Center for Hope Hospice and Palliative Care

“Based on observation, medical record review, facility document review, and staff interviews, it was determined that the facility failed to ensure that an effective infection control plan is developed and maintained by; ensuring that single-use vials of medications are accessed once for one patient and then discarded in accordance with nationally recognized infection control guidelines (L577). This failure resulted in an Immediate Jeopardy, posing a serious risk of harm to the patients. On 5/9/24 at 2:58 PM, Medical Record (MR)19 was reviewed with Staff(S) 1, the Director of Nursing. A review of the “Controlled Drug Administration Records” found in MR19 indicated that partial doses of Hydromorphone 2mg/1ml (a narcotic pain medication) supplied in a single dose container, were administered to Patient (P)19, and the remaining partial doses were saved for future use, not discarded immediately. The facility failed to provide a policy and procedure that addressed the use of single-dose vials and safe injection practices in accordance with nationally recognized infection control guidelines upon request on 5/9/24 at 3:30 PM. The facility was provided an IJ template on 5/9/24 at 4:40 PM. The facility administrators inspected the facility to ensure that all opened single-dose vials were discarded, developed new policies and procedures to address safe injection practices, and educated facility clinical staff members. The survey team verified the implementation of the IJ removal plan on 5/10/24 at 3:30 PM after a facility tour, staff interviews, and review of facility documents. Cross Reference: Condition of Participation 42 CFR 418.60 - Infection Prevention”

“Based on observations, medical record review, staff interviews, and review of facility documents, it was determined the facility failed to ensure that pharmacy services are provided in accordance with accepted standards of practice, State and Federal regulations as evidenced by the failure to develop and implement policies and procedures that address 1.) the accountability for Controlled Dangerous Substances (CDS) including their receipt, administration, and disposition (L691); 2.) the monitoring and reporting of potential CDS diversion (L700); and 3.) facility specific processes for the use and control of medications stored in the automated drug cabinet (ADC) (L691). These failures resulted in Immediate Jeopardy, posing a serious risk of harm to the patients. The facility was given the Immediate Jeopardy Template on 5/9/24 at 4:40 PM. The facility presented the IJ Removal Plan on 5/10/24 at 3:08 AM. The facility developed new policies and procedures to address the accountability for CDS, monitor for and report potential CDS diversion, maintain the patient list in the ADC, and develop processes to monitor medications withdrawn from the ADC. The facility educated all clinical staff on the new processes. These corrective actions were verified during an on-site visit on 5/10/24 that included a facility tour, staff interviews, and facility document review. Cross Reference: 42 CFR 418.106(a) Managing Drugs and Biologicals 42 CFR 418.106 (c) Dispensing of Drugs and Biologicals 42 CFR 418.106(e) Labeling, disposing, and storing of drugs and biologicals 42 CFR 418.106(e)(2)(C)(ii) Disposal of controlled drugs in hospices that provide inpatient care directly. 42 CFR 418.106(e)(3)(ii) Discrepancies in the acquisition, storage, dispensing, administration, disposal, or return of controlled drugs must be investigated immediately by the pharmacist and hospital administrator and where required reported to the appropriate State authority.”

“Based on observation and staff interview, it was determined that the facility failed to ensure enclosed stairwells are not used for storage. Findings include: On 5/9/24 at 11:35 AM, during a tour of the inpatient facility Father Hudson House, in the presence of Staff(S) 15, the maintenance assistant, patient care items including two commodes, two clinical care recliners, and two patient care lifts were stored in the basement level of the exit stairwell which connects the basement to the second floor. During an interview at 11:35 AM, S15 confirmed this finding.”

“Based on observation and staff interview, it was determined that the facility failed to ensure hazardous areas are protected to resist the passage of smoke. Findings include: On 5/8/24 at 11:15 AM, during a tour of Peggy Coloney’s House, in the presence of Staff(S) 9, the Maintenance Supervisor, the three-quarter (3/4) hour fire-rated door separating the kitchen from the dining area was held open with a rubber wedge. During an interview on 5/8/24 at 11:15 AM, S9 stated, “The door was being held open to get lunch carts out.” Surveyors did not observe carts traversing the doorway between 11:15 AM and 11:30 AM. S9 further stated, “The door should only be held open when using the door.” On 5/8/24 at 11:16 AM, in the presence of S9, the soda machine syrup lines were run from the smoke barrier between the Kitchen and the Dining Area. This hole measured approximately 4 inches in diameter and was located behind the serving counter where the soda dispenser was located.”

“Based on observation and staff interviews, it was determined that the facility failed to ensure cooking equipment is centered under the fire suppression system in accordance with the National Fire Protection Associations Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations (NFPA 96) 2011 Edition. Findings include: Reference: National Fire Protection Associations Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations (NFPA 96) 2011 Edition “;96:12.1.2.2 Cooking appliances requiring protection shall not be moved, modified, or rearranged without prior re-evaluation of the fire-extinguishing system by the system installer or servicing agent, unless otherwise allowed by the design of the fire extinguishing system.” On 5/8/24 at 11:55 AM, during a tour of the kitchen at Peggy Coloney’s House, in the presence of Staff (S)9, the Maintenance Supervisor, the stove was located approximately one foot over, causing the required fire suppression nozzles to be misaligned with the cooking burners. The stove was also approximately six inches over, causing the stove to extend past the outer edge of the overhead hood system.”

“Based on observation and staff interview, it was determined that the facility failed to ensure manual pull stations are unobstructed. Findings include: On 5/8/24 at 11:17 AM, a tour of Peggy Coloney’s House was conducted in the presence of Staff(S) 9, the Maintenance Supervisor, the manual pull station located alongside the exit door from the dining area to the outside patio area was obstructed by a square table. During an interview at 11:17 AM, Staff 9 stated, “I see the table in front of the pull station. No one has ever mentioned that to us before.””

“Based on observation and staff interview, it was determined that the facility failed to ensure the building is completely protected by an approved automatic sprinkler system. Findings include: On 5/9/24 at 11:40 AM, during a tour of Father Hudson House (Elizabeth Facility), in the presence of Staff(S) 15, maintenance assistant, it was observed that the walk-in cooler located in the basement lacked sprinkler protection. During an interview at 11:40 AM, S15 confirmed no sprinkler protection was provided in the walk-in cooler. Findings include: Reference: National Fire Protection Associations Standard for the Installation of Sprinkler Systems, 2010 Edition, “;13.8.15.1.2.18.2 Combustible soffits, eaves, overhangs, and decorative frame elements shall not exceed 4 ft 0 in. (1.2 m) in width.” On 5/10/24 at 11:50 AM, at Peggy Coloney’s House, the overhang/carport located in front of the main entrance was attached to the building and enclosed with combustible plywood. This front overhang was attached to the main building and extends approximately 15 feet into the front parking lot. There was no Sprinkler protection observed under the overhang. During an interview at 11:55 AM, Staff 9 stated, “;There are no sprinklers under the overhang.””

“Based on observation, it was determined that the facility failed to ensure that 100% of the inpatient sleeping room doors that open to the corridor are capable of being closed when the door is pushed or pulled. Eight of eight inpatient sleeping rooms are located on the first floor and 17 of 17 inpatient sleeping room doors are located on the second floor. Findings include: On 5/9/24 during a tour of the inpatient hospice, Father Hudson House, between 10:30 AM and 12:30 PM, 100% of the patient sleeping room doors were equipped with door stops located at the bottom of the door. These doorstops were hinged and required a person to manually lift the stop to allow the door to close. The door stops prevent the patient room doors, which open to the corridor, from being closed using a push or pull motion as required. First floor patient room numbers are Room #101-#108. The Second-floor patient room numbers are #201-#217. Staff 15, maintenance assistant, confirmed the above findings.”

“Based on observation and staff interview, it was determined that the facility failed to ensure electrical rooms are maintained free of storage in accordance with the National Electric Code, National Fire Protection Association 70, 2011 edition. Findings include: Reference: National Fire Protection Association’s National Electric Code, 2011 Edition, 70:110.24(E) “Dedicated Equipment Space. All switchboards, panelboards, and motor control centers shall be located in dedicated spaces and protected from damage. ... (1) Indoor ... (a) Dedicated Electrical Space. The space equal to the width and depth of the equipment and extending from the floor to a height of 1.8 m (one point eight meters) (6) six feet above the equipment or to the structural ceiling, whichever is lower, shall be dedicated to the electrical installation. No piping, ducts, leak protection apparatus, or other equipment foreign to the electrical installation shall be located in this zone.” On 5/8/24 at 11:40 AM, during a tour of the inpatient hospice Peggy Coloney’s House, in the Electrical Room near the generator, in the presence of Staff(S) 9, the Maintenance Supervisor, Combustible storage was located in the electrical room consisting of one (1) gasoline-powered portable generator and one (1) approximately six (6) foot tall, rolled carpet. During an interview at 11:40 AM, S9 stated that he/she would have those things removed.”

“Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the hospice physician was represented within the interdisciplinary group (IDG). Findings include: On 5/10/24, a review of Patient (P)1’s medical record for the certification period starting 3/21/2024, revealed that the IDG meeting notes lacked evidence of a physician’s notes and lacked evidence that a physician was present during the IDG meeting. On 5/10/24 at 12:26 PM, upon interview with Staff (S)34, Medical Director, it was stated that the IDG meets every two weeks on Tuesdays at 11:00 AM and that he/she attends the meetings either in-person or virtually. S34 stated that there were no sign-in sheets for each IDG meeting and that there were no formal minutes for these meetings. Per S34, all notes are entered in the individual patient’s charts. S34 further stated that the nurse or other member of the IDG team would note that S1, the Director of Nursing and Clinical Services, was present and that the information shared during IDG was discussed with S34. When asked about documentation in P1’s chart for the IDG, S34 stated that P1 was a field patient and that he/she (S34) would not have an active note in the medical record.”

“Based on staff interviews and a review of facility documents, it was determined that the hospice agency failed to ensure the implementation and maintenance of a quality assurance and patient safety program that incorporated all aspects of the hospice agency’s operation. Findings include: On 5/8/24 at 11:15 AM, a tour of the inpatient hospice Peggy Coloney’s House’s kitchen and dry storage area was conducted with Staff (S)12, the Food Service Director. Upon interview, S12 stated that he/she monitors test tray temperatures daily and has identified issues with maintaining temperatures with food items such as eggs. S12 stated that eggs tend to lose heat quickly during transport as the transport vessels were not heated, just insulated. The action plan and monitoring of the identified temperature issues were requested from S12. S12 provided daily test tray temperature audit sheets for the past 6 months, from December 2023 to May 2024. Upon review, the test tray audits were incomplete with missing days of temperature monitoring and there was no documented evidence concerning food temperature. At 12:20 PM, during an interview, S12 stated that the missing dates coincided with days he/she took time off, further stating that no one had completed the test trays for the incomplete days. S12 further stated that someone should have been responsible and that the test trays should be completed daily, but the monitoring may not be completed if he/she is not there. S12 stated that the information regarding the completion of test tray audits in the absence of the Food Service Director had been provided to the food service staff during informal staff meetings, but this education was not documented. S12 then stated that he/she did not have any current corrective action plans in place. During the interview, S12 stated that he/she does not participate in the hospice’s Quality Assurance and Performance Improvement (QAPI) Program meetings. When questioned about where the identified patient safety and/or quality issues were reported, S12 stated that it was brought up to management and in monthly management meetings. On 5/9/24 at 2:32 PM, the monthly management meeting minutes for the past year were requested for review. S4, the Administrator, stated that there were no formal minutes documented for these meetings. When questioned about how the issues that were brought up in these meetings were monitored and tracked, S4 stated that the leaders keep their informal notes and follow the issues month to month. On 5/10/24 at 12:19 PM, upon request, S4 was unable to provide a copy of a QAPI plan for 2023 and 2024. S4 confirmed that the food service department was not involved in the hospice’s QAPI program and meetings. S4 stated that he/she was now aware of the food service department’s impact on patient safety and how the food service department should be included in the QAPI going forward.”

“Based on observation, staff interviews, and review of facility documents, it was determined the facility failed to ensure that identified quality and patient safety issues related to the food service department were addressed, corrective actions were implemented, and evaluated for effectiveness. Findings include: Peggy Coloney’s House/Scotch Plains: On 5/7/24 at 1:04 PM, the registered dietician consultation reports for the past six months, from November 2023 to May 2024, were requested for review. On 5/8/24, a tour of the food service area was conducted in the presence of Staff (S)12, the Food Service Director. The following was identified: - In the kitchen, floors were visibly dirty with heavy build-up of dirt and debris in the corners and door jambs. - In the dish room, located on the first floor, the floor was observed to have multiple large cracks by the entrance to the room that contained a build-up of dirt and debris. - Gaskets of multiple pieces of equipment in the kitchen were in disrepair (cracked, missing, or pulling away). - Holes were observed in the walls of the dry storage area. - Multiple dirty vases being stored in the dish room on the floor and on a low shelf in areas of high-flow foot traffic. The above findings were identified on the registered dietician’s report dated 3/12/24 and 4/3/24. Upon request, S12 was unable to provide corrective actions or ongoing monitoring of the identified areas of non-compliance from the consultant’s report. S12 stated that when issues are identified they [Food Service Staff] work to correct the issues. Issues that are identified are brought up in Monthly Management Meetings. On 5/9/24 at 2:32 PM, the monthly management meeting minutes for the past year were requested for review. S4, the Administrator, stated that there were no formal minutes documented for these meetings. When questioned about how the issues that were brought up in these meetings were monitored and tracked, S4 stated that the leaders keep their informal notes and follow the issues month to month. Upon request, the facility was unable to provide evidence of corrective action plans for the above-identified deficiencies.”

“Based on observation, medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure 1.) that policies and procedures concerning the use of single-dose medication vials are developed and implemented per nationally recognized infection control guidelines; 2.) that single-use patient care items are prevented from being re-used on other patients. Findings include: On 5/7/24 at 12:02 PM, a tour of Wing 3 in Peggy Coloneys House was conducted in the presence of Staff (S)#. At 12:06 PM, a plastic container with nail care products (nail polish, disposable nail file emery boards, and nail clippers) was discovered in an unlocked cabinet above the nursing station. The emery boards in the container were worn and appeared to have been used multiple times. (are these items stored with clean supplies?) Staff (S) 2, Director of Residential Services, and S8, Licensed Practical Nurse (LPN), confirmed that the emery boards were single-use items and should be disposed of after each use. S2 and S8 were unsure why used emery boards were being returned to the plastic container since home health aides were able to obtain new emery boards from a supply drawer. Findings include: Reference: The Centers for Disease Control and Prevention (CDC) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, states, “...IV.H.5. Do not administer medications from single-dose vials or ampules to multiple patients or combine leftover contents for later use369 453, 1005. Category IA...” Reference: CDC Position — Protect Patients Against Preventable Harm from Improper Use of Single-dose/Single-use Vials (http://www.cdc.gov/injectionsafety/CDCposition-SingleUseVial.html) states, “The Centers for Disease Control and Preventions guidelines call for medications labeled as “;single dose” or “;single use” to be used for only one patient. This practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use.” During a medical record review conducted at Peggy Coloneys House (PCH) on 5/9/24 between 2:25 PM and 3:05 PM with S1, the Director of Nursing, in one of three medical records (#19) reviewed for Controlled Dangerous Substance (CDS) administration, the following documentation identified that single-dose vials of medication were accessed and saved for future use. This is not in accordance with nationally recognized infection control guidelines. The “Controlled Drug Administration Record” (CDAR) found in MR 19, dated 2/5/24 through 2/7/24 for Dilaudid (the brand name for Hydromorphone a narcotic) 2mg (milligrams)/ 1ml (milliliter) amps [ampules] contained the following documentation: On 2/5/24, the facility received a total of 10-1 ml units of Dilaudid 2mg/ml, each a single dose container. On 2/6/24 at 8:30 PM the amount remaining was 3 units. On 2/6/24 at 9:45 PM, 1 mg was administered and 2.5 units were remaining, half of a single dose container was saved for future use. On 2/7/24 at 12:17 AM, 2 mg was administered and 1.5 units were remaining. On 2/7/24 at 3:10 AM 1mg was administered and the amount remaining was 1.0 units, the previously opened single-dose container was administered. On 2/7/24 at 5:34 AM the amount administered was 1 mg and the amount remaining was 0 units. The waste of the 1mg remaining was not documented. The CDAR found in the medical record for Patient (P)19 dated 2/7/24 through 2/8/24 for Hydromorphone 2mg/1ml vials (a narcotic) contained the following documentation: On 2/7/24 the facility received a total of 20, 1 ml units of Hydromorphone 2mg/1 ml, each a single dose vial. On 2/7/24 at 12:00 PM, 2 mg was administered and the amount remaining was 19 units. On 2/7/24 at 2:00 PM, 1mg was administered and the amount remaining was 18.5 units, half of the single dose vial was saved for future use. On 2/7/24 at 6:00 PM, 2 mg was administered and the amount remaining was 17.5 units. On 2/7/24 at 7:10 PM, 1mg was administered and the amount remaining was 16.5 units. On 2/7/24 at 8:45 PM 1mg was administered and the amount remaining was 16 units, one of the previously opened and saved single-dose vials was administered. On 2/8/24 at 12:26 AM, 2mg was administered and the amount remaining was 15 units. On 2/8/24 at 2:40 AM, 1 mg was administered and the amount remaining was 14.5 units, half of a single dose vial was saved for future use. On 2/8/24 at 3:40 AM, 1 mg was administered and the amount remaining was 14 units, the previously opened single-dose vial was administered to P19. During an interview on 5/9/24 at 2:40 PM, S1 confirmed these findings and confirmed that Dilaudid 2mg/ml and Hydromorphone 2mg/ml were supplied in single-dose vials. S1 stated that the single-dose vials should be discarded after one use and not stored for future use. On 5/9/24 the facility’s policy and procedure for safe injection practices, including the use of single dose vials, was requested. S4 confirmed that the facility did not have a policy that addressed the use of single-dose vials on 5/9/24 at 12:15 PM.”

“Based on observations and staff interviews, it was determined the facility failed to ensure that expired medical supplies were removed from patient care areas in two of three nursing units. Findings include: On 5/7/24 at 11:17 AM, a tour of Peggy Coloney’s House (PCH) - Wing Two, was conducted in the presence of Staff (S) 2, Director of Residential Services. During the inspection of the supply cabinets on the unit, the following items were found: Three “;Yankauer Suction Catheters” with an expiration date of 2/28/22. Four “;Purewick Female External Catheters” with expiration dates 6/28/20, 7/28/21 (x2), and 10/28/22. One “;16-French Medline Latex Foley Catheter” with an expiration date of 1/28/22. Three “;14-French Dover Silicone Coated Latex Foley Catheter” with an expiration date of 9/3/23. Two “;Male External Catheter” with expiration dates of 7/3/20 and 3/28/23. On 5/7/24 at 11:35 AM, the above findings were presented to S2. S2 acknowledged the findings and removed the supplies in the presence of surveyors. On 5/7/24 at 12:01 PM, a tour of PCH - Wing Three was conducted. During the tour, the following patient care supplies were found in the supply cabinets: Three “;Exuderm Hydrocolloid Wound Dressing 6x6 inches” with an expiration date of 3/3/24. Three “;Medline Dressing Change Kit with Chlorhexidine” with an expiration date of 5/31/23. Two “;Medline Piston Syringes” with an expiration date of 10/10/23. Two “;Yankauer Suction Catheters” with an expiration date of 2/28/22. Four “;Purewick Female External Catheters” with expiration dates of 6/28/20, 7/28/21 (x2), and 12/28/23. Six “;Male External Catheter” with expiration dates of 9/28/22 (x3), 3/28/23 (x2) and 11/28/23. Also found in the supply cabinet was an opened “;Ace Bandage” and “;Medline Piston Syringe” package. On 5/7/24 at 12:26 PM, the above findings were presented to S2. S2 acknowledged the findings and removed the supplies in the presence of surveyors.”

“Based on a review of two of 12 personnel files (Staff (S)10 and S32), staff interviews, and a review of facility documents, it was determined the facility failed to ensure that all staff receive in-service training annually per facility policy. Findings include: On 5/13/24 at 10:00 AM, the personnel file for S10, a Registered Nurse (RN), was reviewed with S4, President, S20, Executive Vice President, and S21, Director of Human Resources. S10 was hired by the facility in March 2024. A review of S10s in-service education revealed that there was no documented evidence that the following training modules, with a due date of 4/9/24, were completed: HIPAA; Natural Disasters and Workplace Emergencies; Preventing, Recognizing, and Reporting Abuse; Sexual Harassment; Protecting Patient Rights; Introduction to Hospice Care; Minimizing Medical Errors; and Symptom Management; the indicated due date was 3/31/24. Additionally, training modules on, About Advance Directives; Final Hours; and Palliative Nursing; with a due date of 4/4/24 were incomplete. This finding was confirmed by S4, S20, and S21. On 5/13/24 at 10:35 AM, the personnel file for S32, Infection Control Coordinator, was reviewed with S4, S20, and S21. A review of S32s in-service education revealed that there was no documented evidence that the following training modules, with a due date of 4/9/24, were completed: Basics of Workplace Safety; Natural Disasters and Workplace Emergencies; Sexual Harassment; Understanding Workplace Violence; Minimizing Medical Errors; Symptom Management; and Recovering Your QAPI and Compliance Focus. Additionally, the following training modules had not been completed with a due date of 7/11/18: Protecting Patient Rights in Hospice; Introduction to Hospice Care; Final Hours; and Palliative Nursing. This finding was confirmed by S4, S20, and S21. Facility policy titled, “;Education – In-Service,” last reviewed on 9/30/2, states, “;Purpose: To ensure consistent application of safe, appropriate patient care, staff safety measures; and, the effective management of personnel throughout the workplace. Policy: In-service training will be provided throughout the year for all employees, based on their respective roles, skill requirements, interests, and in conformance with state and federal requirements for annual re/education. Procedure: 1. All new personnel will receive mandatory in-services during their orientation... 2. Yearly, all staff and volunteers are required to have training in the following areas: Infection Control; Blood borne Pathogens; Right to Know-Hazard Communication Program; Fire Safety; Body Mechanics; Advanced Directives; Patients Bill of Rights; Elder, Child, and Sexual Abuse; Workplace Violence; Health Insurance Portability and Accountability Act – HIPAA; Pain; Hospice and Palliative Care concepts and philosophy; Emergency Preparedness; and, Alzheimers...””

“Based on medical record review and staff interview, it was determined the facility failed to ensure that the patient’s clinical information is reviewed by the medical director or physician designee before the start of a recertification period. Findings include: On 5/10/24 at 10:30 AM, a medical record review for Patient (P)1 was conducted for the certification period starting 3/21/24. The document, “Hospice Certification of Terminal Illness” was identified in the medical record. Documentation by Staff (S) 38, a Hospice Nurse Practitioner, dated 3/22/24, stated, “... I attest that I had a face-to-face encounter with this patient on 3/22/24, and that the clinical findings of that encounter have been provided to the certifying physician for use in determining continuing eligibility for hospice care ...” Documentation by S39, Hospice Physician, dated 3/27/2024 stated, “... I recertify that this patient is terminally ill with a life expectancy of six months or less if the disease follows its normal course ... By signing, I am confirming that I composed the narrative based on my review of the patient’s medical record or, if applicable, examination of the patient Medical Director/Hospice Physician Signature: Electronically signed by [S39, hospice provider] Date: 3/27/2024 ...” Both S38 and S39 recertified the patient after the certification period had already started. An interview was conducted with S34, Medical Director on 5/10/24 at 12:26 PM. S34 stated that the upcoming recertification of a patient would be discussed in the Interdisciplinary Group Meetings before the end of the current certification period. S34 stated that the Nurse Practitioner would see the patient if they were an outpatient and would write the note for the recertification and the physician would complete the recertifications for the inpatients. It was determined during the medical record review that the physician recertification occurred after the start of the recertification period. The medical record lacked evidence of recertification before the start of the new certification period on 3/21/24. Facility policy titled, “Physician Services (Medical Director, Associate Medical Director, Advance Practice Nurse/NP)” updated 4/6/23 states, “... The duties of the Medical Director and Associates include but are not limited to the following: 1. Reviews clinical information for each hospice patient and provides written certification that is anticipated that the patient’s life expectancy is 6 months or less if the illness runs its normal course. (Note: Re/Certification cannot be provided by a Nurse Practitioner.) ... 2. Before the recertification period for each patient, the medical director/designee will review the patient’s clinical information ...””

“Based on facility document review and staff interviews, it was determined that the facility failed to ensure that pharmacy services are provided under the direction of a qualified pharmacist. Findings include: Reference: N.J.A.C. 13:39-9.23 (b) New Jersey Board of Pharmacy Regulations state, “;...The pharmacist-in-charge or, where provided for in Department of Health rules, the director of pharmaceutical services shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security, and accountability of all drugs. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by the pharmacy technician, intern, or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns, and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the health care facility...” On 5/8/24 at 10:00 AM, the contract for the provider pharmacy, the contract with the pharmacist in charge of pharmacy services at the facility, and the pharmacist reports, or unit inspection reports were requested. On 5/8/24 at 1:50 PM, the contract between the provider pharmacy and the facility dated 12/15/13, was reviewed with Staff (S) 4, the President and Administrator. The “Addendum to Pharmacy Contract” dated 1/6/14 stated, “...The consultant pharmacist shall be responsible for the direction, provision, and quality of pharmaceutical services... The pharmacist shall assist the facility or program with, at a minimum, the following: 1. Training of employees; 2. Educating staff and residents; 3. Establishing policies and procedures... 4. Reviewing medication administration records on a quarterly basis; 5. At least quarterly, inspecting all common areas of the facility or program where medication are stored or administered, documenting any problems and proposing solutions to these problems, and maintaining records of such inspections...” On 5/8/24 at 1:55 PM, upon interview, S4 confirmed that the facility did not have facility inspection reports, or unit inspection reports from the pharmacist, as required by the State Board of Pharmacy regulations. During the interview, S4 further stated that S36, a pharmacist from the provider pharmacy, “inspects sometimes”, however, he/she does not give a report. S4 stated that the facility has an informal consultation agreement with the pharmacy provider. During an interview on 5/9/24 between 12:10 PM and 12:20 PM, S36 confirmed that he/she was the only pharmacist from the provider pharmacy to come to the facility. S36 explained that he/she inspected and maintained the medications stored in the automated drug cabinet (ADC) located in the medication room at Peggy Coloney’s House (PCH), however, he/she did not inspect any of the medication storage areas situated in the patient care units at PCH or Father Hudson House (FHH) or provide the facility with reports or consultation. S36 confirmed that he/she did not participate in facility meetings that discussed pharmacy services, reviewed medical records, or reviewed adverse drug reactions at PCH or FHH.”

“Based on the review of two of three medical records (#18 and #26), staff interviews, and review of facility documents, it was determined that the facility failed to ensure policies and procedures concerning the accountability of Controlled Dangerous Substances (CDS) including their receipt, administration, and disposition are developed and implemented. Findings include: Reference: N.J.A.C. 13:39-9.17(f) New Jersey State Board of Pharmacy Regulations state, “;... DRUG-DISPENSING DEVICES... All medications withdrawn from a drug dispensing device require a medication order by an authorized practitioner. All such medication orders shall be checked by the pharmacist within 24 hours from the time of the original order and so noted on the pharmacy’s patient medication profile ...” After completing the tour of Peggy Coloney’s House (PCH) on 5/8/24 with S1, the Director of Nursing, and S4, the President and Administrator, upon interview, S4 stated that the facility did not have a process to ensure accountability for CDS in the inpatient facilities PCH and Father Hudson House (FHH). During the interview, S4 stated that he/she monitored the billing invoices for CDS purchased, however, he/she did not have a process to monitor the receipt, administration, or disposition of CDS in the facility. When questioned about the CDS administration logs and CDS inventory count logs completed by nursing staff, S1 stated that they are not routinely reviewed, they are scanned into the electronic medical records. When medical records for patients utilizing a PCA (patient-controlled analgesia) pump were requested, S4 stated that the only way to identify patients who utilized PCA pumps for pain management, was to review the billing documentation from the pharmacy, the PCA titration log sheets were scanned into the patient’s medical record after they were completed. During the medical record review, the following discrepancies were identified: One of two medical records (MR16) reviewed with PCA administration, contained incomplete “PCA Documentation” forms for the administration of Hydromorphone (a CDS). On 5/10/24 at 2:24 PM, MR16 was reviewed with S1. S1 explained that the “PCA Documentation” form should have all the spaces at the top of the form completed without cross-outs. The PCA Documentation forms dated 4/19/24 and 4/26/24 lacked the signature of a second nurse on the blank area titled “Medication and Pump settings verified by two nurses.” S1 confirmed this finding and stated that two nurses should sign the form when the PCA is started or when the dose is changed to verify it is correct. A review of the facility policy that refers to the PCA pumps does not include this process. S1 also confirmed the finding that the “ordered rate” and “ordered PCA dose” on the top of the form dated 4/19/24 were crossed out and the rate and dose were changed. S1 stated that a new form should be filled out each time the rate or PCA dose is changed, to ensure tracking of the CDS administration and verification of the change by two nurses. The time and date of the rate/dose change of the Hydromorphone could not be determined by review of the “PCA Documentation” forms. The facility could not ensure the accountability of the CDS. The PCA Documentation form for Hydromorphone found in MR16 dated 4/26/24, had a final quantity remaining of 4.3 ml. There was no documented evidence of the waste for this CDS on the form. On 5/10/24 at 3:00 PM, S1 confirmed this finding and stated that the waste of the remaining CDS should have been documented on the form. Policies and procedures that address the monitoring of CDS in the inpatient facilities at PCH and FHH were requested on 5/8/24 at 10:00 AM. On 5/9/24 at 12:15 PM, S4 confirmed that the inpatient facility did not have written policies for the monitoring of CDS receipt, administration, or waste in the inpatient facilities. During the facility tour on 5/8/24 at PCH, it was identified that the facility was utilizing an automated drug cabinet (ADC) for the storage and distribution of medications, including CDS. This device was new to the facility and S4 confirmed that the ADC was first used in February 2024. The ADC Activity Transaction Report dated 2/1/24 to 5/8/24 was requested on 5/8/24. The following was identified: Twenty of the 33 medications removed were for CDS medications. The report documented the “user” name, the person removing the medication, and the “witness” name, the person cosigning the CDS removal and witnessing the count back of the quantity of CDS remaining. The report indicated that all twenty of the CDS medication removals were removed by and “witnessed” by the same staff member. On 5/9/24 at 12:11 PM, S36, a pharmacist, and S1 confirmed this finding. S36 and S1 confirmed that the computer system in the ADC requires a witness for the count back of the CDS medications and that the witness should be a different staff member, not the person who removed the CDS initially. During a facility tour of PCH in the medication room on 5/8/24 at 2:40 PM with S1, and S17, a pharmacist, the ADC was inspected. The ADC contained emergency doses of medication including CDS. S1 explained that if a patient needed an emergency dose of a medication, staff could remove the medication from the ADC after obtaining a physician’s order. S1 explained that the nurse would enter the patient information into the ADC computer system, enter the verbal order into the ADC computer system, and then remove the medication. S1 was able to access an active patient list in the ADC on 5/8/24 upon request. There were 18 patients on the active list. One patient was selected randomly, Patient (P)24. S1 was able to remove medication from the ADC under P24’s name on 5/8/24. S1 confirmed that P24 was not a current patient. A review of MR24 confirmed that P24 was discharged on 3/11/24. When questioned about who maintained the patient list in the ADC and who removed discharged patients, S1 and S17 did not know. S17 stated that the patient names should be removed at the time of discharge. The facility failed to ensure that the patient list is maintained to limit access to medications including CDS stored inside the ADC and ensure patient confidentiality as required by the New Jersey Board of Pharmacy regulations. On 5/9/24, a review of the ADC Activity Transaction Report dated 2/1/24 to 5/8/24, identified 14 patients, who had CDS removed from the drug cabinet under their names. Two of three medical records reviewed (MR18 and MR26), from that list lacked documentation of a physician’s order and CDS administration documentation for the CDS removed from the ADC. On 5/9/24 at 3:05 PM, a review of MR18 and the corresponding Activity Transaction Report dated 2/1/24 to 5/8/24 conducted with S1 revealed that MR18 lacked documentation of physician’s orders for the two syringes of Lorazepam 0.5mg/ 0.25ml and two syringes of morphine 5mg/ 0.25ml that were removed from the ADC for P18 on 2/2/24 at 11:57 PM and 12:03 AM. MR18 also lacked “Controlled Drug Administration Records” for these medications. It could not be determined if these medications were administered. The facility could not ensure accountability for these CDS. On 5/10/24 at 11:25 AM, a review of MR26 and the corresponding Activity Transaction Report dated 2/1/24 to 5/8/24, with S1, revealed that MR26 lacked documentation of physician’s orders for the Morphine 5mg/0.25ml syringe that was removed from the ADC for P26 on 4/5//24 at 9:03 AM. MR26 also lacked “Controlled Drug Administration Records” for this medication. It could not be determined if this medication was administered. The facility could not ensure accountability for this CDS. On 5/9/24 at 12:10 PM, upon interview on the process that nurses follow to remove medications from the ADC, S36 stated that the nurse obtains a verbal order from the physician, enters it into the electronic medical record, and then enters it into the ADC computer system. The ADC computer system was not linked with the electronic medical record and S36 confirmed that pharmacists do not have remote access to the patient’s electronic medical records. When questioned about how pharmacists verify the orders for medications removed from the ADC, S36 stated that the facility will fax a paper order for a Schedule II CDS, however, the pharmacist only reviews the verbal order that is entered into the ADC for Schedule 3 through 5 CDS. This order was not signed or verified by the prescriber.”

“Based on observations, staff interviews, and facility document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address 1.) the removal of outdated drugs and supplies from the active inventory; 2.) the beyond use dating of multidose vials of medication; 3.) the beyond use dating of glucometer supplies; 4.) the return to the pharmacy or destruction of patient-specific medications after the patient is discharged or the medication is discontinued. Findings include: 1.) On 05/09/24 at 10:35 AM, during a facility tour with Staff(S) #24, Registered Nurse, one box of EvenCareG2 test strips was found stored, in the medication cart located near to the nurses room on floor 1 at Father Hudson house, and available for patient use with the expiration date of 12/15/23. Upon interview, S24 stated that he/she randomly checks expiration dates of all drugs and supplies every 2 weeks or sometimes every month and the facility does not have set time to check for outdated drugs and supplies. This finding was confirmed by S24 on 05/09/24 at 10:45 AM. On 05/09/24, facility’s policy and procedure that address removal of outdated drugs and supplies was requested and at 3:24 PM, S1, the Director of Nursing, confirmed that policy and procedure for outdated drugs was amended on 05/09/24 and given to the survey team, however the facility does not have any policy and procedure that address removal of outdated supplies from the inventory. Reference: The New Jersey Board of Pharmacy regulations, N.J.A.C. 13:39-9.23 STORAGE AND SECURITY, states, “... c) Procedures shall be established to assure the immediate and efficient removal of all outdated and recalled drugs from patient care areas...” Findings include: 1.) Reference: The New Jersey Board of Pharmacy regulations, N.J.A.C. 13:39-9.23 STORAGE AND SECURITY, states, “... c) Procedures shall be established to assure the immediate and efficient removal of all outdated and recalled drugs from patient care areas...” On 05/09/24 at 10:35 AM, during a tour of Father Hudson House with Staff(S) 24, a Registered Nurse, one box of EvenCareG2 blood glucose test strips with an expiration date of 12/15/23, was found in the medication cart near the nurses’ room on the 1st floor, available for patient use. Upon interview, S24 stated that he/she randomly checks the expiration dates of all drugs and supplies every two weeks or sometimes every month. S24 further stated that the facility does not have a set schedule to check for outdated medications and supplies. This finding was confirmed by S24 on 05/09/24 at 10:45 AM. On 05/09/24, the facility’s policy and procedure that addresses the removal of outdated drugs and supplies was requested at 3:24 PM from S1, the Director of Nursing. S1 confirmed that the policy and procedure for outdated drugs was amended on 05/09/24, however, the facility does not have any policy and procedure that addresses the removal of outdated supplies from the active inventory. 2.) On 5/8/24 at 10:23 AM, during a facility tour of Peggy Coloney’s (PCH) House - Wing 1 with Staff (S)1, the Director of Nursing, and S6, a Registered Nurse, one opened needle-punctured multidose vial of Tubersol (tuberculin purified protein derivative) was found stored in the medication refrigerator available for patient use. The manufacturer’s instructions on the vial label stated, “Discard opened product after 30 days.” The opened vial of Tubersol was not marked with an “;opened on” date. It could not be determined when the vial was opened, and therefore when the medication would expire. During an interview, S6 stated that the vial should have been labeled with the date it was opened and was unsure if the Tubersol expired after 28 or 30 days after opening. This finding was confirmed by S1 and S6 on 5/8/24 at 10:25 AM. On 5/8/24 at 12:15 PM, the facility policy concerning the use of single-dose vials and multiple-dose vials was requested. On 5/9/24 at 12:15 PM, S4, the President and Administrator, confirmed that the facility did not have a policy and procedure that addressed the beyond-use dating of multidose vials used for multiple patients. 3.) On 5/8/24 at 10:42 AM, during a tour of PCH - Wing 1 with S1 and S6, two blood glucose monitors were observed stored in the medication cart for patient use along with their corresponding test strips. The blood glucose test strip vial was opened, removed from the original box with strips removed, (how do you know it was opened? Was it found literally open or was the lid open and you could see the strips had been used? - these are things that get questioned during an IDR) upon closer inspection the container lacked information on the date it was opened or the beyond-use date. The manufacturer’s instructions for use stated, “Use within 6 months after first opening or before the expiration date.” The True Metrix Pro blood glucose test strips vial was opened and “3/14” was written on the vial. The manufacturer’s instructions for use stated, “..Discard all unused strips in vial after either the date printed on the test strip vial label or 4 months after date opened, whichever comes first...” It could not be determined if “3/14” was the date it was opened or the expiration date. Upon interview, S6 stated that he/she wasn’t sure how long the test strips were good for once opened and he/she wasn’t sure what “3/14” meant. This finding was confirmed by S1 and S6 on 5/8/24 at 10:45 AM. On 5/8/24 at 11:24 AM, during a tour of PCH - Wing 2 with S1 and S7, a Registered Nurse, a One Touch Ultra Glucometer was observed stored in the medication cart along with an opened container of corresponding test strips, available for patient use. The manufacturer’s instructions for the test strips state, “...Write the discard date (date opened plus 6 months) on the vial label when you first open it. Do Not use test strips beyond the expiration...” The opened container of test strips did not have a date written on it. Upon interview, S7 was unsure when the opened test strips expired, however, he/she thought they expired on the manufacturer’s expiration date. This finding was confirmed by S1 and S7 on 5/8/24 at 11:26 AM. 4.) On 5/8/24 at 10:40 AM, during a tour of PCH - Wing 1 with S1 and S6, medications for Patient(P)14 were observed stored in the medication cart, available for patient use. One bingo card (medication packs with daily meds for each patient) dated 5/3/24 containing 29 tablets of Quetiapine 25 mg (milligrams) (an antipsychotic) was observed labeled for P14. S6 stated that P14 was no longer a patient in the facility and the medication should have been returned to the pharmacy. The medical record review indicated that P14 was discharged on 5/6/24. This finding was confirmed by S1 and S6 on 5/8/24 at 10:41 AM. On 5/8/24 at 11:53 AM, during a tour of PCH - Wing 3 with S1 and S8, a Registered Nurse, medications for P15, a discharged patient, were observed stored in the medication cart, available for patient use, as follows: One bingo card containing 15 tablets of Amlodipine 2.5mg (a blood pressure medication), one bingo card with 15 tablets of Clopidogrel 75 mg (a blood thinner), and one container of artificial tear eye drops. Upon interview, S8 stated that P15 was no longer a patient in the facility, and the medication should have been discarded. Upon medical record review, it was revealed that P15 was discharged on 5/6/24. This finding was confirmed by S1 and S8 on 5/8/24 at 11:55 AM. The facility policy for the removal of discharged patients’ medication from active inventory was requested on 5/8/24. Upon review, the policy titled, “Medication Management” dated 12/21/23 states, “...In Center facilities, medications are disposed of and documented by 2 nurses, using designated methods and containers to ensure they are rendered unusable...” This policy failed to address the process of returning unused medication to the provider pharmacy. This finding was confirmed by S4, the President and Administrator, on 5/9/24 at 12:15 PM.”

“Based on observation, staff interviews, and facility document review, it was determined that the facility failed to ensure the disposal of Controlled Dangerous Substances(CDS) in a manner that renders them non-retrievable in accordance with Federal requirements. Findings include: Reference: The Federal Register, Vol. 79, No. 174, September 9, 2014 Rules and Regulations, https://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf, states, “;...Non-Retrievable Destruction Standard...In the NPRM (Notice of Proposed Rule Making), the DEA (Drug Enforcement Administration) indicated that incineration and chemical digestion are some examples of current technology that may be utilized to achieve the non-retrievable standard. The preamble of the NPRM states that sewering (disposal by flushing down a toilet or sink) and landfill disposal (mixing controlled substances with undesirable items such as kitty litter or coffee grounds and depositing in a garbage collection) are examples of current methods of disposal that do not meet the non-retrievable standard. The term non-retrievable is defined in the rule and is results oriented because the DEAs concern is that the substance be permanently rendered to an unusable state...” Reference: Drug Enforcement Administration regulation 21 CFR 1317.90 Methods of destruction, https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_c.htm, states, “(a) All controlled substances to be destroyed by a registrant, or caused to be destroyed by a registrant, pursuant to 1317.95...(c), shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable...” During a facility tour with Staff #1 (S1) on 5/8/24 at 10:21 AM, in Wing 1 of PCH, a can shaped container was found stored in the cabinet with the glass door at the nurses’ station. When questioned about the container, S6, a registered nurse, explained that the container had dirt and water inside, and was where staff discarded medications including CDS. During a tour of Wing 2 at PCH with S1 on 5/8/24 at 11:16 AM, a silver container was found stored in the glass cabinet at the nurses’ station. When questioned about the container, S7, a registered nurse, stated that it was a “paint can” with water, dirt, and medication inside. S7 stated that medications, including CDS, were disposed of in the paint can. S7 stated that when the can is about three-quarters full he/she will take the can to the maintenance department to be discarded. S7 stated that he/she will receive an new paint can from the maintenance department. During a tour of Wing 3 at PCH with S1 on 5/8/24 at 11:40 AM, a silver container was found in the glass cabinet at the nurses’ station. When questioned about the container, S8, a licensed practical nurse, stated that all medications including CDS were disposed of in the paint can. S8 stated that the can contained dirt and water. S8 stated that when the can was full he/she could take it to the maintenance department, or he/she could close it up and throw it directly in the dumpster as he/she did a few weeks prior to the survey. On 5/8/24 at 12:15 PM in PCH, S9, the Maintenance Supervisor, was questioned about the “paint cans” used for medication disposal. S9 stated that the empty paint cans were purchased from Home Depot. S9 stated that he/she adds topsoil. like Miracle Grow, to the cans prior to distributing them to the nursing units. S9 stated that when the full cans are brought back to the maintenance department, he/she double bags the cans and puts them into the dumpster. S9 confirmed that this is the process that the facility uses to dispose of all medications at both PCH and FHH. This method of disposing of CDS in dirt does not meet the DEA’s definition of non-retrievable referenced above or render the CDS unusable as required by facility policy below. Facility policy titled “Medication Management” dated 12/21/23, reviewed on 5/8/23 at 2:00PM, states, “...In Center facilities, medications are disposed of and documented by 2 nurses using designated methods and containers to ensure they are rendered unusable and safe for disposal...” Findings include: On 05/09/24 at 10:50 AM and 11:05 AM, during a facility tour with Staff(S) #26, Clinical Care Coordinator, on floor 1 and floor 2 at Father Hudson House, Nurses room was observed and an unlocked closet was found inside nurses room contained an unlabeled two black paint cans. Upon interview, S26 stated that all CDS were disposed of into “paint can “ which contains dirt and water. S26 further explained that once paint can is about to be full, he/she will take the can to the maintenance department for disposal. Reference: The Drug Enforcement Agency “21 Code of Federal Register Subpart C - Destruction of Controlled Substances 1317.90 Methods of Destruction “ states, “(a) All controlled substances to be destroyed by a registrant, or caused to be destroyed by a registrant...shall be destroyed in compliance with applicable Federal, State, tribal and local laws and regulations and shall be rendered non-retrievable... (c) The method of destruction shall be consistent with the purpose of rendering all controlled substances to a non-retrievable state in order to prevent diversion of any such substance to illicit purposes and to protect the public health and safety.””

“Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure medications are stored in locked areas. Findings include: Reference: The New Jersey Board of Pharmacy regulations, N.J.A.C 13:39-9.23 STORAGE AND SECURITY, states, “...a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility.1) All drugs shall be secured for safe use and protected against illicit diversion...” During a facility tour of Peggy Coloney’s House (PCH) with Staff (S)1, the Director of Nursing, on 05/08/24 at 10:15 AM in Wing 1, at 11:30 AM in Wing 2, and 12:00 PM in Wing 3, medication and supply cabinets located by the nurses’ station, were observed unlocked. The nurse’s station was accessible to patients and visitors. The cabinets contained the following medications: one full box of Vitamin A&D ointment, Bacitracin ointment, and Triple antibiotic ointment. Upon interview, S1 stated that there was a magnetic lock in the cabinet and the nurse had to swipe the badge in order to open the cabinets, however, the lock was broken and maintenance was currently working to resolve this issue. These findings were confirmed by S1 on 05/08/24 at 12:00 PM.”

“Based on facility document review and staff interviews, it was determined that the facility failed to ensure the development and implementation of polices and procedures that address the investigation and reporting of Controlled Dangerous Substance (CDS) discrepancies. Findings include: On 5/8/24 at 10:00 AM, policies and procedures that address the investigation and reporting of potential drug diversion were requested. On 5/9/24 at 10:00 AM, the facility policy titled, “Use and Disposal of Controlled Substances” (undated) was provided. The policy was reviewed and found to address the disposal of CDS and potential discrepancies in the home setting only and does not include the inpatient facility. During an interview on 5/9/24 at 11:00 AM, Staff (S)4, the President and Administrator, confirmed that the facility did not have a process in place to investigate CDS discrepancies or report potential CDS diversion to State and Federal authorities for the inpatient facility.”

“Based on observation, staff interview, and a review of facility documents, it was determined that the facility failed to maintain a sanitary environment. Findings include: On 5/8/24 at 11:08 AM, a tour of the kitchen area in the inpatient hospice Peggy Coloney’s House was conducted in the presence of Staff (S) 12, the Food Service Director. The following was observed: The floor of the kitchen had a visible build-up of dirt and debris in the corners and edges of the floor and door jambs. The trim of the floor by the doors was peeling away from the wall. There was a quarter-sized hole in the wall of the dry storage room exposing the dry wall underneath. At 12:13 PM, a tour of the first-floor dish room was conducted in the presence of S12. The following was observed: The floor was visibly dirty and had multiple long cracks at the base of the doorway. Multiple dirty vases were stored on the floor and on low shelves. The above findings were confirmed with S12 at the time of discovery. S12 provided the registered dietitian’s consultation report from the last 6 months, November 2023 to May 2024, for review. The following was identified in the report: On 12/20/23, 3/12/24, and 4/3/24, the following was noted to be out of compliance: “Floors were very dirty in all areas of the kitchen; Dish room - repair large floor crack at entrance; and Dish room- remove vases.” Upon request, S12 was unable to provide evidence of corrective actions for the above issues. On 5/9/24, during a tour of Father Hudson House with S28, Assistant Food Service Director, a storage closet was observed in the kitchen that contained plastic spoons for patient use, soda, two jackets hanging on hooks that were identified as personal items of the staff, and two dusters used for cleaning. This finding was shared with S28 at the time of discovery. S28 stated that food items for consumption should not be stored with personal outerwear and housekeeping items.”

“Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that food was prepared in accordance with the facility policy on standard operating procedures to prevent cross-contamination during meal preparation. Findings include: Peggy’s House/Scotch Plains On 5/8/24 at 11:46 AM, during a tour of the kitchen in Peggy Coloney’s House, Staff (S)13, a food service worker, was observed ladling green liquid into cups during meal preparation. S12, the Food Service Director, identified the liquid as soup that was being portioned out into the cups for patient consumption. S13 was not wearing gloves at the time he/she was ladling the soup into the cups. Upon discovery, S12 asked S13 to put on gloves for the preparation of the soup. S12 confirmed that S13 should have had gloves on during this food preparation. Facility document titled, “Kitchen Policy & Procedure Manual” stated, “... HACCP [Hazard Analysis Critical Control Point]- Based Standard Operating Procedures ...Preventing Cross-Contamination During Storage and Preparation ... 4. Avoid touching ready-to-eat food with bare hands ...””

“Based on observations, staff interviews, review of medical records, and review of facility policies and procedures, it was determined that the facility failed to ensure patients were free from restraints unless authorized by a physician in four of four inpatients (Patient (P)2, P3, P5, and P6). Findings include: During patient visits at inpatient facilities, Peggy Colony’s House (PCH) on 5/7/24. and Father Hudson House (FHH) on 5/9/24, it was observed that four of four patients(P) visited (PCH P2, P3, and FHH P5, P6) had all four side rails raised. On 5/9/24 at 11:24 AM, upon interview, Staff (S)2, Director of Residential Services, S23, Registered Nurse (RN), S26, Clinical Care Coordinator, explained that the use of four side rails is not a restraint. It is used as a safety precaution to prevent falls. S2, S23, and S26 stated that they only use all four rails on patients who cannot get out of bed. A review of the medical records for P2, P3, P5, and P6 revealed an order for “;Side rails up.” The order did not specify how many side rails should be up and for what purpose. The medical records for P3, P5, and P6 also had orders for “Fall Precautions.” P2’s medical record did not have an order for “fall precautions.” The medical records for P2, P3, P5, and P6 lacked evidence of restraint orders and restraint monitoring. On 5/9/24, at the PCH inpatient facility, interviews with three staff members (S8, S14, and S33) described the meaning of the order “;Side rails up” as follows: On 5/9/24 at 2:56 PM, S14, Home Health Aide (HHA), stated that the number of side rails he/she puts up depends on what the patient wants and if the patient can get out of bed. PC S14 explained that this order could mean two to four side rails up. If the patient is agitated, he/she uses all four side rails and the bed alarm. On 5/9/24 at 3:03 PM, S8, Licensed Practical Nurse (LPN), stated this order indicates that the patient is a fall risk and needs to be assessed to determine the number of side rails that would be needed. S8 explained that the use of four side rails is not necessarily part of the fall protocol. According to S8, four side rails are decided on an individual basis. During the interview, S8 stated, “;I know four side rails is usually a restraint, but we need to use them for some patients for fall precautions.” On 5/9/24 at 3:10 PM, S33, HHA, explained that this order indicates that all four side rails should be kept up for patient safety and prevention of falls. On 5/10/24 at 12:50 PM, upon request S1, Director of Nursing, failed to provide a Fall Precaution Policy. S1 confirmed that the facility does not have a Fall Precaution Policy. Facility policy titled, “;Restraints” updated 11/30/21 states, “;...Definitions:...A MANUAL or MECHANICAL restraint is defined as any device that is mechanically operated, such as bed rails...” Facility policy titled, “;Restraints – Patient Self-Determination & Safety” reviewed 1/18/24 states, “;...Policy: ... Hospice does not use restraints in the care of its patients. ...””

“Based on review of facility documents and staff interviews, the facility failed to ensure staff received annual restraint education and training in 12 of the 12 staff personnel files reviewed. On 5/10/24 at 12:50 PM, during personnel file review, restraint education conducted upon hire was observed, however evidence of annual restraint education for Staff (S)1, 8, 10, 12-14, 19, 32, 34, 35, 40, and 41 was requested from Staff (S)1, the Director of Nursing, Upon interview, S1 stated that annual restraint education was not done, because the facility does not use restraints. S1 stated that staff only receive restraint education upon hire.”