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Based on policy and procedure review and staff interview, the facility failed to ensure that the Quality/Risk Director was notified of potential risk to patient safety allegations at the time the allegations were made in order to conduct timely follow up and investigation.

Findings:

1. Policy No.: QA titled, "Quality Mgmt Department Scope of Care", revised/reapproved 5/2012, was reviewed on 1/10/13 at approximately 10:40 AM and indicated on pg:
A. 1, under Organizational Plan and Structure section, points 3.1 and 3.2, "Quality/Risk Management Services functions under the direction of the Director of Quality/Risk Management. The Director, Quality/Risk Management, is responsible for the daily operations of the department and has the authority and responsibility for all aspects of planning, implementing, monitoring and evaluating the services and care delivered by the department."
B. 3, under Scope of Care/Activities includes, but not limited to section: Patient Safety, prevention of medical variances that can actually/potentially result in patient injury/harm through an environment that encourages: recognition and acknowledgement of risks to patient safety and medical/health care errors; initiation of actions to reduce these risks; internal reporting of what has been found and the actions taken."
C. 3 & 4, under Quality/Performance Improvement: an overall assessment of the efficiency and/or effectiveness of performance activities and/or care...Identifying problems/reasons for improvement to achieve external and internal customer satisfaction, improving organization performance or achieving strategic goals, analyzing root cause of identified problems/opportunities for improvement and implementing countermeasures to reduce or eliminate identified root causes and improve care...reporting and follow-up of unusual occurrences involving patients and families, reduction, minimization and/or prevention of exposure to risk and/or litigations."

2. Personnel P6 was interviewed on 1/10/13 at approximately 10:06 AM and confirmed:
A. an allegation was made by a surgical tech that they witnessed an anesthesiologist putting Propofol in their pocket prior to a surgical procedure.
B. another allegation was made by a nurse that this same anesthesiologist left the facility while patients were still in the recovery room and threatened to have this nurse terminated if they reported it. This allegation was received via email from this nurse on 1/8/13.
C. the Quality/Risk Director was not made aware of either of these allegations and although they were recently hired and in training/orientation, he/she should have been made aware of these allegations as required by facility policy and procedure.

3. Personnel P3 was interviewed on 1/10/13 at approximately 9:32 AM and confirmed, he/shewere not made aware of these two allegations.

Based on policy and procedure review, medical record review, and staff interview, the facility failed to implement written policies and procedures for the appropriate control, use, and monitoring of drugs according to policy and procedure for 3 of 5 (N2, N4, and N5) closed patient medical records reviewed.

Findings:

1. Policy No.: PHAR470 titled, "Medication Storage", revised/reapproved 5/2012, was reviewed on 1/10/13 at approximately 10:40 AM, and indicated on pg. 1, under Policy section, "It is the policy of [facility] that medications will be stored in a safe manner and to meet all applicable laws and regulations with regards to drug storage and security."

2. Policy No.: A-11 titled, "Anesthesia Care Protocol", revised/reapproved 5/2012, was reviewed on 1/10/13 at approximately 10:40 AM, and indicated on pgs. 6 & 7, under Practice Parameters and Procedures section, point I.7., "The anesthesiologist shall keep a complete record for each operation where he is in attendance on the approved anesthesia form. The Anesthesiologist is responsible for the recording of all events taking place during the induction, maintenance of, and emergence from anesthesia, including dosage and duration of all anesthetic agents, other drugs, and intravenous fluids."

3. Review of closed patient medical records on 1/10/13 at approximately 11:00 AM, indicated patient:

A. N2:
a. had a surgical procedure performed on 10/18/12, under general anesthesia starting at 06:54 AM.
b. per Omnicell Automated Medication Dispensing Report dated 10/18/12, the following was removed by D1 for N2 at:
i. 6:58 AM, one 100 ml vial of propofol 10 mg/1 ml.
ii. 8:12 AM, one 50 ml vial of propofol 10 mg/1 ml.
c. per Anesthesia Record dated 10/18/12:
i. D1 was listed as the anesthesiologist.
ii. at approximately 07:00 AM, 140 mg of propofol was administered.
iii. lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure

B. N3:
a. had a surgical procedure performed on 10/17/12, under monitored anesthesia care (with sedation) starting at 11:09 AM.
b. per Omnicell Automated Medication Dispensing Report dated 10/17/12, the following was removed by D1 for N3 at 11:12 AM, one 50 ml vial of propofol 10 mg/1 ml.
c. per Anesthesia Record dated 10/17/12:
i. D1 was listed as the anesthesiologist.
ii. no propofol was administered during the surgical procedure.

C. N4:
a. had a surgical procedure performed on 10/17/12, under monitored anesthesia care (with sedation) starting at 11:29 AM.
b. per Omnicell Automated Medication Dispensing Report dated 10/17/12, the following was removed by D1 for N4 at 11:47 AM, one 20 ml vial of propofol 10 mg/1 ml.
c. per Anesthesia Record dated 10/17/12:
i. D1 was listed as the anesthesiologist.
ii. at approximately 11:30 AM, 60 mg of propofol was administered.
iii. lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure

D. N5:
a. had a surgical procedure performed on 10/17/12, under monitored anesthesia care (with sedation) starting at 11:54 AM.
b. per Omnicell Automated Medication Dispensing Report dated 10/17/12, the following was removed by D1 for N5 at 11:47 AM, one 50 ml vial of propofol 10 mg/1 ml.
c. per Anesthesia Record dated 10/17/12:
i. D1 was listed as the anesthesiologist.
ii. at approximately 12:00 PM, 60 mg of propofol was administered.
iii. lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure

4. Patients N4 and N5 had propofol removed from the Omnicell Automated Medication Dispenser on the same date at the same time by the same anesthesiologist. Their surgical procedures started at different times, therefore, the medication for patient N5 was stored somewhere other than the Omnicell until the start of their procedure. Also, patient N4's anesthesia started at 11:29 AM, propofol was administered at approximately 11:30 AM, but it was not removed from the Omnicell until 11:47 AM. And, patient N3 had no propofol administered but it was removed from the Omnicell.

5. Medical Staff D1 was interviewed on 1/10/13 via speaker phone at approximately 10:22 AM, with Chief Clinical Officer present and listening and confirmed, [anesthesiologists] remove the Propofol prior to surgical procedures on that day for colonoscopies and we do put these vials into our pockets to be used during each patient's procedure to keep them secure. Facility policy and procedure is not being followed related to to drug storage and security, as well as documentation of rate and total dosage amount administered of anesthetic agents.

Based on policy and procedure review, medical record review and staff interview, the facility failed to ensure intra-operative monitoring related to documentation of rate and total dosage amount of anesthetic agents according to policy and procedure for 3 of 5 (N2, N4, and N5) closed patient medical records reviewed.

Findings:

1. Policy No.: A-11 titled, "Anesthesia Care Protocol", revised/reapproved 5/2012, was reviewed on 1/10/13 at approximately 10:40 AM, and indicated on pgs. 6 & 7, under Practice Parameters and Procedures section, point I.7., "The anesthesiologist shall keep a complete record for each operation where he is in attendance on the approved anesthesia form. The Anesthesiologist is responsible for the recording of all events taking place during the induction, maintenance of, and emergence from anesthesia, including dosage and duration of all anesthetic agents, other drugs, and intravenous fluids."

2. Review of closed patient medical records on 1/10/13 at approximately 11:00 AM, indicated patient:

A. N2 had a surgical procedure performed on 10/18/12, under general anesthesia and at approximately 07:00 AM, 140 mg of propofol (10 mg/1 ml) was administered, and continued via drip beginning around 7:30 AM. This drip is documented as .............. across the form until approximately 09:00 AM. The Anesthesia Record lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure.

B. N4 had a surgical procedure performed on 10/17/12, under monitored anesthesia care (with sedation) and at approximately 11:30 AM, 60 mg of propofol (10 mg/1 ml) was administered, and continued via drip beginning around 11:30 AM. This drip is documented as .............. across the form until approximately 11:52 AM. The Anesthesia Record lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure.

C. N5 had a surgical procedure performed on 10/17/12, under monitored anesthesia care (with sedation) and at approximately 12:00 PM, 60 mg of propofol (10 mg/1 ml) was administered, and continued via drip beginning around 12:00 PM. This drip is documented as .............. across the form until approximately 12:24 PM. The Anesthesia Record lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure.

3. Medical Staff D1 was interviewed on 1/10/13 via speaker phone at approximately 10:22 AM, with Chief Clinical Officer present and listening and confirmed, the initial amount of propofol administered is documented on the Anesthesia Record. Then if it is given via intravenous drip after that, it is written as .............. on the Anesthesia Record. The Anesthesia Record lacked documentation of rate and total dosage amount of propofol administered during the surgical procedure.