| (ii) a federal, state, or county declaration of emergency
is in effect in the county in which the nurse is employed or is in
effect in a contiguous county;
(iii) there is an emergency or unforeseen event of
a kind that:
(I) does not regularly occur
(II) increases the need for health care personnel at
the hospital to provide safe patient care; and
(III) could not prudently be anticipated by the hospital;
or
(iv) the nurse is actively engaged in an ongoing medical
or surgical procedure and the continued presence of the nurse through
the completion of the procedure is necessary to ensure the health
and safety of the patient. The nurse staffing committee shall ensure
that scheduling a nurse for a procedure that could be anticipated
to require the nurse to stay beyond the end of his or her scheduled
shift does not constitute mandatory overtime.
(F) If a hospital determines that an exception exists
under subparagraph (E) of this paragraph, the hospital shall, to the
extent possible, make and document a good faith effort to meet the
staffing need through voluntary overtime, including calling per diems
and agency nurses, assigning floats, or requesting an additional day
of work from off-duty employees.
(G) A hospital may not suspend, terminate, or otherwise
discipline or discriminate against a nurse who refuses to work mandatory
overtime.
(k) Outpatient services. If the facility provides outpatient
services within the facility, written policies and procedures describing
the operation of the services shall be adopted, implemented and enforced.
(l) Pharmacy services. The facility shall provide pharmaceutical
services that meet the needs of the patients.
(1) License. A facility that stores and dispenses prescription
drugs for administration to a patient by a person authorized by law
to administer the drug, shall be licensed, as required, by the Texas
State Board of Pharmacy.
(2) Organization. The facility shall have a pharmacy
directed by a licensed pharmacist.
(3) Medical staff. The medical staff shall be responsible
for developing policies and procedures that minimize drug errors.
This function may be delegated to the facility's organized pharmaceutical
services.
(4) Pharmacy management and administration. The pharmacy
or drug storage area shall be administered in accordance with accepted
professional principles.
(A) Standards of practice as defined by state law shall
be followed regarding the provision of pharmacy services.
(B) The pharmaceutical services shall have an adequate
number of personnel to ensure quality pharmaceutical services including
emergency services.
(i) The staff shall be sufficient in number and training
to respond to the pharmaceutical needs of the patient population being
served. There shall be an arrangement for emergency services.
(ii) Employees shall provide pharmaceutical services
within the scope of their license and education.
(C) Drugs and biologicals shall be properly stored
to ensure ventilation, light, security, and temperature controls.
(D) Records shall have sufficient detail to follow
the flow of drugs from entry through dispensation.
(E) There shall be adequate controls over all drugs
and medications including floor stock. Drug storage areas shall be
approved by the pharmacist, and floor stock lists shall be established.
(F) Inspections of drug storage areas shall be conducted
throughout the hospital under pharmacist supervision.
(G) There shall be a drug recall procedure.
(H) A full-time, part-time, or consulting pharmacist
shall be responsible for developing, supervising, and coordinating
all the activities of the pharmacy services.
(i) Direction of pharmaceutical services may not require
on premises supervision but may be accomplished through regularly
scheduled visits in accordance with state law.
(ii) A job description or other written agreement shall
clearly define the responsibilities of the pharmacist.
(I) Current and accurate records shall be kept of the
receipt and disposition of all scheduled drugs.
(i) There shall be a record system in place that provides
the information on controlled substances in a readily retrievable
manner which is separate from the patient record.
(ii) Records shall trace the movement of scheduled
drugs throughout the services, documenting utilization or wastage.
(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.
Cont'd... |
