HospitalInspections.org

Based on observation, document review, a review of two medical records, and staff interview, it was determined that the nursing care of each patient is not provided in accordance with patient needs.

Findings include:

Reference #1: The "Center for Education and Development Constant Observation, Close Observation, and Patient Observation Education Plan" states, "Purpose: It is the policy of SJH to maintain the safety and security of patients at risk or potentially a danger to themselves or to others. SJH recognizes that close observation of the patient may take different forms, depending on the safety and supervision needs of the patient. These include: constant observation for the suicidal/homicidal patient, a PCA (Patient Care Associate) observer performing close observation at the bedside, and fifteen (15) minute rounding.

Target Audience: RN (Registered Nurse) & PCA

Behavioral Objectives: .... 3. Recognize the new recording form "Constant/Close Observation Record" (CCOR) to be used by the PCA and RN when caring for a patient under observation. .... 1. Constant Observation for the Suicidal/Homicidal Patient: .... Suicide Risk Assessment to be done by RN every shift. The PCA assigned for the Constant Observation receives report from the Primary RN and completes the Constant/Close Observation Record (CCOR). ...."

Reference #2: Hospital policy and procedure titled, "Close Observation Policy" states, " .....
PURPOSE: .... SJHS recognizes that close observation of the patient may take different forms, depending on the safety and supervision needs of the patient. These include, but are not limited to: constant observation for the suicidal/homicidal patient, a PCA observer performing close observation at the bedside, and fifteen (15) minute rounding. ..... Constant Observation for the Suicidal/ Homicidal Patient: Procedure: ..... 5. The PCA assigned for the Constant Observation receives report from the Primary RN and completes the Constant/Close Observation Record (CCOR). ..... 7. The PCA performing the constant observation remains within arms distance at all times, including toileting and traveling for tests. ....."

Reference #3: The instructions at the top of the CCOR form include: "CONSTANT OBSERVATION with continuous bedside observation by PCA for Suicidal/Homicidal Behavior. Documentation of current status done q (every) 15 minutes by PCA and hourly by RN. PCA may only be with that patient.

1. Review of Medical Record #1 revealed the following:

a. The patient was ordered "One to One Observation."

b. CCOR forms lacked evidence that the patient had been observed between 2:45 PM and 11:00 PM on 8/3/18; between 5:30 AM and 7:15 AM on 8/4/18; and between 7:00 AM and 4:00 PM on 8/5/18.

c. The CCOR form dated 8/4/18 indicated that, between the hours of 7:15 PM and 2:45 PM, the patient was observed every 30 minutes; at 7:45 AM. 8:15 AM, 8:45 AM, 9:15 AM, 10:45 AM, 11:15 AM, 12:24 PM, 1:15 PM, 1:45 PM and 2:15 PM.

d. The CCOR form dated 8/5/18 indicted that, between the hours of 7:15 PM and 2:45 PM, the patient was observed every 60 minutes between 4:00 PM and 11:00 PM.

e. There were no entries made on the "RN Assessments" section of the CCOR forms between the hours of 7:00 AM and 2:45 PM on 8/3/18; between 7:15 AM and 2:45 PM on 8/4/18; between 3:00 PM and 10:45 PM on 8/4/18; between 11:00 PM on 8/5/18 and 6:45 AM on 8/6/18; and between 7:00 AM and 11:30 AM on 8/6/18.

2. Review of Medical Record #2 revealed the following:

a. The patient was ordered "One to One Observation."

b. The CCOR forms lacked evidence that the patient had been observed between 10:45 PM on 8/5/18 and 7:00 AM on 8/6/18. There were no entries made on the "RN Assessments" section of the form.

c. On 8/6/18 at 11:15 AM, the current CCOR form was reviewed. There were three entries made on the form for observation, none of which indicated the time that the observations were made.

(i) Staff #12 stated that the PCA told him/her that he/she was "unsure of how to fill out the form." The PCA then entered times of 7:00 AM, 9:00 AM, and 11:00 AM for the three entries. The patient was not documented as having been observed every fifteen minutes.

(ii) There were no entries made on the "RN Assessments" section of the form.

A. Based on staff interview and document review, it was determined that the facility failed to ensure the implementation of policies and procedures that address pharmacy inspection of medication storage areas throughout the facility.

Findings include:

Reference #1: Facility policy titled "Medication Storage" states, "...Inpatient inspections will be conducted monthly...Upon inspection, medication storage areas will be checked according to the floor inspection forms. Written inspection reports shall be prepared and signed by the inspector and co-signed by the Pharmacy Managers or designee..."

1. On 8/7/18 at approximately 11:40 AM, review of the Unit Inspection Log for the calendar year 2018 indicated several units were not inspected on a monthly basis. These units included, but were not limited to:

a. Seton 5-Narc was not inspected in 1/2018, 2/2018, 3/2018, 5/2018, 6/2018, or 7/2018.

b. Seton 5 was not inspected in 2/2018, 3/2018, 4/2018, 6/2018 or 7/2018.

c. Regan 6S was not inspected in 2/2018, 3/2018, 6/2018 or 7/2018.

d. Regan 3S-B was not inspected in 1/2018, 3/2018, 5/2018, 6/2018, or 7/2018.

e. CB2S (SICU) was not inspected in 2/2018. 3/2018, 4/2018, or 7/2018.

f. CAT SCAN was not inspected in 1/2018, 2/2018, 3/2018, 4/2018, 6/2018, or 7/2018.

g. PHO (Xav 7) was not inspected in 1/2018, 2/2018, 3/2018, 4/2018, 6/2018. or 7/2018.

h. ASPAINMGT was not inspected in 2/2018, 3/2018, 5/2018, 6/2018, or 7/2018.

i. Seton 4S was not inspected in 1/2018, 5/2018, 6/2018, or 7/2018.

j. Regan 5N-A was not inspected in 1/2018, 2/2018, 3/2018, 4/2018, 6/2018, or 7/2018.

k. Regan 5S was not inspected in 3/2018, 6/2018, or 7/2018.

2. Staff # 5 and Staff #26 confirmed these findings.



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B. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure that medications are stored in accordance with facility policy.

Findings include:

Reference: Facility policy titled "Medication Storage" states, "Medications dispensed from the pharmacy may not immediately be administered to the patient. Medications must therefore, be delivered and stored under secure and safe conditions... Medications that do not require refrigeration are placed inside bins inside the medication room or in an ADC [Automated Dispensing Device]..."

1. On 8/7/18 at approximately 11:00 AM on Seton 5, multiple labeled, patient specific, medications were found inside the drawer of a work station on wheels (WOW). These medications included: Metoprolol ER 50mg tablet, Senna 8.6 mg tablet, one (1) bottle of Timolol Ophthalmic drops, Clonazepam 0.5mg one-half (1/2) tablet, and one (1) Novolog insulin pen.

a. Staff # 24 stated that medications that were not unit dosed, such as Timolol Ophthalmic drops and Novolog insulin pen, were stored inside the drawer of the WOW.

b. Staff #24 stated that these medications were transferred by one nurse to the next nurse at the end of each shift and not stored in the ADC in the medication room, as required by facility policy.

2. Staff #3 confirmed this finding.

3. Staff #3 and Staff #6 stated that all of the medications that were found inside the drawer of the WOW should have been stored in the patient specific bin in the ADC.

Based on staff interview and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the disposal of partial doses of Controlled Dangerous Substances (CDS) in accordance with Drug Enforcement Agency (DEA) regulations.

Findings include:

Reference #1: Facility policy titled "Hazardous Pharmaceutical Waste- Non-Chemotherapy" states, "... The unused waste portion of a controlled substance should be disposed of by flushing down the sink or toilet..."

Reference #2: Drug Enforcement Agency 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."

Reference #3: The Drug Disposal Act at, https://www.federalregister.gov/documents/2014/09/09/2014-20926/disposal-of-controlled-substances, states, "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."

1. On 8/7/18 at 10;45 AM, Staff #25 stated that partial doses of CDS were discarded in the sink, not rendered non-retrievable as required by the DEA.

a. This method of CDS disposal was confirmed by Staff #5 and Staff #3.

Based on observation, staff interview, and document review, it was determined that the facility failed to ensure the implementation of policies and procedures that address the reporting of controlled drug losses to the appropriate authorities.

Findings include:

Reference: Facility policy titled "Controlled Medications Storage" states, "The following agencies are to be contacted with consultation by SJHS (Saint Joseph's Healthcare System) Legal Counsel in the event of a controlled substance loss: ... Patterson Police Department... New Jersey Department of Health... New Jersey Board of Pharmacy... Drug Enforcement Agency (DEA)...New Jersey Division of Consumer Affairs... New Jersey Drug Control Unit..."

1. On 8/7/18, the facility could not provide evidence that the Patterson Police Department, New Jersey Drug Control Unit, or the Drug Enforcement Agency, were contacted regarding the confirmed incidence of a staff member intentionally diverting Controlled Dangerous Substances for his/her own use, discovered by the facility in June 2018.

a. This finding was confirmed by Staff #5 and Staff #14.