The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RHODE ISLAND HOSPITAL 593 EDDY STREET PROVIDENCE, RI 02903 April 16, 2021
VIOLATION: NURSING SERVICES Tag No: A0385
Based on record review and staff interview, it has been determined that the hospital failed to meet the Condition of Participation relative to Nursing Services for 29 patients who were administered the medication Haldol with a documented allergy to the medication in the patients' medical record. Additionally, 41 patients with a documented allergy to the medication acetaminophen, noted in the patients medical record were administered acetaminophen or a component of acetaminophen. (refer to A-405)
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on record review and staff interview, it has been determined that the hospital failed to administer medications in accordance with their policy resulting in patients with documented allergies to Haldol and acetaminophen receiving the medications or a component of these medications.

Findings are as follows:

The hospital's policy "Medication Administration", last revised in 5/2020, states, in part,
" ...Policy ...Authorization to Administer Medications ...
c. iii. Providers administering medications adhere to the five rights of medication administration prior to administering the medication ...

Before Administering Medication: For all medication administration, the individual administering medication does the following:
1. Verifies the five rights of patient medication administration.
2. Resolves concerns with appropriate personnel.
3. Informs the patient or family about the medication ..."

According to the Lippincott procedure "Medication Administration and Monitoring Checklist", published in January 2007 , the 5 rights to medication administration include verifying, prior to medication administration, that the right patient is being administered the right medication, at the right dose, at the right time, and by the right route.

On 4/16/2021 at approximately 10:30 AM surveyor reviewed a document produced by the Pharmacy that contained information related to the administration of Haldol and acetaminophen to patients with a documented allergy. This document revealed that a total of 24 registered nurses administered Haldol to a patient with a documented allergy and 31 registered nurses administered acetaminophen (or a component of acetaminophen) to a patient with a documented allergy resulting in a total of 55 registered nurses neglecting to verify the right medication was administered to the patient.

During an interview with the hospital's Emergency Department Director of Nursing Services, she acknowledged that the registered nurse (RN) is responsible for identifying allergies in the electronic medical record "storyboard" (an area in the electronic medicatl record that identifies certain patient information, including allergies), at the Omnicell (a machine that dispenses medication), and with the patient (if patient is able). Additionally, she stated that during orientation, nurses are educated to use the pharmacy safety alert as a "last stop" check, not as a replacement to verifying allergies.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on record review and staff interview, it has been determined that the Pharmacy system failed to provide pharmaceutical services to meet the needs of patients with allergies to Haldol and acetaminophen from 1/6/2021 to 4/12/2021.

During this timeframe, of the 727 patients that were administered Haldol, 29 of the patients should have been identified as having a Haldol allergy. Of the 797 patients that were administered acetaminophen, 41 of the patients should have been identified as having an acetaminophen allergy. Additionally, 6 of the 41 patients were inpatient status when administered the acetaminophen (refer to A-491 and A-500).
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on record review and staff interview, it has been determined that the Pharmacy system failed to ensure the safe and appropriate dispensing of Haldol, acetaminophen, Vitamin B complex, Benadryl and paricalcitol(vitamin D) for all patients with documented allergies to the medications.

During a 3 month timeframe from 1/6/2021 to 4/12/2021 the hospitals records indicate that of the 727 patients that were administered Haldol, 29 of the patients should have been identified by a pharmacy generated computer system alert as having a Haldol allergy when the provider was ordering the medication and when attempting to be dispensed from the Omnicell machine (a machine that dispenses medication). Additionally, of the 797 patients that were administered acetaminophen, 41 of the patients should have been identified by a pharmacy computer system alert as having an acetaminophen allergy.

Findings are as follows:

On 12/8/2020 the Information Systems (IS) department was asked by the Pharmacy to develop a system to make a medication available in different forms (pre-filled syringes and vials of Haldol) in the Omnicell, which is accessible to providers and nursing. This project was completed by IS on 1/6/2021. Prior to implementation, the pharmacy was responsible for conducting testing of the functionality of the system. On 1/6/2021, after completion of the testing by the pharmacy department, the system went into production.

During an interview with the Lifespan Director of Accreditation, Regulatory Readiness, Quality Informatics on 4/16/2021 at 1:45 PM, she acknowledged that the pharmacy testing did not include a step to verify that the medication alert for allergies would appear on the computer screen to notify the provider, nursing, or pharmacy of a patients allergy. This omission in testing resulted in multiple patients receiving medications for which they had an identified allergy.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on record review and staff interview, it has been determined that the pharmacy staff failed to review the medication orders for 6 admitted patients, Patient ID #'s 3, 4, 5, 6, 7 and 8 relative to real or potential allergies or sensitivities to the medication acetaminophen.

Findings are as follows:

Review of the Rhode Island Department of Health Pharmacist Regulations (Gen. Laws 5-19.1-5(6)), which include pharmaceutical practices consistent with current standards of practice, pharmacists are responsible for performing a "Drug regimen review" which includes, but is not limited to, performing an evaluation of the prescriptions and patient records for known allergies.

Patient ID #'s 3, 4, 5, 6, 7 and 8 were inpatient and their electronic medical record indicated they had an allergy to acetaminophen. Upon surveyor review of their medication orders, Patient ID #'s 3, 4, 5, 6, 7 and 8 were prescribed and administered medications with an acetaminophen component.

During surveyor interview with the Pharmacy Manager of Operations on 4/14/2021 at 2:40 PM, she acknowledged that when a patient is transferred to the inpatient setting, the medication orders are sent to the pharmacy for pharmacist review. She further stated that it is the responsibility of the pharmacist when verifying inpatient orders to review the medication allergies. The Pharmacy Manager of Operations was unable to provide evidence that the allergies were reviewed for the above patients.