TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER b: HOSPITALS AND AMBULATORY CARE FACILITIES
PART 265 BIRTH CENTER DEMONSTRATION PROGRAM CODE
SECTION 265.1450 NOTICE OF VIOLATION AND PLAN OF CORRECTION
Section 265.1450 Notice of Violation and Plan of Correction
a) Upon determination that the licensee or applicant is in violation of the Act or this Part, the Department shall issue a written Notice of Violation and request a plan of correction. The notice shall specify the violations and shall instruct the licensee or applicant to submit a plan of correction to the Department within 10 days after receipt of the Notice.
b) Within the 10-day period, a licensee or applicant may request additional time for submission of the plan of correction. The Department may extend the period for submission of the plan of correction for an additional 30 days if the Department finds that corrective action by the birth center to abate or eliminate the violations will require substantial capital improvement. The Department will consider the extent and complexity of necessary physical plant repairs and improvements and any impact on the health, safety, or welfare of the clients of the birth center in determining whether to grant a requested extension.
c) Each plan of correction shall be based on the birth center's assessment of the conditions or occurrences that are the basis of the violations and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences. The birth center shall maintain documentation of such assessment and evaluation. Each acceptable plan of correction shall include:
1) The procedure for implementing the plan of correction for each deficiency cited, typed in the right-hand column of the original Statement of Deficiencies;
2) The title of the individual responsible for implementing and monitoring the plan of correction;
3) Documentation that the facility has incorporated systemic improvement efforts into its quality assessment and performance improvement program in order to prevent the recurrence of the deficient practice;
4) Supporting documentation of correction;
5) Procedures for monitoring and tracking to ensure that the plan of correction is effective;
6) A completion date for correction of each deficiency cited, along with interim dates for any phases or intermediate steps; and
7) Date and signature of the authorized representative, on the bottom of page one of the original Statement of Deficiencies and Plan of Correction.
d) Submission of a plan of correction shall not be considered an admission by the birth center that the violation has occurred.
e) The applicant or licensee may submit additional information in response to the Notice of Violation that it believes will clarify the condition or alleged violation. The Department will consider the information in reviewing the applicant's or licensee's response and the plan of correction.
f) The Department will review each plan of correction to ensure that it provides for the abatement, elimination, or correction of the violation. The Department will reject a submitted plan only if it finds any of the following deficiencies:
1) The plan does not address the conditions or occurrences that are the basis of the violation and does not evaluate the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.
2) The plan does not indicate the specific actions that the birth center will be taking to abate, eliminate, or correct the violation.
3) The plan does not provide for measures that will abate, eliminate, or correct the violation.
4) The plan does not provide steps that will avoid future occurrence of the same and similar violations.
5) The plan does not provide for timely completion of the corrective action, considering the seriousness of the violation, any possible harm to the clients, and the extent and complexity of the corrective action.
g) The Department will notify the licensee or applicant if the plan of correction is rejected, including specific reasons for the rejection of the plan. The birth center shall submit a modified plan that addresses the requirements of subsection (c) of this Section within five days after receipt of the notice of rejection.
h) If a licensee or applicant fails to submit a modified plan of correction as required in subsection (g), or if the modified plan is not acceptable to the Department, the Department will specify and impose a plan of correction.
i) The Department will verify the completion of the corrective action required by the plan of correction within the specified time period during subsequent investigations, surveys, and evaluations of the birth center.