| (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) Drugs and biologicals shall be kept in a locked
storage area.
(i) A policy shall be adopted, implemented, and enforced
to ensure the safeguarding, transferring, and availability of keys
to the locked storage area.
(ii) Dangerous drugs as well as controlled substances
shall be secure from unauthorized use.
(C) Outdated, mislabeled, or otherwise unusable drugs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 facility-wide quality assurance
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 available 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.
(m) Quality assurance. The governing body shall ensure
that there is an effective, ongoing, facility-wide, data-driven quality
assurance (QA) program to evaluate the provision of patient care.
(1) Implementation plan. The facility-wide QA program
shall be on-going and have a written plan of implementation.
(A) All organized services related to patient care,
including services furnished by contract, shall be evaluated.
(B) Nosocomial infections and medication therapy shall
be evaluated.
(C) All medical services performed in the facility
shall be evaluated as they relate to appropriateness of diagnosis
and treatment.
(2) Implementation. The facility shall take and document
appropriate remedial action to address deficiencies found through
the QA program. The facility shall document the outcome of the remedial
action.
(3) Discharge planning. The facility 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 facility. 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 facility to a nursing facility shall be screened,
and if appropriate, evaluated, prior to discharge by the facility
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
facility shall contact and arrange for the local mental health authority
designated pursuant to Texas Health and Safety Code, §533.035,
to conduct prior to facility 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.
(n) Radiology services. When radiology services are
provided, written policies and procedures shall be adopted, implemented
and enforced which describe the radiology services provided in the
facility and how employee and patient safety will be maintained.
(1) Proper safety precautions shall be maintained
against radiation hazards. This includes adequate shielding for patients,
personnel, and facilities.
(2) Inspection of equipment shall be made periodically.
Defective equipment shall be promptly repaired or replaced.
(3) Radiation workers shall be checked, by the use
of exposure meters or badge tests, for amount of radiation exposure.
Exposure reports and documentation shall be available for review.
(4) Radiology services shall be provided only on the
order of individuals with privileges granted by the medical staff
and of other physicians or practitioners authorized by the medical
staff and governing body to order such services.
(5) Personnel.
(A) A qualified full-time, part-time, or consulting
radiologist shall supervise the ionizing radiology services and shall
interpret only those radiology tests that are determined by the medical
staff to require a radiologist's specialized knowledge. For purposes
of this section a radiologist is a physician who is qualified by education
and experience in radiology in accordance with medical staff bylaws.
(B) Only personnel designated as qualified by the medical
staff shall use the radiology equipment and administer procedures.
(6) Records. Records of radiology services shall be
maintained. The radiologist or other individuals who have been granted
privileges to perform radiology services shall sign reports of his
or her interpretations.
(o) Respiratory care services. When respiratory care
services are provided, written policies and procedures shall be adopted,
implemented, and enforced which describe the provision of respiratory
care services in the facility. Personnel qualified to perform specific
procedures and the amount of supervision required for personnel to
carry out specific procedures shall be designated in writing.
(p) Waste and waste disposal.
(1) Special waste and liquid/sewage waste management.
(A) The hospital shall comply with the requirements
set forth by the department in §§1.131 - 1.137 of this title
(relating to Definition, Treatment, and Disposition of Special Waste
from Health Care Related Facilities) and the Texas Commission on
Environmental Quality (TCEQ) requirements in 30 TAC §330.1207
(relating to Generators of Medical Waste).
Cont'd... |
