Md. Code Regs. 10.05.01.08 - Quality Assurance Program
A.
The administrator shall ensure that the facility develops and maintains a
quality assurance program which includes:
(1)
Monitoring and evaluation of the quality of patient care;
(2) Identification, evaluation, and
resolution of care problems; and
(3) A peer review process.
B. The facility shall conduct
ongoing quality assurance activities and document the activities on a
continuous basis, but not less than quarterly.
C. Peer Review. The administrator shall
ensure that the facility establishes a peer review process that includes:
(1) A mechanism to evaluate the clinical
performance of each health care practitioner on a continuous basis, but not
less than annually;
(2) Procedures,
approved by a qualified health care practitioner to identify and minimize risks
to the patient; and
(3)
Documentation of each health care practitioner's annual evaluation.
D. Practitioner Performance
Evaluation in a Facility.
(1) The
administrator shall ensure that the facility establishes a practitioner
performance evaluation process that includes a review of care which shall:
(a) Be undertaken for cases chosen at random
and for cases with unexpected adverse outcomes;
(b) Be based on objective review
standards;
(c) Include a review of
the appropriateness of the plan of care for the patient, particularly any
medical procedures performed on the patient, in relation to the patient's
condition; and
(d) Be conducted by
at least two members of the medical staff who:
(i) As appropriate, are of the same specialty
as the member of the medical staff under review; and
(ii) Have been trained in the freestanding
ambulatory care facility's policies and procedures regarding practitioner
performance evaluation.
(2) A review of the care provided by a member
of the medical staff who is a solo practitioner shall be conducted by an
external reviewer.
(3) A
freestanding ambulatory care facility shall take into account the results of
the practitioner performance evaluation process for a member of the medical
staff in the reappointment process.
E. Equipment Quality Control.
(1) The administrator shall ensure that the
facility develops a quality control procedure to monitor the safety and
performance of all biomedical equipment.
(2) In developing its procedures, the
administrator shall consider:
(a) FDA
recommendations; and
(b) The
equipment manufacturer's recommendations.
F. Documentation.
(1) At the time of application, the applicant
shall submit a written description of the facility's quality assurance program
which includes, at a minimum:
(a) A
description of how the facility will comply with §A of this regulation;
and
(b) The manner in which
information will be collected.
(2) The facility shall submit any revisions
to its quality assurance program at the time of licensure renewal.
G. Quality Assurance Records. The
facility shall document the following information for all quality assurance
activities:
(1) A description of identified
problems;
(2) Findings;
(3) Conclusions;
(4) Recommendations;
(5) Actions taken;
(6) Results; and
(7) Follow-up.
Notes
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