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RESEARCH PSYCHIATRIC CTR 2323 E 63RD ST KANSAS CITY, MO Feb. 14, 2013
VIOLATION: ANESTHESIA SERVICES Tag No: A1000
Based on observation, interview and record review the facility failed to:
-Ensure contracted Anesthesia (a drug which results in loss of bodily sensation with or without loss of consciousness) staff developed and maintained specific ECT (psychiatric treatment in which seizures are electrically induced in anesthetized patients (patient has the loss of bodily sensation with or without loss of consciousness) for treatment of severe depression) policies and procedures directing safe anesthesia be provided to ECT patients;
-Develop and consistently follow informed consent policies and procedures for patients scheduled to undergo ECT;
-Develop and consistently follow a time out procedure (a safety check conducted and documented just prior to any procedure where anesthesia was used) before providing ECT treatments;
-Ensure Anesthesia staff developed and consistently followed policies directing an anesthesiologist conduct a pre-anesthesia and post-anesthesia patient evaluation.

The facility routinely provided ECT for 16 to 17 patients three times a week or an estimated 1600 treatments per year. These deficient practices and systemic failures had the potential to place all ECT patients at continued risk and in immediate jeopardy to those patient's health and safety.

The cumulative result of these findings resulted in noncompliance with the Condition of Participation: Anesthesia Services and an Immediate Jeopardy situation. The facility was able to provide an acceptable plan of correction (on 02/14/13) to implement corrective actions and abate the immediate jeopardy.
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
Based on observation, interview and record review the facility failed to:
-Ensure contracted Anesthesia (a drug which results in loss of bodily sensation with or without loss of consciousness) staff developed and maintained specific ECT (psychiatric treatment in which seizures are electrically induced in anesthetized patients (patient has the loss of bodily sensation with or without loss of consciousness) for treatment of severe depression) policies and procedures directing safe anesthesia be provided to ECT patients;
-Ensure two out of two current inpatients (#11 and #27) and 10 out of 10 outpatients (#14, #15, #16, #17, #18, #19, #20, #22, #23 and #24) had obtained informed consents that were properly documented prior to ECT.
-Ensure two out of two current inpatients (#11 and #27) and 10 out of 10 outpatients (#14, #15, #16, #17, #18, #19, #20, #22, #23 and #24) received a post-anesthesia assessment prior to discharge from the ECT department.
-Develop and consistently follow a time out procedure (a safety check conducted and documented just prior to any procedure where anesthesia was used) for two current inpatients (#11 and #27) and four outpatients (#17, #23, #20 and #14) before providing ECT treatments for six time out procedures observed.

The facility routinely provided ECT treatments for 16 to 17 patients three times a week. These failures had the potential to affect all inpatients and outpatients who received ECT. The facility census was 71.

Findings included:

1. Review of the American Society of Anesthesiologist (ASA) Statement on Documentation of Anesthesia Care last amended 10/22/08 showed the following direction:
-The anesthesia department's policies and procedures should be compiled in a single set of rules and regulations or in a procedure and policy manual.
-Such policies and procedures should be consistent with the medical staff bylaws, the facility's operating room policies and local law.
-The policies and procedures should be based on the ASA Manual for Anesthesia Department Organization and Management and other ASA guidelines.

2. During an interview on 02/13/13 at 9:00 AM, Staff OO, Anesthesiologist, stated that anesthesia staff did not have separate policies and procedures and he thought the policies for anesthesia had been included in the ECT nursing policy.

3. During an interview on 02/13/13 at 9:40 AM, Staff CC, Anesthesiologist, stated that anesthesia staff would refer to the policies and procedures from another facility.

4. During an interview on 02/13/13 at 2:30 PM, Staff C, ECT Staff Registered Nurse (RN) stated that the ECT department had anesthesia policies and procedures and she could refer to them if she had a question related to anesthesia. Staff C stated that if she did have a question about policies or procedures for the ECT department, she would refer to Staff G, RN, ECT Supervisor, and not the policy and procedure manual.

5. During an interview on 02/13/13 at 3:00 PM, Staff E, ECT Staff RN, stated that a lot of the department's policies and procedures were on-line. Staff E stated that she would refer to Staff G if she had any questions about a policy or procedure for the ECT department instead of going on-line. Staff E stated that the ECT department did have policies and procedures related to anesthesia services.

6. During an interview on 02/13/13 at 3:30 PM, Staff F, ECT Staff RN, stated that the ECT department's policies and procedures were on-line. Staff F stated that she would refer to Staff G if he was available if she had a question before she would look up a policy or procedure. Staff F stated that she trusted her team before she would look up a specific policy or procedure.

7. During an interview on 02/13/13 at 3:50 PM, Staff G, RN, ECT Supervisor, stated that all the anesthesia policies and procedures were included in the ECT nursing policy and procedure. Staff G stated that staff would ask him questions they had related to the department's policies and procedures if he was available. Staff G stated that the ECT department did not have separate anesthesia policies and procedures. Staff G stated that the ECT department did not have anesthesia policies and procedures on-line and did not have a manual available to staff.

8. Record review of the facility policy title, "Informed Consent" #603.112.85 last revised 02/13 showed the following direction:
-Informed consent shall be obtained for surgical procedures and ECT.
-Any other procedures where consent is required by law.
-Informed consent that is required for any procedure or treatment must additionally indicate evidence that the physician has signed the consent before the procedure or treatment can proceed.
-Such signature delineates that the physician has provided the patient with information specific to a discussion about the patient's proposed care, treatment, and services, and reasonable alternatives, and the risks, benefits, and side effects of the proposed care, treatment or services.
-For any ECT procedure or other procedure/treatment where such signature of the physician is required, assessment for the signature will occur prior to the start of the procedure/treatment and the procedure/treatment halted or postponed until such signature is obtained.

9. During an interview on 02/12/13 at 11:30 AM, Staff L, Psychiatrist, stated that approximately two years ago a patient had to be brought out from anesthesia before they received ECT because the consent form had not been done before the start of the procedure.

10. During an interview on 02/13/13 at 9:00 AM, Staff OO, Anesthesiologist, stated that patients were informed of the risks and benefits of anesthesia but did not sign an informed consent.

11. During an interview on 02/13/13 at 9:40 AM, Staff CC, Anesthesiologist (past Chairman of the Department of Anesthesia) stated that Anesthesia Services did not have a policy for informed consent or a policy that directed staff to obtain a separate consent for ECT. Staff CC stated that he was not aware of the anesthesia consent form used by nursing staff.

12. During an interview on 02/13/13 at 2:24 PM, Staff C, ECT Staff RN stated that ECT nursing staff reviewed with the patients the risks and benefits of anesthesia not the anesthesiologist. Staff C stated that she did not know if there was an informed consent policy for the ECT department or not.

13. During an interview on 02/13/13 at 3:02 PM, Staff E, ECT Staff RN, stated that Anesthesiologist did not review risks and benefits with each patient prior to ECT and that nursing staff signed the consent forms and not the anesthesiologist.

14. Record review of inpatients #11 and #27 and outpatients #14, #15, #16, #17, #18, #19, #20, #22, #23 and #24 Consent for Anesthesia Services form showed for both inpatients and outpatients the patient and nurse signed the forms. The forms did not have the signatures of the anesthesiologist.

15. Review of the ASA Statement on Documentation of Anesthesia Care, last amended on 10/22/08 showed the following direction:
-Documentation was a factor in the provision of quality care and was the responsibility of an anesthesiologist.
-While anesthesia care was a continuum, it was usually viewed as consisting of pre-anesthesia (before), intra-operative/procedural anesthesia, and post-anesthesia (after) components.
-Anesthesia care should be documented to reflect these components and to facilitate review.

16. During an interview on 02/12/13 at 10:46 AM, Staff J, Psychiatrist, stated that patients would need an anesthesia assessment/evaluation prior to ECT.

17. During an interview on 02/12/13 at 11:30 AM, Staff L, Psychiatrist, stated that on average he had one to five patients that received ECT each week and that anesthesia staff performed pre and post anesthesia assessments.

18. During an interview on 02/13/13 at 3:00 PM, Staff E stated that anesthesiologist do not reassess the patients post-anesthesia status before they are discharged from the ECT department. Staff E stated that the anesthesiologist only see a patient if there is a problem.

19. During an interview on 02/13/13 at 3:30 PM, Staff F stated that anesthesia did not assess or see patients before they were discharged from the ECT department. Staff F stated that she had never seen anesthesiologist on the patient units.

20. During an interview on 02/13/13 at 3:50 PM, Staff G, RN, ECT Supervisor, stated that the ECT nursing policy and procedure did not include direction for the anesthesiologist to perform a pre or post anesthesia evaluation. Staff G stated that anesthesia performed a pre assessment when patients arrived to the ECT department.

21. During an interview on 02/14/13 at 9:16 AM, Staff CC, Anesthesiologist, stated that he would begin doing a face to face (post-anesthesia assessment) for both inpatients and outpatients on 02/15/13.

22. Review of the Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices 2012 edition, Position Statement, Preventing Wrong-Patient, Wrong-Site, Wrong Procedure Events, gives direction for multidisciplinary teams that include Perioperative RNs, surgeons, anesthesia care providers, risk managers, and other health care professionals who should collaboratively develop procedures and protocols to prevent wrong-patient, wrong-site, and wrong-procedure events.

23. Record review of the facility's policy titled "ECT Pre-Verification and Time Out Procedure" #603.311.09 last revision dated 08/12 showed the following direction:
-A time-out will occur immediately before starting the procedure.
-Time-out must involve the entire ECT team, at least, but not limited to, psychiatrist, treating RN, and anesthesia personnel.
-Use active communication.
-Initiation of the time-out will be the responsibility of the treating nurse and be conducted in a fail-safe mode, that is, the procedure is not started until any questions or concerns are resolved.
-Include the following elements in the documentation: correct patient identity, agreement on the procedure to be performed.
-If there is a discrepancy in agreement between the team members, an immediate STOP will occur. Any discrepancy must be reconciled before ECT treatment can proceed.

24. During an interview on 02/13/13 at 3:00 PM, Staff E, RN, stated that the following elements were included in the time-out:
-Name of the patient.
-Consent signed by the anesthesiologist.
-Spinal x-ray on the chart.
-Required laboratory test on the chart.

25. During an interview on 02/13/13 at 3:50 PM, Staff G stated that time-out is performed with each patient before ECT. Staff G stated that his time-out is a modified standard surgical time-out. Staff G stated that time-out is used for patient safety to ensure the correct patient and procedure before treatment is administered. Staff G stated that a time-out should be documented in patients' medical records. Staff G stated that the following elements were done in time-out before ECT:
-Check NPO status of the patient.
-Identify the patient.
-Check that consent had been obtained from the patient.
-Check to ensure required laboratory tests were on the chart.

26. Observation in the ECT area showed on 02/11/13 at 1:05 PM, ECT staff failed to perform a time-out prior to the ECT procedure of Patient #17 and on 02/13/13 at 7:20 AM ECT staff failed to perform a time-out prior to the ECT procedure of Patient #22.

27. Observation on 02/13/13 at 8:00 AM of Patient #23 showed Staff G asked Staff QQ, Psychiatrist, if the consent was signed. No time-out was performed prior to the ECT procedure.

28. Observation on 02/13/13 at 8:25 AM of Patient #20 showed Staff G announced time-out and stated the patient's name and that the patient was NPO (had taken nothing by mouth) prior to the ECT procedure.

29. Observation on 02/13/13 at 9:14 AM of Patient #14 showed Staff G announced the patient's name and Staff OO, Anesthesiologist, responded, "okay". Staff G stated time-out and stated that the patient was NPO and asked Staff J, Psychiatrist, if the consent was signed prior to ECT procedure.

30. Observation on 02/13/13 at 12:35 PM of Patient #27 showed Staff G verified the patient's name and date of birth with patient. Staff G did not perform a time-out prior to the ECT procedure.

31. Observation on 02/13/13 at 1:06 PM of Patient #11 showed Staff G stated time-out and verified with Patient #11 her name and NPO status. Staff G did not perform time-out prior to ECT procedure.
VIOLATION: ANESTHESIA RECORD Tag No: A1003
Based on observation, interview, record review, review of the American Society of Anesthesiologist (ASA) Standards for Anesthesia Care and review of the facility quality assessment/performance improvement data, the facility failed to ensure a pre-anesthesia evaluation was documented by an anesthesiologist for each ECT (electroconvulsive therapy, a psychiatric treatment in which seizures are electrically induced in anesthetized patients for therapeutic effect) patient. The facility's quality assessment/performance improvement (QA/PI) data repeatedly identified non-compliance with the requirement over an extended period of time and the facility failed to address the deficient practice with any corrective actions.

The facility census was 71. The facility routinely provided ECT treatment for 16 to 17 patients three times a week.

Findings included:

1. Review of the ASA Statement on Documentation of Anesthesia Care, last amended on 10/22/08 showed the following direction:
-Documentation was a factor in the provision of quality care and was the responsibility of an anesthesiologist.
-While anesthesia care was a continuum, it was usually viewed as consisting of pre-anesthesia (before), intra-operative/procedural (during) anesthesia and post-anesthesia (after) components.
-Anesthesia care should be documented in the patient's medical record to reflect each component.

2. Review of the facility's Medical Staff By-Laws, Section E, paragraph 17, showed direction for the Pre-anesthesia assessment to be completed prior to each ECT treatment and directed that the ECT anesthesia preoperative evaluation should be completed and signed by the anesthesiologist.

3. Record review of the contract between the facility and the Anesthesia Associates of Kansas City (AAKC), Exhibit A "Additional terms and Conditions," paragraph 2A, dated 07/01/00 showed direction for all patients requiring anesthesia services will receive a pre-anesthesia assessment by an anesthesiologist. The contract further directed that the assessment should be documented in the progress notes of the patient's medical record.

4. During an interview on 02/13/13 at 3:50 PM Staff G, ECT Unit Supervisor stated that the anesthesia policy and procedures were included in the facility nursing ECT policy and procedure. Staff G stated that the ECT Unit did not have a policy directing the anesthesiologists to perform pre-treatment and post-treatment evaluation of the patients. Staff G, stated that the department staff looked for completeness of the medical record and completeness of the anesthesia record for a quality improvement (QI) study.

5. During an interview on 02/12/13 at 10:10 AM, Staff K, Psychiatrist, stated that he expected the anesthesiologist to do the following for a patient prior to ECT treatment:
-Review the medical record of each patient.
-Review each patients' medications.
-Perform a pre-admission evaluation prior to each ECT treatment for each patient.
-Document and complete an assessment form before the ECT treatment for each patient.
-Staff K also stated that the ECT Peer Review Committee monitored the quality of anesthesia services on a quarterly basis and there had been problems identified concerning the completion of the pre-anesthesia assessment form.

6. Review of Department Specific Performance Improvement Plan, 2012, for the ECT Unit, Indicator #2 showed the standard was one hundred percent of the pre-anesthesia assessments will be completed to demonstrate compliance with the requirement.

7. Review of the ECT Peer Review Committee's meeting minutes showed the committee was aware of the lower than expected anesthesia documentation studies:
-During the first quarter of 2012, only 92% or 467 of 509 medical records reviewed showed compliance with the requirement;
-During the second quarter of 2012, (dated 07/10/12) only 93% or 366 of 393 medical records reviewed showed compliance with the requirement;
-The committee planned to merely continue to monitor and report findings to the performance improvement (PI) committee meeting. The Committee also planned to report the findings to the ECT Peer Review Committee during the next quarter. The committee planned to develop a corrective action plan to present to Medical Executive Committee that would address the necessary actions to meet the standards. A follow-up evaluation was planned for December, 2012;
-During the third quarter of 2012, (dated 12/04/12) only 93% or 337 of 363 medical records reviewed showed compliance with the requirement;
-The committee again planned to merely continue to monitor and report findings to the PI Committee. The committee also planned to report the findings of deficient performance to the ECT Peer Review Committee next quarter. The committee again planned to develop a corrective action plan to present to the Medical Executive Committee that would address necessary actions to meet the standards that anesthesia staff had failed to meet for the last nine months. A follow up evaluation was now planned for February, 2013.
VIOLATION: OUTPATIENT POST-ANESTHESIA EVALUATION Tag No: A1005
Based on observation, interview, record review and review of the American Society of Anesthesiologist (ASA) Standards for Anesthesia Care, the facility failed to develop and maintain a policy that directed a post-anesthesia evaluation was documented for each ECT (electroconvulsive therapy, a psychiatric treatment in which seizures are electrically induced in anesthetized patients for therapeutic effect) patient.

The facility census was 71. The facility routinely provided ECT treatment for 16 to 17 patients three times a week.

Findings included:

1. Review of the American Society of Anesthesiologist (ASA) Statement on Documentation of Anesthesia Care, last amended on 10/22/08 showed a facility should develop and maintain policies and procedures directing the following:
-Documentation was a factor in the provision of quality care and was the responsibility of an anesthesiologist.
-While anesthesia care was a continuum, it was usually viewed as consisting of pre-anesthesia (before), intra-operative/procedural (during) anesthesia and post-anesthesia (after) components.
-Anesthesia care should be documented in the patient's medical record to reflect the components.

2. During an interview on 02/13/13 at 9:40 AM, Staff CC, Anesthesiologist (past Chairman of the Department of Anesthesia), stated that any anesthesia policies for the ECT unit would be included in the facility ECT policy. Staff CC stated that Anesthesia staff would refer to the policies and procedures from another sister facility.

3. During an interview on 02/13/13 at 3:50 PM, Staff G, RN, ECT Unit Supervisor, stated that policies and procedures relating to anesthesia were included in the ECT policy and procedure. Staff G stated that the ECT policy and procedure did not include a requirement for the anesthesiologist to document a pre-anesthesia assessment or a post-anesthesia assessment. Staff G stated that the ECT department did not have separate anesthesia policies and procedures.

4. During an interview on 02/13/13 at 3:00 PM, Staff E, RN stated that anesthesiologists did not re-assess the patient before they were discharged from the department. Staff E stated that the anesthesiologist would only see a patient if there were any problems.

5. During an interview on 02/13/13 at 3:30 PM, Staff F, RN stated that anesthesia did not see any of the out patients before they were discharged .