(iii) The pharmacist shall be responsible for determining
that all drug records are in order and that an account of all scheduled
drugs is maintained and reconciled with written orders.
(5) Delivery of services. In order to provide patient
safety, drugs and biologicals shall be controlled and distributed
in accordance with applicable standards of practice, consistent with
federal and state laws.
(A) All compounding, packaging, and dispensing of drugs
and biologicals shall be under the supervision of a pharmacist and
performed consistent with federal and state laws.
(B) All drugs and biologicals shall be kept in a secure
area, and locked when appropriate.
(i) A policy shall be adopted, implemented, and enforced
to ensure the safeguarding, transferring, and availability of keys
to the locked storage area.
(ii) Drugs listed in Schedules II, III, IV, and V of
the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall
be kept locked within a secure area.
(C) Outdated, mislabeled, or otherwise unusable drugs
and biologicals shall not be available for patient use.
(D) When a pharmacist is not available, drugs and biologicals
shall be removed from the pharmacy or storage area only by personnel
designated in the policies of the medical staff and pharmaceutical
service, in accordance with federal and state laws.
(i) There shall be a current list of individuals identified
by name and qualifications who are designated to remove drugs from
the pharmacy.
(ii) Only amounts sufficient for immediate therapeutic
needs shall be removed.
(E) Drugs and biologicals not specifically prescribed
as to time or number of doses shall automatically be stopped after
a reasonable time that is predetermined by the medical staff.
(i) Stop order policies and procedures shall be consistent
with those of the nursing staff and the medical staff rules and regulations.
(ii) A protocol shall be established by the medical
staff for the implementation of the stop order policy, in order that
drugs shall be reviewed and renewed, or automatically stopped.
(iii) A system shall be in place to determine compliance
with the stop order policy.
(F) Drug administration errors, adverse drug reactions,
and incompatibilities shall be immediately reported to the attending
physician and, if appropriate, to the hospital-wide quality assessment
and performance improvement program. There shall be a mechanism in
place for capturing, reviewing, and tracking medication errors and
adverse drug reactions.
(G) Abuses and losses of controlled substances shall
be reported, in accordance with applicable federal and state laws,
to the individual responsible for the pharmaceutical services, and
to the chief executive officer, as appropriate.
(H) Information relating to drug interactions and information
on drug therapy, side effects, toxicology, dosage, indications for
use, and routes of administration shall be immediately available to
the professional staff.
(i) A pharmacist shall be readily accessible by telephone
or other means to discuss drug therapy, interactions, side effects,
dosage, assist in drug selection, and assist in the identification
of drug induced problems.
(ii) There shall be staff development programs on drug
therapy available to facility staff to cover such topics as new drugs
added to the formulary, how to resolve drug therapy problems, and
other general information as the need arises.
(I) A formulary system shall be established by the
medical staff to ensure quality pharmaceuticals at reasonable costs.
(r) Quality assessment and performance improvement.
The governing body shall ensure that there is an effective, ongoing,
hospital-wide, data-driven quality assessment and performance improvement
(QAPI) program to evaluate the provision of patient care.
(1) Program scope. The hospital-wide QAPI program shall
reflect the complexity of the hospital's organization and services
and have a written plan of implementation. The program must include
an ongoing program that shows measurable improvements in the indicators
for which there is evidence that they will improve health outcomes,
and identify and reduce medical errors.
(A) All hospital departments and services, including
services furnished under contract or arrangement shall be evaluated.
(B) Health care associated infections shall be evaluated.
(C) Medication therapy shall be evaluated.
(D) All medical and surgical services performed in
the hospital shall be evaluated as they relate to appropriateness
of diagnosis and treatment.
(E) The program must measure, analyze and track quality
indicators, including adverse patients' events, and other aspects
of performance that assess processes of care, hospital services and
operations.
(F) Data collected must be used to monitor the effectiveness
and safety of service and quality of care, and to identify opportunities
for changes that will lead to improvement.
(G) Priorities must be established for performance
improvement activities that focus on high-risk, high-volume, or problem-prone
areas, taking into consideration the incidence, prevalence and severity
of problems in those areas, and how health outcomes and quality of
care may be affected.
(H) Performance improvement activities which affect
patient safety, including analysis of medical errors and adverse patient
events, must be established, and preventive actions implemented.
(I) Success of actions implemented as a result of performance
improvement activities must be measured, and ongoing performance must
be tracked to ensure improvements are sustained.
(2) Responsibility and accountability. The hospital's
governing body, medical staff and administrative staff are responsible
and accountable for ensuring that:
(A) an ongoing program for quality improvement is defined,
implemented and maintained, and that program requirements are met;
(B) an ongoing program for patient safety, including
reduction of medical errors, is defined, implemented and maintained;
(C) the hospital-wide QAPI efforts address priorities
for improved quality of care and patient safety, and that all improvement
actions are evaluated; and
(D) adequate resources are allocated for measuring,
assessing, improving and sustaining the hospital's resources, and
for reducing risk to patients.
(3) Medically-related patient care services. The hospital
shall have an ongoing plan, consistent with available community and
hospital resources, to provide or make available social work, psychological,
and educational services to meet the medically-related needs of its
patients. The hospital also shall have an effective, ongoing discharge
planning program that facilitates the provision of follow-up care.
(A) Discharge planning shall be completed prior to
discharge.
(B) Patients, along with necessary medical information,
shall be transferred or referred to appropriate facilities, agencies,
or outpatient services, as needed for follow-up or ancillary care.
(C) Screening and evaluation before patient discharge
from hospital. In accordance with 42 Code of Federal Regulations (CFR),
Part 483, Subpart C (relating to Requirements for Long Term Care Facilities)
and the rules of the Department of Aging and Disability Services (DADS)
set forth in 40 TAC Chapter 17 (relating to Preadmission Screening
and Resident Review (PASRR)), all patients who are being considered
for discharge from the hospital to a nursing facility shall be screened,
and if appropriate, evaluated, prior to discharge by the hospital
and admission to the nursing facility to determine whether the patient
may have a mental illness, intellectual disability or developmental
disability. If the screening indicates that the patient has a mental
illness, intellectual disability or developmental disability, the
hospital shall contact and arrange for the local mental health authority
designated pursuant to Health and Safety Code, §533.035, to conduct
prior to hospital discharge an evaluation of the patient in accordance
with the applicable provisions of the PASRR rules. The purpose of
PASRR is:
(i) to ensure that placement of the patient in a nursing
facility is necessary;
(ii) to identify alternate placement options when applicable;
and
(iii) to identify specialized services that may benefit
the person with a diagnosis of mental illness, intellectual disability,
or developmental disability.
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