| (A) The ESRD facility shall comply with the requirements set forth by the department in §§1.131-1.137 of this title (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities) and the Texas Commission on Environmental Quality (TCEQ) requirements in 30 Texas Administrative Code, §330.1207 (relating to Generators of Medical Waste). (B) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with Title 30, Texas Administrative Code, Chapter 285 (relating to On-Site Sewage Facilities). (2) Waste containers. (A) Waste containers shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location(s) into closed containers. (B) Waste containers shall be cleaned and properly maintained and free of visible residue. (C) All containers for other municipal solid waste shall be leak-resistant, have covers, be rodent-proof, and comply with local sanitation requirements. (D) Nonreusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations. (d) Hepatitis B prevention. (1) The facility shall offer hepatitis B vaccination to previously unvaccinated, susceptible new staff members in accordance with 29 Code of Federal Regulations, §1910.1030(f)(1) - (2) (concerning Bloodborne Pathogens). Staff vaccination records shall be maintained in each staff member's health record. (2) Prevention requirements concerning patients. (A) Hepatitis B vaccination. (i) With an order from the patient's nephrologist, facility staff shall make the hepatitis B vaccine available to a patient who is susceptible to hepatitis B, provided that the patient has coverage or is willing to pay for vaccination. (ii) The facility shall make available to patients literature describing the risks and benefits of the hepatitis B vaccination. (B) Serologic screening of patients. (i) The Hepatitis B virus (HBV) serological status to include Hepatitis B surface antigen (HBsAg), total anti-Hepatitis B core antibody (anti-HBc), and antibody to Hepatitis B surface antigen (anti-HBs) of all patients should be known before admission to the hemodialysis unit. The anti-HBc results obtained previously or on admission shall be maintained in the clinical record and repeated only if clinically indicated. (ii) A patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer shall have been screened for hepatitis B surface antigen (HBsAg) within one month before or at the time of admission to the facility or have a known hepatitis B surface antibody (anti-HBs) status of at least 10 milli-international units per milliliter no more than 12 months prior to admission. The facility shall document how this screening requirement is met. (iii) Repeated serologic screening shall be based on the antigen or antibody status of the patient. (I) Monthly screening for HBsAg is required for patients whose previous test results are negative for anti-HBs. (II) Screening of HBsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis, but must be performed at least annually. (C) Isolation procedures for the HBsAg-positive patient. (i) An ESRD facility which was licensed prior to the effective date of these rules shall comply with §117.101 of this title (relating to Construction Requirements for an Existing End Stage Renal Disease Facility). An ESRD facility which is licensed after the effective date of these rules shall treat patients positive for HBsAg in a separate treatment room which complies with §117.102(d)(4) of this title (relating to Construction Requirements for a New End Stage Renal Disease Facility). (ii) Separate dedicated supplies and equipment, including blood glucose monitors, shall be used to provide care to the Hepatitis B positive patients. All supplies used in the isolation area/room, such as clamps, blood pressure cuffs, testing reagents, etc., shall be labeled "isolation" and not routinely removed from the isolation area/room. (iii) Refillable concentrate containers shall be surface disinfected at the completion of each treatment. Refillable acid concentrate containers shall be kept in the isolation area/room and refilled at the door. Refillable bicarbonate concentrate containers shall be removed for cleaning and disinfection. In the disinfection area, containers labeled "isolation" container(s) and pick-up tube(s) shall be segregated in a dedicated, designated area away from all other containers and pick-up tubes. (iv) Separate gowns shall be used in the isolation area/room and removed before leaving the isolation area/room. Any one entering the isolation area/room during the patient's treatment must wear a protective gown. (v) Dedicated cleaning supplies (i.e., mop, bucket) for the cleaning of the isolation area/room and blood spills shall be utilized and labeled "isolation." (vi) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for an HBsAg-positive patient's use only. (vii) When a direct patient care staff member is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping shall be Hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and be assigned to the same staff member who is caring for the HBsAg-positive patient. (viii) If an HBsAg-positive patient is discharged, the equipment which had been reserved for that patient shall be given intermediate-level disinfection prior to use for a patient testing negative for HBsAg. (ix) In the case of patients new to dialysis or a patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer, if these patients are admitted for treatment before results of HBsAg or anti-HBs testing are known, these patients shall undergo treatment as if the HBsAg test results were potentially positive, except that they shall not be treated in the HBsAg isolation room, area, or machine. (I) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area which is outside of traffic patterns and may not reuse the dialyzer until the HBsAg test results are known. (II) The dialysis machine used by this patient shall be given intermediate-level disinfection prior to its use by another patient. (III) The facility shall obtain HBsAg status results of the patient no later than three days from admission. (e) Tuberculosis prevention. (1) The facility's direct care staff shall be screened for tuberculosis upon employment prior to patient contact, or provide documentation of negative tuberculosis status. (2) Subsequent screening of facility staff shall be performed after any potential exposure to laryngeal or pulmonary tuberculosis. (3) Respiratory isolation procedures and precautions developed by the facility shall be employed by facility staff providing treatment to patients with pulmonary tuberculosis. (4) The facility shall screen patients for tuberculosis when indicated by the presence of risk factors for, or the signs and symptoms of tuberculosis. Screening shall be performed after potential exposure to active laryngeal or pulmonary tuberculosis. (f) The facility shall adopt, implement, and enforce a policy for offering and providing pneumococcal and influenza vaccines for elderly persons. The policy shall: (1) establish that an elderly person, defined as 65 years of age or older, who receives ongoing care at the facility, is offered, to the extent possible as determined by the facility, the opportunity to receive the pneumococcal and influenza vaccines, if a physician, or an advanced practice registered nurse or physician assistant on behalf of a physician, determines that the vaccine is in the person's best interest. If the facility decides it is not feasible to offer the vaccine, the facility shall provide the person with information on other options for obtaining the vaccine; (2) include provisions that the influenza vaccine shall be offered according to the Centers for Disease Control annual recommendations, and the pneumococcal vaccine shall be offered throughout the year; (3) require that the person administering the vaccine ask the elderly patient if they are currently vaccinated against influenza or pneumococcal disease, assess potential contraindications, and then, if appropriate, administer the vaccine under approved facility protocols; (4) address required documentation of the vaccination in the patient clinical record; and (5) include that the department may waive requirements related to the administration of the vaccines based on established shortages of the vaccines. |
