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Based on interviews and record reviews, the CAH (Critical Access Hospital) failed to ensure that an effective reporting process was in place that proactively identified causative factors with corrective actions implemented to reduce or prevent ADR (Adverse Drug Reactions), medication errors and "near misses", and the CAH failed to have a process in place to report unexpected or significant adverse drug reactions to the Food and Drug Administration (FDA) in accordance with the MedWatch Program.

Findings:
A review of the hospital policy titled, "Adverse Drug Reactions and Medication Error Reporting", revised on 7/09/14 and provided by S5RPh as the most current, revealed in part: When nursing personnel discovers an ADR, the RN in charge will notify the prescribing physician. When a medication error occurs, a medication error report form must be filled out by the nursing supervisor. The Director of Nursing will take the reports to the Director of Pharmacy for review and the reports will be discussed at the P&T (Pharmacy and Therapeutics Committee) and recommendations will be made by the P&T committee. The reports are then kept on file in the Pharmacy Department.

In an interview on 6/09/15 at 1:20 p.m. with S5RPh, she indicated that she was the Director of Pharmacy. S5RPh was asked about the reporting of ADR and medication errors. S5RPh indicated that the ADR and medication errors were solely based on incident reporting by staff to identify ADR and medication errors. S5RPh indicated that the Pharmacy Department did not perform periodic/random chart audits to capture additional ADR or medication errors. S5RPh further indicated that "near misses" were under-reported by staff since there was not a system in place to capture "near misses". S5RPh indicated that the ADR and medication error incident reports were filed in the Pharmacy Department after they are reviewed by the Director of Nursing and the P&T committee S5RPh was asked for the data and analyses of the reports and how corrective actions were determined and evaluated for compliance. S5RPh indicated that she did not perform any data analyses on ADR or medication errors and would usually just have inservices with staff/individuals as needed. S5RPh was asked if unexpected or significant ADR were reported to the Food and Drug Administration (FDA) in accordance with the MedWatch Program. S5RPh indicated that she was not aware of that program.

In an interview on 6/09/15 at 3:10 p.m. with S2CNO, she indicated that she was the RPh's supervisor. S2CNO was asked about the reporting of ADR and medication errors. S2CNO indicated that ADR and medication error incidents reports were reviewed by her and then presented to the P&T committee. S2CNO indicated that neither she nor the P&T committee performed any data analyses on the ADR and/or medication error incident reports to determined what specific corrective actions should be implemented and evaluated for compliance. S2CNO indicated that the hospital conducted staff in-services as needed and/or individual staff in-services. S2CNO was asked if unexpected or significant ADR were reported to the Food and Drug Administration (FDA) in accordance with the MedWatch Program. S2CNO indicated that she was not aware of that program.

In an interview on 6/10/15 at 9:30 a.m. with S4QA, he was asked if ADR, medication errors or "near misses" were quality indicators being monitored by the QA (Quality Assurance) department. S4QA indicated that he had no quality indicators being monitored for ADR, medication errors or "near misses".

Based on interviews and record reviews, the CAH (Critical Access Hospital) failed to ensure that policies were developed that incorporated the OPO (Organ Procurement Organization) and the hospital's definition of Clinical Triggers, Imminent Death and Timely Notification in order to identify potential donors as agreed upon by the hospital's OPO contract and in accordance with the Louisiana Uniform Anatomical Gift Act. This failed practice was evidenced by no documentation in the hospital's "Organ and Tissue Donation" policy that included a definition of Clinical Triggers, Imminent Death and Timely Notification.
Findings:

A review of the hospital's OPO signed contract, provided by S2CNO, as the current contract, revealed in part: By entering into this agreement, the Donor Hospital agrees to meet all the obligations set forth by the Louisiana Uniform Anatomical Gift Act and CMS. Timely referral is defined as within 2 hours or less of when a Donor Hospital identifies a patient that meets the criteria for medically established "Clinical Triggers/ Imminent Death" for organ donation evaluation as established by the Donor Hospital's definition of "Clinical Triggers/Imminent Death".

A review of the hospital policy titled, "Organ/Tissue/Eye Donation-Nursing Staff Responsibilities", REF 2135, as provided by S2CNO as the most current, revealed in part: It is the responsibility of the CAH to notify the OPO of all deaths. The charge nurse will give the OPO the information required and the OPO will make the decision if patient qualifies as a donor. An OPO representative will speak to a family member about possible organ donation if indicated.

In an interview on 6/08/15 at 2:30 p.m. with S2CNO, she was asked about the hospital's OPO policy and the clinical triggers that identified possible "imminent death" patients and the timeliness of notifying the hospital's OPO of possible "imminent death" patients in regard to potential organ donation. S2CNO indicated the hospital did not have a policy that defined "clinical triggers", "imminent death", or timely notification to the OPO. S2CNO indicated that staff did not notify the OPO until after the patient had died and she was not aware of the OPO agreement/requirement to notify the OPO of a patient's "imminent death". S2CNO further indicated that the staff tried to call the OPO in a timely manner after a patient had died and that the hospital did not have a policy that specified a time frame. S2CNO indicated that the hospital policy titled, "Organ/Tissue/Eye Donation-Nursing Staff Responsibilities", REF 2135 was the only hospital policy in place for Organ/Tissue/Eye Donation.

Based on record review and interview, the critical access hospital failed provide patients an ongoing program of activities directed by a qualified activity professional for 3 of 3 swing bed patients (Patient #5, 6, 18). Findings:

Review of the medical records for Patients #5, 6, and 18 revealed that they were admitted to the hospital in swing bed status. Further review of their records revealed no documented evidence of ongoing activities by a qualified activity professional.

On 06/10/15 at 11:30 a.m., interview with S2CNO confirmed that the hospital did not employ a qualified activity professional to provide ongoing activities to the patients in swing bed status.