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Based on interview with facility staff, and document review of the facility's non-controlled drug discrepancy data, the hospital failed to assure that a system for analyzing and resolving potential medication errors and discrepancies had been implemented, as evidenced by:

1) The facility's failure to ensure that all unit Nursing Managers received a copy of the facility's "Automatically scheduled monthly Pandora reports", for November, 2011, and that these reports were reviewed and analyzed by the Nursing Managers, and that action had been taken by these Managers to reduce and/or eliminate the number of non-controlled drug discrepancies and potential medication errors. (See A-266).

The cumulative effect of this systemic problem resulted in the hospital's inability to provide effective oversight for the reduction or elimination of non-controlled drug discrepancies and potential medication related errors.

Based on review of the facility's Plan of Correction for the facility's 7/14/11 validation survey, interviews with the facility's Director of Pharmacy, Nursing Director, and Nurse Managers, and review of the facility's discrepancy data the facility failed to implement a system for analyzing all of the facility's potential medication errors and discrepancies with the potential that some medication errors would not be identified.

Findings:

Interview with the facility's Director of Pharmacy on 1/11/12 at 9:30 a.m. revealed that the facility had still been unable to account for all of their non-controlled medication discrepancies (missing and extra doses) in their automated drug dispensing cabinets since 11/2/11 (the facility's correction date on the facility's 7/14/11 Validation Survey Plan of Correction). The Director of Pharmacy stated that there was no way for the facility to go through every non-controlled drug discrepancy and resolve them. The Pharmacy Director pointed out that the facility had only focused on anticoagulant, (medication that slows or stops blood from clotting), automated drug dispensing count discrepancies. A review was conducted of a sample of the facility's automated drug dispensing count discrepancies on 1/11/12. This review revealed that the facility still had numerous unresolved non-controlled automated drug dispensing count discrepancies. The Director of Pharmacy indicated during the interview that he was still unsure of how he could resolve all of the facility's non-controlled drug discrepancies and reduce the facility's total number of non-controlled drug discrepancies.

Review of the facility's 7/14/11 Validation Survey Plan of Correction (POC) which the facility stated would go into effect on 11/2/11, indicate the POC stated the following: "Automatically scheduled monthly Pandora reports of non-controlled drug count discrepancies in descending order of frequency will be sent by the Director of Pharmacy to the nursing unit managers for evaluation starting in November. Particular drugs will be identified by the nurse manager in coordination with the Pharmacy Director for further monitoring based on frequency and risk. More detailed reports of actual usage of the selected drug will be generated to assist in any necessary investigation. The nurse manager will summarize the findings and actions taken in a standard report format submitted to the Pharmacy Director and the Vice President for Nursing Services."

On 1/11/12 between 2:15 p.m. and 3:30 p.m., the Director of Pharmacy and surveyor went up to the nursing floors to interview the Nursing Managers (two) for Medical Oncology and the Surgical Unit. The Nursing Director for both Units also joined in on the interviews. The Nurse Manager for the Medical Oncology Unit was able to provide an electronic copy of a hospital wide non-controlled drug Pharmacy Pandora report for 11/11. During the interview, the Medical Oncology Nurse Manager was unable to provide any evidence that she had printed out, reviewed, analyzed, or taken any action on this report. The Nurse Manager was also unable to provide evidence that she had summarized any findings from the report and submitted any information back to the Pharmacy Director or the Vice President of Nursing Services for their review, as outlined in the facility's Plan of Correction (POC). The Nurse Manager also stated during the interview on 1/11/12 at 2:15 p.m. that she was unclear about how she was supposed to use the data, which had been provided to her in this Pharmacy Pandora report.

During a second interview with the facility's Surgical Nurse Manager on 1/11/12 at 3:10 p.m., the Surgical Nurse Manager indicated that he did not have a written or electronic copy of the November Pandora report and that he "vaguely remembered, possibly receiving a Pharmacy Pandora report in December". During the interview, the Surgical Unit Nurse Manager was unable to provide any evidence that he had printed out, reviewed, analyzed, or taken any action on this report. The Nurse Manager also stated during the interview on 1/11/12 at 3:10 p.m. that he was unclear about how he was supposed to use the data, which had been provided to him in this Pandora report. The Nurse Manager was also unable to provide evidence that he had summarized any findings from the 11/11 Pharmacy Pandora report (which he was unable to produce during the survey). The Surgical Nurse Manager was also unable to provide evidence that he had submitted any information regarding this report, back to the Pharmacy Director or the Vice President of Nursing Services for their review.






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Based on observation, interview with facility staff, and document review the hospital failed to ensure safe and effective pharmaceutical services had been provided as evidenced by:

1) The facility ' s failure to ensure that all unit Nursing Managers received the facility ' s " Automatically scheduled monthly Pandora reports " for November, 2011 , that these reports were reviewed and analyzed by the Nursing Managers, and that action had been taken by these Managers to reduce the number of non-controlled drug discrepancies and potential medication errors. (See A-266).

2) The facility ' s failure to ensure that its " High Alert Medication " dated 7/2010, policy, was clear and provided facility nursing staff with specific guidance and direction for medication administration and patient safety. (See A-500).

3) The facility ' s failure to develop written policies and procedures for reporting significant medication errors and for defining the specific level of medication error, which should have been reported to the facility ' s Pharmaceutical & Therapeutics (P&T) Committee. (See A-500).

4) The facility ' s failure to incorporate its bedside bar coding, " Scan and Remove " process into the facility ' s Medication Administration policy, dated 9/2011, and procedure as outlined in the facility ' s 7/14/11 Validation survey Plan of Correction. (See A-500).

5) The facility ' s failure to ensure that all prescription medications were kept secure from unauthorized access both by patients and staff. (See A-500).

6) The facility ' s failure to ensure that expired medications were not available for patient administration in the facility ' s Operating Rooms. (See A-505).


The cumulative effects of these systemic problems resulted in the hospital ' s inability to provide pharmaceutical services and care in a safe and effective manner in accordance with facility ' s statutorily-mandated Condition of Participation for Pharmaceutical Services.

Based on review of the facility's 7/14/11 Validation Survey Plan of Correction, interview with the facility's Director of Pharmacy, interview with the facility's "Step Down Intensive Care Unit" Nurse, and interview with the Emergency Room Staff, observation of the facility's Emergency Room Pediatric Crash Cart, and review of the facility's policies and procedures the facility failed to:

1) Develop written policies and procedures and systems for reporting significant medication errors as well as defining which levels of Medication Errors would be reported to the facility's Pharmaceutical & Therapeutics (P & T) Committee.
2) Incorporate the facility's bedside bar coding ("Scan and Remove") process into the facility's Medication Administration policy and procedure as outlined in the facility's 7/14/11 Validation survey Plan of Correction.
3) Keep all prescription drugs secure from unauthorized access.
4) To develop a clear, "High Alert Medications Policy",( 7/21010), which facility staff could clearly understand and implement.

These failures had the potential to cause, 1) ongoing lack of review and monitoring of medication errors by the Pharmacy Department and the Pharmaceuticals and Therapeutics Committee, 2) failed communication and clarification with the facility nursing staff of medication administration practices, including those for High Alert Medications, and 3) access to medications by unauthorized persons.

Findings:

1) Review of the facility's Plan of Correction (POC) involving Labetalol (a blood pressure medication) which resulted in a fatal medication error from the facility's July 2011 survey, revealed that the facility had written the following statement in its POC: "Adverse drug reactions, pharmacy interventions and medication errors are reported to and reviewed by the Pharmacy and Therapeutics Committee quarterly. Significant medication errors (those causing permanent harm or death) will be reported monthly."

Interview with the facility's Director of Pharmacy on 1/11/12 at 9:30 a.m. confirmed that the facility had not developed a policy and procedure or any type of documented system for how the hospital was going to report "significant medication errors" to the facility's Pharmacy and Therapeutics Committee (P&T). The Director of Pharmacy was asked where the statement above, had come from? The Director of Pharmacy indicated that he was not sure, but he confirmed that this was his understanding for how the facility was supposed to report "significant medication errors" to P&T. No official documented system of reporting could be provided during the survey.

Further review of the facility's various medication policies and procedures, (Adverse Drug Reaction Reporting 1/08, Disclosure of Unanticipated Medical Outcomes 11/10, Quality assessment Incident Report 4/!0), revealed that the facility did not have any type of established policy and procedure or system which outlined the level of medication errors, which needed to be reported to P&T. Interview with the facility's Director of Pharmacy on 1/11/12 at 1:30 p.m. revealed that his understanding was that only medication errors which were G level (an error that resulted in permanent patient harm) or higher was to be reported to P&T. Medication error which resulted in initial or prolonged hospitalization and caused temporary patient harm, (F level), were not required to be reported to the facility's P&T (despite their importance). The Federal Drug Administration (FDA) Medwatch Adverse Reporting Program, classifies the facility's level F medication errors as being reportable. The FDA Medwatch Program is the FDA gateway program for clinically important safety information and for reporting serious problems with human medical products, including medications.

2) Review of the facility's Plan of Correction dated 9/27/11 stated the following: "On 9/27/11 the Pharmacy implemented bedside bar coding and it was decided to continue the process of "Scan on Remove". The policy and procedure for Medication Administration was revised to reflect this change. "Review of the facility's Medication Administration policy and procedure on 1/11/12 at 3:45 p.m. revealed that the facility's Medication Administration policy and procedure had not been changed or updated to include the "Scan on Remove" process as indicated in the facility's POC. The Director of Pharmacy was interviewed on 1/11/12 at 3:50 p.m. and he stated that the "Scan on Remove" update/revision, must have been missed by the facility, as this information was no reflected in the facility's current Medication Administration policy and procedure.

3) Inspection of the facility's Emergency Room on 1/12/12 at 10:45 a.m. revealed a Pediatric Crash Cart (emergency drug supply for children requiring resuscitation). This Crash Cart was stationed against one of the walls outside of a patient's room. Closer inspection of the top of the Pediatric Crash Cart revealed a (prescription only) Atropine Sulfate 0.1mg/ml (10 ml) syringe for injection (during an emergency event). The Emergency Room Manager, the Emergency Room Supervisor, and the Director of Pharmacy all indicated that this Atropine Sulfate syringe should not have been unsecured on the top of this Pediatric Crash Cart and accessible to guests or employees who walked by this Emergency Crash Cart.

The facility's Plan of Correction from the 7/14/11 Validation survey stated: "Pharmacy conducts monthly inspections of all medication storage areas as required by the State Board of Pharmacy. In addition, checking medication storage areas for unsecured medications was added to the rounds conducted by a team of clinical staff twice each month." This portion of the Plan of Corrections was written by the facility in response to a vial of Labetalol which, was unsecured (found outside of the facility's Pyxis machine, an automated drug dispensing cabinet), which ultimately resulted in one of the facility's patient's death.

4) Review of the facility's policy and procedure entitled: "Housewide Administrative Manual High Alert Medications Policy" on 1/10/12 at 11:30 a.m. revealed that this policy and procedure identified the following drugs as "High Alert Medications": 1) Heparin, (anticoagulant), 2) Insulin, (controls the concentration of glucose in the blood), 3) Potassium Intravenous Solution, (an essential electrolyte for the smooth running of the human body), 4) Paralytic Agents, ( block neuromuscular transmission resulting in paralysis of the muscles), 5) Opiates (which is a very general category that includes more than 50 different drugs), and 6) Saline High Concentration.

Dorland's 27th Edition Medical Dictionary defines "Opiates" as: "a remedy containing or derived from opium; also any drug that induces sleep".

Interview with the facility's Director of Pharmacy on 1/10/12 at 11:45 a.m. revealed that he was aware of that there are numerous medications in the "Opiate" class. During the interview, the Director of Pharmacy, he was asked if Vicodin (a very commonly prescribed "Opiate" medication) would be included in the facility's high alert medication. The Director of Pharmacy indicated that even though Vicodin is an "Opiate" medication, it would not be considered a "high alert medication" in his mind unless this medication was being administered concurrently with another "Opiate" medication. The Director of Pharmacy was also asked if all "Opiates" were considered "High Alert Medications" and he stated that they could be when combined with other drugs, but not all "Opiates" by themselves would fit into the category of a "High Alert Medication".

On 1/10/12 at 2:00 p.m. the facility's Resource Nurse, in the Step Down Intensive Care Unit was interviewed. The Nurse was given a copy of the facility's current: "Housewide Administrative Manual High Alert Medications Policy" to review. I then asked the Resource Nurse if he felt that every "Opiate" medication was considered a High Alert Medication based on what he had just read in the policy and procedure. The Resource Nurse replied after thinking for a few moments: "I believe that every "Opiate" medication, "even Vicodin" would be considered a High Alert Medication based on this policy". The Resource Nurse was then asked if the facility's "High Alert Medication Policy ", clearly stated which "Opiate" medications should be considered "High Alert Medications". The Resource Nurse indicated that this policy and procedure was not very clear about which "Opiates" are considered, "High Alert Medications".

Further interview with the facility's Director of Pharmacy and review of the facility's "High Alert Medication Policy and Procedure", revealed that even though Patient Controlled Analgesic pumps (PCAs), which included Morphine, Demerol, Dilaudid, and other "opium derived drugs" are not required to have a double check (have a second nurse verify that the dose is correct), based on the facility current High Alert Medication Policy and Procedure, facility staff were completing this double check up on the medical floors of the hospital. During the interview above with the Director of Pharmacy, he indicated that all nursing staff in the facility are expected and required to implement a "double check" for any PCA when the pump is first started or if a syringe of the "Opiate" drug is being added to a PCA pump, despite the facility's policy and procedures silence on this requirement.






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Based on observation of the facility's Surgery Department (Operating Room 8's Anesthesiologist's Medication Cart), interview with the facility's Operating Room Director and the Director of Pharmacy, the facility failed to ensure that expired medications were not available for patient administration with the potential that expired, ineffective medications could be used for patient care.

Findings:

Observation of the facility's Operating Room #8 Anesthesia Medication Cart on 1/12/12 at 10:15 a.m. revealed two vials of Nimbex (a paralyzing medication, used in surgery) 20 mg/10 ml had been removed from the refrigerator on 12/20/11 (this date had been marked on the lid of each of the vials). Review the drug manufacturer's label information and review of the facility's policy and procedure both indicated that this medication, must be discarded after 21 days from the time that it has first been removed from the refrigerator. Both of the Nimbex vials had been kept out of the refrigerator for 23 days, based on the dates on each lid (more than 48 hours beyond the time allotted to the facility to discard these vials).

Based on observation, staff review and record review the facility failed to ensure that their policy and procedure for the time-out process ( an assessment tool used immediately after a a patient is placed on a ventilator), when laminated time-out check lists were not found on the two rented ventilators. This failure left the potential for staff to do the time-out process incorrectly, not addressing all the steps and potentially placing the patient at risk for ineffective oxygenation.

Findings:

During tour of the Intensive Care Unit on 1/10/12 at 9 a.m., it was noted that Patient 1 ( in Room 2122), was on a ventilator. Further observation of the ventilator revealed there was no laminated time-out checklist attached to the ventilator.

During an interview on 1/10/12 at 9:05 a.m., Administrative Staff A concurred that the time-out checklist was missing and stated this ventilator was one of two rented ventilators the facility had been using for a month. Administrative Staff A stated the two rented ventilators were the same as the facility's ventilators and the laminated time-out checklist should've been attached.

On 1/11/12 at 12:10 p.m., tour of Respiratory's clean storage area revealed the other rented ventilator, which had been tested and was ready for use, did not have a laminated time-out checklist attached.

Review of the facility's policy and procedure indicated the policy stated the time-out procedure was developed to perform on the intubated patient after connection to the ventilator. The tool consists of 12 assessment items to ensure the ventilator is properly functioning to provide the patient proper oxygenation. The time-out checklist was laminated and placed on every ventilator by 5/19/11/. The respiratory therapist completes the time-out process using the checklist immediately after the patient is attached to the ventilator.