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Tag No.: A0489
Based on a review of facility documents, medical records, and staff interviews, it was determined the facility department of pharmaceutical services failed to follow policies and procedures to minimize drug errors.
This condition is not met as evidence by:
Based on a review of a facility documentation including a facility investigation, personnel records, medical records, and staff interview, the phamacy failed to follow policies for medication distribution and staff training which resulted in multiple medication errors in the radiology department.
Findings include:
A facility investigative report dated April 1, 2022, revealed that Neostigmine syringes were found by Xray staff in the refrigerator where, "Stingfree" syringes are normally stocked. The facility investigation revealed that on March 31, 2022, prior to 8:00 AM, two boxes, each containing 5 prefilled syringes of Neostigmine were removed from the pharmacy and taken to the Radiology Department, in place of the "sting-free" buffered lidocaine requested from the Radiology Department.
The investigation indicated that between March 31, 2022 and April 1, 2022, five procedures were performed that included the use of buffered lidocaine. It was after the fifth procedure that the radiology technician discovered that the medication used was neostigmine and not buffered lidocaine as the color of the syringe was different.
The following standard was cited to show nature of non-compliance:
Refer to 482.25 (a) Standard: Pharmacy Management and Administration
Tag No.: A0491
Based on a review of facility policies and documents, and review of medical records (MR), and personnel files (PF), and staff interview (EMP), it was determined that the facility failed to follow their policy and maintain safety through their medication delivery process for five of five patients (MR1, MR2, MR3, MR4, MR5), and failed to ensure four of four radiology technologists were appropriately trained for the delivery of medications (PF1, PF2, PF3, PF4),
Findings include:
On March 6, 2022, a review of the facility policy titled, "Medication Distribution System," revised date of April 1, 2020, revealed, "Administration A. Procedure/Protocols...7. Distribution of medications may be performed only after the approval of a licensed pharmacist."
On March 6, 2022, a review of the facility policy titled, "Medication Administration," revised date of January 11, 2022, revealed, "Administration 6. Nuclear and radiology technologists: may administer medications as outlined in their job description and approved by entity specific protocol."
A facility investigative report dated April 1, 2022, revealed that Neostigmine syringes were found by Xray staff in the refrigerator where, "Stingfree" syringes are normally stocked. The facility investigation revealed that on March 31, 2022, prior to 8:00 AM, two boxes, each containing 5 prefilled syringes of Neostigmine were removed from the pharmacy and taken to the Radiology Department, in place of the "sting-free" buffered lidocaine requested from the Radiology Department.
The investigation indicated that between March 31, 2022 and April 1, 2022, five procedures were performed that included the use of buffered lidocaine. It was after the fifth procedure that the radiology technician discovered that the medication used was neostigmine and not buffered lidocaine as the color of the syringe was different.
On April 6, 2022, a review of the medical records of the affected patients was completed and revealed the following:
A review revealed that MR1 was an inpatient and had a midline placement procedure on March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injection, route local infiltration. IR Midline insert Study result revealed, "Patient tolerated procedure well."
A review revealed that MR2 was an outpatient and had a shoulder arthrogram scheduled for March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injection, route local administration. Arthrogram study results dated March 31, 2022, revealed, "Technique...Upon administering local anesthetic with a 25 gauge hypodermic needle, the patient expressed severe pain and declined to proceed with the fluoro guided injection. Approximately 30 minutes post anesthesia administration, the patient was complaining of difficulty swallowing. The patient was advised to proceed to ED."
A review revealed that MR3 was an outpatient and had bilateral hip injections on March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml x 2) intradermal (right hip). A second order for the same medication was ordered for the left hip. The procedure report dated March 31, 2022, revealed, "Technique...The patient tolerated the procedure well with improvements in pain following procedure...Impression: Technically successful fluoro-guided bilateral hip injection."
An emergency department (ED) note for MR#3 dated March 31, 2022, at 2:39 PM revealed, "History...[MR#3] is...here for dizziness (patient was at CBH for an outpatient procedure...became dizzy and had a near syncopal episode resulting in a rapid response being called. Upon arrival to the ED patient was awake and alert, diaphoretic, with a fluctuating heart rate between 38-51. Patient also with abdominal pain..."
A review revealed that MR4 was an ICU inpatient and had a placement of a PICC line on April 1, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injectable. The procedure report dated April 1, 2022, revealed, "IR-PICC Study result...Technique...The skin over the access site was anesthetized with lidocaine. It was later discovered that there was a potential medication error with possible injection of neostigmine rather than buffered lidocaine."
A review revealed that MR5 had a paracentesis on April 1, 2022. Medication order was for buffered lidocaine 0.9% (5ml) with the ordered dose of 10ml injection for local infiltration. The US Paracentesis with guidance study result dated April 1, 2022, revealed, "Impression...the patient became hypotensive and had sudden sensation of the need to move his bowels during the procedure...The patient was discharged to the ED following the procedure for constant evaluation/monitoring...It was subsequently discovered that the wrong medication was provided by the pharmacy for local anesthesia. Rather than buffered lidocaine, neostigmine was injected."
During an interview on April 6, 2022, at 9:15 AM, EMP1 confirmed that at least some of the above patients received the Neostigmine in place of the ordered sting-free buffered lidocaine and required additional medical treatment. Further interview confirmed it could not positively be determined exactly who received the wrong medications or the dosage of the incorrect medications administered to each patient.
During an interview on April 6, 2022, at 1:15 PM, EMP9 confirmed that on April 31, 2022, the tech pulled 2 boxes of neostigmine (5 prefilled syringes in each box) off the shelf, held them up to the pharmacist (who was on the telephone), and stated, "I'm taking these sting-free to radiology." EMP8 stated the pharmacist stated she was distracted and just nodded her head to the technician, who proceeded to deliver the neostigmine in place of the sting free buffered lidocaine to radiology. Further interview confirmed pharmacy staff didn't follow their procedure and confirmed that the pharmacist has the ultimate responsibility to ensure the proper medications leave the pharmacy area.
During a review on April 6, 2022, at 2:00 PM, the personnel files of radiology technologists revealed that PF1, PF2, PF3, and PF4 did not have medication administration outlined in their job description. Further review revealed that PF1, PF2, PF3, and PF4 were not trained in medication administration, despite the facility assigning radiology technologists responsibility in the medication delivery process that resulted in the incorrect medications being administered to five patients.
During an interview on April 6, 2022 at 2:15 PM, EMP1 confirmed the above findings.
Tag No.: A0535
Based on a review of facility documentation, medical record review (MR), and interview (EMP), it was determined the facility failed to ensure there were policies and procedures to protect patients from medication errors.
Findings include:
A facility investigative report dated April 1, 2022, revealed that Neostigmine syringes were found by Xray staff in the refrigerator where, "Stingfree" syringes are normally stocked. The facility investigation revealed that on March 31, 2022, prior to 8:00 AM, two boxes, each containing 5 prefilled syringes of Neostigmine were removed from the pharmacy and taken to the Radiology Department, in place of the "sting-free" buffered lidocaine requested from the Radiology Department.
The investigation indicated that between March 31, 2022 and April 1, 2022, five procedures were performed that included the use of buffered lidocaine. It was after the fifth procedure that the radiology technician discovered that the medication used was neostigmine and not buffered lidocaine as the color of the syringe was different.
On April 6, 2022, a review of the medical records of the affected patients was completed and revealed the following:
MR#1 was an in-patient and had a midline placement procedure on March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injection, route local infiltration. IR Midline insert Study result revealed, "Patient tolerated procedure well."
MR#2 was an outpatient and had a shoulder arthrogram scheduled for March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injection, route local administration. Arthrogram study results dated March 31, 2022, revealed, "Technique...Upon administering local anesthetic with a 25 gauge hypodermic needle, the patient expressed severe pain and declined to proceed with the fluoro guided injection. Approximately 30 minutes post anesthesia administration, the patient was complaining of difficulty swallowing. The patient was advised to proceed to ED."
MR#3 was an outpatient and had bilateral hip injections on March 31, 2022. Medication order was for buffered lidocaine 0.9% (5ml x 2) intradermal (right hip). A second order for the same medication was ordered for the left hip. The procedure report dated March 31, 2022, revealed, "Technique...The patient tolerated the procedure well with improvments in pain following procedure...Impression: Technically successful fluoro-guided bilateral hip injection."
An emergency department (ED) note for MR#3 dated March 31, 2022, at 2:39 PM revealed, "History...[MR#3] is...here for dizziness (patient was at CBH for an outpatient procedure...became dizzy and had a near syncopal episode resulting in a rapid response being called. Upon arrival to the ED patient was awake and alert, diaphoretic, with a fluctuating heart rate between 38-51. Patient also with abdominal pain..."
MR#4 was an ICU inpatient and had a placement of a PICC line on April 1, 2022. Medication order was for buffered lidocaine 0.9% (5ml) injectable. The procedure report dated April 1, 2022, revealed, "IR-PICC Study result...Technique...The skin over the access site was anesthetized with lidocaine. It was later discovered that there was a potential medication error with possible injection of neostigmine rather than buffered lidocaine."
MR#5 had a paracentesis on April 1, 2022. Medication order was for buffered lidocaine 0.9% (5ml) with the ordered dose of 10ml injection for local infiltration. The US Paracentesis with guidance study result dated April 1, 2022, revealed, "Impression...the patient became hypotensive and had sudden sensation of the need to move his bowels during the procedure...The patient was discharged to the ED following the procedure for constant evaluation/monitoring...It was subsequently discovered that the wrong medication was provided by the pharmacy for local anesthesia. Rather than buffered lidocaine, neostigmine was injected."
During an interview on April 6, 2022, at 9:15 AM, EMP1 confirmed that at least some of the above patients received the Neostigmine in place of the ordered sting-free buffered lidocaine and required additional medical treatment. Further interview confirmed it could not positively be determined exactly who received the wrong medications or the dosage of the incorrect medications administered to each patient.
During an interview on April 6, 2022, at 12:30 PM, EMP8 confirmed there is no policy or written process in place in the Radiology department to identify who takes medications from refrigerator and opens onto sterile field. Further interview confirmed that the radiology department does not have a reconciliation of medication process for the medications stored in the refrigerator.
Tag No.: A0747
Based on a review of facility documents and medical records (MR), and staff interview (EMP), it was determined that the facility failed to have active hospital-wide programs for the surveillance, prevention, and control infectious diseases as evidence by failure to develop and implement policies and procedures to ensure that all staff were fully vaccinated for Covid-19 as evident by the failure to implement nine of ten components of the vaccine mandate (A-0792).
Tag No.: A0792
Based on a review of facility documents and staff interviews (EMP), it was determined that the facility failed to develop and implement policies and procedures to ensure that all staff were fully vaccinated for Covid-19 as evident by the failure to implement nine of ten components of the vaccine mandate.
Findings include:
A review of the facility's COVID-19 Vaccination Policy, last revised November 10, 2021, revealed, "Administration: As of November 1, 2021, all new hires will be required to provide proof of vaccination documentation demonstrating fully vaccinated status or an approved accommodation prior to their first day of employment. Active employees without an approved accommodation were required to have their first dose of their Covid-19 vaccination by January 28, 2022 and must be fully vaccinated and provided proof of vaccination documentation by February 28, 2022. Employees returning to work from an approved continuous leave of absence are expected to take steps to comply with this policy within 14 calendar days of returning to work. All employees are responsible to attest to their vaccination status. Employees are required to upload proof of vaccination documentation. There records of vaccinations will be maintained by Employee Health. Such records will not be included in the employee's personnel files. Contracted and Embedded Workforce Personnel (including independent contractor and agency staff) are expected to comply with this policy; however, will not be required to upload proof of vaccination. Accommodation Requests: Employees may be exempted from being fully vaccinated with an approved accommodation due to qualifying medical conditions or an approved religious accommodation. Temporary medical accommodations may be provided until the employee is medically cleared and, at which time, are provided with a reasonable amount of time to comply with this policy. Employees who are seeking a medical accommodation or religious accommodation will need to follow the request process via HR Services > HR Topics > Employee Resources > Employee Accommodations. In addition to Employees receiving a notice of approved accommodation, Employee Health will also mark the employee's accommodation as approved in the Employee Health record. Employees who are approved for an accommodation will be deemed unvaccinated for the purpose of adhering to the PPE and Masking requirements, or other requirements the Company may establish."
A review of facility documents revealed that there were no policies or processes in place for ensuring contracted and embedded workforce personnel (including independent contractor and agency staff) have received, at a minimum, a single-dose Covid-19 vaccine, or the first dose of the primary vaccination series for a multi-dose Covid-19 vaccine prior to staff providing any care, treatment, or other services for the hospital and/or its patients.
A review of facility documents revealed that there were no policies or processes in place for ensuring contracted and embedded workforce personnel (including independent contractor and agency staff) were fully vaccinated for Covid-19, except for those who have been granted exceptions to the vaccination requirements, or those for whom Covid-19 vaccination must be temporarily delayed.
A review of facility documents revealed that only Canonsburg Hospital employees were included in Covid 19 vaccination tracking. Further review revealed that the tracking did not include students, trainees, volunteers, and individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.
A review of facility documents revealed that only Canonsburg Hospital employees were included in Covid 19 vaccination tracking of individuals who have obtained any booster dose as recommended by CDC. Further review revealed that the tracking did not include students, trainees, volunteers, and individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.
A review of facility documents revealed that there were no policies or processes in place for which contracted and embedded workforce personnel (including independent contractor and agency staff) may request an exemption from the staff Covid-19 vaccination requirements.
A review of facility documents revealed that there were no policies or processes in place for tracking and securely documenting information provided by contracted and embedded workforce personnel (including independent contractor and agency staff) who have requested, and for whom the hospital has granted, an exception from the staff Covid-19 vaccination requirements.
A review of facility documents revealed that there were no policies or processes in place for ensuring that all documentation, which confirms recognized clinical contraindications to Covid-19 vaccines, and which supports contracted and embedded workforce personnel's (including independent contractor and agency staff) request for medical exemptions from vaccination, had been signed and dated by a licensed practitioner, who was not the individual requesting the exception, and who was acting within their respective scope of practice.
A review of facility documents revealed that there were no policies or processes in place for ensuring the tracking and secure documentation of the vaccination status of contracted and embedded workforce personnel (including independent contractor and agency staff) for whom Covid-19 vaccination must be temporarily delayed, due to clinical precautions and considerations.
A review of facility documents revealed that there were no policies or processes in place for ensuring a contingency plan for contracted and embedded workforce personnel (including independent contractor and agency staff) who are not fully vaccination for Covid-19.
During an interview on April 6, 2022, EMP1 confirmed that contracted and embedded workforce personnel, independend contractors, and agency staff are expected to comply with the facility's Covid-19 Vaccination Policy, however not required to upload into the facility's system proof of vaccination.