| (6) Under the provisions of the National Vaccine Injury
Compensation Program (NVICP), the health-care provider under whose
authority a covered vaccine is administered (i.e., the physician issuing
the written protocol) must maintain certain information in the patient's
permanent record. In order for the physician to comply with the provisions
of the NVICP, the pharmacist shall provide the physician with the
information specified in subsection (g) of this section.
(7) Before preparing an immunization or vaccine and
between each patient contact, the pharmacist shall cleanse his or
her hands with an alcohol-based waterless antiseptic hand rub or shall
wash his or her hands with soap and water. If gloves are worn, the
pharmacist shall change gloves between patients.
(8) The pharmacist shall comply with all other state
and federal requirements regarding immunizations or vaccinations.
(f) Drugs.
(1) Drugs administered by a pharmacist under the provisions
of this section shall be in the legal possession of:
(A) a pharmacy, which shall be the pharmacy responsible
for drug accountability, including the maintenance of records of administration
of the immunization or vaccination; or
(B) a physician who shall be responsible for drug accountability,
including the maintenance of records of administration of the immunization
or vaccination.
(2) Drugs shall be transported and stored at the proper
temperatures indicated for each drug.
(3) Pharmacists while actively engaged in the administration
of immunizations or vaccinations under written protocol, may have
in their custody and control the drugs for immunization or vaccination
that are identified in the written protocol and any other dangerous
drugs listed in the written protocol to treat adverse reactions.
(4) After administering immunizations or vaccinations
at a location other than a pharmacy, the pharmacist shall return all
unused prescription medications to the pharmacy or physician responsible
for the drugs.
(g) Notifications.
(1) A pharmacist engaged in the administration of immunizations
or vaccinations shall provide notification of the administration to:
(A) the physician who issued the written protocol within
24 hours of administering the immunization or vaccination; and
(B) the primary care physician of the patient, as provided
by the patient or patient's agent, within 14 days of administering
the immunization or vaccination.
(2) The notifications required in paragraph (1) of
this subsection shall include the:
(A) name and address of the patient;
(B) age of the patient if under 14 years of age;
(C) name of the patient's primary care physician as
provided by the patient or patient's agent;
(D) name, manufacturer, and lot number of the vaccine
administered;
(E) amount administered;
(F) date the vaccine was administered;
(G) site of the immunization or vaccination (e.g.,
right arm, left leg, right upper arm);
(H) route of administration of the immunization or
vaccination (e.g., intramuscular, subcutaneous, by mouth); and
(I) name, address, and title of the person administering
the immunization or vaccination.
(h) Records.
(1) Maintenance of records.
(A) Every record, including notifications, required
to be made under this section shall be kept by the pharmacist administering
the immunization or vaccination and by the pharmacy when in legal
possession of the drugs administered. Such records shall be available
for at least two years from the date of such record, for inspecting
and copying by the board or its representative and to other authorized
local, state, or federal law enforcement or regulatory agencies.
(B) Records, including notifications, may be maintained
in an alternative data retention system, such as a data processing
system or direct imaging system provided:
(i) the records maintained in the alternative system
contain all of the information required on the manual record; and
(ii) the data processing system is capable of producing
a hard copy of the record upon request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(2) Records of administration under written protocol.
(A) Records of administration shall be maintained by
the pharmacist administering immunizations or vaccinations. Such records
shall include:
(i) all of the administration record requirements of
subparagraph (B) of this paragraph; and
(ii) include the name and address of the pharmacy or
physician in legal possession of the immunization or vaccination administered.
(B) A pharmacy, when responsible for drug accountability,
shall maintain a record of administration of immunizations or vaccinations
by a pharmacist. The records shall be kept and maintained by patient
name. This record shall include:
(i) a copy of the written protocol under which the
immunization or vaccination was administered and any patient-specific
deviations from the protocol;
(ii) name and address of the patient;
(iii) age of the patient if under 14 years of age;
(iv) name of the patient's primary care physician as
provided by the patient or patient's agent;
(v) name, manufacturer, and lot number of the vaccine
administered;
(vi) amount administered;
(vii) date the vaccine was administered;
(viii) site of the immunization or vaccination (e.g.,
right arm, left leg, right upper arm);
(ix) route of administration of the immunization or
vaccination (e.g., intramuscular, subcutaneous, by mouth); and
(x) name, address, and title of the person administering
the immunization or vaccination.
(3) Written protocol.
(A) A copy of the written protocol and any patient-specific
deviations from the protocol shall be maintained in accordance with
paragraph (2) of this subsection.
(B) A standard protocol may be used or the attending
physician may develop an immunization/vaccination protocol for the
individual patient. If a standard protocol is used, the physician
shall record what deviations, if any, from the standard protocol are
ordered for the patient. The pharmacy that is in possession of the
vaccines administered shall maintain a copy of any deviations from
the standard protocol ordered by the physician.
(C) Written protocols, including standard protocols,
any patient-specific deviations from a standard protocol, and any
individual patient protocol, shall be reviewed by the physician and
pharmacist at least annually and revised if necessary. Such review
shall be documented in the records of the pharmacy that is in possession
of the vaccines administered.
(i) Confidentiality.
(1) In addition to the confidentiality requirements
specified in §291.27 of this title (relating to Confidentiality)
a pharmacist shall comply with:
(A) the privacy provisions of the federal Health Insurance
Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and
any rules adopted pursuant to this act;
(B) the requirements of Medical Records Privacy contained
in Chapter 181, Health and Safety Code;
(C) the Privacy of Health Information requirements
contained in Chapter 28B of the Insurance Code; and
(D) any other confidentiality provisions of federal
or state laws.
(2) This section shall not affect or alter the provisions
relating to the confidentiality of the physician-patient communication
as specified in the Medical Practice Act, Chapter 159.
|
| Source Note: The provisions of this §295.15 adopted to be effective October 4, 1998, 23 TexReg 9745; amended to be effective December 19, 2001, 26 TexReg 10313; amended to be effective December 6, 2009, 34 TexReg 8721; amended to be effective January 1, 2016, 40 TexReg 8788 |
