Harbor Oaks Hospital

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 38269 Based on observation, interview and record review, the facility failed to ensure safe handling and preparation of medications, resulting in the potential for less-than-optimal outcomes for all patients receiving medication on Unit A4 at the time of observation. Findings include: A-398 Failure to ensure staff adhere to the facility policy for medication preparation.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 38269 Based on observation, interview and record review, the facility failed to ensure safe handling and preparation of medications, resulting in the potential for less-than-optimal outcomes for all patients receiving medication on Unit A4 at the time of observation. Findings include: On 01/22/2026 at 0945, during the facility tour, Staff U was observed in the medication room located on Unit A4 completing medication preparation and administration. On 01/22/2026 at 1000, during observation one vial of single use sterile water for injection was found stored in a bin on the medication counter with no protective cap and puncture holes in the rubber stopper. Staff U confirmed the findings at the time of discovery, and stated, “We use that for diluting medication.” On 01/22/2026 at 1005, two plastic trays were found in a lower cabinet with small white paper cups placed in the tray. The white paper cups were observed to contain unit-dosed packaged medications. The individual cups had no patient identification; however, each row of cups had a card located at the beginning of the row with a patient identification affixed to the label. Staff U was asked to explain the policy for medication preparation, Staff U stated, “I prepared today’s medication for my shift, because we are busy.” When queried again what the medication preparation policy stated, Staff U responded, “I don’t know what the policy is.” On 1/22/2026 at 1010, Nurse Manager Staff T who was responsible for the unit was queried about the medication preparation policy and about the practice observed, Staff T responded, “I don’t know.” On 01/22/2026 at 1030, Chief Nursing Officer Staff C arrived at the medication room and confirmed, “our medication preparation policy does not support preparation of medications ahead of time, especially not for a whole shift.” Review of policy titled: “Medication Administration and Records,” last revised date 06/2023. Page 2 of 4, “4.2 Medication Administration Procedure, 4.2.2 General Administration Procedure 4.2.2.3 The nurse will prepare and administer only one (1) patient’s medication at a time.” Policy related to single use vials was requested from Director of Quality Staff E on 01/22/2026 at 1022 and from the Director of Risk Management Staff D on 01/22/2026 at 1135 and on 01/22/2026 at 1150, policy was not received prior to exit.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 48772 Based on observation, interview and record review, the facility failed to ensure nursing staff adhered to the policies and procedures of the facility, failed to provide adequate evaluation of contracted nursing personnel, and failed to ensure standards of practice for medication administration, resulting in administration of an overdose of medication to 1 (P-1) of 10 patients reviewed. See tags: A0398 - Supervision of Nursing Personnel A0405 - Administration of Drugs”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 48772 Based on record review and interview, the facility failed to ensure nursing staff adhered to the policies and procedures of the facility and failed to provide adequate evaluation of contracted nursing personnel, resulting in a medication administration error for 1 (P-1) of 10 records reviewed, where the patient received an overdose which required transfer to an acute care facility. Findings include: P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder. During medical record review, it was noted on the medication administration record on 10/20/25 at 2021, Trileptal 37.5mg was given by RN (Staff I). Staff I documented on a nursing progress note, dated 10/20/25 at 2244, “patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg.” The progress note indicated that poison control, the psychiatrist, primary care physician, and P-1’s family were notified. However, there was no evidence of documentation indicating the communication or recommendations from the primary care physician or any evidence of orders for frequency for observation/vital signs or what symptoms to monitor for potential medication toxicity. It was also noted that nursing failed to document vital signs or progress notes on 10/21/25 between 0001 and 0554. During personnel file review, it was noted that Staff I’s Pharmacology Competency, provided by the employment agency, was dated 7/10/24. There was no evidence of current competency. These findings were reviewed and acknowledged by the Chief Nursing Officer (Staff C) during an interview on 11/4/25 at 1317. Policy PHR-159, Medication Administration and Records (Reviewed 5/2025) states, “The correct medication will be located in the automated medication machine. 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.” Policy 2.25.00, Medical Facility Transfer (Revised 07/2024) states, in non-life-threatening conditions, the RN will contact the Medical Doctor and report his/her assessment of the patient’s current medical condition. The Medical Doctor advises the RN of the immediate action to be taken.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 48772 Based on interview and record review, the facility failed to ensure standards of practice for medication administration for 1 (P-1) of 10 patients reviewed, resulting in overdose and transfer to an acute care facility. Findings include: P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder. P-1 was ordered Trileptal 300mg/5ml, 37.5mg by mouth twice daily on 10/16/25. During medical record review, it was noted on the medication administration record on 10/20/25 at 2021, Trileptal 37.5mg was given by RN (Staff I). Staff I documented on a nursing progress note, dated 10/20/24 at 2244, “patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg.” On 10/21/25 at 0800, P-1 vomited, had diarrhea, and was observed to be lethargic, pale, shaking, and unsteady on her feet. P-1 was transported via ambulance to an acute care hospital on 10/21/25 at 0930. This finding was reviewed and acknowledged by the Chief Nursing Officer (Staff C) during an interview on 11/3/25 at 1345. Policy PHR-159, Medication Administration and Records (Reviewed 5/2025) states, “The correct medication will be located in the automated medication machine. 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.””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 48772 Based on interview, observation, and record review, the pharmacy failed to ensure that medications were dispensed in a manner to minimize potential adverse events in 1 (P-1) of 10 records reviewed, resulting in overdose and transfer to acute care hospital. Findings include: P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder. During medical record review, it was noted on a nursing progress note, completed by RN (Staff I), dated 10/20/25 at 2244 stated, “patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg.” The pharmacist (Staff L) stated that when a pediatric patient was on Trileptal suspension, a 60ml vial would be sent to the unit (containing 3600mg) during an interview on 11/3/25 at 1500. P-1 was ordered 75mg per day, and one 60ml vial contained dosing for 48 days was sent to the unit. A tour of the pharmacy was conducted on 11/4/25 at 0930. One stock bottle (containing 250ml) was noted on the pharmacy shelves as well as multiple sleeves of 300mg/5ml medication cups. Staff L stated the 300mg/5ml doses were ordered and delivered to the nursing units on 10/29/25. Staff L stated the stock bottle will be discarded when it expires. The facility failed to follow pharmacy minimum standard guidelines. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 2013; 70:1619-30. Standard V. Preparing, packaging, and labeling medications: Unit dose packaging. “Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration (e.g., withdrawal of doses from containers, reconstitution of powdered drug products, labeling of containers, and splitting of tablets) by final users should be minimized.””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 47415 Based on interview and record review the facility failed to obtain informed consent from the patient for the administration of psychotropic medications for one (P-5) of 5 patients reviewed for informed consent, resulting in the loss of a patient’s right to make an informed decision. Findings include: On 8/5/25 at 1000, review of the medical record revealed P-5 was a male 23-year-old male, admitted to the facility on 7/22/25 at 1455. P-5 was admitted with the primary diagnosis of bipolar disorder, with current episodes of manic behaviors. Record review revealed that P-5 was his own legal guardian. The social work notes of 7/25/25 at 1124, revealed that father had legal medical power of attorney and had submitted a petition for emergency guardianship to the county court, with a hearing scheduled for 8/13/25. No emergency guardianship documents were found in the record. On 7/31/25 at 1408, a medication consent for Risperdal, lithium carbonate, and Uzedy LAI (long acting injectable), all psychotropic drugs, was signed by the mother who was listed as “emergency guardian”. Staff double witnessed mothers’ signature on medication consent form. On 8/5/25 at 1100, an interview with the director of clinical services Staff O revealed that patient’s parents were the medical power of attorney, and that they were in the process for filing for emergency guardianship. On 8/6/25 at approximately 1100. Staff O provided a verbal update stating she checked with the court and emergency guardianship was not in place or obtained during P-5’s stay. Review of policy titled, “Obtaining Consent for Psychotropic Medications Recipient Rights”, dated 5/23, revealed: “It is the policy of (facility)...that all medication will be administered in accordance with the patient’s rights to informed consent ...Initial administration of psychotropic ...Informed consent from the patient or ...guardian is necessary to administer psychotropic medications””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45245 Based on interview and record review, the facility failed to obtain verbal consent prior to medication administration for 1 (P-6) of 20 patients sampled for review, resulting in the loss of P-6’s right to make an informed decision. Findings include: Review of “History/Chief Complaint,” dated 02/05/25, revealed, “(P-6) is an 8-year-old male with no prior history of medical or psychological illness. The patient is reporting that he got into a physical fight with his mom. He reports feeling depressed and hearing demons. Mom reports that around 10/24 he began making statements that he was going to stab himself and leave a blood trail, wrap cords around his neck or spill liquid onto electronics so that he would electrocute himself.” P-6 was admitted to the facility ’ s Adolescent Unit on 02/04/25, for treatment of major depressive disorder, recurrent severe without psychotic features. During telephone interview with the complainant on 02/10/25, the complainant stated that her minor son (P-6) was given the anti-psychotic drug Abilify without parental consent. The complainant stated that several medications were requested to be considered for consent, and she told the facility that she would need to research the medications and get back to them. Review of “Physician’s Order,” #19, revealed that Abilify (Aripiprazole) 2.5 milligrams by mouth at bedtime was ordered on 02/08/25. The Abilify order stated “No Consent,” and the indication was for adjunct therapy for obsessive compulsive disorder. Review of “Medication Administration Record (MAR)” demonstrated that P-6 was administered Abilify 2.5 milligrams by mouth on 02/06/25 and 02/07/25 at 2100. Review of the medical record failed to demonstrate that either verbal or written consent was obtained before administering the drug to P-6. Review of P-6’s MAR with Director of Quality (Staff N) on 02/11/25 at 1230 confirmed that P-6 received two doses of Abilify without parental consent. Review of facility policy titled “Obtaining Consent for Psychotropic Medications,” #100.11, revised 11/2011,revealed, “The patient or the patient’s parent/guardian shall have the right to accept or refuse chemotherapy treatment.””

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 45246 Based on observation, interview, and record review, the facility failed to ensure that that dietary staff adhered to the safety practices and facility’s policies for food handling and storage affecting all patients, and failed to ensure individual patient nutritional needs were met in accordance with practitioner’ orders for dietary consult for one patient (P-2), resulting in the potential for negative outcomes for all patients in a facility that likely being served and consumed undated and/or expired food, food served in unsanitary manner and potential for food-born illnesses. Findings include: See Specific Tags: A-619 Failure to ensure that dietary staff adhered to the safety practices and facility’s policies for food handling and storage A-629 Failure to ensure that special nutritional needs of the patients are met”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 45246 Based on interview, and record review, the facility failed to follow its grievance policies and procedures resulting in incomplete investigation of grievances for two patients (P-35 and 36) of 4 grievances reviewed, lack of accurate and timely follow up, and potential for negative outcomes. Findings include: On 11/14/24 at 1323 during interview with facility’s Director of Risk and Compliance, Staff B, he stated that former Patient Advocate, Staff KK, left on 10/24/24 and facility is currently in a process of hiring for this position. When asked who was responsible for grievance process (maintaining the complaint and grievances log, conducting investigations of grievances and following up with patients/responsible parties), Staff B stated it was Recipient Rights officer, Staff V’s, responsibility. On 11/20/24 at 1130 grievances were reviewed for P-35 and P-36. Grievance file for P-35 contained 2 follow up response letters regarding grievance submitted by the patient during her stay at the facility. Letters were signed by a Patient advocate, Staff KK. One letter addressed results of the facility investigation regarding physical altercation with the other patient. Allegations were substantiated. Letter stated that “Interviews were conducted with you and the other peer”. No documentation was found in a file supporting the findings, no record of the interviews with the patients of witnesses. This complaint was not logged in a Complaint log provided by facility. Second letter addressed allegation of verbal abuse by staff. The documentation attached in a file had an interview record with P-35 and a staff member who witnessed and reported a verbal abuse towards the patient. Response letter stated: “The allegations were unable to be substantiated”. Review of the grievance file for P-36 revealed a response letter sent to the patient. Letter was not dated. Further, letter indicated that allegation was “that you (P-36) hit a peer in a face”. The allegation was substantiated. The facility’s complaint log was reviewed and revealed that P-36 filed 2 grievances with facility on 9/23/24. One for “boundaries- patient/patient”, with resolution: “After a full investigation it was found that the patient did violate the patient’s boundaries”. And a second one for “patient care- staff”, with resolution: “After a full investigation it was found that staff was appropriate towards the patient”. There was no documentation in a grievance file provided by facility supporting that investigation regarding the allegation of inappropriate behavior by staff was completed and a follow up resolution letter was sent to the patient regarding her grievance. Chief Operating Officer, Staff DD, was interviewed on 11/20/24 at 1145 and confirmed the above findings. Facility’s policy “Complaint and Grievances Procedures”, effective 07/2024, was reviewed on 11/20/24 and revealed: “Purpose. To provide standard operating procedures for addressing customer care complaints, customer service complaints, and CMS complaints or grievances regarding services rendered to patients and to reinforce the obligation of respective staff to listen and respond to patient concerns and when necessary forward complaints or grievances to the appropriate person for resolution. Procedure. 7. On average, a written response will be provided within 7 business days to the patient who is the subject of the grievance or the patient’s legal representative regarding the grievance in a language and manner that is easily understood. The written response must contain the name of the facility contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion. 11. A log will be kept documenting all grievances, the date of the grievance, name of the grievant, how the grievance was received, medical record number of the patient, responsible party, date of resolution and outcome”.”

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 45245 Based on interview and record review, the facility failed to ensure that patient rights were exercised for one (P-23) of 36 patients reviewed for patient rights, resulting in the unmet exercise of patient rights. Findings include: Review of facility handout document “Your Rights When Receiving Mental Health Services in Michigan,” states under “Civil Rights,” “Your civil rights are protected even though you are receiving mental health services. You have the right to an education, the right to register and to vote. (Mental Health Code Section 704; Administrative Rule 330.7009).” An interview was conducted with Recipient Rights Advisor (Staff V) on 11/14/24 at 1335. Staff V was questioned how patients would participate in the presidential election voting process. Staff V stated that patients can file for an “Absentee” ballot, up until the Friday (11/01/24) prior to the election. Staff V was next queried who was responsible for ensuring patients rights to vote. Staff V stated that the responsibility was his. Staff V stated, “I went through and canvassed the units for two weeks prior to the election.” Staff V was questioned if he had provided voting information to P-23. Staff V stated that he spoke with P-23 the day before the election (11/04/23) about her inpatient complaints, but not about voting. Staff V was next asked if he ’ d spoke with P-23 prior to 11/04/24. Staff V stated, “I did not, I didn ’ t know she was in the hospital.” Staff V was next questioned if he had any documentation of P-23 being informed of her voting rights? Staff V stated, “No. I should have documented.” Record review of P-23’s chart revealed the patient was admitted to the facility on 10/30/2024, the Wednesday before the absentee ballot deadline.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45246 Based on interview, and record review, the facility failed to provide comprehensive discharge information to patient’s representative (guardian) for one patient (P-31) of 4 patients reviewed, resulting in patient’s guardian not being included in a final step of patient discharge process, lacking full information needed to post-discharge patient care, and inability to exercise the right to make informed decisions with potential for negative outcomes for the patient. Findings include: During phone interview with P-31’s legal guardian on 11/19/24 at 1715, he stated that P-31 was discharged from the facility on 4/17/24 and arrived home with incomplete discharge paperwork in hand. He added that he is P-31’s responsible party and details of discharge were not discussed with him prior to patient leaving the facility. Guardian also expressed concern that 2 new medications were prescribed to the patient, and he had no prescription sent to the pharmacy. He added that he had to call facility after patient was discharged and ask for the prescriptions. On 11/20/24 at 0930 interview with Director Clinical Services, Staff D, was conducted. Staff D was asked to explain discharge process and the role and involvement of the legal guardian when patient unable to make his/her own decisions. Staff D explained that discharge process begins on admission and responsible party has to be involved in all decisions regarding care if patient unable to make his/her own decisions. When asked what would be included in the process of the discharge instructions review, Staff D stated that social worker need to speak with the guardian or patient’s representative and document this in the notes. Also, there should be a documentation that the responsible party agreed to a discharge plan and signing off by phone. This part should be included in the discharge paperwork which will be send with the patient. Further, Staff D was asked if newly prescribed medications would be sent to a pharmacy of choice prior to the patient’s discharge. Staff D said “yes”, all new medication prescriptions will be automatically sent to a pharmacy before patient leaves the facility. Review of the P-31’s record on 11/19/24 revealed that patient was a 35-year-old male admitted to facility on 4/12/24 at 1050 with diagnoses of Major depressive disorder with psychosis. Patient also had a history of Dravet syndrome (is an epilepsy syndrome that begins in infancy or early childhood and can include a spectrum of symptoms ranging from mild to severe), and developmental disorder. P-31 had a court appointed legal guardian. Further record review revealed a discharge summary note completed by social worker and dated 4/16/24 1405: “Case manager met with patient for discharge planning and informed of aftercare appointment. Further review of the provided discharge documentation revealed a discharge form not signed by the patient or legal guardian. No notes were found with documentation that discharge information was discussed with legal guardian and he agreed with the terms of patient’s discharge. Review of the provider’s orders indicated two new to the patient medications that were added during his stay in a facility. Both medications: Escitalopram (an antidepressant belonging to a group of drugs called selective serotonin reuptake inhibitors) 10 mg oral once a day, and Quetiapine (Seroquel- atypical antipsychotic medication) 50 mg oral once a day were part of the discharge documentation under medications to continue to take. No record indicated that patient’s legal guardian was aware that both new medications needed to be continued after discharge. Prescription history provided by facility revealed that both medications were entered in a system and automatically sent to pharmacy on 4/17/24 at 1439. P-31 left facility on 4/17/24 at 1124. Facility policy “Discharge Planning” effective 07/2024, was reviewed on 11/20/24 and revealed: “It is the policy that discharge planning for any level of care within facility will begin upon the patient’s admission to the unit/program. Therapists, in conjunction with the treatment team, will identify initial discharge plans and address barriers to discharge at the earliest opportunity. Aftercare treatment and residential needs will be incorporated into the discharge planning process. Patients will have in hand a completed discharge instruction sheet when they leave the unit program. Staff will obtain all necessary release of information forms for the communication with aftercare treatment teams. Throughout the discharge planning process therapists will keep in close communication with all appropriate parties to ensure a smooth transition for the patient upon discharge and document process in medical record. Procedures. D. Therapists: 10. Document discharge on progress note. E. RN: 3. Review medication to ensure that all prescriptions and/or medications are ready, i.e. sent to pharmacy, back from pharmacy, correct, etc. 5. Go over final discharge instructions with patient and/or family/guardian. 6. Complete medical portions of discharge sheet and review with patient/family/guardian as appropriate for their signature. 7. Complete Discharge note”.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 45246 Based on observation, interview, and record review, the facility failed to ensure that established policies and procedures for labeling and storing produce, preparing and serving food are maintained and followed by dietary staff resulting in all patients in a facility potentially being served and consumed undated and/or expired food and potential for a food-born illnesses. Findings include: On 11/19/24 from 1110 to approximately 1135 the kitchen tour was conducted with facility’s Infection Preventionist and Nurse Educator, Staff CC, and Director of Dietary Services, Staff S. Dry storage room was inspected and revealed clear storage bin with cookies in individual packages with no expiration dates on the packets. Further, clear plastic bin was observed with pop tarts in individual packages with no expiration dates on the packets. Staff S was asked if these snacks were to be distributed for patients’ consumption. Staff S confirmed that the snacks were for the patients. Staff CC and Staff S were asked how kitchen staff knows that these snacks were not expired. Staff CC said they should be dated after the original box with expiration date was opened and snacks were transferred to the clear bins for storage. Next, the produce refrigerator was inspected. There were the following clear bags found without expiration dates on them: chocolate cookies, pretzel sticks, omelettes, and 6 bags of cubed chicken. There were 2 long bricks of semi-hard yellow cheese that were opened, and the top was wrapped with a clear plastic wrap. Upon picking them up from the shelf, the wrap fell of, and cheese was exposed to the air and touch. There was a clear plastic bag with shredded cheese inside, unlabeled, undated and open. Cheese was falling out when bag was touched. Two bags of shredded lettuce were observed on the top shelf in clear bags with no expiration dates on them. Further, the freezer was inspected. Multiple debris were found on the floor under the shelves. There was a meat product in a clear package laying directly on the floor under the shelf. Next, the food preparation area of the kitchen was observed. There were 16 clear bags with pita bread lying on the counter. No expiration date was found on the bags. Kitchen staff was preparing lunch for delivery to the units. Kitchen staff was observed wearing gloves, touching different kitchen surfaces, and packing food with the same gloves. Multiple fruit cups in plastic factory packages were observed to be placed in Styrofoam containers that contained fries and chicken sandwiches. Total of 7 boxes were found with plastic cups inside. When asked if this was a usual practice, kitchen staff said that the other option would be to put the cups separately on the trays. On 11/19/24 at 1140 Unit P2 kitchenette was inspected with Staff CC. A food cart was found with 20 ready to serve Styrofoam containers with lunch. Staff CC inspected all containers and found chicken fingers with fries in them along with fruit cups in plastic factory packages. Staff CC was queried if factory packaged food usually served in a same containers as freshly prepared food. Staff CC stated that it should not be placed inside with the prepared meal. Facility’s Food storage policy, dated 07/2024, was reviewed on 11/19/24 and revealed: “Purpose. To ensure that food and supplies used by the Dietary department will be stored in a clean and safe environment, consistent with all applicable regulations for storage. Procedure. 1. Frozen and refrigerated items will be labeled, dated with date received, and stored in the appropriate freezer and refrigeration units immediately after delivery. a. All items will be placed on shelving units off the floor. d. All food items sorted after opening or preparation will be covered, labeled, and dated with both the date opened and the 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. Any prepackaged items, or individually packaged items, will be labeled with the manufacturer’s expiration date when removed from the original packaging”.”

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 15195 Based on interview and record review, the facility failed to provide a nutritional consultation for 1 (#2) of 3 patients reviewed for special diet requirements, resulting in the potential for less than optimal outcomes. Findings include: Medical record review revealed that patient #2 was a 17-year-old female admitted to the female pediatric behavioral health unit on 7/9/24 through 7/12/24 for diagnoses of anorexia nervosa (eating disorder), suicidal ideation, and celiac disease (an immune reaction to eating gluten-- a protein found in foods containing wheat, barley or rye). The patient’s medical record documented allergies to wheat, Penicillin, and Imitrex. On 11/13/24 at approximately 1200, review of patient #2’s medical record with the Director of Quality (Staff C) revealed that the initial nursing assessment on 7/10/24 at approximately 0215 triggered a nutritional assessment/consult to be done. The Director of Quality stated that the facility policy allowed the nutritional consult to be done within 72 hours when triggered by nursing. Medical record review also revealed that on 7/10/24 at 0700 the psychiatrist ordered a dietitian consult due to allergy to wheat and celiac disease. Then again on 7/10/24 at 0900, the psychiatrist ordered the dietitian consult “now” due to patient’s BMI 16.6 (body mass index - low) and patient has an eating disorder. On 11/19/24 at approximately 0930, interview with the Registered Dietitian (Staff U) and Chief Nursing Officer (Staff E) revealed that the registered dietitian (RD) had up to 72 hours to complete the nutritional assessment. The RD was not always on site but could be called in if needed. It was not determined why the RD did not respond to the physician “now” order for consultation. The RD confirmed that if she was made aware of the “now” order, she would have seen the patient that day for a nutritional consult on 7/10/24. The patient was discharged on 7/12/24 without a nutritional consult. Review of the dietary/nutrition policies and procedures provided by the facility revealed that they did not address nutritional consults or diets/meals that were ordered “now.” This was verified by the Director Risk/Compliance (Staff B) on 11/21/24 at approximately 1200.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45246 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.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 38269 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.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 45246 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 CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 45246 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.”