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Based on interview and documentation in 2 of 2 medical records reviewed of patients who had orders for isolation precautions (Patients 1 and 2), it was determined that the hospital failed to ensure the medical record contained complete, consistent and clear documentation related to isolation precautions in order to appropriately monitor the patient's condition.
* Orders for isolation precautions were incomplete; and
* Documentation reflecting implementation of isolation precautions was incomplete, unclear and inconsistent.

Findings included:

1. The medical record for Patient 1 was reviewed. The patient was admitted to the hospital on 03/26/2015 at 0929 with diagnoses of syncope, dehydration, vomiting, and diarrhea. The record contained an order dated 03/26/2015 for contact/enteric isolation precautions. The order had no start time and the frequency of the order was "qs." The "Precaution Reason" for the order was "Acute Diarrhea." The order also reflected "Other Comments C-Diff Pending." The end date/time for the order was 04/05/2015 at 0814.

A nurse flowsheet titled "Worklist Charting" was reviewed. The flowsheet had daily columns check marked for documenting "Contact/Enteric Isolation" precautions. The columns dated from 03/26/2015 through 04/03/2015 were not completed and were blank and therefore it was unclear whether or not the isolation precautions were in place for those dates; and on 04/04/2015 and 04/05/2015 the documentation in the columns reflected "Not Done" and there was no documentatation to reflect the reason the isolation precautions were documented as "Not Done". In addition, the flowsheet had daily columns check marked for documenting "Precautions (Specify)." The columns were not completed and were blank from 03/26/2015 through 04/05/2015. It was unclear what type of precautions those referred to and whether or not they were in place for those dates.

2. The medical record for Patient 2 was reviewed. The patient was admitted to the hospital on 04/27/2015 at 1641 with diagnoses of fever, cough and weakness. The record contained an order dated 04/27/2015 at 2008 for droplet isolation precautions. The frequency of the order was "qs" and the "Precaution Reason" was "[CAP]." The end date/time for the order was 04/29/2015 at 1643.

A nurse flowsheet titled "Worklist Charting" was reviewed. The flowsheet had daily columns check marked for documenting "Droplet Isolation" precautions and "Precautions (Specify)." On 04/27/2015 both the "Droplet Isolation" and "Precautions (Specify)" columns reflected one entry recorded "Started"; and on 04/28/2015 both the "Droplet Isolation" precautions and "Precautions (Specify)" columns each reflected one entry recorded "In Use." The "Droplet Isolation" and "Precautions (Specify)" columns were not completed and were blank on 04/29/2015, and therefore it was unclear whether the isolation precautions were in place on that date. The patient was not discharged until 04/29/2015 at 1644.

3. The medical records for Patients 1 and 2 were reviewed with Regulatory & Accreditation, IC and Risk Management staff on 07/21/2015 beginning at 1400. These findings were confirmed during an interview conducted with those staff present at the time of the record review.

Based on observation, interview, review of policies and procedures, and other documents, it was determined the hospital failed to develop and implement policies and procedures for infection prevention in the following areas:
* Isolation Precautions were not implemented in accordance with hospital policies and procedures on the Medical unit;
* Policies and procedures were not implemented to ensure surgical hand scrub solutions were not expired and available for use;
* Policies and procedures for sterilization and disinfection processes were not fully developed, implemented and/or in accordance with manufacturer's instructions;
* Policies and procedures were not developed to ensure humidity was maintained at acceptable levels in the surgical services department;
* Policies and procedures for disinfectants used throughout the hospital for cleaning environmental surfaces were not developed to ensure appropriate use in accordance with manufacturer instructions.

Findings included:

1. A tour of the Medical unit was conducted with Risk Management staff on 07/21/2015 beginning at 1010. The following observations were made:

* At 1030, the outside of patient room 8103 was observed. The door to the room was open. A "Contact Precautions" sign was attached to the door and included the following instructions: "Patient, Family, and Visitors...You or your loved one is in Contact Precautions. These precautions prevent spread of infection between patients in hospitals. This type of infection is spread by directly touching the patient or something they have touched...You will see doctors and staff doing the following...Gloves, Gowns, Masks, Goggles...They must wear gloves and gown while in the room and remove them before leaving. They might also wear mask and goggles." However, with the door in the open position, the sign was not readily visible upon room entry from all angles of the hallway. A RT was observed inside the room. The RT touched the patient and used a stethoscope to listen to the patient's breath sounds. The RT did not have a gown on during the observation.

* At 1035, the outside of patient room 8110 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall.

* At 1040, the outside of patient room 8112 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. In addition, the sign was partially covered by a piece of paper that had "NPO [after] MN" hand written on it, and therefore all of the instructions on the sign were not visible.

* Also at 1040, the outside of patient room 8115 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. In addition, the sign was partially covered by a dietary menu, and therefore all of the instructions on the sign were not visible.

At 1045, the outside of patient room 8116 was observed. A "Contact Enteric Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. The sign was partially covered by a piece of paper that read "I have a PICC Catheter," and therefore all of the instructions on the sign were not visible.

* At 1050, the outside of patient room 8120 was observed. A "Contact Precautions" sign was attached to the door. The sign was partially covered by a piece of paper that read "BLEEDING PRECAUTIONS," and therefore all of the instructions on the sign were not visible.

* At 1055, the outside of patient room 8121 was observed. A "Droplet Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible from all angles of the hall.

* At 1105, the outside of patient room 8126 was observed. The door to the room was open. A "Contact Precautions" sign was attached to the door. The sign was not readily visible from all angles of the hallway. A CNA was observed writing on a whiteboard inside the room. The CNA did not have a gown or gloves on. An interview was conducted with the CNA at the time of the observation. The CNA stated he/she didn't think a gown and gloves were needed because he/she didn't touch the patient. During an interview conducted with the Nurse Manager on 07/21/2015 at 1130, he/she confirmed that the CNA should have had a gown and gloves donned when he/she was inside the room.

* The policy and procedure titled "Contact Precautions" dated "Effective Date: 9/1/2012" reflected the following: "To describe precautionary measures required to protect patients, health care workers (HCWs) and others from exposure to potentially pathogenic microorganisms transmitted by contact with the patient or items in the patient's environment...Contact Enteric Precautions are to be used...With patients that present with acute diarrhea with unknown etiology...Maintained until a noninfectious cause for the diarrhea is determined, or until symptoms are resolved; and...With patients with the following known or suspected diagnosis...C.diff..." The Procedure section of the policy reflected "Place appropriate signage on patient door...Gowns and gloves...Are to be donned upon entry to the patient's room..."

The policy and procedure titled "Droplet Precautions" dated "Effective Date: 9/1/2012" reflected the following: "To describe precautionary measures required to protect patients, health care workers (HCWs) and others from exposure to potentially pathogenic microorganisms transmitted by droplets and/or by contact with the patient or items in the patient's environment." The Procedure section of the policy reflected "...Place appropriate signage on the door..."

2. A tour of the surgical services department was conducted with a Regulatory and Accreditation individual on 07/22/2015. The following observations were made:

* At 0900 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 14. The expiration date on the container was "09/12".

* At 0910 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 16. The expiration date on the container was "03/15".

* At 0915 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 20. The expiration date on the container was "09/12".

3. A tour of the decontamination and scope reprocessing areas of the SPD was conducted with the Manager of SP on 07/22/2015. The following observations were made:

* At 1130 a sink used to pre-clean surgical instruments was observed with the Manager of SP. Multiple wire brushes were observed hanging above the sink. During an interview at the time of the observation, the manager indicated that the brushes were used as part of the instrument pre-cleaning process. He/she stated that the brushes were used until "they showed wear and tear" and were not cleaned and disinfected daily or on a regularly scheduled basis. During an interview conducted on 07/22/2015 at 1215, the Manager of SP stated he/she had no policy and procedure for cleaning and replacing the brushes that were used to pre-clean surgical instruments in accordance with manufacturer's instructions.

* At 1215 two automated scope reprocessors used for high level disinfection were observed. A water purification and filter system was observed behind each of the reprocessors. Each filter system had a "Replace Filter" schedule posted on it that read "Minimum Replacement Frequency...Carbon Filter: Semi Annually...0.2 Micron Filter: Semi Annually." The schedule had handwritten filter change dates and each date was followed by an individual's initials. The last documented filter change date for both reprocessor systems was 04/15/2014. An interview was conducted with the Manager of SP at the time of the observation. The manager stated he/she thought the filters needed to be changed every six months. During an interview conducted on 07/22/2015 at 1530 the Director of Facilities confirmed that the last time the filters were changed was 04/15/2014 (more than a year ago).

* At 1230 a sink area used for pre-cleaning endoscopes was observed with the Manager of SP. SPD staff present during the observation indicated that the solution used for cleaning endoscopes was prepared by placing a gray tub in the sink, filling the tub half way with luke warm water and adding 3 pumps V. Mueller Instrument Enzymatic to the water. The gray tub identified by staff as the tub used for diluting the enzymatic was observed. There was no information on the gray tub to indicate how many gallons it held or other information to ensure accurate dilution of the enzymatic in accordance with manufacturer instructions. A gallon container of V. Mueller Instrument Enzymatic was observed and manufacturer instructions on the label of the container reflected the following: "Presoak and Manual Cleaning: Add 1 to 2 ounces per gallon of water for standard cleaning. Recommend soak time for instruments is 5 minutes or longer for difficult stains. Solution should be aspirated through lumens and channels of instruments. Scrub instruments and rinse thoroughly with warm water, aspirating water through lumens and channels to completely remove all traces of solution. Discard solution after each use."

* During an interview with a Regulatory and Accreditation individual on 07/22/2015 at 1540, he/she stated the gray tub that was observed on 07/22/2015 at 1230 and described by staff as used for diluting the enzymatic was not the correct tub. He/she stated the tub that should have been used had "holes" in the side of it for measuring water so that the enzymatic could be appropriately diluted.

* During an interview with IC staff on 07/22/2015 at 1615, he/she stated the hospital had no policy and procedure developed that addressed the scope pre-cleaning process used by SPD staff.

4. Policies and procedures were not fully developed to include steps to take during circumstances in which a discrepancy may occur between a device manufacturer's instructions and automated high level disinfection equipment manufacturer's instructions including the following example: The policy and procedure titled "Care and Cleaning of Endoscopes" dated "Effective Date: 10/10/2011" and an undated training document provided titled "Manual Cleaning of Endoscopes" were reviewed and did not include steps to take during circumstances in which a discrepancy may occur between a device manufacturer's instructions and the automated high level disinfection equipment (scope reprocessor) manufacturer's instructions.

5. Policies and procedures were not fully developed to include steps to take during circumstances in which a discrepancy may occur between surgical instrument and sterilizer manufacturer instructions including the following example: The policy and procedure titled "Expedited Sterilization Processes (Flashing)" dated "Effective Date: 05/09/2008" was reviewed and reflected the following: "...Flashing Procedure...Exposure times and temperature settings will follow written instructions from manufacturers of surgical instruments, sterilizers, and flash containers...All implantable items should be sterilized for 10 minutes at 270 C using a cycle specified by the manufacturer." The policy contained no information related to steps to take during circumstances in which a discrepancy may occur between instrument and sterilizer manufacturer instructions. This was confirmed during an interview with a Regulatory and Accreditation individual on 07/22/2015 at 1615.

6. An interview was conducted with the Director of Facilities on 07/22/2015 at 1445. He/she stated the hospital had no policy and procedure for ensuring the humidity was monitored and maintained at acceptable levels in the surgical services department. He/she stated that although the humidity was monitored by an automated system, there was no process to address the steps that should be taken if they were identified outside acceptable levels. The director stated the humidity should be maintained between 20-60 percent in the ORs.

Automated humidity log records provided for 25 ORs for 04/23/2015 through 07/20/2015 were reviewed. Log records reflected there were times when the humidity was outside the acceptable range. Examples included but were not limited to the following:
* In "OR-3" the humidity was 62 percent on 06/02/2015, 06/05/2015 and 06/14/2015; 64 percent on 06/06/2015; 63 percent on 06/07/2015; and 65 percent on 06/08/2015.
* In "OR-12" the humidity was 62 percent on 05/17/2015, 05/25/2015, 06/05/2015 and 06/07/2015; 65 percent on 05/18/2015 and 06/08/2015; and 67 percent on 05/19/2015.
* In "OR-15" the humidity was 64 percent on 06/05/2015 and 06/06/2016.
There was no documentation to reflect steps taken to address those humidity levels, including any individuals who may have been notified.

7. In OR 28 on 07/22/2015 at 1020 a bottle with a label affixed that read "Super HDQ Neutral One-Step Disinfectant" was observed with a Regulation and Accreditation individual. There was no date or other information on the bottle to indicate when the disinfectant solution expired or how long it was effective after it was dispensed from the primary container into the bottle.

* In a janitor closet on 07/22/2015 at 1030, a gallon container connected to a dispensing unit was observed with EVS staff. There was no expiration date observed on the gallon container or a date when the container was opened. During an interview with the EVS staff at the time of the observation they indicated that the reusable bottles of "Super HDQ Neutral One-Step Disinfectant" were brought to the janitor closet every 24 hours where they were emptied and then refilled from the dispensing unit. They acknowledged there was no expiration date on the container connected to the dispensing unit, and stated they did not know when the disinfectant expired.

* In a utility room on 07/22/2015 at 1105 three bottles with a label that read "Super HDQ Neutral One-Step Disinfectant" were observed with the Manager of SP. There was no date or other information on the bottles to indicate when the shelf life of the disinfectant or when the disinfectant expired. During an interview with the manager at the time of the observation, he/she indicated that the bottles were reused and refilled from a dispensing unit "a minimum of weekly." He/she acknowledged there was no date or other information on the bottles to indicate when the disinfectant expired and when it was dispensed from the dispensing unit into the bottles.

* During an interview with an EVS supervisor on 07/22/2015 at 1345, he/she indicated that "Super HDQ Neutral One-Step Disinfectant" was the primary disinfectant used by the hospital and stated "It's used anywhere a disinfectant is used."

* Review of an Email dated 07/22/2015 at 1438 which addressed manufacturer's instructions for the "Super HDQ" disinfectant used by the hospital reflected: "Ideally, once a concentrated disinfectant has been diluted to proper in use dilution, the solution should be used that day. If necessary, the solution can be used for up to one week."

* During an interview conducted with the Interim Manager of Quality on 07/22/2015 at 1600, he/she acknowledged that the hospital had no policy and procedure to ensure that "Super HDQ Neutral One-Step Disinfectant" was used in accordance with manufacturer instructions including shelf life after dilution and expiration of the disinfectant.

8. The Sacred Heart Medical Center (SHMC) at RiverBend Infection Prevention and Control Plan FY15 reflected the following: "Policy Drafting...Review and revision of PH OWN Infection & Control policies and procedures are the responsibility of the IPs with input from affected areas and will be based on national guidelines, best practices and evidence as available...policies and procedures that have a possible infection risk component are the responsibility of the respective hospital care area with review and/or input of the IPs."

Based on interview and documentation in 2 of 2 medical records reviewed of patients who had orders for isolation precautions (Patients 1 and 2), it was determined that the hospital failed to ensure the medical record contained complete, consistent and clear documentation related to isolation precautions in order to appropriately monitor the patient's condition.
* Orders for isolation precautions were incomplete; and
* Documentation reflecting implementation of isolation precautions was incomplete, unclear and inconsistent.

Findings included:

1. The medical record for Patient 1 was reviewed. The patient was admitted to the hospital on 03/26/2015 at 0929 with diagnoses of syncope, dehydration, vomiting, and diarrhea. The record contained an order dated 03/26/2015 for contact/enteric isolation precautions. The order had no start time and the frequency of the order was "qs." The "Precaution Reason" for the order was "Acute Diarrhea." The order also reflected "Other Comments C-Diff Pending." The end date/time for the order was 04/05/2015 at 0814.

A nurse flowsheet titled "Worklist Charting" was reviewed. The flowsheet had daily columns check marked for documenting "Contact/Enteric Isolation" precautions. The columns dated from 03/26/2015 through 04/03/2015 were not completed and were blank and therefore it was unclear whether or not the isolation precautions were in place for those dates; and on 04/04/2015 and 04/05/2015 the documentation in the columns reflected "Not Done" and there was no documentatation to reflect the reason the isolation precautions were documented as "Not Done". In addition, the flowsheet had daily columns check marked for documenting "Precautions (Specify)." The columns were not completed and were blank from 03/26/2015 through 04/05/2015. It was unclear what type of precautions those referred to and whether or not they were in place for those dates.

2. The medical record for Patient 2 was reviewed. The patient was admitted to the hospital on 04/27/2015 at 1641 with diagnoses of fever, cough and weakness. The record contained an order dated 04/27/2015 at 2008 for droplet isolation precautions. The frequency of the order was "qs" and the "Precaution Reason" was "[CAP]." The end date/time for the order was 04/29/2015 at 1643.

A nurse flowsheet titled "Worklist Charting" was reviewed. The flowsheet had daily columns check marked for documenting "Droplet Isolation" precautions and "Precautions (Specify)." On 04/27/2015 both the "Droplet Isolation" and "Precautions (Specify)" columns reflected one entry recorded "Started"; and on 04/28/2015 both the "Droplet Isolation" precautions and "Precautions (Specify)" columns each reflected one entry recorded "In Use." The "Droplet Isolation" and "Precautions (Specify)" columns were not completed and were blank on 04/29/2015, and therefore it was unclear whether the isolation precautions were in place on that date. The patient was not discharged until 04/29/2015 at 1644.

3. The medical records for Patients 1 and 2 were reviewed with Regulatory & Accreditation, IC and Risk Management staff on 07/21/2015 beginning at 1400. These findings were confirmed during an interview conducted with those staff present at the time of the record review.

Based on observation, interview, review of policies and procedures, and other documents, it was determined the hospital failed to develop and implement policies and procedures for infection prevention in the following areas:
* Isolation Precautions were not implemented in accordance with hospital policies and procedures on the Medical unit;
* Policies and procedures were not implemented to ensure surgical hand scrub solutions were not expired and available for use;
* Policies and procedures for sterilization and disinfection processes were not fully developed, implemented and/or in accordance with manufacturer's instructions;
* Policies and procedures were not developed to ensure humidity was maintained at acceptable levels in the surgical services department;
* Policies and procedures for disinfectants used throughout the hospital for cleaning environmental surfaces were not developed to ensure appropriate use in accordance with manufacturer instructions.

Findings included:

1. A tour of the Medical unit was conducted with Risk Management staff on 07/21/2015 beginning at 1010. The following observations were made:

* At 1030, the outside of patient room 8103 was observed. The door to the room was open. A "Contact Precautions" sign was attached to the door and included the following instructions: "Patient, Family, and Visitors...You or your loved one is in Contact Precautions. These precautions prevent spread of infection between patients in hospitals. This type of infection is spread by directly touching the patient or something they have touched...You will see doctors and staff doing the following...Gloves, Gowns, Masks, Goggles...They must wear gloves and gown while in the room and remove them before leaving. They might also wear mask and goggles." However, with the door in the open position, the sign was not readily visible upon room entry from all angles of the hallway. A RT was observed inside the room. The RT touched the patient and used a stethoscope to listen to the patient's breath sounds. The RT did not have a gown on during the observation.

* At 1035, the outside of patient room 8110 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall.

* At 1040, the outside of patient room 8112 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. In addition, the sign was partially covered by a piece of paper that had "NPO [after] MN" hand written on it, and therefore all of the instructions on the sign were not visible.

* Also at 1040, the outside of patient room 8115 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. In addition, the sign was partially covered by a dietary menu, and therefore all of the instructions on the sign were not visible.

At 1045, the outside of patient room 8116 was observed. A "Contact Enteric Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall. The sign was partially covered by a piece of paper that read "I have a PICC Catheter," and therefore all of the instructions on the sign were not visible.

* At 1050, the outside of patient room 8120 was observed. A "Contact Precautions" sign was attached to the door. The sign was partially covered by a piece of paper that read "BLEEDING PRECAUTIONS," and therefore all of the instructions on the sign were not visible.

* At 1055, the outside of patient room 8121 was observed. A "Droplet Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible from all angles of the hall.

* At 1105, the outside of patient room 8126 was observed. The door to the room was open. A "Contact Precautions" sign was attached to the door. The sign was not readily visible from all angles of the hallway. A CNA was observed writing on a whiteboard inside the room. The CNA did not have a gown or gloves on. An interview was conducted with the CNA at the time of the observation. The CNA stated he/she didn't think a gown and gloves were needed because he/she didn't touch the patient. During an interview conducted with the Nurse Manager on 07/21/2015 at 1130, he/she confirmed that the CNA should have had a gown and gloves donned when he/she was inside the room.

* The policy and procedure titled "Contact Precautions" dated "Effective Date: 9/1/2012" reflected the following: "To describe precautionary measures required to protect patients, health care workers (HCWs) and others from exposure to potentially pathogenic microorganisms transmitted by contact with the patient or items in the patient's environment...Contact Enteric Precautions are to be used...With patients that present with acute diarrhea with unknown etiology...Maintained until a noninfectious cause for the diarrhea is determined, or until symptoms are resolved; and...With patients with the following known or suspected diagnosis...C.diff..." The Procedure section of the policy reflected "Place appropriate signage on patient door...Gowns and gloves...Are to be donned upon entry to the patient's room..."

The policy and procedure titled "Droplet Precautions" dated "Effective Date: 9/1/2012" reflected the following: "To describe precautionary measures required to protect patients, health care workers (HCWs) and others from exposure to potentially pathogenic microorganisms transmitted by droplets and/or by contact with the patient or items in the patient's environment." The Procedure section of the policy reflected "...Place appropriate signage on the door..."

2. A tour of the surgical services department was conducted with a Regulatory and Accreditation individual on 07/22/2015. The following observations were made:

* At 0900 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 14. The expiration date on the container was "09/12".

* At 0910 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 16. The expiration date on the container was "03/15".

* At 0915 a gallon container of Scrub Care Povidone Iodine Cleansing Solution surgical hand scrub was observed and available for use at the scrub sink outside CVOR 20. The expiration date on the container was "09/12".

3. A tour of the decontamination and scope reprocessing areas of the SPD was conducted with the Manager of SP on 07/22/2015. The following observations were made:

* At 1130 a sink used to pre-clean surgical instruments was observed with the Manager of SP. Multiple wire brushes were observed hanging above the sink. During an interview at the time of the observation, the manager indicated that the brushes were used as part of the instrument pre-cleaning process. He/she stated that the brushes were used until "they showed wear and tear" and were not cleaned and disinfected daily or on a regularly scheduled basis. During an interview conducted on 07/22/2015 at 1215, the Manager of SP stated he/she had no policy and procedure for cleaning and replacing the brushes that were used to pre-clean surgical instruments in accordance with manufacturer's instructions.

* At 1215 two automated scope reprocessors used for high level disinfection were observed. A water purification and filter system was observed behind each of the reprocessors. Each filter system had a "Replace Filter" schedule posted on it that read "Minimum Replacement Frequency...Carbon Filter: Semi Annually...0.2 Micron Filter: Semi Annually." The schedule had handwritten filter change dates and each date was followed by an individual's initials. The last documented filter change date for both reprocessor systems was 04/15/2014. An interview was conducted with the Manager of SP at the time of the observation. The manager stated he/she thought the filters needed to be changed every six months. During an interview conducted on 07/22/2015 at 1530 the Director of Facilities confirmed that the last time the filters were changed was 04/15/2014 (more than a year ago).

* At 1230 a sink area used for pre-cleaning endoscopes was observed with the Manager of SP. SPD staff present during the observation indicated that the solution used for cleaning endoscopes was prepared by placing a gray tub in the sink, filling the tub half way with luke warm water and adding 3 pumps V. Mueller Instrument Enzymatic to the water. The gray tub identified by staff as the tub used for diluting the enzymatic was observed. There was no information on the gray tub to indicate how many gallons it held or other information to ensure accurate dilution of the enzymatic in accordance with manufacturer instructions. A gallon container of V. Mueller Instrument Enzymatic was observed and manufacturer instructions on the label of the container reflected the following: "Presoak and Manual Cleaning: Add 1 to 2 ounces per gallon of water for standard cleaning. Recommend soak time for instruments is 5 minutes or longer for difficult stains. Solution should be aspirated through lumens and channels of instruments. Scrub instruments and rinse thoroughly with warm water, aspirating water through lumens and channels to completely remove all traces of solution. Discard solution after each use."

* During an interview with a Regulatory and Accreditation individual on 07/22/2015 at 1540, he/she stated the gray tub that was observed on 07/22/2015 at 1230 and described by staff as used for diluting the enzymatic was not the correct tub. He/she stated the tub that should have been used had "holes" in the side of it for measuring water so that the enzymatic could be appropriately diluted.

* During an interview with IC staff on 07/22/2015 at 1615, he/she stated the hospital had no policy and procedure developed that addressed the scope pre-cleaning process used by SPD staff.

4. Policies and procedures were not fully developed to include steps to take during circumstances in which a discrepancy may occur between a device manufacturer's instructions and automated high level disinfection equipment manufacturer's instructions including the following example: The policy and procedure titled "Care and Cleaning of Endoscopes" dated "Effective Date: 10/10/2011" and an undated training document provided titled "Manual Cleaning of Endoscopes" were reviewed and did not include steps to take during circumstances in which a discrepancy may occur between a device manufacturer's instructions and the automated high level disinfection equipment (scope reprocessor) manufacturer's instructions.

5. Policies and procedures were not fully developed to include steps to take during circumstances in which a discrepancy may occur between surgical instrument and sterilizer manufacturer instructions including the following example: The policy and procedure titled "Expedited Sterilization Processes (Flashing)" dated "Effective Date: 05/09/2008" was reviewed and reflected the following: "...Flashing Procedure...Exposure times and temperature settings will follow written instructions from manufacturers of surgical instruments, sterilizers, and flash containers...All implantable items should be sterilized for 10 minutes at 270 C using a cycle specified by the manufacturer." The policy contained no information related to steps to take during circumstances in which a discrepancy may occur between instrument and sterilizer manufacturer instructions. This was confirmed during an interview with a Regulatory and Accreditation individual on 07/22/2015 at 1615.

6. An interview was conducted with the Director of Facilities on 07/22/2015 at 1445. He/she stated the hospital had no policy and procedure for ensuring the humidity was monitored and maintained at acceptable levels in the surgical services department. He/she stated that although the humidity was monitored by an automated system, there was no process to address the steps that should be taken if they were identified outside acceptable levels. The director stated the humidity should be maintained between 20-60 percent in the ORs.

Automated humidity log records provided for 25 ORs for 04/23/2015 through 07/20/2015 were reviewed. Log records reflected there were times when the humidity was outside the acceptable range. Examples included but were not limited to the following:
* In "OR-3" the humidity was 62 percent on 06/02/2015, 06/05/2015 and 06/14/2015; 64 percent on 06/06/2015; 63 percent on 06/07/2015; and 65 percent on 06/08/2015.
* In "OR-12" the humidity was 62 percent on 05/17/2015, 05/25/2015, 06/05/2015 and 06/07/2015; 65 percent on 05/18/2015 and 06/08/2015; and 67 percent on 05/19/2015.
* In "OR-15" the humidity was 64 percent on 06/05/2015 and 06/06/2016.
There was no documentation to reflect steps taken to address those humidity levels, including any individuals who may have been notified.

7. In OR 28 on 07/22/2015 at 1020 a bottle with a label affixed that read "Super HDQ Neutral One-Step Disinfectant" was observed with a Regulation and Accreditation individual. There was no date or other information on the bottle to indicate when the disinfectant solution expired or how long it was effective after it was dispensed from the primary container into the bottle.

* In a janitor closet on 07/22/2015 at 1030, a gallon container connected to a dispensing unit was observed with EVS staff. There was no expiration date observed on the gallon container or a date when the container was opened. During an interview with the EVS staff at the time of the observation they indicated that the reusable bottles of "Super HDQ Neutral One-Step Disinfectant" were brought to the janitor closet every 24 hours where they were emptied and then refilled from the dispensing unit. They acknowledged there was no expiration date on the container connected to the dispensing unit, and stated they did not know when the disinfectant expired.

* In a utility room on 07/22/2015 at 1105 three bottles with a label that read "Super HDQ Neutral One-Step Disinfectant" were observed with the Manager of SP. There was no date or other information on the bottles to indicate when the shelf life of the disinfectant or when the disinfectant expired. During an interview with the manager at the time of the observation, he/she indicated that the bottles were reused and refilled from a dispensing unit "a minimum of weekly." He/she acknowledged there was no date or other information on the bottles to indicate when the disinfectant expired and when it was dispensed from the dispensing unit into the bottles.

* During an interview with an EVS supervisor on 07/22/2015 at 1345, he/she indicated that "Super HDQ Neutral One-Step Disinfectant" was the primary disinfectant used by the hospital and stated "It's used anywhere a disinfectant is used."

* Review of an Email dated 07/22/2015 at 1438 which addressed manufacturer's instructions for the "Super HDQ" disinfectant used by the hospital reflected: "Ideally, once a concentrated disinfectant has been diluted to proper in use dilution, the solution should be used that day. If necessary, the solution can be used for up to one week."

* During an interview conducted with the Interim Manager of Quality on 07/22/2015 at 1600, he/she acknowledged that the hospital had no policy and procedure to ensure that "Super HDQ Neutral One-Step Disinfectant" was used in accordance with manufacturer instructions including shelf life after dilution and expiration of the disinfectant.

8. The Sacred Heart Medical Center (SHMC) at RiverBend Infection Prevention and Control Plan FY15 reflected the following: "Policy Drafting...Review and revision of PH OWN Infection & Control policies and procedures are the responsibility of the IPs with input from affected areas and will be based on national guidelines, best practices and evidence as available...policies and procedures that have a possible infection risk component are the responsibility of the respective hospital care area with review and/or input of the IPs."