HospitalInspections.org

Based on record review, policy review and staff interview it was determined the hospital failed to ensure all adverse drug reactions were reported as per policy. (C277) The systemic effect of these practices resulted in the hospital's inability to ensure all medications are administered safely and adverse drug reactions are identified, analyzed, and trended. The hospital active census was 16.

Based on record review, staff interview, and policy review it was determined the hospital failed to ensure all adverse drug reactions were reported as per policy. This affected one ( Patient #5) of ten medical records reviewed. The active census was 16.

Findings include:

Review of the Policy and Procedure for Adverse Drug Reaction Reporting Pharmacy: RC.02.01.01, MM.07.01.03, PI.01.01.01 ( Effective date 05/21/16) states an adverse drug reaction is any untoward reaction experienced by a patient as a result of drug therapy. The reaction is one which is unintended and can be harmful, and which occurs at normal dosages used for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. Adverse drug reactions will include the classification of the reaction and severity of the reaction.

The nurse or other professional in charge of the patient involved will complete the " Adverse Drug Reaction Report," once completed all reports are sent to the pharmacy department. A pharmacist will investigate the incident and complete the " Pharmacy Adverse Drug Reaction Report" upon receipt of the original report. The summary report is presented to the Pharmacy and Therapeutics committee for its review. The reports are analyzed for trends and will determine whether action may be taken to reduce the incidents of reactions.

1. Review of the medical record for Patient #5 revealed the patient had a past medical history of chronic obstructive pulmonary disease with a tracheostomy in place, congestive heart failure and insulin dependent diabetes. The medical record confirmed the patient was admitted on the following dates for management and/or an exacerbation of a chronic medical condition 08/13/18, 01/21/19, 01/23/19 and 03/20/19.

The medical record noted the following allergies on 08/13/18; Aspirin, Carafate, Codeine, Darvocet, Demerol, Dilantin, Nubain, Parafon Forte DSC, Paxil, Percocet, Prozac, and Vicodin. The patient denied any allergies to Penicillins and Cephlasporins.

Review of the physician documentation for hospital admission dated 08/13/18 noted the patient presented to the emergency room on 08/13/18 at 3:18 PM due to shortness of breath and bilateral pain in the lower extremities. The patient received several breathing treatments and Solu-Medrol and began to feel better. However, the patient had a high blood sugar level and the laboratory results revealed the patient had a significant urinary tract infection. The patient was administered insulin to lower the blood sugar level and was ordered Rocephin 1 gm to be administered intravenously for infection. Per the physician, the plan was to discharge the patient following the antibiotic infusion. Further review of the medical record noted the antibiotic began infusing on 08/13/18 at 7:04 PM and at 7:49 PM the patient was being prepared to transfer to a higher level of care via a helicopter due to acute respiratory failure with hypoxia. The medical record noted the patient was on a ventilator at 8:18 PM. The patient was noted to be stable upon transfer to the higher level of care upon discharge. The medical record lacked evidence the respiratory decline was related to the Rocephin administration and this was not noted as an allergy on the medical record.

Review of the physician documentation dated 01/21/19 revealed the patient presented to the emergency room due to generalized weakness, fatigue, elevated blood sugar levels, and headache. The patient's hyperglycemia was managed and the insulin order was increased. The medical record did not note Rocephin as an allergy on the medical record on this date. The patient was placed on observation, stabilized, and discharged.

On 01/23/19 at 5:49 PM the patient arrived to the emergency department via the emergency squad with complaints of high blood sugar levels in the 400-500 range. Through the course of treatment the physician ordered Rocephin 1 gm IVPB which was not listed as an allergy in the medical record. The antibiotic began infusing at 6:50 PM and at 6:51 PM the patient reportedly told the nurse, " I received an antibiotic on 08/13/18 that may have caused an allergic reaction." The nurse noted Rocephin was administered on 08/13/18 and immediately stopped the antibiotic infusion at 6:52 PM. The patient did report tingling in the mouth and some difficulty breathing. The patient was administered Benadryl and Solu-Medrol and given a breathing treatment. The patient was stabilized and prepared for transfer to another hospital on 01/23/19 at 8:56 PM. Rocephin (difficulty breathing) was added to the medical record as an allergy on 01/23/19 at 7:04 PM.

Review of the medical record for admission date 03/20/19 at 4:11 PM revealed the patient was admitted to the intensive care unit from the emergency room. The patient was started on intravenous Zosyn for possible pneumonia and sepsis. The allergies listed on the inpatient admission for this date failed to include an allergy to Rocephin.

This finding was confirmed with Staff B on 04/03/19 at 2:39 PM. In addition, Staff B confirmed no adverse event report (s) were documented as per policy following the adverse reaction(s) to Rocephin.

During discussion with administrative staff it was reported the medical records from the emergency room are not visible to the inpatient units unless staff log into the electronic health record and review the emergency room visit. An admission from the emergency department to the inpatient unit requires staff to call the receiving unit and give a verbal report. A (SBAR) hand off report is to be printed/reviewed by the staff nurse on the receiving unit. The (SBAR) hand off report included Rocephin as an allergy for Patient #5, however, this did not make it to the medical record on the inpatient unit.