Current through Reg. 49, No. 38; September 20, 2024
(a) Quality
Assurance (QA) Program. A licensed abortion facility shall maintain a QA
program in the facility which shall be implemented by a QA committee. The QA
program shall be ongoing and have a written plan of implementation. This plan
shall be reviewed and updated or revised at least annually by the QA Committee.
The QA program shall include measures for quality improvement in the
measurement of the facility's delivery of service. Quality assurance documents
pertinent to the facility shall be kept within the facility.
(b) QA committee membership. At a minimum,
the QA committee shall consist of at least:
(1) the medical consultant designated by the
facility;
(2) an advanced practice
registered nurse, a physician assistant, a registered nurse, or a licensed
vocational nurse; and
(3) at least
two other members of the facility's staff.
(c) Frequency of QA committee meetings. The
QA committee, by consensus, shall meet at least quarterly to identify issues
with respect to which quality assurance activities are necessary.
(d) Minimum responsibilities. The QA
committee shall:
(1) evaluate all organized
services related to patient care, including services furnished by
contract;
(2) ensure that there is
a review of any abortion procedure complication(s), and shall make use of the
findings in the development and revision of facility policies;
(3) address issues of unprofessional conduct
by any member of the facility's staff (including contract staff);
(4) monitor infection control as outlined in
§
139.49
of this title (relating to Infection Control Standards) and post-procedure
infections as outlined in §
139.41
of this title (relating to Policy Development and Review);
(5) address medication therapy
practices;
(6) address the
integrity of surgical instruments, medical equipment, and patient supplies;
and
(7) address services performed
in the facility as they relate to appropriateness of diagnosis and
treatment.
(e) Patient
care and service issues. The QA committee shall identify and address patient
care services and information issues and implement corrective action plans as
necessary.
(1) Identifying issues that
necessitate corrective action. The QA committee shall be responsible for
identifying issues that necessitate corrective action by the committee, such as
issues which negatively affect care or services provided to patients.
(2) Plan of corrective action. The QA
committee shall develop and implement plans of action to correct identified
deficiencies.
(3) Remedial action.
The QA committee shall take and document remedial action to address
deficiencies found through the QA program. The facility shall document the
outcome of the remedial action.
(f) Departmental review.
(1) The department shall not use good faith
efforts by the QA committee to identify and correct deficiencies as a basis for
deficiency(ies), citation(s), or sanction(s).
(2) Department surveyors shall verify that:
(A) the facility has a QA committee which
addresses concerns; and
(B) the
facility staff know how to access that process.
