HospitalInspections.org

Based on observation, interview, and record review, the hospital's Governing Body was not effective in carrying out its responsibilities for the operation of the hospital from 09/01/16 through 01/18/17 and on 01/25/17, in that:


1. The Chief Executive Officer did not effectively manage the entire hospital;

Cross Refer to Tag 0057


2. The Chief Nursing Officer (CNO) and Infection Control Preventionist failed to identify infection control breaches in the sterilization process unit;

Cross Refer to Tag 0386


3. Biological indicators (BIs) were not performed when sterilizing implants, citing 84 of 93 implant loads to determine whether the most resistant spores were present or not. And, weekly monitoring with a challenge pack containing a BI and with a load of instruments was not conducted to ensure the sterilizer's efficacy, citing 19 of 20 weeks.

Cross Refer to Tag 0749


4. Infection Control policies and procedures were not implemented.

Cross Refer to Tag 0748

Based on observation, interview, and record review, the facility's Chief Executive Officer did not effectively manage the entire hospital, in that the chief nursing officer and infection control preventionist failed to identify infection control breaches in the sterilization process unit from 09/01/16 through 01/18/17. The breaches were as follows:


1. Sterilization of implants did not include biological indicator performances, and


2. Weekly monitoring with a challenge pack containing a BI and with a load of instruments was not conducted, citing 19 of 20 weeks.



Findings included:


1. Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show implants were sterilized with biological indicators performed. The following were the dates when implants were sterilized without BIs performed:

01/03/17 - 1st, 4th, and 8th load
01/04/17 - 2nd load
01/06/17 - 1st and 3rd load
01/09/17 - 3rd load
01/10/17 - 3rd load
01/11/17 - 3rd and 6th load
01/16/17 - 2nd load
01/17/17 - 5th load
01/18/17 - 6th load

12/01/16 - 1st load
12/05/17 - 5th and 6th load
12/06/16 - 3rd load
12/07/16 - 8th load
12/13/16 - 9th load
12/14/16 - 1st load
12/15/16 - 1st load
12/16/16 - 2nd load
12/19/16 - 4th load
12/20/16 - 1st load
12/21/16 - 3rd load
12/27/16 - 1st and 4th load
12/28/16 - 2nd load
12/29/16 - 7th load

11/02/16 - 5th load
11/07/16 - 4th and 7th load
11/08/16 - 7th load
11/09/16 - 3rd load
11/14/16 - 2nd load
11/16/16 - 2nd and 7th load
11/22/16 - 3rd load
11/28/16 - 5th and 6th load
11/29/16 - 4th load
11/30/16 - 4th load
10/03/16 - 2nd load

10/05/16 - 2nd load
10/07/16 - 2nd load
10/10/16 - 2nd, 3rd, and 6th
10/11/16 - 4th and 5th load
10/12/16 - 1st, 2nd, and 5th load
10/17/16 - 1st and 3rd load
10/18/16 - 5th load
10/19/16 - 5th and 6th load
10/21/16 - 1st and 4th load
10/25/16 - 6th load
10/26/16 - 3rd and 7th load
10/31/16 - 2nd and 7th load

09/02/16 - 3rd and 4th load
09/07/16 - 1st, 6th, and 8th load
09/08/16 - 1st load
09/09/16 - 3rd load
09/12/16 - 5th load
09/14/16 - 1st load
09/16/16 - 3rd load
09/20/16 - 5th load
09/26/16 - 4th load
09/27/16 - 2nd and 4th load
09/28/16 - 5th load
09/29/16 - 5th load
09/30/16 - 3rd, 4th, and 5th load


2. Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show weekly monitoring with a challenge pack containing a BI and with a load of instruments was conducted, hereunder were the dates:

2017 January 2nd, 9th, and 16th
2016 December 5th, 12th, and 27th
2016 November 7th, 14th, 21st, and 28th
2016 October 3rd, 10th, 17th, 24th, and 31st
2046 September 5th, 12th, 19th, and 26th


In an interview on 01/25/17 at 1:30 PM and on 01/26/17 at 10:40 AM, Personnel #3 confirmed the above findings. Personnel #2 stated the above findings were not identified until an accrediting body informed the hospital.


Hospital policy reference #120015 "Sterilization" revised 12/02/13 required "...Implantable devices should be sterilized with a biological indicator ...Sterilization ...documentation should include ...results of the physical, chemical, and biological monitors. Weekly monitoring with a challenge pack containing a BI and chemical indicator with a load containing instruments will be done in all sterilizers."


Hospital policy reference #1001 "Infection Prevention and Control Program" revised 11/22/16 required "...program ensures that this organization develops, implements, and maintains an active, organization-wide program for the prevention, control and investigation of infections and communicable diseases ...Identifying risks in the healthcare organization through a risk assessment annually..."

Based on interview and record review, the facility's Interim Chief Nursing Officer (CNO) failed to oversee the Sterilization Process Unit and Infection Control Department in that from 09/01/16 through 01/18/17:

1. Biological indicators (BIs) were not performed when sterilizing implants, citing 84 of 93;

2. Weekly monitoring with a challenge pack containing a BI and with a load of instruments was not conducted as per policy, citing 19 of 20 weeks.


Findings included:

1. Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show implants were sterilized with biological indicators performed. The following were the dates when implants were sterilized without BIs performed:

01/03/17 - 1st, 4th, and 8th load
01/04/17 - 2nd load
01/06/17 - 1st and 3rd load
01/09/17 - 3rd load
01/10/17 - 3rd load
01/11/17 - 3rd and 6th load
01/16/17 - 2nd load
01/17/17 - 5th load
01/18/17 - 6th load

12/01/16 - 1st load
12/05/17 - 5th and 6th load
12/06/16 - 3rd load
12/07/16 - 8th load
12/13/16 - 9th load
12/14/16 - 1st load
12/15/16 - 1st load
12/16/16 - 2nd load
12/19/16 - 4th load
12/20/16 - 1st load
12/21/16 - 3rd load
12/27/16 - 1st and 4th load
12/28/16 - 2nd load
12/29/16 - 7th load

11/02/16 - 5th load
11/07/16 - 4th and 7th load
11/08/16 - 7th load
11/09/16 - 3rd load
11/14/16 - 2nd load
11/16/16 - 2nd and 7th load
11/22/16 - 3rd load
11/28/16 - 5th and 6th load
11/29/16 - 4th load
11/30/16 - 4th load
10/03/16 - 2nd load

10/05/16 - 2nd load
10/07/16 - 2nd load
10/10/16 - 2nd, 3rd, and 6th
10/11/16 - 4th and 5th load
10/12/16 - 1st, 2nd, and 5th load
10/17/16 - 1st and 3rd load
10/18/16 - 5th load
10/19/16 - 5th and 6th load
10/21/16 - 1st and 4th load
10/25/16 - 6th load
10/26/16 - 3rd and 7th load
10/31/16 - 2nd and 7th load

09/02/16 - 3rd and 4th load
09/07/16 - 1st, 6th, and 8th load
09/08/16 - 1st load
09/09/16 - 3rd load
09/12/16 - 5th load
09/14/16 - 1st load
09/16/16 - 3rd load
09/20/16 - 5th load
09/26/16 - 4th load
09/27/16 - 2nd and 4th load
09/28/16 - 5th load
09/29/16 - 5th load
09/30/16 - 3rd, 4th, and 5th load

2. Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show weekly monitoring with a challenge pack containing a BI and with a load of instruments was conducted, hereunder were the dates:

2017 January 2nd, 9th, and 16th
2016 December 5th, 12th, and 27th
2016 November 7th, 14th, 21st, and 28th
2016 October 3rd, 10th, 17th, 24th, and 31st
2046 September 5th, 12th, 19th, and 26th

In an interview on 01/25/17 at 3:50 PM, the Interim CNO confirmed the above findings.

The Interim CNO's job description dated 01/23/17 required to "Implement standards...Ensures compliance with policies and procedures regarding department operations...and infection prevention and control.

Hospital policy reference #120015 "Sterilization" revised 12/02/13 required "...Implantable devices should be sterilized with a biological indicator ...Sterilization ...documentation should include ...results of the physical, chemical, and biological monitors. Weekly monitoring with a challenge pack containing a BI and chemical indicator with a load containing instruments will be done in all sterilizers."

Hospital policy reference #1001 "Infection Prevention and Control Program" revised 11/22/16 required "...program ensures that this organization develops, implements, and maintains an active, organization-wide program for the prevention, control and investigation of infections and communicable diseases ...Identifying risks in the healthcare organization through a risk assessment annually..."

Based on observation, interview, and record review, the hospital's Infection Control Preventionist failed to provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases in that:


1. Infection Control breaches were not identified in the Sterilization Process Department from 09/01/16 through 01/18/17; and

Cross Refer to Tag 0749


2. Infection Control breaches were identified during a tour in Sterilization Process Unit and Preoperative Unit on 01/25/17.

Cross Refer to Tag 0748

Based on observation, interview, and record review, the hospital's Infection Control Preventionist did not implement policies governing control of infections and failed to identify breaches of infection control practices in the Sterilization Process Department from 09/01/16 through 01/18/17, and in the preoperative area on 01/25/17, in that:


1. Implants were sterilized without biological indicators (BIs) performed, citing 84 of 93 implant loads;


2. Weekly monitoring with a challenge pack containing a biological indicator and with a load of instruments was not conducted as per policy, citing 19 of 20 weeks;


3. The infection control indicators did not include biological indicator performances for every implant load and the weekly monitoring of biological indicators to ensure infection control practices were methodically evaluated in 2016;


4. 11 of 15 needle holders and surgical scissors were sterilized in a closed position. These surgical instruments were found in a bin in the sterile supply room ready to use on surgical procedures;


5. An enzymatic and water solution was observed in the sink of the decontamination room. The water was not accurately measured when added to the enzymatic solution called "Prolystica."


6. 1 of 1 nurse anesthetist in the preoperative area wore a mask hanging around the neck on 01/25/17.


Findings included:


Review of the sterilization log from 09/01/16 through 01/18/17 reflected the following:


1. 84 of 93 implants loads were sterilized without biological indicators performed that could determine whether the most resistant spores were present or not.


2. Weekly monitoring with a challenge pack containing a biological indicator and with a load of instruments were not conducted for 19 of 20 weeks to test the sterilizer's efficacy.


In an interview on 01/25/17 at 4:00 PM, Personnel #2 was informed of the above findings and confirmed the findings.


3. Review of the hospital's infection control indicators did not include biological indicator performances in implants load and weekly biological indicator testing to determine if resistant spores were present or not.


In an interview on 01/25/17 at 4:10 PM, Personnel #2 was informed of the above findings. She confirmed the findings and stated sometime late last year she added a "weekend biological testing" indicator.


4. In the sterile supply room at 3:00 PM, the surveyor observed 11 of 15 needle holders and surgical scissors sterilized in a closed position. These instruments were ready for use on surgical procedures. The findings were confirmed by Personnel #4 and stated the instruments should have been opened.


5. In the decontamination room at 3:08 PM, the surveyor observed a sink with water and "Enzymatic Prolystica" solution. Personnel #6 was asked for the manufacturer's direction for use of the "Enzymatic Prolystica." Personnel #6 replied she used 1/8 to 1/2 fluid ounces of the enzymatic solution to a gallon of water. Personnel #6 was asked if she measured the gallon of water accurately. She replied she did not and she used approximation only.


6. In the preoperative area at 3:15 PM, the surveyor observed 1 of 1 nurse anesthetist (Personnel #7) wearing a mask hanging around the neck. This was confirmed by Personnel #1 and she stated Personnel #7 should not have worn a mask outside the restricted area.


Hospital policy reference #120015 "Sterilization" revised 12/02/13 required "...Implantable devices should be sterilized with a biological indicator ...Sterilization ...documentation should include ...results of the physical, chemical, and biological monitors. Weekly monitoring with a challenge pack containing a BI and chemical indicator with a load containing instruments will be done in all sterilizers."


Hospital policy reference #1001 "Infection Prevention and Control Program" revised 11/22/16 required "...program ensures that this organization develops, implements, and maintains an active, organization-wide program for the prevention, control and investigation of infections and communicable diseases ...Identifying risks in the healthcare organization through a risk assessment annually..."


Hospital policy reference #11015 "Cleaning and Care of Surgical Instruments ..." revised 08/15/13 page 8 required "Instruments with hinges should be opened and those with removable parts should be disassembled. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or pegs designed to contain instruments."


Hospital policy reference #1001 "Infection Prevention and Control Program" revised 11/22/16 Requiring disinfectants ...and germicides to be used in accordance with the manufacturer's instructions."


Hospital policy reference #4010 "Attire in the Operating Room" effective 05/2016 page 2 required "Masks will be removed when leaving the operating room area."

Based on interview and record review, the hospital's Infection Control Preventionist did not identify that biological indicators were not performed in sterilizing implants, citing 84 of 93 implant loads, and weekly testing's of biological indicators (BIs) were not conducted, citing 19 of 20 weeks from 09/01/16 through 01/18/17.


Findings included:


Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show implants were sterilized with biological indicators performed. The following were the dates when implants were sterilized without BIs performed:


01/03/17 - 1st, 4th, and 8th load
01/04/17 - 2nd load
01/06/17 - 1st and 3rd load
01/09/17 - 3rd load
01/10/17 - 3rd load
01/11/17 - 3rd and 6th load
01/16/17 - 2nd load
01/17/17 - 5th load
01/18/17 - 6th load

12/01/16 - 1st load
12/05/17 - 5th and 6th load
12/06/16 - 3rd load
12/07/16 - 8th load
12/13/16 - 9th load
12/14/16 - 1st load
12/15/16 - 1st load
12/16/16 - 2nd load
12/19/16 - 4th load
12/20/16 - 1st load
12/21/16 - 3rd load
12/27/16 - 1st and 4th load
12/28/16 - 2nd load
12/29/16 - 7th load

11/02/16 - 5th load
11/07/16 - 4th and 7th load
11/08/16 - 7th load
11/09/16 - 3rd load
11/14/16 - 2nd load
11/16/16 - 2nd and 7th load
11/22/16 - 3rd load
11/28/16 - 5th and 6th load
11/29/16 - 4th load
11/30/16 - 4th load
10/03/16 - 2nd load

10/05/16 - 2nd load
10/07/16 - 2nd load
10/10/16 - 2nd, 3rd, and 6th
10/11/16 - 4th and 5th load
10/12/16 - 1st, 2nd, and 5th load
10/17/16 - 1st and 3rd load
10/18/16 - 5th load
10/19/16 - 5th and 6th load
10/21/16 - 1st and 4th load
10/25/16 - 6th load
10/26/16 - 3rd and 7th load
10/31/16 - 2nd and 7th load

09/02/16 - 3rd and 4th load
09/07/16 - 1st, 6th, and 8th load
09/08/16 - 1st load
09/09/16 - 3rd load
09/12/16 - 5th load
09/14/16 - 1st load
09/16/16 - 3rd load
09/20/16 - 5th load
09/26/16 - 4th load
09/27/16 - 2nd and 4th load
09/28/16 - 5th load
09/29/16 - 5th load
09/30/16 - 3rd, 4th, and 5th load


2. Review of the facility's Sterilization Log from 09/01/16 through 01/18/17 did not show weekly monitoring with a challenge pack containing a BI and with a load of instruments was conducted, hereunder were the dates:


2017 January 2nd, 9th, and 16th
2016 December 5th, 12th, and 27th
2016 November 7th, 14th, 21st, and 28th
2016 October 3rd, 10th, 17th, 24th, and 31st
2046 September 5th, 12th, 19th, and 26th


In an interview on 01/25/17 at 1:30 PM and on 01/26/17 at 10:40 AM, Personnel #3 confirmed the above findings.


Hospital policy reference #120015 "Sterilization" revised 12/02/13 required "...Implantable devices should be sterilized with a biological indicator ...Sterilization ...documentation should include ...results of the physical, chemical, and biological monitors. Weekly monitoring with a challenge pack containing a BI and chemical indicator with a load containing instruments will be done in all sterilizers."


Hospital policy reference #1001 "Infection Prevention and Control Program" revised 11/22/16 required "...program ensures that this organization develops, implements, and maintains an active, organization-wide program for the prevention, control and investigation of infections and communicable diseases ...Identifying risks in the healthcare organization through a risk assessment annually..."