| (17) Prior to batch preparation, a label shall be affixed
to the mixing tank that includes the date of preparation and the chemical
composition or formulation of the concentrate being prepared. This
labeling shall remain on the mixing tank until the tank has been emptied.
(18) Mixing tanks shall be permanently labeled to identify
the chemical composition or formulation of their contents.
(19) At a minimum, single machine containers shall
be labeled with sufficient information to differentiate the contents
from other concentrate formulations used in the LSRH and permit positive
identification by users of container contents.
(20) Permanent records of batches produced shall be
maintained to include the concentrate formula produced, the volume
of the batch, lot number(s) of powdered concentrate packages, the
manufacturer of the powdered concentrate, date and time of mixing,
test results, person performing mixing, and expiration date (if applicable).
(21) If dialysate concentrates are prepared in the
facility, the manufacturers' recommendations shall be followed regarding
any preventive maintenance. Records shall be maintained indicating
the date, time, person performing the procedure, and the results (if
applicable).
(cc) With the advice and consent of a patient's attending
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.
(dd) The LSRH shall make available to patients literature
describing the risks and benefits of the hepatitis B vaccination.
(ee) A patient new to dialysis 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
LSRH shall document how this screening requirement is met.
(1) Repeated serologic screening shall be based on
the antigen or antibody status of the patient.
(2) Monthly screening for HBsAg is required for patients
whose previous test results are negative for HBsAg.
(3) Screening of HBsAg-positive or anti-HBs-positive
patients may be performed on a less frequent basis, provided that
the LSRH's policy on this subject remains congruent with Appendices
i and ii of the National Surveillance of Dialysis Associated Disease
in the United States, 2000, published by the United States Department
of Health and Human Services.
(ff) The LSRH shall treat patients positive for HBsAg
in a segregated treatment area that includes a hand washing sink,
a work area, patient care supplies and equipment, and sufficient space
to prevent cross-contamination to other patients.
(1) A patient who tests positive for HBsAg shall be
dialyzed on equipment reserved and maintained for the HBsAg-positive
patient's use only.
(2) When a caregiver is assigned to both HBsAg-negative
and HBsAg-positive patients, the HBsAg-negative patients assigned
to this grouping must 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.
(3) If an HBsAg-positive patient is discharged, the
equipment that had been reserved for that patient shall be given intermediate
level disinfection prior to use for a patient testing negative for
HBsAg.
(4) In the case of patients new to dialysis, 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.
(A) The LSRH shall treat potentially HBsAg-positive
patients in a location in the treatment area that is outside of traffic
patterns until the HBsAg test results are known.
(B) The dialysis machine used by this patient shall
be given intermediate level disinfection prior to its use by another
patient.
(C) The LSRH shall obtain HBsAg status results of the
patient no later than three days from admission.
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