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Based on review of facility documents, staff interviews, and observations, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:

42 CFR 482.25 Pharmaceutical Services

Based on observation, review of Institute for Safe Medication Practice guidelines, and staff interview, conducted on June 14, 2017, it was determined that the facility failed to ensure the implementation of acceptable standards of practice for medication preparation.

Findings include:

Reference: Institute for Safe Medication Practices (ISMP) Safe Practice guidelines for Adult IV Push Medications, Appendix A, states, "3.5 Do NOT withdraw IV push medications from commercially available, cartridge-type syringes into another syringe for administration."

1. Sixteen (16) carpuject prefilled syringe cartridges of Morphine 4 mg (milligram)/1 ml (milliliter) were found in the Pyxis drug dispensing device located in the Emergency Holding Area.

2. Upon interview, Staff #4 stated that carpuject devices are not available. He/she stated that the medication is removed into another syringe by using a syringe and a needle.

3. These findings were confirmed by Staff #4.

Based on observation, document review, and staff interview conducted on June 14 and 15, 2017, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to ensure that medications are administered in accordance with acceptable standards of practice. Refer to Tag 0405.

2. The facility failed to ensure that medications are stored in accordance to manufacturer's recommendations. Refer to Tag 0491.

3. The facility failed to ensure control and accountability of Controlled Dangerous Substances (CDS). Refer to Tag 0494.

4. The facility failed to ensure that drugs and biologicals are controlled and distributed in accordance with applicable standards of practice. Refer to Tag 0500.

5. The facility failed to ensure the implementation of policies and procedures addressing the reporting of drug diversion events. Refer to Tag 0509.

Based on observation, document review, and staff interview conducted on June 15, 2017, it was determined that the facility failed to ensure that medications are stored and maintained in accordance with manufacturer's recommendations.

Findings include:

1. During an observation in the Pharmacy Department, five (5) vials of unopened Folic Acid and one vial of opened and needle punctured, Folic Acid were found in the medication refrigerator. The manufacturer's instructions states, "Storage/Stability: Store at 20 C to 25 C (68 F to 77 F); protect from light."

2. During an observation, one (1) intravenous bag of Metronidazole and two (2) intravenous bags of Sodium Chloride 0.9% were found stored out of the overwrap provided by the manufacturer, without any indication of a beyond use date. Once the medications are taken out of the overwrap, the manufacturer's expiration date does not apply.

a. Upon request, Staff #8 was unable to provide a policy and procedure addressing the beyond use date for medications removed from the overwrap.

3. The above findings were confirmed by Staff #1.

Based on document review and staff interview conducted on June 14, 2017, it was determined that the facility failed to ensure implementation of policies and procedures addressing the accountability of controlled dangerous substances (CDS).

Findings include:

Reference: Facility policy titled "Automated Dispensing Cabinets" states, "Procedure: ... D. Medication wastage-Controlled Substances ...The wastage must be witnessed by an appropriate licensed professional (e.g., registered nurse, pharmacist, and a physician).The wasted medication is to be documented at the time the medication is wasted."

1. The removal of one (1) Hydromorphone (Dilaudid) 2 mg (milligram)/1 ml (milliliter) syringe, a Schedule II CDS, is recorded on the Pandora Medstation report, on 2/3/17 at 5:56 PM, for Patient #4. The administration of "Dilaudid 1 mg," on 2/3/17 at 18:02, is recorded on the medication administration summary in Medical Record #4. There is no evidence of wastage of the remaining 1 mg of Dilaudid.

2. The removal of one (1) Hydromorphone 2 mg/1 ml syringe, a Schedule II CDS, is recorded on the Pandora Medstation report, on 2/6/17 at 9:04 AM, for Patient #5. The administration of "Dilaudid 1 mg," on 2/6/17 at 11:31 AM, is recorded on the medication administration summary in Medical Record #5. There is no evidence of wastage of the remaining 1 mg of Dilaudid.

3. The removal of one (1) Morphine 4 mg/1 ml syringe, a Schedule II CDS, is recorded on the Pandora Medstation report, on 2/6/17 at 7:34 PM, for Patient #6. The administration of "Morphine 2 mg," on 2/6/17 at 7:39 PM, is recorded on the medication administration summary in Medical Record #6. There is no evidence of wastage of the remaining 2 mg of Morphine.

4. The removal of one (1) Morphine 4 mg /1 ml syringe, a Schedule II CDS, is recorded on the Pandora Medstation report, on 3/5/17 at 2:57 PM, for Patient #7. The administration of "Morphine 2 mg," on 3/5/17, is recorded on the medication administration summary in Medical Record #7. There is no evidence of wastage of the remaining 2 mg of Morphine.

5. The removal of one (1) Hydromorphone 2 mg /1 ml syringe, a Schedule II CDS, is recorded on the Pandora Medstation report, on 1/29/17 at 4:03 PM, for Patient #8. The administration of "Dilaudid 1 mg," on 1/29/17, is recorded on the medication administration summary in Medical Record #8. There is no evidence of wastage of the remaining 1 mg of Dilaudid.

6. These findings were confirmed by Staff #1 and Staff #4.

A. Based on observation, document review, and staff interview conducted on June 15, 2017, it was determined that the facility failed to ensure the implementation of policies and procedures addressing the disposal of Controlled Dangerous Substances (CDS).

Findings include:

Reference: Facility policy titled "Medication Management of Hazardous Waste" states, "... 5. Pharmaceuticals may not be poured down any drain or flushed down any toilet... ."

1. Review of Medical Record #1 indicated that Patient #1 was administered 0.5 ml (milliliter) of Morphine 4 mg (milligram)/ 1 ml and the remaining 0.5 ml was wasted. Upon interview, Staff #4 stated that the partial doses of narcotic wastages are "either squirted in the sharps container or to the sink." Staff #6 confirmed that the narcotic wastages would be disposed of down the sink.

2. The above findings were confirmed by Staff #1.

B. Based on observation, document review, and staff interview conducted on June 15, 2017, it was determined that the facility failed to ensure implementation of policies and procedures addressing the distribution of medications obtained through the automated dispensing machines (ADM).

Findings include:

1. During an observation, on 6/15/17 at 12:10 PM, the contents of two patient medication cassette drawers were compared with the Medication Administration Record (MAR). The following discrepancies were found:

a. Two (2), 50 ml, bags of Cefazolin 1 gm (gram)/ D5W were found in the cassette drawer for Patient #2. The administration times listed on the electronic MAR (eMAR) were 1 gm at 9:54 PM on 6/12/17 and 05:57 AM on 6/13/17.

i. Upon interview, Staff #13 stated that the medication was discontinued on June 13, 2017 and the bags should have been taken out of the cassette drawer by pharmacy personnel. She/he stated that any medications that remained in the cassette during the 24 hour exchange should be removed by the pharmacy technician and returned to the pharmacy.

b. One (1) unit-dose tablet of Trazadone 100 mg (milligram) was found in the cassette drawer for Patient #3. It was recorded on the eMAR that the medication had been administered on June 14, 2017 at 10:30 PM. Staff #13 stated that this medication should have not been in the cassette drawer.

c. Two (2) unit-dose tablets of Aspirin 81 mg were found in the medication cassette for Patient #3. These medications are available to the nurse from the ADM. It was recorded on the eMAR that the medication had been discontinued on June 12, 2017. The tablets had not been returned to the ADM and had not been removed by the pharmacy technician.

2. These findings were confirmed by Staff #1 and Staff #4.

C. Based on observation, document review, and staff interview conducted on June 15, 2017, it was determined that the facility failed to ensure the development of policies and procedures addressing the maintenance of the vaccine cold chain in accordance with acceptable standards of practice.

Findings include:

Reference: The Centers for Disease Control and Prevention website states, "Vaccines that will be used at an off-site or satellite facility should be delivered directly to that facility. If that is not possible, transport of vaccines should be done using a portable vaccine refrigerator with a temperature monitoring device placed with the vaccines. If this is not available, qualified containers and pack-outs can be used with a temperature monitoring device. ...Frozen varicella-containing vaccines should never be transported except in an emergency."

1. During an observation in the main pharmacy department, vaccines were found in the medication refrigerators.

a. Upon interview, Staff #1 stated that the facility stocks vaccines for an offsite, outpatient family practice clinic located a few miles away.

b. Upon request, Staff #8 was unable to provide policies and procedures addressing the transportation of vaccines and maintaining the vaccine cold chain. He/she stated that the facility did not have policies and procedures addressing this.

c. Review of the Drug Stock Requisition Form for the family practice indicated that frozen varicella-containing vaccines were listed on the form.

2. These findings were confirmed by Staff #1.

Based on staff interview and document review conducted on June 14, 2017, it was determined that the facility failed to ensure that criminal acts or potentially criminal acts, that occur within the facility and pose a danger to the safety of patients, are immediately reported to the appropriate police authorities and the necessary Federal and State agencies.

Findings include:

Reference: Facility polity titled "Controlled Substance & Target Drug Hospital Wide Diversion Prevention Program" states, "HUMC Mountainside fulfills reporting requirements according to the laws in the State of New Jersey and Federal law as it applies regarding the diversion of CS or target non-controlled drugs. The Director of Pharmacy will report to the DEA when immediately evident the discovery of any losses, including amounts and strengths. ...The Organization follows any other applicable requirements, the loss of controlled substances are reported in accordance to applicable Federal and State Laws of New Jersey, which includes, but is not limited to local law enforcement and the Board of Nursing, Division of Consumer Affairs, and the Department of Attorney General to individual responsible for the pharmacy department and to the Chief Executive Officer, as appropriate."

1. Upon interview, Staff #1 stated that, from 3/24/17 through 4/7/17, the facility had conducted an investigation of possible drug tampering and diversion by an employee. Staff #1 confirmed that the results of the investigation concluded that theft of property and narcotic diversion related to gross misconduct had occurred, resulting in termination of the employee.

a. Staff #1 stated that, as of June 14, 2017, she/he had not reported this criminal activity, which poses a threat to the safety of patients, to the police authorities.

b. Staff #1 stated that the she/he is not sure if the Board of Pharmacy or Drug Enforcement Agency were notified. She/he was unable to provide evidence that the facility had notified these agencies.

2. The above findings were confirmed by Staff #1.