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35031 23 MILE RD

NEW BALTIMORE, MI 48047

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review the facility failed to obtain informed consent by the patient's legal representative for the administration of a psychotropic medication for one (P-1) of four minor patients reviewed for informed consent, resulting in the loss of a patient's right to make an informed decision. Findings include:

On 04/02/24 at 1405, P-1 medical record was reviewed. The record indicated P-1, was an Autistic 8-year-old male with diagnoses including major depression, disruptive mood dysregulation disorder,oppositional defiance disorder, and attention deficit disorder (ADD). (P-1) was admitted to the Specialized Inpatient Pediatric Unit (SIPU) on 03/4/24 and removed against medical advice (AMA) by his legal representative (mother) on 03/14/24. Further review of the record revealed a physician order dated 03/08/24 prescribing Strattera (a psychotropic medication used to treat ADD) 18 milligrams (mg) by mouth every morning for P-1. Review of P-1 medication administration records revealed P-1 was administered a total of five doses of Strattera 18 mg by mouth every morning from 03/09/24 through 03/13/24, however the medical record contained no evidence that P-1's legal representative consented to the administration of Strattera.

During an interview with the Director of Quality, Staff A, on 04/02/24 at 1445, Staff A acknowledged, after reviewing P-1's medical record, there was no evidence that P-1's legal representative consented to the administration of Strattera.

Upon further review of the medical record a medication consent form dated 03/13/2024 revealed a "revocation of consent" for two medications, one which was named in the complaint (Strattera) at 1020. The revocation was dated 03/13/2024 at 1020, and signed by two Registered Nurses employed by the facility. A document titled "notes," dated 03/13/2024, located under "current medication list" included: Sertraline HCL (medication used to treat depression), and Strattera both medications were recorded as "not having consent from the legal representative."

On 04/03/24 at 1040 a record review occurred of the facility policy and procedure titled, "Medication Consent," last revised 5/20/23. This document indicated that it was the policy of the hospital "to obtain written, informed consent from any patient who will be receiving psychotropic medication." This policy also indicated, under procedures section for child and adolescent patients, that it was the intent of the hospital "to obtain informed consent from the responsible parent or legal guardian of a child/adolescent (17 years or younger) patient."

NURSING SERVICES

Tag No.: A0385

Based on observation, interview, and record review the facility failed to ensure that medications were prepared, labeled, and administered in a safe manner for the 22 patients were receiving treatment on the unit and to ensure that licensed nursing personnel know the facility's policies and procedures resulting in the likelihood of harmful adverse outcomes to the patients. Findings include:

See Specific Tag:

A-398 Failure to ensure nursing staff know and adhere to facility's policies and procedures for medication preparation and administration.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on observation, interview, and record review, the facility failed to ensure that licensed nursing personnel know the facility's policies and procedures regarding safe medication preparation, labeling, and administration resulting in unsafe practices and likelihood of harmful adverse outcomes to all patients. Findings include:

On 4/3/24 at 0820 to 1000, Unit A2 was observed for medication preparation and administration. Chief Nursing Officer (CNO), Staff E, was present during the observation. Registered nurses, Staff R and Staff S, were observed and interviewed in the medication room during preparation to administer medication to the patients. Multiple plastic white trays were observed on the counter with small white paper cups in them. White paper cups were observed to contain multiple medications. Some cups contained pills that were previously removed from their packages. No labels were present on the cups. Other white paper cups contained medications in unit dose packages. Staff R and Staff S were asked to explain the process of medication preparation and administration. Staff R explained that night shift nurses prepare/pull the medications from the storage units, Pyxis (automated medication dispensing system). Day shift nursing staff then administer medications to the patients by identifying the patient (scanning the wrist band) and checking the order in electronic medical record.

During the above interview Staff S was observed to inadvertently bump one of the plastic trays. A white paper cup fell on the floor and two unpackaged small pills fell out. Staff S collected the pills from the floor, placed them back in a paper cup and set them on a counter. Staff S was asked what she will do with those pills, and she stated that she will dispose them later.

During the above observations in the medication room a syringe with clear liquid was observed lying on the counter next to the white plastic tray. This syringe was not labeled. Nurses were asked about the syringe and what medication was in it. Staff R stated that it was Insulin medication that she had drawn for one of the patients this morning. Staff R said that she obtained patient's blood sugar level and prepared insulin for the patient according to the provider's order. Staff R was queried why she did not label the syringe. Staff R acted surprised and said that she had drawn the medication herself from the Insulin vial with the other nurse present in the room (Staff S) and she would be the one to administer it to the patient soon. Staff R said that there is only one patient on this unit who receives Insulin. Staff R proceeded to state that nursing staff had always been doing it this way. Staff E, Chief Nursing Officer, was present in the room during this observation.

On 04/03/24 at 0858, a patient was observed at the medication room distribution window. Staff R wiped patient's right upper arm with alcohol swab and administered the medication from the unlabeled syringe with clear liquid.

During interview with Staff E, on 04/03/24 at 1348, she shared that she was an experienced nurse and an experienced leader. She worked in the facility for many years prior to assuming CNO role. She has been in this role for a month now. CNO was asked about medication preparation, labeling and administration practices of the nursing staff reporting to her. Staff E stated that she was surprised and disappointed while observing nursing staff earlier that day during medication preparation. She stated that after this observation she immediately instructed nurses to dispose opened oral medications. Further, she explained to nursing staff that they need to obtain medications in packages, and only open them in front of the patients after confirming the order and the patient identification. Staff E was questioned if this is her expectation that nurses know and follow facility's policies. Which she confirmed. When asked about the prefilled, unlabeled syringe found on the counter, she wasn't sure what exactly happened. When asked if this practice (not to label syringes with medications, leave them on a counter and later administer them to the patient) was acceptable, Staff E said, "absolutely not". Staff E was queried if she was aware that Staff R proceeded to give the medication in unlabeled syringe to the patient. She said no. Next, Staff E was asked if any further actions will be taken. She stated that nursing staff will be re-educated immediately about the facility's policies and procedures regarding medication administration.

Medication Administration policies were requested and reviewed on 04/03/24.
Policy Medications Preparation and Administration Oral Products, dated 05/2022, revealed.
"Statement of policy:
Nursing personnel will be aware of safe methods of preparing and administering medication.
4.0 Procedure:
4.1 Nurses will remove unit doses of drugs and remove the seal of the drug and hand it to the patient with sufficient, suitable liquid to swallow the drug. The nurse may alternatively place the oral drug in a medication cup and present that to the patient with suitable liquid. The medication must remain in unit dose unit provided to the patient.
4.6 All medication containers, syringes (unless immediately administered to patient) and patient-specific multi-dose meds (for example, eye drops, inhaler) will be properly labeled with at least 2 patient identifiers to prevent administration error.
Policy Medication Administration and Record, dated 05/2022, revealed.
Statement of purpose:
To established procedures for timely, accurate, and safe administration of medication.
4.2.2 General administration guidelines:
4.2.2.1 The correct medication will be located in the Med-Dispense Cart. The nurse will compare the final dosage form of the drug and the entry on the medication administration record to confirm that the drug, dose, and route of administration are correct.
4.2.2.3 The nurse will prepare and administer only one (1) patient's medication at a time."

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, interview, and record review facility failed to ensure that established policies and procedures for labeling and storing produce are maintained and followed by dietary staff resulting in all patients on the unit (census of 22) potentially consuming unsafe food and experiencing food-born illness. Findings include:

On 04/02/24 at 1050, during initial tour of the facility with facility's Infection Preventionist/Nurse Educator, Staff N, nourishment room was toured on Unit OA. A blue plastic box was observed in a refrigerator, unmarked, full of wrapped in clear plastic sandwiches with no expiration date on any of them. When Staff N was asked how unit staff knows that these sandwiches were still good and safe for patients to consume, she stated that kitchen staff knows when to rotate the sandwiches. They (sandwiches) get delivered in a box, that box had an expiration date on it. Next, the freezer in a nourishment room was opened and inspected. Upon opening freezer, it did not feel cold. There were 4 ice-cream bars found in a freezer that were soft to touch and did not have expiration date on them. There was a thermometer in a freezer that was showing 0F (zero Fahrenheit). Staff N took it out of the freezer. Staff N was asked if freezer was checked by dietary staff today. She stated yes. The freezer and refrigerator logs were found attached to the refrigerator with 4/1/24 and 4/2/24 dates marked as checked, and temperatures were marked in the appropriate range (freezer temperatures were marked as 0F for both dates). Staff N confirmed the findings.

On 4/2/24 at 1330, interview was conducted with Dietary Manager, Staff O, and Staff N. Staff O stated that he has been in his role for 3 months. His duties were to oversee kitchen staff, make sure all orders were placed in timely manner, make sure kitchen was operational, and help where needed as a part of the team. Staff O shared that he preferred hands on approach and to lead by example. When asked about products expiration dates checking process, he stated that dietary staff was responsible to rotate the stock and discard expired products. When asked regarding sandwiches being stored in refrigerators on the units without being marked for expiration dates, Staff O indicated that that issue already had been addressed by dating the outside of the bins in refrigerators. Staff O was queried how staff would know which sandwich had expired, he said they will replace them all with a new expiration date on the bin. When asked about thermometer in a freezer not recording exact temperature, Staff N noted that it had been replaced by facilities maintenance department.

Facility Food Storage Policy was requested and reviewed on 04/03/24. Policy, effective 11/2018 and revised 11/2022, indicated:

"Dietary will maintain food and supplies in a safe and consistent manner to ensure food safety.
Procedures
1. Frozen and refrigerated items will be labeled, dated with date received, and stored in the appropriate freezer and refrigeration units immediately after delivery.
d) All food items sorted after opening or preparation will be covered, labeled, and dated- both date opened and date to be discarded. All opened perishable food items will be discarded within 72 hours of opening.
f) Any food that is refrigerated and undated is discarded immediately.
i) Do not use any food that has remained out for 2 hours or more.

5. Each refrigerator unit will have an internal thermometer. Temperatures will be checked and recorded daily on the log."

Reviewed Policy did not address faulty thermometers and what actions staff should take if one was discovered to be out of order.