Newton Medical Center

“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: 50602 Based on two of ten medical records (MR) reviewed (MR2 and MR6), facility document review, and staff interviews, it was determined that the facility failed to ensure that policies and procedures addressing the administration of titrated Controlled Dangerous Substance (CDS) medication infusions according to physicians’ orders are implemented. Findings include: Facility policy titled “Titration of Continuous Intravenous Medication,” effective 12/07/2023, stated, “ ... 7. Nursing will document dose adjustments as well as baseline assessment and the patient’s response to the titration of medication in the medical record based on practitioner order.” On 05/22/25, medical records were reviewed with Staff (S)2 (Risk Manager) and S5 (Quality and Patient Safety Project Manager). The Medication Administration Record (MAR) found in MR2, dated 03/15/25, contained the order, “Morphine [opiate medication used to manage moderate to severe pain] in sodium chloride 0.9% [NS] infusion [1 mg/ml] ... Frequency: Titrate ...Admin Instructions: Start at 1 mg/hour [milligram/hr] every 20 minutes to goal of RDOS [Respiratory Distress Observation Scale] 4-6. Decrease continuous infusion rate by 50% if RDOS=0 or no pain over last 4 hours.” Below the order under “Timestamps,” the morphine infusion was documented as started on 03/15/25 at 11:45 AM at 1 mg/hr. The infusion was then titrated at four different times with increases in doses until a final rate of 25mg/hr before it was discontinued on 03/15/25 at 02:45 PM. The RDOS scale was reviewed under the “Flowsheets” portion of MR2, and it was revealed that MR2 lacked documentation of the RDOS scale on 03/15/25. MR2 lacked documentation of RDOS during the time of administration of the morphine infusion and for each increase in the infusion rate as required by the physician’s order. The MAR found in MR6 included an order dated 02/20/25 at 11:55 AM for “Morphine in sodium chloride 0.9% infusion [1 mg/ml] ... Frequency: Titrate ...Admin Instructions: Start at 1 mg/hr and titrate by 1 mg/hour every 20 minutes to goal RDOS 4-6. Decrease continuous infusion rate by 50% if RDOS=0 or no pain over last 4 hours.” Further under “Timestamps,” the morphine infusion was documented as started on 02/20/25 at 12:22 PM at 1 mg/hr. The infusion rate was increased seven times to a final rate of 8 mg/hr before it was discontinued on 02/20/25 at 03:29 PM. MR6 lacked documentation of RDOS as required for the rate change per the physician’s order. S5 confirmed on 05/22/25 at 02:30 PM, that the documentation for the RDOS assessments on the above records were missing and should have been documented.”

“CONTENT OF RECORD CFR(s): 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services. This Standard is not met as evidenced by: 50602 Based on two of ten medical records (MR) reviewed (MR1 and MR5), facility document review, and staff interviews, it was determined that the facility failed to ensure that medication orders for titrated Controlled Dangerous Substance (CDS) infusions are complete and include the frequency of rate changes and the clinical goal, in accordance with facility policy. Findings include: Facility policy titled “Titration of Continuous Intravenous Medication,” effective 12/07/2023, stated “ ...1. Medication Titration Orders will include the following components: ...c. Starting dose (e.g., start at 5 mcg/kg/min) d. Titrating dose (e.g., titrate by 5 mcg/kg/min) e. Titration frequency (e.g., every 5 minutes) f. Documentation of clinical goal (e.g., titrate to Richmond Agitation Sedation Scale [RASS] goal of 0 to -2) ....2. Each titratable medication has predefined components as noted in Appendix A, B (adults), ...4. Pharmacy will contact the practitioner to clarify the order if any of the elements are missing (e.g., goal blood pressure) and if a default value is not available from the titration order ...” On 05/22/25, medical records were reviewed with Staff (S)2 (Risk Manager) and S5 (Quality and Patient Safety Project Manager). The Medication Administration Record (MAR) found in MR1, dated 02/05/25, contained an order for Morphine (opiate medication for management of moderate to severe pain) with the directions “... Frequency: Titrate ...Admin Instructions: Titrate to comfort.” The physician’s order lacked the frequency and a clinical goal. MR1 lacked documentation of the Respiratory Distress Observation Scale (RDOS) in the flowsheets. A total of seven rate increases for the morphine infusion were documented between 02/05/25 and 02/06/25. The starting dose on 02/05/25 at 11:37 PM was 0.5 mg/hr, and the final dose on 02/06/25 at 11:56 AM was 7 mg/hr. The MAR found in MR5 was reviewed. On 02/20/25, an order for morphine contained the following directions: “ ... Admin Instructions: Titrate to comfort.” The physician’s order lacked the frequency and a clinical goal. S5 confirmed both orders for morphine infusion lacked the frequency for the rate change and a clinical goal to titrate the medication accordingly. On 05/22/25 at 02:40PM, S2 confirmed these findings and stated that the specific assessment scale indicated for the titrated infusions “should be in the doctor’s orders.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 39724 Based on medical records review, facility document review, and staff interviews, it was determined that the facility failed to ensure that policies and procedures to minimize Controlled Dangerous Substance (CDS) diversion are developed and implemented including: 1.) that CDS waste is completed in a timely manner; and 2.) that intravenous (IV) solutions of CDS are secured in accordance with facility policy. Findings include: 1. Facility policy titled “Controlled Dangerous Substances,” dated 11/04/24, stated, “... Any dose of CDS removed from an ADC [automated drug cabinet] or secured storage area that is not administered will be returned to the ADC external return bin if intact or wasted if opened or partially used as soon as possible ...” On 05/22/25 at 10:33 AM, on unit 1 South, Staff (S)10 (Registered Nurse [RN]) stated that when an IV [Intravenous] infusion containing CDS is discontinued, nursing staff will remove the container from the IV pump and measure the contents of the remaining infusion to document the amount of the wasted CDS in the Omnicell (automated drug cabinet). S10 stated that the expectation is that the CDS will be wasted immediately after stopping the pump. S10 stated that if a patient with a CDS infusion expires, the nurse who discontinues the infusion should remove the CDS remaining immediately and waste it with a witness. On 05/22/25 at 10:46 AM, on unit 1 South, S11 (RN) stated that when a CDS infusion is discontinued, the amount of medication remaining is measured, and the waste is documented in Omnicell with a witness. S11 stated that CDS waste should be completed right away, “it is a priority.” On 05/22/25 at 11:10 AM, on unit 1 South, S12 (Assistant Nurse Manager) explained that CDS waste is documented in the Omnicell “right away’ with a witness. On 05/22/25 at 11:25 AM, on unit 1 South, S13 (RN) stated that on 03/13/25 he/she was assigned Patient (P) 3, who was ordered a morphine (a Schedule II CDS) 100 mg (milligrams)/ 100 ml (milliliter) infusion. S13 stated that P3 expired, and he/she discontinued the morphine infusion. S13 stated that one of his/her other patients needed immediate attention, and the container of morphine solution was left on the IV pump at P3’s bedside. S13 stated that he/she “should have discarded the morphine right away.” S13 stated that when he/she returned to the room later, the morphine infusion was not there. The resulting facility investigation failed to determine what happened to the remaining morphine solution. On 05/22/25 at 1:20 PM, S14 (Pharmacy Manager Operations) reviewed the facility policy titled “Controlled Dangerous Substances” and stated that CDS waste should be completed as soon as possible and confirmed that the facility policy statement is vague. S14 clarified that the expectation is that in non-procedural areas, the CDS waste should be completed within “60 minutes” (or one hour). On 05/22/25, medical records (MR) containing orders for morphine infusions and the corresponding Omnicell CDS waste reports were reviewed with and S2 (Risk Manager) and S5 (Quality and Patient Safety Project Manager). The following was identified: The Medication Administration Record (MAR) found in MR1 indicated that the morphine infusion was stopped on 02/06/25 at 3:05 PM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 02/06/25 at 4:32 PM. This is more that one hour after the morphine was stopped. The MAR found in MR2 indicated that the morphine infusion was stopped on 03/15/25 at 2:45 PM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 03/15/25 at 4:56 PM. This is more than one hour after the morphine was stopped. The MAR found in MR3 indicated that the morphine infusion was stopped on 03/13/25 at 10:04 PM. The corresponding Omnicell waste report indicated that the remaining morphine was not wasted. The MAR found in MR4 indicated that the morphine infusion was stopped on 02/03/25 at 12:21 AM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 02/03/25 at 5:39 AM. This is more than one hour after the morphine was stopped. The MAR found in MR6 indicated that the morphine infusion was stopped on 02/20/25 at 2:29 PM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 02/20/25 at 4:43 PM. This is more than one hour after the morphine was stopped. The MAR found in MR8 indicated that the morphine infusion was stopped on 03/27/25 at 2:25 PM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 03/27/25 at 4:29 PM. This is more than one hour after the morphine was stopped. The MAR found in MR10 indicated that the morphine infusion was stopped on 02/04/25 at 3:03 AM. The corresponding Omnicell waste report indicated that the remaining morphine was wasted on 02/04/25 at 6:29 AM. This is more than one hour after the morphine was stopped. On 05/22/25 at 2:35 PM S2 and S5 confirmed these findings. 2. Facility policy titled “Patient Controlled Analgesia, Adult and Pediatrics,” dated 11/02/2023, stated, “... Administration ... When the PCA (patient controlled analgesia) is initiated, or changed ... two (2) RNs [Registered Nurses] will independently: ...Verify the pump is secured in the case ...” On 05/22/25 at 10:25 AM, S10 (RN) stated that when he/she has to administer or change a CDS IV bag such as morphine, he/she makes sure that the IV bag is secured in a clear plastic box that prevents the CDS from being removed from the IV pole/pump. On 05/22/25 at 10:48 AM, S11 (RN) stated that when he/she sets up a CDS medication like morphine in a PCA pump, he/she makes sure that the medication is secured in a clear plastic box on the IV pole. S11 stated that each unit has the clear lockable storage boxes available in the Storage Room on the unit. S11 stated that if the clear plastic box wasn’t available, he/she would make a call to the Nursing Supervisor or go to another unit to get one. On 05/22/25 at 11:05 AM, 2 clear lockable boxes used to secure CDS IV medication on the IV pole were observed in the Storage Room on unit 1 South, available for use. On 05/22/25 at 11:25 AM, S13 (RN) stated that on 03/13/25 he/she noticed that the morphine 100 mg/100 ml being administered to Patient (P)3 via a standard pump was not secured in a clear plastic lockable box. S13 stated that as a newly trained staff member, he/she had previously cared for a patient with a morphine IV infusion, and that patient’s medication was secured in the clear box on the IV pole. S13 stated that he/she asked his/her charge nurse, S16, if the medication should be in a locked box and was told that those boxes weren’t used very much on the unit 1 South. S13 confirmed that on 03/13/25, when he/she discontinued the IV infusion of morphine for P3, the IV bag of morphine was labeled and unsecured on the IV pole. S13 confirmed that he/she did not waste the remaining morphine immediately, and after retuning from another patient’s room, the IV bag containing the morphine was missing. On 05/22/25 at 1:20 PM, S14 (Pharmacy Supervisor Operations) confirmed that the facility policy titled, “Patient Controlled Analgesia, Adult and Pediatrics” dated 11/02/2023, required the staff to secure the CDS for PCA IV infusion in the clear plastic lock box on the IV pole. When asked about CDS infusions that are not delivered by a PCA pump, but by a standard IV pump, S14 indicated that the clear box was not required. S14 could not explain why an IV bag containing morphine 100 mg/100 ml on a standard pump was not required to be secured, but the same IV bag in a PCA pump was required to be secured. S14 confirmed that the facility did not have a process or policy to ensure the security of CDS administered by a standard infusion pump.”

“REPORTING ABUSES/LOSSES OF DRUGS CFR(s): 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. This Standard is not met as evidenced by: 39724 Based on facility document review and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the reporting of the loss of Controlled Dangerous Substances (CDS) in accordance with State and Federal regulations. Findings include: On 05/22/25 at 10:00 AM, during the entrance conference with Staff (S)1 (Nursing Manager), S2 (Risk Manager), and S3 (Chief Medical Officer), it was confirmed that the facility reported an incidence of CDS loss that occurred on 03/14/25. S1 confirmed that a 100 ml (milliliter) container of intravenous (IV) morphine (a Schedule II CDS) solution 100 mg (milligram)/100 ml that was partially administered to Patient (P)3, with approximately 84 ml remaining, could not be accounted for. Facility investigation documentation and internal and external agency reporting documentation were requested at this time. On 05/22/25 at 11:42 AM, the facility policy that addressed the reporting requirements for CDS loss was requested and provided. Facility documents related to internal and external agency reporting were reviewed. Reference: Code of Federal Regulations Title 21 Chapter 2 Part 1301.76 (b) stated, “ ... The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant must also file a complete and accurate DEA Form 106 with the Administration through DEA’s Diversion Control Division secure network application within 45 days after discovery of the theft or loss ... “ Reference: N.J.A.C. 13:45H-2.5(d) Controlled Dangerous Substances Act, stated, “ ... The registrant shall notify the Drug Control Unit of the theft or loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DDC-52 form regarding such loss or theft ... “ On 05/22/25 at 11:45 AM, S1, S4 (Director of Quality Patient Safety), and S5 (Quality patient Safety Project Manager) confirmed that the only external agency reporting completed was to the police department and the New Jersey Department of Health. On 05/22/25 at 1:10 PM, S14 (Pharmacy Manager Operations) provided the DEA (Drug Enforcement Administration) Form 106. The Form 106 was submitted to the DEA on 05/16/25, more than 60 days after the facility discovered the event. This is not is accordance with the Federal regulation referenced above. On 05/22/24 at 1:11 PM, S14 confirmed that the facility failed to report the loss of the CDS to the New Jersey Drug Control Unit (NJ DCU) on a DDC-52 form, in accordance with the State regulations referenced above. Facility policies and procedures titled, “Internal Investigation,” last reviewed 03/01/25, “Reporting and Open Communication,” last reviewed 03/01/25, and “Drug Diversion Awareness,” last reviewed 03/01/25, received on 05/22/25, failed to include the requirement to report the loss of CDS to the DEA and NJ DCU in accordance with State and Federal regulations. This was confirmed with S14 on 05/22/25 at 1:25 PM.”

“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: 51148 Based on the review of four of ten medical records for Patient (P)1, P6, P7, and P10, staff interviews, and review of facility documents, it was determined the facility failed to ensure that medications brought from home are inventoried upon admission in accordance with facility policy. Findings include: Facility policy titled, “Patient’s Own Medication Storage and Use During Hospitalization” effective 4/28/23 stated, “... Procedure: On Admission ... 1. Upon admission, the nurse will ask every hospitalized patient to present all personal medication in his/her possession ... 2e. Nursing will document in the EHR [Electronic Health Record] that a POM [Patient’s Own Medication] will be stored in the pharmacy...” On 4/23/25 a review of P1’s medical record was conducted and revealed the following: P1 arrived at the facility’s ED on 11/9/24 at 2:02 PM with a chief complaint of abdominal pain. At 3:54 PM, the Provider discussed with P1 the plan to admit to which the patient agreed. At 4:51 PM, P1 was transferred to an inpatient bed on 2W [2West], a Medical-surgical unit. At 7:30 PM, the nursing assessment lacked documentation that belongings including medications brought from home were inventoried. On 11/10/24 at 10:33 AM, P1 was examined bedside by the admitting physician. The Significant Event Note from 11/10/24 at 9:13 PM stated, “ ... Code blue called at 8:35 PM for patient having unresponsiveness ...from the bathroom, had a bottle of pills in a prescription bottle labeled as Cipro[Ciprofloxacin] but containing 4 mg [milligrams] Dilaudid tablets. Patient was intubated by RT [Respiratory Therapist] successfully, initial rhythm PEA [Pulseless Electrical Activity] throughout code. Due to lack of perfusing rhythm, pronounced as deceased at 9pm. Pupils fixed and dilated, absent heart and lung sounds. ... 10:06pm notified by charge nurse that white powdery substance was also found around the sink in patient’s bathroom with scattered pills. ...” A review of the security narrative stated, “ ...Security followed up with Medical Records for patient belongings. Medical Records advised there are no ‘Inventory Belongings Form’ ... no visitors recorded visiting [P1] ...” During the review of P1’s medical record, the section, “ ... Medication brought by patient ... yes no ...” failed to indicate that the patient’s belongings were assessed and inventoried to include medications brought from home, upon admission. At 10:46 AM, an interview was conducted with S11 (RN) on the 2W unit who was asked about the process for belongings of patients that arrive from the ED. S11 stated, the floor does their own inventory of belongings and documents in the electronic medical record (EMR) once the patient reaches the unit. S11 was asked to explain the process for home medication brought to the unit. S11 explained, all medication is inventoried and sent to the pharmacy in a sealed bag for verification. The pharmacy profiles the medication and if it is not a formulary medication, it is dispensed by the pharmacy when the patient needs it. If it is a formulary medication, the patient is informed that the same medication will be given to them while they are in the facility. The patient’s medication remains in the pharmacy and the patient receives their medication back when they are discharged. If the patient has controlled medications that are non-formulary, they are dispensed from the pharmacy one pill at a time. S11 added, the status of any home medication is documented in the patient’s chart as ‘sent to pharmacy’ or ‘sent home with family’. At 10:54 AM, an interview was conducted with S13 (RN) on 2-West. S13 was asked about the process for home medication and stated, medication brought with the patient is sent to the pharmacy with a medication documentation sheet. One copy goes to the pharmacy and the other copy goes inside the patient belongings bag. S13 stated the medical record is then updated to reflect that the patient brought their own medication, then it will be sent to the pharmacy. S13 then demonstrated how to document if a patient brings medications from home in the EMR. Under the patient belongings section, medications brought from home is a yes or no question, which should be completed upon admission when inventorying the patient’s belongings. 48414 Additional medical records reviewed, revealed the following: P6 presented to the ED on 4/21/25 at 3:51 PM with a complaint of Cough, and Shortness of Breath. P6 was admitted on 4/21/25 at 6:59 PM to 2-West Medical/Surgical unit. The section, “ ... Medication brought by patient ...yes no ...” was not marked. P6’s medical record lacked documentation that medications brought from home was assessed upon admission. P7 presented to the ED on 4/19/25 at 9:51 AM with a complaint related to reproductive health. P7 was admitted on 4/19/25 at 4:32 PM to 2-West Medical/Surgical unit. The section, “ ... Medication brought by patient ...yes no ...” was not marked. P7’s medical record lacked documentation that medications brought from home was assessed upon admission. P10 presented to the ED on 8/29/24 at 5:38 PM with a complaint of Altered Mental Status. P10 was admitted on 8/30/24 at 4:50 PM to 2-West Medical/Surgical unit. The section, “ ... Medication brought by patient ...yes no ...” was not marked. P10’s medical record lacked documentation that medications brought from home was assessed upon admission. On 4/23/25 these above findings were reviewed with Staff (S)1 (Nurse Manager 2 West Medical/Surgical unit and Covering Director of Nursing), S2 (Director of Nursing ED), S3 (Risk Manager), S4 (Chief Medical Officer), S5 (Accreditation Manager), S6 (Quality and Patient Safety), and S7 (Executive Director Risk Management. Upon interview, S1 confirmed medications brought in by a patient is part of the admission assessment during the inventory of belongings. Every patient should be asked if they brought any medications. S1 also confirmed every patient should have documented “yes or no” for medications brought by patient in their medical record. If a patient brings their own medications, they should be inventoried then sent to the pharmacy or sent home. At 1:12 PM, S1 was asked if education related to belongings and medication brought from home was provided to 2-West staff after the incident involving P1 occurred, S1 stated he/she has discussions during huddle with staff. S1 then confirmed there was no education provided to staff related to belongings and medications brought from home since the incident occurred with P1.”