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Based on interview and review of the hospital's quality plan, quality improvement program, and performance data, the Critical Access Hospital's Governing Body failed to meet the requirements for the Condition of Participation for Organizational Structure.

Failure to meet established organizational structure requirements and responsibilities impaired the hospital's ability to provide quality care in a safe environment.

Reference: CFR 485.627(a) "The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing, and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment."

Findings included:

The Governing Body failed to ensure the hospital developed and implemented an effective quality assurance program for investigating and analyzing serious patient outcomes, and for developing and monitoring performance indicators to minimize patient risk.

Due to the scope and severity of deficiencies detailed under the Conditions of Participation at 42 CFR 485.641 Periodic Evaluation and Quality Monitoring, the Condition of Participation for Organizational Structure was NOT MET.

Cross-reference: Tag C0330.
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Based on interview and review of the hospital's quality assurance plan and quality program documentation, the Critical Access Hospital (CAH) failed to implement its plan to monitor, evaluate, and improve the quality of patient care services through routine data collection and analysis.

Failure to systematically collect and analyze facility performance data limits the hospital's ability to identify problems and formulate action plans. This reduces the likelihood of sustained improvements in clinical care and patient outcomes.

References:

§485.641(a) Standard: Periodic Evaluation. (1) The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year and includes review of -
(i) The utilization of CAH services, including at least the number of patients served and the volume of services;
(ii) A representative sample of both active and closed clinical records; and
(iii) The CAH's health care policies.
(2) The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed...

(5)(i) The CAH staff considers the findings of the evaluations, including findings or recommendations of the QIO; and takes corrective action if necessary; (5)(ii) The CAH also takes appropriate remedial action to address deficiencies found through the quality assurance program; (5)(iii) The CAH documents the outcome of all remedial action.

Findings included:

1. Review of the hospital's policy titled "Quality Improvement Plan", Reference #24.001, revised February 2017 and reviewed 08/15/18, showed that all hospital personnel and departments were expected to be actively involved with the quality program. Each department was to develop a dashboard report that monitored "important departmental work process and departmental services." Contracted services providing direct patient care or services affecting the health and safety of patients would be included in the on-going monitoring activities.

2. On 10/11/18 between 10:00 AM and 11:45 AM, Surveyor #7 interviewed the hospital's quality program director (Staff #701) and reviewed the hospital's quality program. This interview and review showed the following:

a. The program did not include and assess performance metrics for all hospital services and departments as directed by the hospital's quality plan.

b. Contracted patient care service providers not reviewed through the medical staff credentialing process (e.g. teleradiology, reference laboratory, and biomedical equipment maintenance services) were reviewed by individual department managers. Results of these performance reviews were not forwarded to the hospital's quality committee.

c. Adverse occurrences such as falls and medication errors were analyzed individually but not aggregated to determine if the causes of these events had common factors, patterns, and trends. This deficiency was identified during the hospital's last state licensing survey in 2017 but was not corrected according to the hospital's plan of correction.

d. The hospital did not perform an annual CAH program evaluation in 2017. The hospital did not have a policy and procedure for performing annual program evaluations according to Centers for Medicare and Medicaid Services requirements.

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 485.641 Periodic Evaluation and Quality Monitoring was NOT MET.
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