Section 210.1500  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 violation(s), 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 ten-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, when the Department finds that corrective action by the Model to abate or eliminate the violation(s) 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 patients of the Model in determining whether to grant a requested extension.

c)         Each plan of correction shall be based on an assessment by the Model of the conditions or occurrences that are the basis of the violation(s) and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.  Evidence of such assessment and evaluation shall be maintained by the Model.  Each plan of correction shall include:

1)         A description of the specific corrective action the Model is taking, or plans to take, to abate, eliminate, or correct the violation(s) cited in the Notice;

2)         A description of the steps that will be taken to avoid future occurrences of the same and similar violation(s); and

3)         A specific date by which the corrective action will be completed.

d)         Submission of a plan of correction shall not be considered an admission by the Model that the violation(s) 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(s).  The Department will consider the information in reviewing the applicant's or licensee's response and the plan of correction.

f)         The Department shall review each plan of correction to ensure that it provides for the abatement, elimination, or correction of the violation.  The Department shall 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 an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.

2)         The plan is not specific enough to indicate the actual actions the Model 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 occurrences 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 patients, and the extent and complexity of the correction action.

g)         The Department shall notify the licensee or applicant if the plan of correction is rejected, including specific reasons for the rejection of the plan.  The Model shall submit a modified plan that addresses the requirements of subsection (c) of this Section within five days after receipt of notice of rejection.

h)         If a licensee or applicant fails to make a timely submission of a modified plan of correction, or such modified plan is not acceptable to the Department, a plan of correction shall be specified and imposed by the Department.

i)          The Department shall 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 Model.