met its obligations under this section by notifying the APRN or physician assistant in writing that the APRN's or physician assistant's clinical privileges no longer exist at that hospital.
(IV) Nothing in this clause shall be construed as modifying Texas Occupations Code Chapter 204 or 301, or any other law relating to the scope of practice of physicians, APRNs, or physician assistants.
(V) This clause does not apply to an employer-employee relationship between an APRN or physician assistant and a hospital.
(G) The governing body shall ensure that the hospital complies with the requirements concerning physician communication and contracts as set out in HSC §241.1015.
(H) The governing body shall ensure the hospital complies with the requirements for reporting to the Texas Medical Board the results and circumstances of any professional review action in accordance with Texas Occupations Code §160.002 and §160.003.
(I) The governing body shall be responsible for and ensure that any policies and procedures adopted by the governing body to implement the requirements of this chapter shall be implemented and enforced.
(5) Hospital administration. The governing body shall appoint a chief executive officer or administrator who is responsible for managing the hospital.
(6) Patient care. In accordance with hospital policy adopted, implemented, and enforced, the governing body shall ensure that:
(A) every patient is under the care of:
(i) 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 or the state's regulatory mechanism;
(ii) a dentist who is legally authorized to practice dentistry by the state and who is acting within the scope of his or her license; or
(iii) a podiatrist, but only with respect to functions which he or she is legally authorized by the state to perform.
(B) patients are admitted to the hospital only by members of the medical staff who have been granted admitting privileges;
(C) a physician is on duty or on-call at all times;
(D) specific colored condition alert wrist bands that have been standardized for all hospitals licensed under HSC Chapter 241, are used as follows:
(i) red wrist bands for allergies;
(ii) yellow wrist bands for fall risks; and
(iii) purple wrist bands for do not resuscitate status;
(E) the governing body shall consider the addition of the following optional condition alert wrist bands and document in the minutes of the meeting of the governing body in which the discussion was held:
(i) green wrist bands for latex allergy; and
(ii) pink wrist bands for restricted extremity;
(F) the governing body shall adopt, implement, and enforce a policy and procedure regarding the removal of personal wrist bands and bracelets as well as a patient's right to refuse to wear condition alert wrist bands; and
(G) the governing body shall adopt, implement, and enforce policies and procedures regarding do-not-resuscitate (DNR) orders issued in the hospital by the attending physician that comply with HSC Chapter 166, Subchapter E , including policies and procedures regarding the rights of a patient and person authorized to make treatment decisions regarding the patient's DNR status; notice and medical record requirements for DNR orders and revocations; and actions the attending physician and hospital must take pursuant to HSC §166.206 when the physician or hospital and the patient or person authorized to make treatment decisions regarding the patient's DNR status are in disagreement about the execution of, or compliance with, a DNR order. The policies and procedures shall include the following:
(i) Except in circumstances described by HSC §166.203(a)(2) and (3), a DNR order issued for a patient is valid only if a physician providing direct care to the patient issues the order, the order is dated, and the order is issued in compliance with:
(I) the written and dated directions of a patient who was competent at the time the patient wrote the directions;
(II) the oral directions of a competent patient delivered to or observed by two competent adult witnesses, at least one of whom must be a person not listed under HSC §166.003(2)(E) or (F);
(III) the directions in an advance directive enforceable under HSC §166.005 or executed in accordance with HSC §§166.032, 166.034, 166.035, 166.082, 166.084, or 166.085;
(IV) the directions of a patient's:
(-a-) legal guardian;
(-b-) agent under a medical power of attorney acting in accordance with HSC Chapter 166, Subchapter D; or
(-c-) proxy as designated and authorized by a directive executed in accordance with HSC Chapter 166, Subchapter B to make a treatment decision for the patient if the patient becomes incompetent or otherwise mentally or physically incapable of communication; or
(V) a treatment decision made in accordance with HSC §166.039.
(ii) A DNR order that is not issued in accordance with HSC §166.203(a)(1) is valid only if:
(I) the patient's attending physician issues the order, the order is dated; and
(-a-) the order is not contrary to the directions of a patient who was competent at the time the patient conveyed the directions;
(-b-) in the reasonable medical judgment of the patient's attending physician, the patient's death is imminent, within minutes to hours, regardless of the provision of cardiopulmonary resuscitation; and
(-c-) in the reasonable medical judgment of the patient's attending physician, the DNR order is medically appropriate; or
(II) the patient's attending physician issues the order for a patient who is incompetent or otherwise mentally or physically incapable of communication and the order is in compliance with a decision:
(-a-) agreed upon by the attending physician and the person responsible for the patient's health care decisions; and
(-b-) concurred in by another physician who is not involved in the direct treatment of the patient or who is a representative of an ethics or medical committee of the health care facility in which the person is a patient.
(iii) A DNR order takes effect at the time the order is issued, as provided by HSC §166.203(b), provided the order is placed in the patient's medical record as soon as practicable, and may be issued and entered in a format acceptable under the policies of the hospital.
(iv) Unless notice is provided in accordance with HSC §166.204(a), before placing in a patient's medical record a DNR order described by HSC §166.203(a)(2), a physician, physician assistant, nurse, or other person acting on behalf of the hospital shall:
(I) notify the patient of the order's issuance; or
(II) if the patient is incompetent, make a reasonably diligent effort to contact or cause to be contacted and notify of the order's issuance:
(-a-) the patient's known agent under a medical power of attorney or legal guardian; or
(-b-) for a patient who does not have a known agent under a medical power of attorney or legal guardian, a person described by HSC §166.039(b)(1), (2), or (3).
(v) In accordance with HSC §166.205(a), a physician providing direct care to a patient for whom a DNR order is issued shall revoke the patient's DNR order if:
(I) an advance directive that serves as the basis of the DNR order is properly revoked in accordance with HSC Chapter 166;
(II) the patient expresses to any person providing direct care to the patient a revocation of consent to or intent to revoke a DNR order issued under HSC §166.203(a); or
(III) the DNR order was issued under HSC §166.203(a)(1)(D) or (E) or §166.203(a)(3) and the person responsible for the patient's health care decisions expresses to any person providing direct care to the patient a revocation of consent to or intent to revoke the DNR order.
(vi) A person providing direct care to a patient under the supervision of a physician shall notify the physician of a request to revoke a DNR order or the revocation of an advance directive under HSC §166.205(a).
(vii) A patient's attending physician may at any time revoke a DNR order executed under:
(I) HSC §166.203(a)(1)(A), (B), or (C), provided that:
(-a-) the order is for a patient who is incompetent or otherwise mentally or physically incapable of communication; and
(-b-) the decision to revoke the order is:
(-1-) agreed on by the attending physician and the person responsible for the patient's health care decisions; and
(-2-) concurred in by another physician who is not involved in the direct treatment of the patient or who is a representative of an ethics or medical committee of the health care facility in which the person is a patient;
(II) HSC §166.203(a)(1)(E), provided that the order's issuance was based on a treatment decision made in accordance with HSC §166.039(e);
(III) HSC §166.203(a)(2); or
(IV) HSC §166.203(a)(3).
(viii) A patient's attending physician shall revoke a DNR order issued for the patient under HSC §166.203(a)(2) if, in the attending physician's reasonable medical judgment, the condition described by HSC §166.203(a)(2)(B)(i) is no longer satisfied.
(ix) For a patient who was incompetent at the time notice otherwise would have been provided to the patient under HSC §166.203(c)(1) and if a physician providing direct care to the patient later determines that, based on the physician's reasonable medical judgment, the patient has become competent, a physician, physician assistant, or nurse providing direct care to the patient shall disclose the order to the patient, provided that the physician, physician assistant, or nurse has actual knowledge:
(I) of the order; and
(II) that a physician providing direct care to the patient has determined that the patient has become competent.
(x) On admission to the hospital, the hospital shall provide to the patient or person authorized to make treatment decisions regarding the patient's DNR status notice of the policies and procedures adopted under this subparagraph.
(7) Services. The governing body shall be responsible for all services furnished in the hospital, whether furnished directly or under contract. The governing body shall ensure that services are provided in a safe and effective manner that permits the hospital to comply with applicable rules and standards. At hospitals that have a mental health service unit, the governing body shall adopt, implement, and enforce procedures for the completion of criminal background checks on all prospective employees that would be considered for assignment to that unit, except for persons currently licensed by this state as health professionals.
(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 (o) of this section.
(9) Photo identification badge. The governing body shall adopt a policy requiring employees, physicians, contracted employees, and individuals in training who provide direct patient care at the hospital to wear a photo identification badge during all patient encounters, unless precluded by adopted isolation or sterilization protocols. The badge must be of sufficient size and worn in a manner to be visible and must clearly state:
(A) at minimum the individual's first or last name;
(B) the department of the hospital with which the individual is associated;
(C) the type of license held by the individual, if applicable under Texas Occupations Code Title 3; and
(D) the provider's status as a student, intern, trainee, or resident, if applicable.
(g) Infection control. The hospital 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 surveillance of infections and communicable diseases.
(1) Organization and policies. A person shall be designated as infection control professional. The hospital 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 health care associated infections and communicable diseases between patients and personnel.
(B) The infection control professional shall maintain a log of all reportable diseases and health care associated infections designated as epidemiologically significant according to the hospital's infection control policies.
(C) A written policy shall be adopted, implemented, and enforced for reporting all reportable diseases to the local health authority and the Texas Department of State Health Services (DSHS) in accordance with Chapter 97 of this title (relating to Communicable Diseases) and HSC §98.103 and §98.1045.
(D) The infection control program shall include active participation by the pharmacist.
(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 hospital-wide quality assessment and performance improvement program and training programs shall address problems identified by the infection control professional.
(B) Successful corrective action plans in affected problem areas shall be implemented.
(3) Universal precautions. The hospital shall adopt, implement, and enforce a written policy to monitor compliance of the hospital and its personnel and medical staff with universal precautions in accordance with HSC Chapter 85.
(h) Laboratory services. The hospital shall maintain directly or have available adequate laboratory services to meet the needs of its patients.
(1) Hospital laboratory services. A hospital 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 hospitals 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 hospital 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 hospital 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.
(D) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examination.
(E) When blood and blood components are stored, there shall be written procedures readily available containing directions on how to maintain them within permissible temperatures and including instructions to be followed in the event of a power failure or other disruption of refrigeration. A label or tray with the recipient's first and last names and identification number, donor unit number and interpretation of compatibility, if performed, shall be attached securely to the blood container.
(F) The hospital shall establish a mechanism for ensuring that the patient's physician or other licensed health care professional is made aware of critical value lab results, as established by the medical staff, before or after the patient is discharged.
(4) Chemical hygiene. A hospital that provides laboratory services 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.
(i) Linen and laundry services. The hospital shall provide sufficient clean linen to ensure the comfort of the patient.
(1) For purposes of this subsection, contaminated linen is linen which has been soiled with blood or other potentially infectious materials or may contain sharps. Other potentially infectious materials means:
(A) human body fluids such as semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;
(B) any unfixed tissue or organ (other than intact skin) from a human (living or dead); and
(C) Human Immunodeficiency Virus (HIV)-containing cell or tissue cultures, organ cultures, and HIV or Hepatitis B Virus (HBV)-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.
(2) The hospital, whether it operates its own laundry or uses commercial service, shall ensure the following.
(A) Employees of a hospital involved in transporting, processing, or otherwise handling clean or soiled linen shall be given initial and follow-up in-service training to ensure a safe product for patients and to safeguard employees in their work.
(B) Clean linen shall be handled, transported, and stored by methods that will ensure its cleanliness.
(C) All contaminated linen shall be placed and transported in bags or containers labeled or color-coded.
(D) Employees who have contact with contaminated linen shall wear gloves and other appropriate personal protective equipment.
(E) Contaminated linen shall be handled as little as possible and with a minimum of agitation. Contaminated linen shall not be sorted or rinsed in patient care areas.
(F) All contaminated linen shall be bagged or put into carts at the location where it was used.
(i) Bags containing contaminated linen shall be closed before transport to the laundry.
(ii) 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.
(iii) All linen placed in chutes shall be bagged.
(iv) 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.
(G) Linen shall be processed as follows.
(i) 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 §133.169(e) of this chapter (relating to Tables) shall be met.
(ii) 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.
(iii) Commercial dry cleaning of fabrics soiled with blood also renders these items free of the risk of pathogen transmission.
(H) Flammable liquids shall not be used to process laundry but may be used for equipment maintenance.
(j) Medical record services. The hospital 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 hospital shall employ or contract with adequate personnel to ensure prompt completion, filing, and retrieval of records.
(2) The hospital shall have a system of coding and indexing medical records. The system shall allow for timely retrieval by diagnosis and procedure, to support medical care evaluation studies.
(3) The hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with HSC Chapter 241, Subchapters G and E, §241.103, and §241.1031 .
(4) The medical record shall contain information to justify admission and continued hospitalization, support the diagnosis, reflect significant changes in the patient's condition, 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) If an attending physician issues a DNR order for a patient under HSC Chapter 166, Subchapter E, that order shall be entered into the patient medical record as soon as practicable. In the event a physician revokes a DNR order under HSC Chapter 166, Subchapter E, that revocation shall be entered into the patient medical record as soon as practicable. To the extent this paragraph conflicts with requirements elsewhere in this subsection, this paragraph prevails.
(6) Medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.
(7) All orders (except verbal orders) must be dated, timed, and authenticated the next time the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders provides care to the patient, assesses the patient, or documents information in the patient's medical record.
(8) All verbal orders must be dated, timed, and authenticated within 96 hours by the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders.
(A) Use of signature stamps by physicians and other licensed practitioners credentialed by the medical staff may be allowed in hospitals when the signature stamp is authorized by the individual whose signature the stamp represents. The administrative offices of the hospital 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. The use of a signature stamp by any other person is prohibited.
(B) A list of computer codes and written signatures shall be readily available and shall be maintained under adequate safeguards.
(C) Signatures by facsimile shall be acceptable. If received on a thermal machine, the facsimile document shall be copied onto regular paper.
(9) Medical records (reports and printouts) shall be retained by the hospital in their original or legally reproduced form for a period of at least ten years. A legally reproduced form is a medical record retained in hard copy, microform (microfilm or microfiche), or other electronic medium. 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, including a health history, performed no more than 30 days before admission or within 24 hours after admission, which shall be placed in the patient's medical record within 24 hours after admission;
(D) an updated medical record entry documenting an examination, completed and documented in the patient's medical record within 24 hours after admission, for any changes in the patient's condition when the medical history and physical examination are completed within 30 days before admission;
(E) admitting diagnosis;
(F) diagnostic and therapeutic orders;
(G) 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;
(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.
(10) A hospital may not destroy a medical record from the forensic medical examination of a sexual assault victim until the 20th anniversary of the date the record was created, in accordance with HSC Chapter 241, Subchapter E, §241.1031.
(11) If a patient was less than 18 years of age at the time the patient was last treated, the hospital may authorize the disposal of those medical records relating to the patient on or after the date of the patient's 20th birthday or on or after the 10th anniversary of the date on which the patient was last treated, whichever date is later.
(12) The hospital shall not destroy medical records that relate to any matter that is involved in litigation if the hospital knows the litigation has not been finally resolved.
(13) The hospital shall provide written notice to a patient, or a patient's legally authorized representative, that the hospital may authorize the disposal of medical records relating to the patient on or after the periods specified in this section. The notice shall be provided to the patient or the patient's legally authorized representative not later than the date on which the patient who is or will be the subject of a medical record is treated, except in an emergency treatment situation. In an emergency treatment situation, the notice shall be provided to the patient or the patient's legally authorized representative as soon as is reasonably practicable following the emergency treatment situation.
(14) If a licensed hospital should close, the hospital shall notify HHSC 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.
(k) 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.
(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 (for example, 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;
(E) include criteria for determining the privileges to be granted and a procedure for applying the criteria to individuals requesting privileges;
(F) include a requirement that a physical examination and medical history be done no more than 30 days before or 24 hours after an admission for each patient by a physician or other qualified practitioner who has been granted these privileges by the medical staff:
(i) the medical history and physical examination shall be placed in the patient's medical record within 24 hours after admission;
(ii) when the medical history and physical examination are completed within the 30 days before admission, an updated examination for any changes in the patient's condition must be completed and documented in the patient's medical record within 24 hours after admission; and
(G) include procedures regarding DNR orders issued in the hospital by an attending physician that comply with HSC Chapter 166, Subchapter E , including policies and procedures regarding the rights of a patient and person authorized to make treatment decisions regarding the patient's DNR status; notice and medical record requirements for DNR orders and revocations; and actions the attending physician and hospital must take pursuant to HSC §166.206 when the physician or hospital and the patient or person authorized to make treatment decisions regarding the patient's DNR status are in disagreement about the execution of, or compliance with, a DNR order.
(i) Except in circumstances described by HSC §166.203(a)(2) and (3), the procedures shall include that a DNR order issued for a patient is valid only if a physician providing direct care to the patient issues the order, the order is dated, and the order is issued in compliance with:
(I) the written and dated directions of a patient who was competent at the time the patient wrote the directions;
(II) the oral directions of a competent patient delivered to or observed by two competent adult witnesses, at least one of whom must be a person not listed under HSC §166.003(2)(E) or (F);
(III) the directions in an advance directive enforceable under HSC §166.005 or executed in accordance with HSC §§166.032, 166.034, 166.035, 166.082, 166.084, or 166.085;
(IV) the directions of a patient's:
(-a-) legal guardian;
(-b-) agent under a medical power of attorney acting in accordance with HSC Chapter 166, Subchapter D; or
(-c-) proxy as designated and authorized by a directive executed in accordance with HSC Chapter 166, Subchapter B to make a treatment decision for the patient if the patient becomes incompetent or otherwise mentally or physically incapable of communication; or
(V) a treatment decision made in accordance with HSC §166.039.
(ii) The procedures shall include that a DNR order that is not issued in accordance with HSC §166.203(a)(1) is valid only if:
(I) the patient's attending physician issues the order, the order is dated; and
(-a-) the order is not contrary to the directions of a patient who was competent at the time the patient conveyed the directions;
(-b-) in the reasonable medical judgment of the patient's attending physician, the patient's death is imminent, within minutes to hours, regardless of the provision of cardiopulmonary resuscitation; and
(-c-) in the reasonable medical judgment of the patient's attending physician, the DNR order is medically appropriate; or
(II) the patient's attending physician issues the order for a patient who is incompetent or otherwise mentally or physically incapable of communication, and the order is in compliance with a decision:
(-a-) agreed upon by the attending physician and the person responsible for the patient's health care decisions; and
(-b-) concurred in by another physician, who is not involved in the direct treatment of the patient or who is a representative of an ethics or medical committee of the health care facility in which the person is a patient.
(iii) The procedures shall include that a DNR order takes effect at the time the order is issued, as provided by HSC §166.203(b), provided the order is placed in the patient's medical record as soon as practicable, and may be issued and entered in a format acceptable under the policies of the hospital.
(iv) The procedures shall include that unless notice is provided in accordance with HSC §166.204(a), before placing in a patient's medical record a DNR order described by HSC §166.203(a)(2), a physician, physician assistant, nurse, or other person acting on behalf of the hospital shall:
(I) notify the patient of the order's issuance; or
(II) if the patient is incompetent, make a reasonably diligent effort to contact or cause to be contacted and inform of the order's issuance:
(-a-) the patient's known agent under a medical power of attorney or legal guardian; or
(-b-) for a patient who does not have a known agent under a medical power of attorney or legal guardian, a person described by HSC §166.039(b)(1), (2), or (3).
(v) The procedures shall include that in accordance with HSC §166.205(a), a physician providing direct care to a patient for whom a DNR order is issued shall revoke the patient's DNR order if:
(I) an advance directive that serves as the basis of the DNR order is properly revoked in accordance with HSC Chapter 166;
(II) the patient expresses to any person providing direct care to the patient a revocation of consent to or intent to revoke a DNR order issued under HSC §166.203(a); or
(III) the DNR order was issued under HSC §166.203(a)(1)(D) or (E) or §166.203(a)(3), and the person responsible for the patient's health care decisions expresses to any person providing direct care to the patient a revocation of consent to or intent to revoke the DNR order.
(vi) The procedures shall include that a person providing direct care to a patient under the supervision of a physician shall notify the physician of the request to revoke a DNR order or the revocation of an advance directive under HSC §166.205(a).
(vii) The procedures shall include that a patient's attending physician may at any time revoke a DNR order executed under:
(I) HSC §166.203(a)(1)(A), (B), or (C), provided that:
(-a-) the order is for a patient who is incompetent or otherwise mentally or physically incapable of communication; and
(-b-) the decision to revoke the order is:
(-1-) agreed on by the attending physician and the person responsible for the patient's health care decisions; and
(-2-) concurred in by another physician who is not involved in the direct treatment of the patient or who is a representative of an ethics or medical committee of the health care facility in which the person is a patient;
(II) HSC §166.203(a)(1)(E), provided that the order's issuance was based on a treatment decision made in accordance with HSC §166.039(e);
(III) HSC §166.203(a)(2); or
(IV) HSC §166.203(a)(3).
(viii) The procedures shall include that a patient's attending physician shall revoke a DNR order issued for the patient under HSC §166.203(a)(2) if, in the attending physician's reasonable medical judgment, the condition described by HSC §166.203(a)(2)(B)(i) is no longer satisfied.
(ix) The procedures shall include that for a patient who was incompetent at the time notice otherwise would have been provided to the patient under HSC §166.203(c)(1) and if a physician providing direct care to the patient later determines that, based on the physician's reasonable medical judgment, the patient has become competent, a physician, physician assistant, or nurse providing direct care to the patient shall disclose the order to the patient, provided that the physician, physician assistant, or nurse has actual knowledge:
(I) of the order; and
(II) that a physician providing direct care to the patient has determined that the patient has become competent.
(l) Mental health services.
(1) Mental health services unit. A hospital may not admit patients to a mental health services unit unless the unit is approved by HHSC as meeting the requirements of §133.163(q) of this title.
(2) Admission criteria. A hospital providing mental health services shall have written admission criteria that are applied uniformly to all patients who are admitted to the service.
(A) The hospital's admission criteria shall include procedures to prevent the admission of minors for a condition which is not generally recognized as responsive to treatment in an inpatient setting for mental health services.
(i) The following conditions are not generally recognized as responsive to treatment in a hospital unless the minor to be admitted is qualified because of other disabilities, such as:
(I) cognitive disabilities due to intellectual disability; or
(II) learning disabilities.
(ii) A minor may be qualified for admission based on other disabilities which would be responsive to mental health services.
(B) The medical record shall contain evidence that admission consent was given by the patient, the patient's legal guardian, or the managing conservator, if applicable.
(C) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.
(D) A voluntarily admitted patient shall sign an admission consent form before admission to a mental health unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.
(3) Compliance. A hospital providing mental health services shall comply with the following rules:
(A) 26 TAC Chapter 568 (relating to Standards of Care and Treatment in Psychiatric Hospitals);
(B) Chapter 404, Subchapter E of this title (relating to Rights of Persons Receiving Mental Health Services);
(C) Chapter 405, Subchapter E of this title (relating to Electroconvulsive Therapy (ECT));
(D) Chapter 414, Subchapter I of this title (relating to Consent to Treatment with Psychoactive Medication--Mental Health Services); and
(E) Chapter 415, Subchapter F of this title (relating to Interventions in Mental Health Programs).
(m) Mobile, transportable, and relocatable units. The hospital shall adopt, implement, and enforce procedures which address the potential emergency needs for those inpatients who are taken to mobile units on the hospital's premises for diagnostic procedures or treatment.
(n) Nuclear medicine services. If the hospital provides nuclear medicine services, these services shall meet the needs of the patients in accordance with acceptable standards of practice and be licensed in accordance with §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material).
(1) Policies and procedures. Policies and procedures shall be adopted, implemented, and enforced which will describe the services nuclear medicine provides in the hospital and how employee and patient safety will be maintained.
(2) Organization and staffing. The organization of the nuclear medicine services shall be appropriate to the scope and complexity of the services offered.
(A) There shall be a medical director or clinical director who is a physician qualified in nuclear medicine.
(B) The qualifications, training, functions, and responsibilities of nuclear medicine personnel shall be specified by the medical director or clinical director and approved by the medical staff.
(3) Delivery of services. Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice and in accordance with §289.256 of this title.
(A) In-house preparation of radiopharmaceuticals shall be by, or under, the direct supervision of an appropriately trained licensed pharmacist or physician.
(B) There shall be proper storage and disposal of radioactive materials.
(C) If clinical laboratory tests are performed by the nuclear medicine services staff, the nuclear medicine staff shall comply with CLIA 1988 in accordance with the requirements specified in
42 CFR Part 493
.
(D) Nuclear medicine workers shall be provided personnel monitoring dosimeters to measure their radiation exposure. Exposure reports and documentation shall be available for review.
(4) Equipment and supplies. Equipment and supplies shall be appropriate for the types of nuclear medicine services offered and shall be maintained for safe and efficient performance. The equipment shall be inspected, tested, and calibrated at least annually by qualified personnel.
(5) Records. The hospital shall maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.
(A) The physician approved by the medical staff to interpret diagnostic procedures shall sign and date the interpretations of these tests.
(B) The hospital shall maintain records of the receipt and disposition of radiopharmaceuticals until disposal is authorized by DSHS' in accordance with §289.256 of this title.
(C) Nuclear medicine services shall be ordered only by an individual whose scope of state licensure and whose defined staff privileges allow such referrals.
(o) Nursing services. The hospital shall have an organized nursing service that provides 24-hour nursing services as needed.
(1) Organization. The hospital shall have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care.
(A) Nursing services shall be under the administrative authority of a chief nursing officer (CNO) who shall be an RN and comply with one of the following:
(i) possess a master's degree in nursing;
(ii) possess a master's degree in health care administration or business administration;
(iii) possess a master's degree in a health-related field obtained through a curriculum that included courses in administration and management; or
(iv) be progressing under a written plan to obtain the nursing administration qualifications associated with a master's degree in nursing, which shall:
(I) describe efforts to obtain the knowledge associated with graduate education and to increase administrative and management skills and experience;
(II) include courses related to leadership, administration, management, performance improvement and theoretical approaches to delivering nursing care; and
(III) provide a time-line for accomplishing skills.
(B) The CNO in hospitals with 100 or fewer licensed beds and located in counties with a population of less than 50,000, or in hospitals that have been certified by the Centers for Medicare and Medicaid Services as critical access hospitals in accordance with the
42 CFR Part 485
, Subpart F, §485.606(b), shall be exempted from the requirements in subparagraph (A)(i) - (iv) of this paragraph.
(C) The CNO shall be responsible for the operation of the services, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.
(D) The CNO shall report directly to the individual who has authority to represent the hospital and who is responsible for the operation of the hospital according to the policies and procedures of the hospital's governing board.
(E) The CNO shall participate with leadership from the governing body, medical staff, and clinical areas, in planning, promoting and conducting performance improvement activities.
(2) Staffing and delivery of care.
(A) The nursing services shall adopt, implement and enforce a procedure to verify that hospital nursing personnel for whom licensure is required have valid and current licensure.
(B) There shall be adequate numbers of RNs, licensed vocational nurses (LVNs), and other personnel to provide nursing care to all patients as needed.
(C) There shall be supervisory and staff personnel for each department or nursing unit to provide, when needed, the immediate availability of an RN to provide care for any patient.
(D) An RN shall be on duty in each building of a licensed hospital that contains at least one nursing unit where patients are present. The RN shall supervise and evaluate the nursing care for each patient and assign the nursing care to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.
(E) The nursing staff shall develop and keep current a nursing plan of care for each patient which addresses the patient's needs.
(F) The hospital shall establish a nurse staffing committee as a standing committee of the hospital. The committee shall be established in accordance with HSC §§161.031 - 161.033, to be responsible for soliciting and receiving input from nurses on the development, ongoing monitoring, and evaluation of the staffing plan. As provided by HSC, §161.032, the hospital's records and review relating to evaluation of these outcomes and indicators are confidential and not subject to disclosure under Texas Government Code Chapter 552 and not subject to disclosure, discovery, subpoena or other means of legal compulsion for their release. As used in this subsection, "committee" or "staffing committee" means a nurse staffing committee established under this subparagraph.
(i) The committee shall be composed of:
(I) at least 60 percent registered nurses who are involved in direct patient care at least 50 percent of their work time and selected by their peers who provide direct care during at least 50 percent of their work time;
(II) at least one representative from either infection control, quality assessment and performance improvement or risk management;
(III) members who are representative of the types of nursing services provided at the hospital; and
(IV) the chief nursing officer of the hospital who is a voting member.
(ii) 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.
(iii) The committee shall meet at least quarterly.
(iv) 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 subparagraph (G) of this paragraph;
(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.
(G) 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.
(i) The official nurse services staffing plan and policies shall:
(I) require significant consideration to 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 from retaliation nurses who provide input to the nurse staffing committee; and
(VI) comply with subsection (o) of this section.
(ii) The plan shall:
(I) set minimum staffing levels for patient care units that are:
(-a-) based on multiple nurse and patient considerations including:
(-1-) patient characteristics and number of patients for whom care is being provided, including number of admissions, discharges and transfers on a unit;
(-2-) intensity of patient care being provided and variability of patient care across a nursing unit;
(-3-) scope of services provided;
(-4-) context within which care is provided, including architecture and geography of the environment, and the availability of technology; and
(-5-) nursing staff characteristics, including staff consistency and tenure, preparation and experience, and the number and competencies of clinical and non-clinical support staff the nurse must collaborate with or supervise.
(-b-) determined by the nursing assessment and in accordance with evidence-based safe nursing standards; and
(-c-) recalculated at least annually, or as necessary;
(II) include a method for adjusting the staffing plan shift to shift for each patient care unit based on factors, such as, the intensity of patient care 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 and should be developed based upon a review of the codes of ethics developed by the nursing profession through national nursing 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. At least one from each of the following three types of outcomes shall be correlated to the adequacy of staffing:
(-a-) nurse-sensitive patient outcomes selected by the nurse staffing committee, such as, patient falls, adverse drug events, injuries to patients, skin breakdown, pneumonia, infection rates, upper gastrointestinal bleeding, shock, cardiac arrest, length of stay, or patient readmissions;
(-b-) operational outcomes, such as, work-related injury or illness, vacancy and turnover rates, nursing care hours per patient day, on-call use, or overtime rates; and
(-c-) substantiated patient complaints related to staffing levels;
(VII) incorporate a process that facilitates the timely and effective identification of concerns about the adequacy of the staffing plan by the nurse staffing committee established pursuant to subparagraph (F) of this paragraph. This process shall include:
(-a-) a prohibition on retaliation for reporting concerns;
(-b-) a requirement that nurses report concerns timely through appropriate channels within the hospital;
(-c-) orientation of nurses on how to report concerns and to whom;
(-d-) encouraging nurses to provide input to the committee relating to nurse staffing concerns;
(-e-) review, assessment, and response by the committee to staffing concerns expressed to the committee;
(-f-) a process for providing feedback during the committee meeting on how concerns are addressed by the committee established under subparagraph (F) of this paragraph; and
(-g-) use of the nurse safe harbor peer review process pursuant to Texas Occupations Code §303.005;
(VIII) include policies and procedures that require:
(-a-) orientation of nurses and other personnel who provide nursing care to all patient care units to which they are assigned on either a temporary or permanent basis;
(-b-) that the orientation of nurses and other personnel and the competency to perform nursing services is documented in accordance with hospital policy;
(-c-) that nursing assignments be congruent with documented competency; and
(IX) be used by the hospital as a component in setting the nurse staffing budget and guiding the hospital in assigning nurses hospital wide.
(iii) 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.
(iv) There shall be a semiannual evaluation by the staffing committee of the effectiveness of the official nurse services staffing plan and variations between the staffing plan and actual staffing. The evaluation shall consider the outcomes and nursing-sensitive indicators as set out in clause (ii)(VI) of this subparagraph, patient needs, nurse satisfaction measures collected by the hospital, and evidence based nurse staffing standards. This evaluation shall be documented in the minutes of the committee established under subparagraph (F) of this paragraph and presented to the hospital's governing body. Hospitals may determine whether this evaluation is done on a unit or facility level basis. To assist the committee with the semiannual evaluation, the hospital shall report to the committee the variations between the staffing plan and actual staffing. This report of variations shall be confidential and not subject to disclosure under Texas Government Code Chapter 552 and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release.
(v) The staffing plan shall be retained for a period of two years.
(H) Nonemployee licensed nurses who are working in the hospital shall adhere to the policies and procedures of the hospital. The CNO shall provide for the adequate orientation, supervision, and evaluation of the clinical activities of nonemployee nursing personnel which occur within the responsibility of the nursing services.
(I) The hospital shall annually report to DSHS on:
(i) whether the hospital's governing body has adopted a nurse staffing policy;
(ii) whether the hospital has established a nurse staffing committee that meets the membership requirements of subparagraph (F) of this paragraph;
(iii) 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
(iv) the nurse-sensitive outcome measures the committee adopted for use in evaluating the hospital's official nurse services staffing plan.
(3) 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;
(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.
(4) Drugs and biologicals. Drugs and biologicals shall be prepared and administered in accordance with federal and state laws, the orders of the individuals granted privileges by the medical staff, and accepted standards of practice.
(A) All drugs and biologicals shall be administered by, or under supervision of, nursing or other personnel in accordance with federal and state laws and regulations, including applicable licensing rules, and in accordance with the approved medical staff policies and procedures.
(B) All orders for drugs and biologicals shall be in writing, dated, timed, and signed by the individual responsible for the care of the patient as specified under subsection (f)(6)(A) of this section. When telephone or verbal orders must be used, they shall be:
(i) accepted only by personnel who are authorized to do so by the medical staff policies and procedures, consistent with federal and state laws;
(ii) dated, timed, and authenticated within 96 hours by the prescriber or another practitioner who is responsible for the care of the patient and has been credentialed by the medical staff and granted privileges which are consistent with the written orders; and
(iii) used infrequently.
(C) There shall be a hospital procedure for immediately reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs to the attending physician and, if appropriate, to the hospital-wide quality assessment and performance improvement program.
(5) Blood transfusions.
(A) Transfusions shall be prescribed in accordance with hospital policy and administered in accordance with a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.
(B) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to written, adopted, implemented, and enforced hospital policy.
(C) Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.
(D) The patient must be observed during the transfusion and for an appropriate time thereafter for suspected adverse reactions.
(E) Pretransfusion and posttransfusion vital signs shall be recorded.
(F) When warming of blood is indicated, this shall be accomplished during its passage through the transfusion set. The warming system shall be equipped with a visible thermometer and may have an audible warning system. Blood shall not be warmed above 42 degrees Celsius.
(G) Drugs or medications, including those intended for intravenous use, shall not be added to blood or blood components. A 0.9 percent sodium chloride injection, United States Pharmacopeia, may be added to blood or blood components. Other solutions intended for intravenous use may be used in an administration set or added to blood or blood components under either of the following conditions:
(i) they have been approved for this use by the Federal Drug Administration; or
(ii) there is documentation available to show that addition to the component involved is safe and efficacious.
(H) There shall be a system for detection, reporting and evaluation of suspected complications of transfusion. Any adverse event experienced by a patient in association with a transfusion is to be regarded as a suspected transfusion complication. In the event of a suspected transfusion complication, the personnel attending the patient shall notify immediately a responsible physician and the transfusion service and document the complication in the patient's medical record. All suspected transfusion complications shall be evaluated promptly according to an established procedure.
(I) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.
(6) Reporting and peer review of a vocational or registered nurse. A hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with the Texas Occupations Code §§301.401 - 301.403, 301.405, and Chapter 303, and with the rules adopted by the Texas Board of Nursing in 22 TAC §217.16 (relating to Minor Incidents), §217.19 (relating to Incident-Based Nursing Peer Review and Whistleblower Protections), and §217.20 (relating to Safe Harbor Nursing Peer Review and Whistleblower Protections).
(7) Policies and procedures related to workplace safety.
(A) The hospital shall adopt, implement, and enforce policies and procedures related to the work environment for nurses which:
(i) improve workplace safety and reduce the risk of injury, occupational illness, and violence; and
(ii) increase the use of ergonomic principles and ergonomically designed devices to reduce injury and fatigue.
(B) The policies and procedures adopted under subparagraph (A) of this paragraph, at a minimum, must include:
(i) evaluating new products and technology that incorporate ergonomic principles;
(ii) educating nurses in the application of ergonomic practices;
(iii) conducting workplace audits to identify areas of risk of injury, occupational illness, or violence and recommending ways to reduce those risks;
(iv) controlling access to those areas identified as having a high risk of violence; and
(v) promptly reporting crimes committed against nurses to appropriate law enforcement agencies.
(8) Safe patient handling and movement practices.
(A) The hospital shall adopt, implement, and enforce policies and procedures to identify, assess, and develop strategies to control risk of injury to patients and nurses associated with the lifting, transferring, repositioning, or movement of a patient.
(B) The policies and procedures shall establish a process that, at a minimum, includes the following:
(i) analysis of the risk of injury to both patients and nurses posed by the patient handling needs of the patient populations served by the hospital and the physical environment in which patient handling and movement occurs;
(ii) education of nurses in the identification, assessment, and control of risks of injury to patients and nurses during patient handling;
(iii) evaluation of alternative ways to reduce risks associated with patient handling, including evaluation of equipment and the environment;
(iv) restriction, to the extent feasible with existing equipment and aids, of manual patient handling or movement of all or most of a patient's weight to emergency, life-threatening, or otherwise exceptional circumstances;
(v) collaboration with and annual report to the nurse staffing committee;
(vi) procedures for nurses to refuse to perform or be involved in patient handling or movement that the nurse believes in good faith will expose a patient or a nurse to an unacceptable risk of injury;
(vii) submission of an annual report to the governing body on activities related to the identification, assessment, and development of strategies to control risk of injury to patients and nurses associated with the lifting, transferring, repositioning, or movement of a patient; and
(viii) development of architectural plans for constructing or remodeling a hospital or a unit of a hospital in which patient handling and movement occurs, with consideration of the feasibility of incorporating patient handling equipment or the physical space and construction design needed to incorporate that equipment at a later date.
(p) Outpatient services. If the hospital provides outpatient services, the services shall meet the needs of the patients in accordance with acceptable standards of practice.
(1) Organization. Outpatient services shall be appropriately organized and integrated with inpatient services.
(2) Personnel.
(A) The hospital shall assign an individual to be responsible for outpatient services.
(B) The hospital shall have appropriate physicians on staff and other professional and nonprofessional personnel available.
(q) Pharmacy services. The hospital shall provide pharmaceutical services that meet the needs of the patients.
(1) Compliance. The hospital shall provide a pharmacy which is licensed, as required, by the Texas State Board of Pharmacy. Pharmacy services shall comply with all applicable statutes and rules.
(2) Organization. The hospital 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 hospital'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 the 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. 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) All drugs and biologicals shall be kept in a secure area, and locked when appropriate.
(i) A policy shall be adopted, implemented, and enforced to ensure the safeguarding, transferring, and availability of keys to the locked storage area.
(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be kept locked within a secure area.
(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 hospital-wide quality assessment and performance improvement 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 accessible 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.
(r) Quality assessment and performance improvement. The governing body shall ensure that there is an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care.
(1) Program scope. The hospital-wide QAPI program shall reflect the complexity of the hospital's organization and services and have a written plan of implementation. The program must include an ongoing program that shows measurable improvements in the indicators for which there is evidence that they will improve health outcomes and identify and reduce medical errors.
(A) All hospital departments and services, including services furnished under contract or arrangement shall be evaluated.
(B) Health care associated infections shall be evaluated.
(C) Medication therapy shall be evaluated.
(D) All medical and surgical services performed in the hospital shall be evaluated as they relate to appropriateness of diagnosis and treatment.
(E) The program must measure, analyze, and track quality indicators, including adverse patients' events, and other aspects of performance that assess processes of care, hospital services and operations.
(F) Data collected must be used to monitor the effectiveness and safety of service and quality of care, and to identify opportunities for changes that will lead to improvement.
(G) Priorities must be established for performance improvement activities that focus on high-risk, high-volume, or problem-prone areas, taking into consideration the incidence, prevalence, and severity of problems in those areas, and how health outcomes and quality of care may be affected.
(H) Performance improvement activities which affect patient safety, including analysis of medical errors and adverse patient events, must be established, and preventive actions implemented.
(I) Success of actions implemented as a result of performance improvement activities must be measured, and ongoing performance must be tracked to ensure improvements are sustained.
(2) Responsibility and accountability. The hospital's governing body, medical staff and administrative staff are responsible and accountable for ensuring that:
(A) an ongoing program for quality improvement is defined, implemented and maintained, and that program requirements are met;
(B) an ongoing program for patient safety, including reduction of medical errors, is defined, implemented and maintained;
(C) the hospital-wide QAPI efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated; and
(D) adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's resources, and for reducing risk to patients.
(3) Medically-related patient care services. The hospital shall have an ongoing plan, consistent with available community and hospital resources, to provide or make available social work, psychological, and educational services to meet the medically-related needs of its patients. The hospital also shall have an effective, ongoing discharge planning program that facilitates the provision of follow-up care.
(A) Discharge planning shall be completed before 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 hospital. In accordance with
42 CFR Part 483
, Subpart C and the HHSC rules set forth in 26 TAC Chapter 303 (relating to Preadmission Screening and Resident Review (PASRR)), all patients who are being considered for discharge from the hospital to a nursing facility shall be screened, and if appropriate, evaluated, before discharge by the hospital and admission to the nursing facility to determine whether the patient may have a mental illness, intellectual disability or developmental disability.
(i) If the screening indicates that the patient has a mental illness, intellectual disability or developmental disability, the hospital shall contact and arrange for the local mental health authority designated pursuant to HSC §533.035, to conduct before hospital discharge an evaluation of the patient in accordance with the applicable provisions of the PASRR rules.
(ii) 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.
(4) Implementation. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.
(s) Radiology services. The hospital shall maintain, or have available, diagnostic radiologic services according to needs of the patients. All radiology equipment, including X-ray equipment, mammography equipment and laser equipment, shall be licensed and registered as required under Chapter 289 of this title (relating to Radiation Control). If therapeutic services are also provided, the services, as well as the diagnostic services, shall meet professionally approved standards for safety and personnel qualifications as required in §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts); §289.229 of this title (relating to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices); §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography); and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) . In a special hospital, portable X-ray equipment may be acceptable as a minimum requirement.
(1) Policies and procedures. Policies and procedures shall be adopted, implemented, and enforced which will describe the radiology services provided in the hospital and how employee and patient safety will be maintained.
(2) Safety for patients and personnel. The radiology services, particularly ionizing radiology procedures, shall minimize hazards to patients and personnel.
(A) Proper safety precautions shall be maintained against radiation hazards. This includes adequate radiation shielding, safety procedures and equipment maintenance and testing.
(B) Inspection of equipment shall be made by or under the supervision of a licensed medical physicist in accordance with §289.227(o) of this title. Defective equipment shall be promptly repaired or replaced.
(C) Radiation workers shall be provided personnel monitoring dosimeters to measure the amount of radiation exposure they receive. Exposure reports and documentation shall be available for review.
(D) Radiology services shall be provided only on the order of individuals granted privileges by the medical staff.
(3) 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.
(4) 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.
(t) Renal dialysis services.
(1) Hospitals may provide inpatient dialysis services without an additional license under HSC Chapter 251. Hospitals providing outpatient dialysis services shall be licensed under HSC Chapter 251.
(2) Hospitals may provide outpatient dialysis services when the governor or the president of the United States declares a disaster in this state or another state. The hospital may provide outpatient dialysis only during the term of the disaster declaration.
(3) Equipment.
(A) Maintenance and repair. All equipment used by a facility, including backup equipment, shall be operated within manufacturer's specifications, and maintained free of defects which could be a potential hazard to patients, staff, or visitors. Maintenance and repair of all equipment shall be performed by qualified staff or contract personnel.
(i) Staff shall be able to identify malfunctioning equipment and report such equipment to the appropriate staff for immediate repair.
(ii) Medical equipment that malfunctions must be clearly labeled and immediately removed from service until the malfunction is identified and corrected.
(iii) Written evidence of all maintenance and repairs shall be maintained.
(iv) After repairs or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning to service. This testing must be documented.
(v) A facility shall comply with the federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §360i(b), concerning reporting when a medical device as defined in
21 USC §321
(h) has or may have caused or contributed to the injury or death of a patient of the facility.
(B) Preventive maintenance. A facility shall develop, implement, and enforce a written preventive maintenance program to ensure patient care related equipment used in a facility receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently as recommended by the manufacturer. The preventive maintenance may be provided by facility staff or by contract.
(C) Backup machine. At least one complete dialysis machine shall be available on site as backup for every ten dialysis machines in use. At least one of these backup machines must be completely operational during hours of treatment. Machines not in use during a patient shift may be counted as backup except at the time of an initial or an expansion survey.
(D) Pediatric patients. If pediatric patients are treated, a facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and bl

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## Nearby sections

- [25 Tex. Admin. Code § 133.41 25 TAC § 133.41. Hospital Functions and Services](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C133_S133_41.md)
- [25 Tex. Admin. Code § 133.42 25 TAC § 133.42. Patient Rights](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C133_S133_42.md)
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- [25 Tex. Admin. Code § 133.55 25 TAC § 133.55. Workplace Violence Prevention](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C133_S133_55.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C133_S133_41. Check the current official text before relying on it. Not legal advice.
