The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

OUR LADY OF BELLEFONTE HOSPITAL 1000 SAINT CHRISTOPHER DRIVE ASHLAND, KY 41101 Nov. 9, 2012
VIOLATION: NURSING SERVICES Tag No: A0385
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, review of facility's policy and review of the manufacturer's (Roche Diagnostics) instructions for disinfecting the glucometer, it was determined the facility failed to ensure nursing staff were properly instructed in the proper method of disinfecting the glucometer which resulted in improper disinfecting of the glucometer after patient use for one (1) of thirty (30) patients (Patient #10).

Review of facility's policy, "Accu-Chek Inform Blood Glucose Monitoring System," and the manufacturer's instructions for disinfecting the glucometer, "Accu-Chek Inform System Operator's Manual," both revealed to disinfect the glucometer, a one (1) to ten (10) dilution of sodium hypochlorite (bleach) in water would be used. Review of Patient #10's medical record revealed he/she was an insulin dependent diabetic that was admitted on [DATE] with a Primary Diagnosis of Left Knee Cellulitis. Finger stick blood glucose levels were ordered before meals and at bedtime to monitor his/her blood sugar level. Observation of Certified Nursing Assistant (CNA) #1 using the glucometer while performing a finger stick to measure the glucose or blood sugar level of Patient #10 revealed she disinfected the glucometer after patient use with alcohol swabs.

Interview with the Director of Infection Control (IC) revealed glucometers should be disinfected between each patient use with a bleach solution or bleach wipes. She further revealed she believed nursing staff used alcohol swabs because she had not instructed the nursing staff to only use bleach wipes.

Interview with the Point of Care Coordinator (POCC) revealed she trained new nursing staff at orientation and trained unit trainers that trained all nursing staff annually for the glucometer competency testing. One element of this competency training was to properly disinfect the glucometer. The POCC further revealed she had instructed staff and trainers that using alcohol swabs to disinfect the glucometer between patient use was acceptable.

The facility's failure to ensure nursing staff were trained on the proper method for disinfecting glucometers were disinfected properly between patient use placed patients at risk for serious injury, harm or death. The facility was notified on 11/08/12 that Immediate Jeopardy was determined to exist related to the Condition of Participation Nursing Services. The facility initiated corrective actions, and the Immediate Jeopardy was removed on 11/09/12, prior to exit on 11/09/12.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, review of facility's policy and review of the glucometer manufacturer's (Roche Diagnostics) instructions, it was determined the facility failed to properly instruct nursing staff on the proper way to disinfect glucometers between patient use which resulted in improper disinfection of the glucometer after patient use for one (1) of thirty (30) patients (Patient #10).

The findings include:

Review of the facility's policy, "Accu-Chek inform Blood Glucose Monitoring System, " policy number P-EQ-14, revised 05/2009, revealed to disinfect the glucometer, a one (1) to ten (10) solution of bleach water would be used.

Review of the glucometer manufacturer's instructions by Roche Diagnostics, "Accu-Chek Inform System Operator's Manual, " undated, revealed a one (1) to ten (10) dilution of sodium hypochlorite (bleach) with water would be used to disinfect the glucometer.

Review of Patient #10's medical record revealed he/she was admitted on [DATE] with Diagnoses which included Left Knee Cellulitis and Insulin Dependent Diabetes. He/she was ordered to have blood sugar or glucose monitoring before meals and at bedtime.

Observation of Certified Nursing Assistant (CNA) #1, on 11/07/12 at 12:00 PM, using the glucometer after a finger stick to measure the blood sugar level of Patient #10, revealed the CNA disinfected the glucometer after using on Patient #10, by wiping it with alcohol swabs.

Interview with the Lab Director, on 11/07/12 at 1:34 PM, revealed she believed a bleach solution was recommended by the manufacturer of the glucometers for disinfection between patient use.

Interview with the Point of Care Coordinator (POCC), on 11/07/12 at 1:35 PM, revealed she instructed new employees at orientation on the proper use of glucometers. She also stated she trained the unit trainers on glucometers use so that they could conduct the annual training/competency testing on glucometers. She further revealed she had trained that disinfecting the glucometers with alcohol swabs between patient use was acceptable. Additional interview with the POCC, on 11/09/12 at 8:24 AM, revaled she had been instructing the trainers that alcohol swabs, Super Sani-Cloths or bleach wipes were acceptable to use in disinfecting the glucometer between patient use. She further revealed she had been the POCC for a year and taught the same material about glucometers that had been used by the previous POCC.

Interview with the Director of Infection Control (IC), on 11/07/12 at 1:57 PM, revealed glucometers should be disinfected between patient use with a bleach solution or bleach wipe. She further revealed she believed some of the nursing staff used alcohol swabs because she had not instructed the staff to only use bleach wipes.

Interview with the Quality Improvement Coordinator, on 11/08/12 at 3:07 PM, revealed all Registered Nurses (RN's) and CNA's got initial glucometer training/competency testing at new employee orientation (NEO) and annually thereafter. She further revealed each unit had their own trainer, from the train the trainer program, to do the annual training/testing. She also stated the POCC did the initial training at NEO and trained the unit trainers.

Interview with CNA #1, on 11/08/12 at 2:55 PM, revealed she did use alcohol swabs when disinfecting the glucometer after use on Patient #10 at 12:00 PM on 11/07/12. She stated she had been trained to use bleach wipes to disinfect the glucometer between patient use, but was nervous and disinfected the glucometer the way she had been previously instructed when she worked at a nursing home.

The facility failed to provide a safe environment whcih placed patient at risk for serious injury, harm or death. On 11/08/12 Immediate Jeopardy was determined to exist.
The facility initiated corrective actions. These actions were as follows:

The facility contacted Roche Diagnostics, manufacturer of the Accu-Chek glucometers on 11/09/12. A "Disinfecting Procedure for the Accu-Chek Inform System, " 2005, was received by FAX with the instruction from Roche to add to the Accu-Chek Operating Manual. This addition listed the appropriate disinfecting solutions to include bleach wipes and Super-Sani Cloths. The facility policy, "Accu-Chek Inform Blood Glucose Monitoring System," policy number P-EQ-14, revised 11/2012, was changed to include appropriate methods to disinfect the glucometer between patient use was with bleach wipes or Super-Sani Cloths.

Retraining on the revised glucometer policy began on 11/09/12. By exit on 11/09/12, approximately one hundred (100) members of the nursing staff had been trained. Interview with the Director of Case Management and Quality, on 11/09/12 at 11:35 AM, revaled all nursing staff working on 11/09/12 would be retrained on the revised glucometer policy requirements on 11/09/12. Other nursing staff would be retrained by the house supervisors before working. The plan was to have all staff retrained within a week.

Interviews with eight (8) nursing staff (RN's and CNA's), on 11/09/12, revealed all had received retraining on the revised glucometer policy and stated only bleach clothes or Super-Sani Cloths could be used to disinfect glucometers between patient use.

The Immediate Jeopardy was removed on 11/09/12, prior to exit on 11/09/12.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, review of facility's policy and review of the manufacturer's (Roche Diagnostics) instructions for disinfecting the glucometer, it was determined the facility failed to ensure nursing staff was properly instructed in the proper method of disinfecting the glucometer which resulted in improper disinfecting of the glucometer after patient use.

Review of facility's policy, "Accu-Chek Inform Blood Glucose Monitoring System," and the manufacturer's instructions for disinfecting the glucometer, "Accu-Chek Inform System Operator's Manual," both revealed to disinfect the glucometer, a one (1) to ten (10) dilution of sodium hypochlorite (bleach) in water would be used. However, observation revealed staff disinfected the glucometer with alcohol swabs.

Interview with the Director of Infection Control (IC) revealed glucometers should be disinfected between each patient use with a bleach solution or bleach wipes. However, she had not instructed the nursing staff to only use bleach wipes.

Interview with the Point of Care Coordinator (POCC) revealed she trained new nursing staff at orientation and unit trainers who trained all nursing staff annually for the glucometer competency testing. per interview she had instructed staff and trainers that using alcohol swabs to disinfect the glucometer between patient use was acceptable.

The facility's failure to ensure nursing staff was trained on the proper method for disinfecting glucometers, which resulted in improper disinfection of them between patient use, placed patients at risk for serious injury, harm or death. The facility was notified on 11/08/12 that Immediate Jeopardy was determined to exist related to the Condition of Participation Infection Control. The facility initiated corrective actions, and the Immediate Jeopardy was removed on 11/09/12, prior to exit on 11/09/12.

Refer to A0748
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, review of facility's policy and review of the glucometer manufacturer's (Roche Diagnostics) instructions, it was determined the facility failed to properly instruct nursing staff on the proper way to disinfect glucometers between patient use which resulted in improper disinfection of the glucometer after patient use for one (1) of thirty (30) patients (Patient #10).

The findings include:

Review of the facility's policy, "Accu-Chek inform Blood Glucose Monitoring System", policy number P-EQ-14, revised 05/2009, revealed to disinfect the glucometer, a one (1) to ten (10) solution of bleach water would be used.

Review of the glucometer manufacturer's instructions by Roche Diagnostics, "Accu-Chek Inform System Operator's Manual", undated, revealed a one (1) to ten (10) dilution of sodium hypochlorite (bleach) with water would be used to disinfect the glucometer.

Review of Patient #10's medical record revealed he/she was admitted on [DATE] with Diagnoses which included Left Knee Cellulitis and Insulin Dependent Diabetes. He/she was ordered to have blood sugar or glucose monitoring before meals and at bedtime.

Observation of Certified Nursing Assistant (CNA) #1, on 11/07/12 at 12:00 PM, using the glucometer after a finger stick to measure the blood sugar level of Patient #10, revealed the CNA disinfected the glucometer after using on Patient #10, by wiping it with alcohol swabs.

Interview with the Lab Director, on 11/07/12 at 1:34 PM, revealed she believed a bleach solution was recommended by the manufacturer of the glucometers for disinfection between patient use.

Interview with the Point of Care Coordinator (POCC), on 11/07/12 at 1:35 PM, revealed she instructed new employees at orientation on the proper use of glucometers. She also stated she trained the unit trainers on glucometers use so that they could conduct the annual training/competency testing on glucometers. She further revealed she had trained that disinfecting the glucometers with alcohol swabs between patient use was acceptable. Additional interview with the POCC, on 11/09/12 at 8:24 AM, revealed she had been instructing the trainers that alcohol swabs, Super Sani-Cloths or bleach wipes were acceptable to use in disinfecting the glucometer between patient use. She further revealed she had been the POCC for a year and taught the same material about glucometers that had been used by the previous POCC.

Interview with the Director of Infection Control (IC), on 11/07/12 at 1:57 PM, revealed glucometers should be disinfected between patient use with a bleach solution or bleach wipe. She further revealed she believed some of the nursing staff used alcohol swabs because she had not instructed the staff to only use bleach wipes.

Interview with the Quality Improvement Coordinator, on 11/08/12 at 3:07 PM, revealed all Registered Nurses (RN's) and CNA's got initial glucometer training/competency testing at new employee orientation (NEO) and annually thereafter. She further revealed each unit had their own trainer, from the train the trainer program, to do the annual training/testing. She also stated the POCC did the initial training at NEO and trained the unit trainers.

Interview with CNA #1, on 11/08/12 at 2:55 PM, revealed she did use alcohol swabs when disinfecting the glucometer after use on Patient #10 at 12:00 PM on 11/07/12. She stated she had been trained to use bleach wipes to disinfect the glucometer between patient use, but was nervous and disinfected the glucometer the way she had been previously instructed when she worked at a nursing home.

The facility's failure to ensure nursing staff was trained on the proper method for disinfecting glucometers, which resulted in improper disinfection of them between patient use, placed patients at risk for serious injury, harm or death. On 11/08/12 Immediate Jeopardy was determined to exist.

The facility initiated corrective actions. These actions were as follows:

The facility contacted Roche Diagnostics, manufacturer of the Accu-Chek glucometers on 11/09/12. A "Disinfecting Procedure for the Accu-Chek Inform System, " 2005, was received by FAX with the instruction from Roche to add to the Accu-Chek Operating Manual. This addition listed the appropriate disinfecting solutions to include bleach wipes and Super-Sani Cloths. The facility policy, "Accu-Chek Inform Blood Glucose Monitoring System," policy number P-EQ-14, revised 11/2012, was changed to include appropriate methods to disinfect the glucometer between patient use was with bleach wipes or Super-Sani Cloths.

Retraining on the revised glucometer policy began on 11/09/12. By exit on 11/09/12, approximately one hundred (100) members of the nursing staff had been trained. Interview with the Director of Case Management and Quality, on 11/09/12 at 11:35 AM, revealed all nursing staff working on 11/09/12 would be retrained on the revised glucometer policy requirements on 11/09/12. Other nursing staff would be retrained by the house supervisors before working. The plan was to have all staff retrained within a week.

Interviews with eight (8) nursing staff (RN's and CNA's), on 11/09/12, revealed all had received retraining on the revised glucometer policy and stated only bleach clothes or Super-Sani Cloths could be used to disinfect glucometers between patient use.

The Immediate Jeopardy was removed on 11/09/12, prior to exit on 11/09/12.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview and review of the 2012 edition of "Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings", it was determined the facility failed to monitor and maintain the temperature and relative humidity (RH) levels to ensure patients received care in a safe environment in nine (9) of nine (9) operating rooms (OR's), (Main OR's #1, #2, #3 and #4 and Same Day Surgery (SDS) OR #1, #2, #3, #4, and #5).

Observation of all nine (9) OR's revealed temperatures and RH levels were not within the acceptable range of AORN standards. Interview with the Maintenance Specialist, Clinical Nurse Specialist for Surgical Services and Nursing Manager for SDS revealed there was not a policy or process in place to monitor, document and ensure the temperature and RH levels for each OR were within the acceptable range of the AORN standards before surgery was performed.

The facility's failure to ensure a system was in place to ensure temperature and RH levels were monitored and maintained at appropriate levels placed patients at risk for serious injury, harm or death. Immediate Jeopardy was identified under the Condition of Participation for Surgical Services. The facility was notified of the Immediate Jeopardy on 11/08/12. The facility initiated corrective actions; consequently, the Immediate Jeopardy was removed prior to exit on 11/09/12.

(Refer to A0951)
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview and review of the 2012 edition, " Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings", it was determined the facility failed to monitor, document and maintain the temperature and relative humidity (RH) levels in operating rooms (OR's) to ensure patients received care in a safe environment for nine (9) of nine (9) OR's (Main OR #1, #2, #3 and #4 and Same Day Surgery (SDS) OR #1, #2, #3, #4 and #5).

The findings include:

Review of the 2012 edition of, "Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings", revealed established recommended practices to reflect the acceptable RH ranges of 30 to 60% and temperature ranges of 68 to 73 degrees Fahrenheit (F) in OR's. The 2012 edition of AORN revealed low temperature and RH levels increased the risk of electrostatic charges which pose a fire hazard in the oxygen-enriched environment or when flammable agents were in use and increased the potential for dust. High temperature and RH levels increased the risk for microbial growth in areas where surgery was performed.

Observation of the Main OR's #1, #2, #3 and #4, on 11/08/12 at 4:45 PM, revealed the temperatures and RH levels were as follows: OR #1, 64.3 degrees F and 23.5% RH; OR #2, 65.1 degrees F and 25.2% RH; OR #3, 64.7 degrees F and 26.2% RH; and OR #4, 65.4 degrees F and 28.0% RH. The SDS OR's, on 11/08/12 at 5:10 PM, were as follows: OR #1, 65.0 degrees F and 28.3% RH; OR #2, 65.0 degrees F and 26.9% RH; OR #3, 64.4 degrees F and 29.7% RH; OR #4, 64.3 degrees F and 28.7% RH; and OR #5, 64.3 degrees F and 28.9% RH.

Interview with the Maintenance Specialist, on 11/07/12 at 2:08 PM, revealed Main ORs #1, #2 and #3 had the same central computerized air handling system, and the RH levels were taken from sensors in this system. However, he further revealed the RH levels and temperatures in these OR's, although visually checked every shift, were not documented. He further stated that parameters set for computer monitoring of temperatures was 60 to 70 degrees F, and the computer would alarm if the temperatures were not within this range. The Maintenance Specialist further revealed Main OR #4 was not on the central computerized system, and temperatures were not checked in this OR. He further revealed RH levels were checked in Main OR #4 daily but not recorded. He also stated it was the Main OR staff's responsibility to contact maintenance if there was a problem. The Maintenance Specialist revealed the facility tried to keep all RH levels in the 40 to 50% range. He also stated he did not document any communication from OR Staff about problems with temperatures and RH levels in the OR's.

Additional interview with the Maintenance Specialist, on 11/08/12 at 2:34 PM, revealed SDS ORs #1, #2, #3, #4 and #5 were on the same computerized air handling system. He further revealed there was not a process or policy that directed monitoring and/or documenting temperatures and RH levels in all SDS OR's.

Interview with the Clinical Nurse Specialist for Surgical Services, on 11/07/12 at 1:42 PM, revealed the facility tried to follow AORN guidelines. She further revealed temperatures and RH levels were monitored by maintenance, and she had not been notified there was a problem. She also stated that she believed SDS OR's were handled the same way, with maintenance monitoring and notifying staff if there was a problem.

Interview with the Clinical Nurse Specialist for Surgical Services and the Nurse Manager of SDS, on 11/08/12 at 2:34 PM, revealed there was no facility policy mandating or directing either OR staff or maintenance staff to monitor and document temperatures and RH levels in all of the nine (9) facility OR's or to assign responsibility for ensuring all OR's would be within the AORN parameters before surgery was performed.

The facility failed to provide a safe environment which placed patients at risk for serious injury, harm or death. On 11/08/12 Immediate Jeopardy was determined to exist.

The facility initiated corrective actions. Those actions were as follows:

The facility developed a new policy, "Surgical Suite Environmental Control Monitoring", dated 11/2012, which mandated daily temperature and RH level monitoring with documentation for all OR's. The parameters for temperature and RH levels were 68 to 73 degrees F and 30 to 60% RH before surgery could be performed which are the AORN parameters. This new policy also revealed the assigned responsibility for both the OR staff and maintenance (plant operations) staff. Also, the policy stipulated documentation would be required for any readings outside AORN parameters and the action(s) to get the OR temperature and RH levels within the acceptable AORN parameters must also be documented.

The facility trained staff on the new policy requirements, beginning on 11/09/12. Before exiting on 11/09/12, the Main OR had seventeen (17) of twenty-four (24) staff members who had completed the training; the SDS OR had ten (10) of fifteen (15) staff members who had completed the training; and the maintenance department had six (6) of nine (9) staff members who had completed the training. In total, thirty-three (33) of forty-eight (48) or 69% of staff members required to complete the training on the new policy had done so by exit on 11/09/12.

Interview with the Clinical Nurse Specialist for Surgical Services, on 11/09/12 at 2:17 PM, revealed all OR and maintenance staff members not yet trained on the new policy would be trained before being allowed to work.

Interviews with three (3) OR staff members and one (1) maintenance staff member, on 11/09/12, revealed all had received the training on the new policy, understood how to implement its requirements and would have no difficulty doing so.

Interview with the Vice-President of Operations, on 11/09/12 at 11:35 AM, revealed contract specialists for the air handling systems had made calibrations to the systems so that the AORN standards for temperature and RH levels in all OR's were met.

Observation of all the nine (9) OR temperature and RH levels, on 11/09/12 at 11:00 AM, revealed the following: Main OR #1, 68.6 degrees F and 32% RH; OR #2, 71.5 degrees F and 32% RH; OR #3, 68.8 degrees F and 33% RH; and 69.1 degrees F and 31% RH. The results for the SDS OR's were: #1, 69 degrees F and 36% RH; #2, 69.2 degrees F and 37% RH; #3, 69.1 degrees F and 36% RH; #4, 68.9 degrees F and 36% F; and #5, 70.9 degrees F and 37% RH. All these levels fell within the AORN parameters.

The Immediate Jeopardy was removed on 11/09/12, prior to exit on 11/09/12.