HospitalInspections.org

Based on review of the restraint policy and procedure, review of the Assignment Completion Report (documentation of completion of continuing education) and staff interview, the hospital failed to provide evidence that all physicians and licensed independent practitioners authorized to order restraint or seclusion had been educated on the hospital's policy. There were 119 physicians on the active medical staff, 12 (NP) nurse practitioners and 20 (PA) physician assistants. The facility was not able to provide a list of the physicians and LIPs (Licensed Independent Practitioners - PAs and NPs) who could potentially order restraint and seclusion. The facility was able to provide evidence of restraint training for only 8 physicians. Census on first day of survey was 172, which included 150 at the main campus and 22 at the offsite inpatient location . Findings are:

A. Review of the policy and procedure titled Restraint and Seclusion with an effective date of 4/20/07 and a last revised date of 8/10 revealed the following concerning education:
"Physician or LIP who order seclusion or restraint will receive education regarding hospital policy."

Interview with the Director of Education on 12/7/10 from 2:10 PM to 2:25 PM revealed that the hospital intended to train all physicians and LIPs on the restraint or seclusion policy.

B. The facility provided a document titled Assignment Completion Report. Review of this report revealed that 8 physicians had completed computer based training on Restraint/Seclusion between 9/10/09 and 6/28/10.

C. Interview with the Director of Education on 12/7/10 from 2:10 PM to 2:25 PM confirmed that the hospital could provide no evidence that any other physicians or LIPs had received training on the hospital's policy and procedure on restraint and seclusion.

Based on a review of 5 complaints and the related patient medical records, staff interviews, review of facility policy, employee coaching sessions, incident reports and a lack of documented evidence, the hospital Performance Improvement Program failed to implement preventive measures identified through the patient complaint process for 1of 5 sampled complaint/grievances selected for review.

The hospital reported a total patient census of 150 inpatients at the main campus and 22 patients at the offsite inpatient location on the first survey day, 11/30/10. Findings are:

A. Patient 0000 submitted a 'patient safety concern' via the electronic reporting Healthstreams system regarding an intravenous (IV) fluid she received on 7/19/10. The report indicated the patient was to receive the IV at the increased rate of 3 milliliters per kilogram per hour (mL/kg/hour) for 1 hour and then the rate was to be decreased to 1mL/kg/hour for 6 hours after the radiographic imaging Cation Tomography (CT) procedure. This is to mediate die-contrast induced nephropathy (disease of the kidney). The patient indicated, in the written concern, that she received most of the IV solution within 2 1/2 hours, rather than 6 hours, as ordered by the physician.

B. Review of medical record of Patient 0000 reflected the following physician orders on 7/19/2010:
- "CT scan Abd/pelvis with contrast"(cation tomography scan of the abdomen/pelvis with isovue contrast);
- Pharmacy to supply Dextrose 5 percent (%) water 1,000mL with Sodium Bicarbonate 150 milliequivalent (mEq) per liter;
- Precontrast rate 3 mL/kg/hr for 1 hour IV immediately prior to contrast infusion; Infuse 1 ml/kg/hr during contrast exposure and 6 hours after procedure".

Review of medical record also showed a CT/X-RAY CONTRAST ASSESSMENT which stated, " Contrast type: Isovue 370, amount 100." This resulted in a total volume of 1,100ml fluid. IV start time: 10:54 (am)"

Review of PHYSICIAN'S ORDERS AND PROGRESS NOTES on 7/19/10 1:12 PM,
"Have pt. [patient] receive total amount of bicarb infusion, then dismiss. Indication: Bicarb infusion at pre-contrast rate 'p' [after] contrast was given for CT scan".

The patient's pre-IV administration blood pressure taken at 9:50 AM was reported as 151/70. The patient's post IV administration blood pressure taken at 1:24 PM was reported as 180/76. The physician was notified at 1:12 PM on 7/19/10 and the patient was subsequently dismissed at 1:33 PM.

Based on review of the medical record, Patient 0000 received the entire 1,100 ml of fluid in 2.5 hours rather than over a 6-hour period as ordered.

Hospital staff completed a followup phone call with Patient 0000 on 7/20/10 at 9:15 AM and determined the patient was not having any problems following the procedure.

C. On 12/3/10 from 1:20 PM to approximately 2:00 PM, interviews conducted with the Director of Perianesthesia Services, Registered Pharmacist and the Clinical Engineer were as follows:
1. The Director of Perianesthesia Services stated that she was unavailable during this incident and investigated the complaint 6 days after the occurance. She provided documented evidence of coaching sessions completed with the 2 Registered Nurses (RN) involved with Patient 0000 incident.

Review of the results of the coaching sessions with RN-1 and RN-2 showed the following:
a. Session conducted on 8/3/10 with RN-1, who started the IV and initially programmed the IV pump, stated that she set the pump at the correct rate and that the pump must have malfunctioned. When questioned further as to why she did not tag the malfunctioning unit and remove it from service, she indicated, it did not occur to her to do so. In addition, RN-1 stated she did not check the IV pump before the patient left the department and indicated that she would double check her calculations from now on.
b. Session conducted on 8/4/10 with RN-2, who was notified by the patient of the increased flow rate of the IV, reset the pump to the correct, slower rate. RN-2 also notified the doctor. RN-2 indicated the pump responded appropriately and seemed to be functioning correctly. Since the pump responded correctly when RN-2 reset it and it "...was working for the rest of the infusion", the pump was not tagged for repair. Coaching session documented "education as to the equipment needing to go down (to the Bio-engineering department for evaluation) no matter what was given".

Director of Perianesthesia Services also stated the potentially faulty IV pump could be anywhere in the facility, and could be in current use, as the hospital does not have an equipment tracking system.

2. Interview with the Clinical Engineer revealed the hospital is equipped with approximately 230 IV pumps and all of them are evaluated annually for performance characteristics. Additionally, the department had not received any notice regarding malfunctioning IV pumps since the 7/19/10 incident. Approximately 100 of the pumps had been evaluated, as a part of the routine preventative maintenance program as of 12/3/10.

D. Review of hospital policy #12-04-03 labeled, "Equipment & Product Malfunction Problem" stated:
'The person identifying the problem will:
1. Immediately cease use of the product or piece of equipment....
8. Forward devices with accessories/supply(s) (properly packaged) with all labels/information to the Department Director or House Manager"

E. Incident Reporting Information System form filed by the Director of Perianesthesia Services in the followup section stated, "No Detectable Harm (to the patient)", RN-1 felt it was an equipment error; however the pump was not turned in (by RN-1) for repair."

F. Interviews conducted with 6 members of the Performance Improvement Council on 12/2/10 at 10:00 AM confirmed the lack of followup to remove a potentially defective IV pump from service.

G. Review of the Performance Improvement Reports/Activities for Fiscal Year 2010/2011 reflected, "Increase accountability for incorrect patient and medication errors." with a checking mechanism to: "Watch the specific action plans from the units/managers with these errors identified."

H. Due to the failure of the facility to adequately investigate the above stated occurrence, failure to follow written policies to promptly remove potentially faulty equipment from service and allowing a piece of equipment to be available for patient care, failure to determine or implement staff education/training, the performance improvement program regarding this complaint cannot be considered adequate.

Based on staff interview, review of medical record, review of credential files, review of Medical Staff Bylaws, review of Rules and Regulations of the Medical Staff, review of the Appointment, Reappointment and Credential Manual and review of the surgical schedule for CRNAs (Certified Registered Nurse Anesthetist), the hospital failed to ensure the Medical Staff followed the bylaws approved by the governing body by allowing:
- Physician Assistants to assist in surgery without the Governing Body granting them those privileges; and
- Physicians and CRNAs whose privileges had been temporarily suspended due to delinquent medical records to continue to provide services in the hospital while suspended.
Based on the serious nature of the findings, the Condition of Participation for Medical Staff is not in compliance.

The medical staff of the hospital consisted of 119 Active Staff, 23 Consulting Staff, 3 Courtesy Staff and 48 Allied Health Professionals (Nurse Practitioners, Physician Assistants and Certified Registered Nurse Anesthetists). Census on the first day of survey was 172, which included 150 at the main campus and 22 at the offsite inpatient location. Findings are:

A. Review of medical records for Patient 47 with admit date of 11/14/10 and Patient 4 with admit date of 11/30/10 revealed each patient had undergone a surgical procedure with Physician Assistant (PA)-L, listed as the "Assistant" to the surgeon for these 2 patients. Review of the credential file for PA-L revealed Physician Assistant Scope of Practice with no privilege for assisting in a surgical procedure. Interview with the Medical Staff Office Manager on 12/2/10 at 2:52 PM indicated that this same Scope of Practice form was used for all physician assistants. Interview on 12/3/10 at 11:21 AM with the Director of Surgery revealed the hospital has 8 physician assistants who assist in surgery ( PA-L, PA-N, PA-O, PA-P, PA-Q, PA-R, PA-S and PA-T).

Review of the Appointment, Reappointment and Credentialing Manual with last revised date 2/24/10 revealed the following under Article VII Policy on Credentialing of Allied Health Professionals Part A, Section 5 Conditions of Service: "AHPs [includes physician assistants] may only act within the scope of practice or clinical privileges specifically granted by the Board." The Medical Staff was allowing 8 physician assistants identified as assisting in surgery to practice clinical privileges that had not been granted by the Governing Body. (Refer to A353)

B. Review of the Rules and Regulations of the Medical Staff, Article IV-Part A, Section 7. Consequences, Failure to Complete Medical Records reads: "A temporary suspension of privileges shall occur for failure to complete medical record documentation, 24 hours after the physician receives a warning of potential delinquency by phone. That suspension of privileges shall take the form of withdrawal of all privileges to practice medicine....This temporary suspension of privileges shall be effective until delinquencies are completed."

The Director of Health Information Manager (HIM) on 12/2/10 identified that Physician-1, CRNA-1 and CRNA-2 currently had temporary suspension of privileges due to delinquent records. Review of the surgical schedule for CRNAs and interview with the Director of HIM on 12/2/10 at 9:30 AM revealed CRNA-1 was notified of being "off Staff" on 11/24/10 and continued to performed a total of 5 anesthesia services in the operating room until 12/2/10 and CRNA-2 was notified of being "off staff" on 11/24/10 and continued to perform a total of 9 anesthesia services in the operating room until 12/2/10. Interview with the Supervisor for Invasive Cardiac Procedures on 12/2/10 revealed Physician-1 was "off staff" on 11/24/10 and continued to perform 3 invasive cardiac procedures. (Refer to A353 II)

The hospital Medical Staff was allowing 8 physician assistants to assist in surgery without the Governing Body granting them those privileges and was allowing 1 physician and 2 CRNAs to provide services in the hospital even though their privileges had been temporarily suspended.

I. Based on review of credential files, review of the Medical Staff Bylaws, review of the Appointment, Reappointment and Credential Manual, review of medical records, and staff interview, the hospital failed to ensure that the Medical Staff followed the Bylaws in regards to granting of clinical privileges for surgery tasks for 8 of 8 AHPs (Allied Health Professionals), specifically physician assistants. The medical staff of the hospital consisted of 119 Active Staff, 23 Consulting Staff, 3 Courtesy Staff and 48 Allied Health Professionals (Nurse Practitioners, Physician Assistants and Certified Registered Nurse Anesthetists). Census on the first day of survey was 172, which included 150 at the main campus and 22 at the offsite inpatient location. Findings are:

A. Review of medical records for Patient 47 with admit date of 11/14/10 and Patient 4 with admit date of 11/30/10 revealed each patient had undergone a surgical procedure. Review of the OR (operating room)/Procedure Report revealed Physician Assistant (PA)-L was listed as the "Assistant" to the surgeon for these 2 patients.

B. Review of the credential file for PA-L revealed a document titled Physician Assistant Scope of Practice. This document was signed by PA-L and Physician-M in September 2008. The Governing Board had granted the clinical privileges listed on this Physician Assistant Scope of Practice document on 1/28/09. Review of the Physician Assistant Scope of Practice document revealed no reference to assisting in surgical procedures, what assisting could be done and the amount of supervision that would be required.

C. Interview with the Medical Staff Office Manager and the Credentialing Coordinator on 12/2/10 at 2:52 PM revealed the following:
- Confirmed that the Physician Assistant's Scope of Practice included no reference to assisting with surgical procedures;
- Indicated that this same Scope of Practice form was used for all physician assistants; and
- Indicated that this would be a system problem, as other physician assistants assist in surgery.

During interview on 12/3/10 at 11:21 AM with the Director of Surgery a list of PAs that assist in surgery was provided. This list contained the names of 8 PAs (PA-L, PA-N, PA-O, PA-P, PA-Q, PA-R, PA-S and PA-T). During this interview, after looking at the Physician Assistant Scope of Practice for PA-L, the only comment was that PA-L had been "assisting [Physician - M] for a long time."

D. Review of the Medical Staff Bylaws with a last revised date of 2/24/10 revealed the following under Article VIII - Appointment to the Medical Staff, 8.1 Qualifications for Appointment, 8.1.1 General:
"Appointment to the medical staff is a privilege which shall be extended only to professionally competent individuals who continuously meet the qualifications, standards and requirements set forth in these bylaws, the rules and regulations, accompanying manuals and policies..."

Review of the Appointment, Reappointment and Credentialing Manual with last revised date 2/24/10 revealed the following under Article VII Policy on Credentialing of Allied Health Professionals Part A, Section 5 Conditions of Service:
"AHPs may only act within the scope of practice or clinical privileges specifically granted by the Board."

The Medical Staff was allowing PA-L and the other 7 physician assistants identified as assisting in surgery to practice clinical privileges that had not been granted by the Governing Body.


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II. Based on staff interviews, review of the Rules and Regulations of the Medical Staff, and review of the policy for monitoring for delinquent medical records suspension and reinstatement of privileges, the facility failed to ensure the Rules and Regulations were followed by the Medical Staff by allowing 2 Certified Registered Nurse Anesthetists (CRNA-1, CRNA-2) and 1 Physician (Physician-1) to provide non-emergent patient services after they had been notified of being "off staff" due to delinquent medical records and failed to ensure the completion of 444 medical records with in the allotted time frame of 30 days after the dismissal of a patient. Findings are:

A. Review of the Rules and Regulations of the Medical Staff, Article IV-Part A, Section 7. Consequences, reads: Failure to complete Medical Records: A temporary suspension of privileges shall occur for failure to complete medical record documentation, 24 hours after the physician receives a warning of potential delinquency by phone. That suspension of privileges shall take the form of withdrawal of all privileges to practice medicine with respect to:
- Admission of inpatient or observation patients (except emergencies);
- Scheduling of inpatient or observation admissions for a later date;
- Calling to admit inpatients or observation patients under another's physician's name;
- Placing of the physician's name on the face sheet as Primary, Referring, or Admitting Physician;
- Admission of non-emergent anesthesia;
- Scheduling of elective, non emergent outpatient surgery or invasive procedures;
- Performing of any elective, non-emergent or non invasive procedures;
- Emergency Room physicians will not be scheduled to work when placed "off staff".

This temporary suspension of privileges shall be effective until delinquencies are completed. The physician may order outpatient testing, such as lab, X-rays, and tests performed by another on staff physician. Exceptions to these provisions may be granted by the Department Chair or his/her designee, for good cause. Failure to complete these medical records within 30 days from the date of temporary suspension of privileges shall constitute an immediate voluntary relinquishment of clinical privileges and immediate resignation from the medical staff, for which no fair hearing rights are granted. Furthermore, accumulation of an aggregate of 60 days on the temporary suspension list in any one calendar year shall result in the same action as 30 days consecutively on the temporary suspension list."

Review of the policy titled Monitoring for Delinquent Medical Records Suspension and Reinstatement of Privileges reads: "It is the policy of Good Samaritan Hospital and Richard Young Hospital to monitor medical record completion for the Medical Staff on a weekly basis for compliance with the By-Laws and Regulations of the Medical Staff."

B. Interview with the Health Information Manager (HIM) on 12/2/10 at 9:30 AM identified the facility had a total of 444 delinquent medical records as "being over the allowed 30 days to complete."
1. Behavioral Health Inpatients - Total of 25 medical records lacking a discharge summary and history and physicals;
2. Emergency Services - Total of 65 medical records, reasons not given;
3. Endoscope - Total of 7 medical records lacking 10 history and physicals;
4. Inpatient - Total of 254 medical records lacking 183 discharge summaries and 6 history and physicals;
5. Inpatient rehab unit - Total of 2 medical records, reasons not given;
6. Observation - Total of 3 medical records, reasons not given;
7. Oncology and Radiation - Total of 4 medical records, reasons not given;
8. Outpatient Services - Total of 15 medical records lacking 1 discharge summary;
9. Outpatient Surgery - Total of 27 medical records lacking 3 history and physicals; and
10. Radiology - Total 3 medical records, reason not given.

Further interview revealed all departments and staff are notified throughout the hospital by computer 5 times a day, and the departments and staff with the delinquent records are called by HIM periodically. Further acknowledged "several physicians and staff contributed to the delinquent medical charts." Examples are:
- Physician-1 contributed to 132 delinquent medical records;
- Physician-2 contributed to 14 delinquent medical records;
- Physician-3 contributed to 2 delinquent medical records.

C. Review of surgical schedule for CRNAs and continued interview with the HIM and Anesthesia supervisor revealed CRNA-1 was notified of being "off Staff" on 11/24/10 and continued to performed a total of 5 anesthesia services in the operating room until 12/2/10. CRNA-2 was notified of being "off staff" on 11/24/10 and continued to perform a total of 9 anesthesia services in the operating room until 12/2/10. The anesthesia services were identified by the Anesthesia supervisor as a scheduled procedure and non-emergent. Interview with the supervisor for invasive cardiac procedures on 12/2/10 revealed Physician-1 was "off staff" on 11/24/10 and continued to perform 3 invasive cardiac procedures that were identified by the cardiac supervisor as non-emergent.

Based on a review of 5 patient complaint reports and related patient medical records, facility policy, employee coaching sessions, incident reports and staff interviews, the hospital failed to ensure acceptable levels of patient safety for patient care equipment, such as intravenous (IV) pumps. The facility failed to identify and remove a potentially faulty IV pump from service in July 2010, failed to adequately train staff to program IV pumps and remove them from service as needed when a problem was idenitified to ensure an acceptable level of patient safety for other patients. Facility reported a patient census of 150 on the main campus and 22 at the offsite inpatient location the first day of survey.

On 12/2/10 at 3:20 PM after consultation with Regional Office for the Centers for Medicare & Medicaid Services (CMS) representative, a determination was made that all patients have been placed at risk of receiving medications from a potentially faulty IV pump since 7/19/10, and the decision was made that Immediate Jeopardy (IJ) conditions existed. The CEO and 6 members of the senior leadership team were notified of the IJ on 12/2/2010 at 4:30 PM. On 12/8/10 at 10:30 AM, after discussion with a representative from the CMS Regional Office, the decision to abate the IJ was made after the hospital conducted equipment checks for all IV pumps and educated staff to protect all patients. The findings were of such a serious nature that the facility was found to be out of compliance with the Condition of Participation for Physical Environment. (Refer to A-724)

Based on a review of 5 patient complaint reports and related patient medical records, facility policy, employee coaching sessions, incident reports and a staff interviews, the hospital failed to ensure acceptable levels of patient safety for patient care equipment, such as intravenous (IV) pumps. The facility reported a patient census of 150 on the main campus and 22 at the offsite inpatient location the first day of survey. Findings are:

A. Patient 0000 submitted a 'patient safety concern' via the electronic reporting Healthstreams system regarding an intravenous (IV) fluid she received on 7/19/10. The report indicated the patient was to receive the IV at the increased rate of 3 milliliters per kilogram per hour (mL/kg/hour) for 1 hour and then the rate was to be decreased to 1mL/kg/hour for 6 hours after the radiographic imaging Cation Tomography (CT) procedure. This is to mediate die-contrast induced nephropathy (disease of the kidney). The patient indicated, in the written concern, that she received most of the IV solution within 2 1/2 hours, rather than 6 hours, as ordered by the physician.

B. Review of medical record for Patient 0000 reflected the following physician orders, "CT scan Abd/pelvis with contrast"(cation tomography scan of the abdomen/pelvis with isovue contrast),
- Pharmacy to supply Dextrose 5 percent (%) water 1,000mL with Sodium Bicarbonate 150 milliequivalent (mEq) per liter;
- Precontrast rate 3 mL/kg/hr for 1 hour IV immediately prior to contrast infusion
- Infuse 1 ml/kg/hr during contrast exposure and 6 hours after procedure".

Medical record CT/X-RAY CONTRAST ASSESSMENT stated, "Contrast type: Isovue 370, amount 100." This resulted in a total volume of 1,100ml fluid. "IV start time: 10:54 (am)".

Review of Physician's Orders and Progress Notes dated 7/19/10 at 1:12 PM stated, " Have pt. (patient) receive total amount of bicarb infusion, then dismiss. "Indication: Bicarb infusion at pre-contrast rate 'p' [after] contrast was given for CT scan".

The patient's pre-IV administration blood pressure taken at 9:50 AM was reported as 151/70. The patient's post IV administration blood pressure taken at 1:24 PM was reported as 180/76. Physician was notified at 1:12 PM on 7/19/10 and the patient was subsequently dismissed at 1:33 PM. Patient 0000 received the entire 1,100 ml of fluid in 2.5 hours rather than the 6 hours, as ordered.

A followup phone call conducted by hospital staff to the patient on 7/20/10 at 9:15 AM determined the patient was not having any problems.

C. On 12/3/2010 from 1:20 PM to approximately 2:00 PM interviews conducted with the Director of Perianesthesia Services, Registered Pharmacist and the Clinical Engineer were as follows:
1. The Director of Perianesthesia Services stated that she was unavailable during this incident and investigated the complaint 6 days after the occurance. She provided documented evidence of the coaching sessions completed with the 2 Registered Nurses (RN) involved with Patient 0000.

Review of the results of the coaching sessions with RN-1 and RN-2 showed the following:
a. Session conducted on 8/3/10 with RN-1, who started the IV and initially programmed the IV pump, stated she set the pump at the correct rate and that the pump must have malfunctioned. When questioned further, as to why she did not tag the malfunctioning unit and remove it from service, she indicated it did not occur to her to do so. In addition, RN-1 stated she did not check the IV pump before the patient left the department and indicated that she would double check her calculations from now on.
b. Session conducted on 8/4/10 with RN-2, who was notified by the patient of the increased flow rate of the IV, reset the pump to the correct, slower rate. RN-2 also notified the doctor of the incident. RN-2 indicated the pump responded appropriately and seemed to be functioning correctly. Since the pump responded correctly when RN-2 reset it, and it "..was working for the rest of the infusion", the pump was not tagged for repair. Coaching session documented, "Education as to the equipment needing to go down (to the Bio-engineering department for evaluation) no matter what was given".

Director of Perianesthesia Services also stated the potentially faulty IV pump could be anywhere in the facility, and could be in current use, as the hospital, does not have an equipment tracking system.

2. Interview with the Clinical Engineer revealed the hospital is equipped with approximately 230 IV pumps and all of them are evaluated annually for performance characteristics. Additionally, the department had not received any notice regarding malfunctioning IV pumps since the 7/19/10 incident. Approximately 100 of the pumps had been evaluated, as a part of the routine preventative maintenance program as of 12/3/10.

D. Review of hospital policy #12-04-03 labeled, "Equipment & Product Malfunction Problem" stated:
'The person identifying the problem will:
1. Immediately cease use of the product or piece of equipment....
8. Forward devices)(s) with accessories/supply(s)(properly packaged) with all labels/information to the Department Director or House Manager".

E. Incident Reporting Information System form filed by the Director of Perianesthesia Services in the followup section stated, "No Detectable Harm (to the patient)". RN-1 felt it was an equipment error; however, the pump was not turned in (by RN-1)for repair."

F. Interviews conducted with 6 members of the Performance Improvement Council on 12/2/10 at 10:00 AM confirmed the lack of followup to remove a potentially defective IV pump from service.

G. A review of the Performance Improvement Reports/Activities for fiscal year 2010/2011 reflected, "Increase accountability for incorrect patient and medication errors." with a checking mechanism to: "Watch the specific action plans from the units/managers with these errors identified."

H. The facility failed to ensure patient equipment was evaluated when a potential problem was idenitified with an IV pump, failed to ensure prompt removal of the equipment from patient service and allowed a potentially mal-functioning IV pump to be available for use with other patients placing all patients at risk.

On 12/2/10 at 3:20 PM after consultation with the State Agency Program Manager and a Regional Office for the Centers for Medicare & Medicaid Services (CMS) representative, a determination was made that all patients have been placed at risk of receiving medications from a potentially faulty IV pump since 7/19/10, the decision was made to declare an Immediate Jeopardy (IJ) situation.

The CEO and 6 members of the senior leadership team were notified of the IJ on 12/2/2010 at 4:30 PM.

Documented evidence of staff training regarding correct programing of IV pumps and retraining staff on removing faulty equipment from use for 499 Nurses had been accomplished by 5:00 PM on 12/7/10.

In addition, 82 infusion controllers and 235 infusion modules were tested and approved for patient use by 12/7/10 at 5:00 PM

On 12/8/10 at 10:30 AM after discussion with a representative from the CMS Regional Office, the decision to abate the IJ was made.

Based on review of credential files, review of medical records and staff interview, the hospital failed to ensure that 1 of 2 Allied Health Professional credential files reviewed had privileges that included surgical privileges when performing surgical tasks PA (Physician Assistant)-L. The hospital identified 8 Allied Health Professionals (all were physician assistants) that assisted physicians in surgery. The hospital had credentialed 48 Allied Health Professionals with 20 of those being physician assistants. Census on the first day of survey was 172, which included 150 at the main campus and 22 at the offsite inpatient location. Findings are:

A. Review of medical records for Patient 47 with admit date of 11/14/10 and Patient 4 with admit date of 11/30/10 revealed each patient had undergone a surgical procedure. Review of the OR (operating room)/Procedure Report revealed PA-L was listed as the "Assistant" to the surgeon for these 2 patients.

B. Review of the credential file for PA-L revealed a document titled Physician Assistant Scope of Practice. This document was signed by PA-L and by the Supervising Physician in September of 2008. Review of the document revealed no reference to assisting with surgical procedures.

C. Interview with the Medical Staff Office Manager and the Credentialing Coordinator on 12/2/10 at 2:52 PM revealed the following:
- Confirmed that the Physician Assistant's Scope of Practice included no reference to assisting with surgical procedures; and
- Indicated this same Scope of Practice form was used for all Physician Assistants.

D. During interview on 12/3/10 at 11:21 AM with the Director of Surgery, a list of PAs that assist in surgery was provided. This list contained the names of 8 PAs (PA-L, PA-N, PA-O, PA-P, PA-Q, PA-R, PA-S and PA-T). During this interview, after looking at the Physician Assistant Scope of Practice for PA-L, the only comment was that PA-L had been "assisting [Physician - M] for a long time."