1. (a) The facility shall take the following measures for Hepatitis B prevention.

   1. (1) The facility shall offer Hepatitis B vaccination to all previously unvaccinated, susceptible new staff members in accordance with Code of Federal Regulations, Title 29 §1910.1030(f)(1) - (2) (relating to Bloodborne Pathogens). Staff vaccination records shall be maintained in each staff member's health record.
   2. (2) 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 the vaccination.
   3. (3) The facility shall ensure the most recent Centers for Disease Control and Preventions (CDC) Hepatitis B Vaccine Information Statement is available to patients.

   4. (4) The facility shall ensure serologic screening of patients.

      1. (A) The facility must record 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 before admission to the hemodialysis unit. The facility shall maintain the anti-HBc results obtained previously or on admission in the clinical record and repeated only if clinically indicated.
      2. (B) A patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer shall have been screened for HbsAg within one month before or at the time of admission to the facility or have a known anti-HBs status of at least 10 milli-international units per milliliter no more than 12 months before admission. The facility shall document how this screening requirement is met.

      3. (C) Repeated serologic screening shall be based on the patient's antigen or antibody status.

         1. (i) Monthly screening for HbsAg is required for patients whose previous test results are negative for anti-HBs.
         2. (ii) Screening of HbsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis but shall be performed at least annually.

   5. (5) The facility shall follow appropriate isolation procedures for an HBsAg-positive patient.

      1. (A) An end stage renal disease (ESRD) facility licensed before February 9, 2009, shall comply with §507.16(c)(8) of this chapter (relating to Change in Status). An ESRD facility licensed after February 9, 2009, shall treat patients positive for HBsAg in a separate treatment room that complies with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).
      2. (B) 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 or room, such as clamps, blood pressure cuffs, testing reagents, etc., shall be labeled "isolation" and not routinely removed from the isolation area or room.
      3. (C) Refillable concentrate containers shall be surface disinfected at the completion of each treatment. Refillable acid concentrate containers shall be kept in the isolation area or room and refilled at the door. Refillable bicarbonate concentrate containers shall be removed for cleaning and disinfection. In the disinfection area, containers labeled "isolation" containers and pick-up tubes shall be segregated in a dedicated, designated area away from all other containers and pick-up tubes.
      4. (D) Separate gowns shall be used in the isolation area or room and removed before leaving the isolation area or room. Anyone entering the isolation area or room during the patient's treatment shall wear a protective gown. Gowns used in the isolation area or room shall be discarded at the end of each treatment day. If visibly soiled, gowns shall be changed and discarded immediately.
      5. (E) Dedicated cleaning supplies (such as a mop and bucket) for cleaning the isolation area or room and blood spills shall be used and labeled "isolation."
      6. (F) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for an HBsAg-positive patient's use only.
      7. (G) 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 assigned to the same staff member who is caring for the HBsAg-positive patient.
      8. (H) If an HBsAg-positive patient is discharged, the equipment that had been reserved for that patient shall be given intermediate-level disinfection before use for a patient testing negative for HBsAg.

      9. (I) 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.

         1. (i) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area that is outside of traffic patterns and shall not reuse the dialyzer until the HBsAg test results are known.
         2. (ii) The dialysis machine used by the HBsAg-positive patient shall be given intermediate-level disinfection before its use by another patient.
         3. (iii) The facility shall obtain the patient's HBsAg status results within three calendar days of admission.

2. (b) The facility shall take the following measures for tuberculosis prevention.

   1. (1) The facility direct care staff shall be screened for tuberculosis upon employment before patient contact, or provide documentation of negative tuberculosis status, per current CDC recommendations.
   2. (2) Subsequent screening of facility staff shall be performed after any potential exposure to laryngeal or pulmonary tuberculosis, per current CDC recommendations.
   3. (3) Facility staff shall follow the facility's respiratory isolation procedures and precautions when providing treatment to patients with pulmonary tuberculosis.
   4. (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, per current CDC recommendation.

3. (c) The facility shall adopt, implement, and enforce a policy for offering and providing pneumococcal and influenza vaccines. The policy shall:

   1. (1) include provisions that the influenza vaccine shall be offered according to the CDC annual recommendations, and the pneumococcal vaccine shall be offered throughout the year;
   2. (2) require the facility staff administering the vaccine to ask the 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;
   3. (3) address required vaccination documentation in the patient clinical record; and
   4. (4) include that the Texas Health and Human Services Commission may waive vaccine administration requirements based on established vaccine shortages.

Source Note:The provisions of this §507.38 adopted to be effective December 23, 2025, 50 TexReg 8289.