| (a) Maintenance of records.
(1) Every inventory or other record required to be
kept under the provisions of §291.71 of this title (relating
to Purpose), §291.72 of this title (relating to Definitions), §291.73
of this title (relating to Personnel), §291.74 of this title
(relating to Operational Standards), and this section contained in
Institutional Pharmacy (Class C) shall be:
(A) kept by the institutional pharmacy and be available,
for at least two years from the date of such inventory or record,
for inspecting and copying by the board or its representative, and
other authorized local, state, or federal law enforcement agencies;
and
(B) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the board. If the pharmacy maintains the
records in an electronic format, the requested records must be provided
in a mutually agreeable electronic format if specifically requested
by the board or its representative. Failure to provide the records
set out in this subsection, either on site or within 72 hours, constitutes
prima facie evidence of failure to keep and maintain records in violation
of the Act.
(2) Records of controlled substances listed in Schedules
I and II shall be maintained separately from all other records of
the pharmacy.
(3) Records of controlled substances listed in Schedules
III - V shall be maintained separately or readily retrievable from
all other records of the pharmacy. For purposes of this subsection,
readily retrievable means that the controlled substances shall be
asterisked, redlined, or in some other manner readily identifiable
apart from all other items appearing on the record.
(4) Records, except when specifically required to be
maintained in original or hard-copy form, may be maintained in an
alternative data retention system, such as a data processing or direct
imaging system, provided:
(A) the records in the alternative data retention system
contain all of the information required on the manual record; and
(B) the alternative data retention system is capable
of producing a hard copy of the record upon the request of the board,
its representative, or other authorized local, state, or federal law
enforcement or regulatory agencies.
(b) Outpatient records.
(1) Outpatient records shall be maintained as provided
in §291.34 (relating to Records), and §291.35 (relating
to Official Prescription Requirements), in chapter 291, subchapter
B of this title.
(2) Outpatient prescriptions, including, but not limited
to, furlough and discharge prescriptions, that are written by a practitioner
must be written on a form which meets the requirements of §291.34(b)(7)(A)
of this title. Medication order forms or copies thereof do not meet
the requirements for outpatient forms.
(3) Controlled substances listed in Schedule II must
be written on an official prescription form in accordance with the
Texas Controlled Substances Act, §481.075, and rules promulgated
pursuant to the Texas Controlled Substances Act, unless exempted by
chapter 315 of this title (relating to Controlled Substances). Outpatient
prescriptions for Schedule II controlled substances that are exempted
from the official prescription requirement must be manually signed
by the practitioner.
(c) Patient records.
(1) Original medication orders.
(A) Each original medication order shall bear the following
information:
(i) patient name and room number or identification
number;
(ii) drug name, strength, and dosage form;
(iii) directions for use;
(iv) date; and
(v) signature or electronic signature of the practitioner
or that of his or her authorized agent.
(B) Original medication orders shall be maintained
with the medication administration records of the patients.
(2) Patient medication records (PMR). A patient medication
record shall be maintained for each patient of the facility. The PMR
shall contain at a minimum the following information:
(A) Patient information:
(i) patient name and room number or identification
number;
(ii) gender, and date of birth or age;
(iii) weight and height;
(iv) known drug sensitivities and allergies to drugs
and/or food;
(v) primary diagnoses and chronic conditions;
(vi) primary physician; and
(vii) other drugs the patient is receiving; and
(B) Medication order information:
(i) date of distribution;
(ii) drug name, strength, and dosage form; and
(iii) directions for use.
(3) Controlled substances records. Controlled substances
records shall be maintained as follows:
(A) All records for controlled substances shall be
maintained in a readily retrievable manner; and
(B) Controlled substances records shall be maintained
in a manner to establish receipt and distribution of all controlled
substances.
(4) Schedule II controlled substances records. Records
of controlled substances listed in Schedule II shall be maintained
as follows:
(A) Records of controlled substances listed in Schedule
II shall be maintained separately from records of controlled substances
in Schedules III, IV, and V, and all other records;
(B) An institutional pharmacy shall maintain a perpetual
inventory of any controlled substance listed in Schedule II; and
(C) Distribution records for controlled substances
listed in Schedule II shall bear the following information:
(i) patient's name;
(ii) prescribing or attending practitioner;
(iii) name of drug, dosage form, and strength;
(iv) time and date of administration to patient and
quantity administered;
(v) name, initials, or electronic signature of the
individual administering the controlled substance;
(vi) returns to the pharmacy; and
(vii) waste (waste is required to be witnessed and
cosigned, electronically or manually, by another individual).
(5) Floor stock records.
(A) Distribution records for Schedules II - V controlled
substances floor stock shall include the following information:
(i) patient's name;
(ii) prescribing or attending practitioner;
(iii) name of controlled substance, dosage form, and
strength;
(iv) time and date of administration to patient;
(v) quantity administered;
(vi) name, initials, or electronic signature of the
individual administering drug;
(vii) returns to the pharmacy; and
(viii) waste (waste is required to be witnessed and
cosigned, manually or electronically, by another individual).
(B) The record required by subparagraph (A) of this
paragraph shall be maintained separately from patient records.
(C) A pharmacist shall review distribution records
with medication orders on a periodic basis to verify proper usage
of drugs, not to exceed 30 days between such reviews.
(6) General requirements for records maintained in
a data processing system.
(A) Noncompliance with data processing requirements.
If a hospital pharmacy's data processing system is not in compliance
with the board's requirements, the pharmacy must maintain a manual
recordkeeping system.
(B) Requirements for backup systems. The facility shall
maintain a backup copy of information stored in the data processing
system using disk, tape, or other electronic backup system and update
this backup copy on a regular basis, at least monthly, to assure that
data is not lost due to system failure.
(C) Change or discontinuance of a data processing system.
(i) Records of distribution and return for all controlled
substances. A pharmacy that changes or discontinues use of a data
processing system must:
(I) transfer the records to the new data processing
system; or
(II) purge the records to a printout which contains
the same information as required on the audit trail printout as specified
in paragraph (7)(B) of this subsection. The information on this printout
shall be sorted and printed by drug name and list all distributions/returns
chronologically.
(ii) Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(I) transfer the records to the new data processing
system; or
Cont'd... |
