The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST MARY'S GENERAL HOSPITAL 350 BOULEVARD PASSAIC, NJ 07055 June 13, 2018
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on document review and staff interview conducted on June 13, 2018, it was determined that the facility failed to ensure that the Director of Pharmacy properly supervised all the activities of the pharmacy service.

Findings include:

1. Upon interview, Staff #5 stated that the Director of Pharmacy recently resigned and the Interim Director of Pharmacy was not available.

2. Upon interview, Staff #4 stated that Staff #3, a pharmacy technician, is responsible for reviewing the narcotic transactions.

a. Upon interview, Staff #3 stated that he/she would take the pink anesthesia record and compare it to the narcotic transaction record.

i. Staff #3 staed that if the anesthesia record was illegible, he/she would choose a different anesthesia record.

ii. Staff #3 stated that he/she did not recieve formal training in reviewing the narcotic transactions.

b. Upon request, Staff #3 was unable to provide evidence of the narcotic transactions reviewed.

3. The above findings were confirmed by Staff #5 and Staff #6.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on staff interview and document review conducted on June 13, 2018, it was determined that the facility failed to ensure that quality indicators for controlled dangerous substances were measured, analyzed, and tracked.

Findings include:

1. The facility Plan of Correction, submitted on May 16, 2018, for failure to ensure adequate accountability of Controlled Dangerous Substances, states, "Compliance will be monitored by PIC, or designee, via transaction audits. Audits will be completed as follows: 10 audits per week of narcotic transactions, 10 audits per week of anesthesia record sheets and once daily for narcotic discrepancies. Ongoing compliance will be sustained by: Audits will continue until compliance is maintained for three months. Once compliance is achieved, PIC, or designee will perform 10 audits of narcotic transactions per month, 10 audits of anesthesia record per month and one audit per week for any delay in documenting waste, discrepancy on anesthesia record, or unresolved discrepancy within 24 hours will be reported to respective director or CNO. ... These (sic) data will be reviewed by the CNO, and reported to the Hospital Quality Committee monthly by the PIC."

a. Review of the weekly Narcotic Transaction audit tool revealed the following:

i. One hundred forty-four (144) Anesthesia records were reviewed by the facility staff between April, 2018 to May, 2018.

ii. Staff #4 was not able to provide evidence of ten (10) audits per week of narcotic transactions, ten (10) audits per week of anesthesia record sheet, or one (1) audit of daily narcotic discrepancies.

i. Upon interview, Staff #4 confirmed that he/she is not familiar with quality improvement projects, monitoring tools, collecting, measuring and analyzing data.

2. Upon request, Staff #1 was not able to provide evidence of monthly aggregated data reviewed and reported to the Hospital Quality Committee.

3. Staff #1 and Staff #5 confirmed that the monitoring tool developed following the Federal Allegation survey of March 27, 2018 failed to ensure adequate accountability of Controlled Dangerous Substances.

4. The above findings were confirmed by Staff #1, Staff #5, and Staff #6.