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Based on observation, interview and record review, the hospital's Governing Body failed to ensure all policies governing the facility's operation for quality health care were implemented as evidenced by:

1. The facility did not ensure the Perioperative environment (operating rooms, sterile processing room, sterile storage and decontamination room) and shared glucometers (hand-held device used to check patient's blood sugar) were adequately sanitized when the hospital's cleaning produce's "contact time" (also called dwell or wet time; time product must remain wet on surfaces to ensure death of microbes) was not followed per manufacture's instructions; (Refer to A-0749),

2. Staff did not consistently monitor and/or take corrective action related to temperature levels, humidity, and air exchanges in the Perioperative area (Refer to A-0749),

3. Operating room staff did not consistently wear appropriate surgical attire, perform antiseptic surgical skin preparation per national standards (clean and sanitize the skin prior to surgery), and perform hand hygiene after touching an unsanitized cell phone during surgery (Refer to 0749), and

4. Facility did not have Polity and Procedures for monitoring air exchanges in the Perioperative areas and for usage of personal cell phones in the operating room and the policy and procedure for sanitizing the shared glucometers did not reflect national standards (Refer to 0749).

The cumulative effects of these systemic problems resulted in the hospital's governing body, administrative officials and the medical staff's inability to ensure the provision of quality health care and services in a safe environment.

Findings:

During an interview on 5/24/18 at 10:05 a.m., Governing Body Member H (GB H) stated Management Staff N presented Quality Assessment and Performance Improvement (QAPI) projects and updates to the Governing Board. She stated issues with mold in the Perioperative area had dominated the prior year. GB H stated the following issues had not been brought before the Governing Board: 1) issues with HVAC (heating, ventilation, and air conditioning), that could effect temperature and humidity in the perioperative area, 2) issues with air balance reports (used to assess air exchange in the operating rooms), and 3) issues with sanitizers (E23) used by staff to clean the environment. She stated she was not aware some policies and procedures were missing.

Review of facility bylaws (amended 8/10/17) indicated, " Article 4 Powers and Duties 4.1 Governing body, The Governing Body shall have overall administrative and professional responsibility for the Hospital as the governing body of the district...(c) to be ultimately responsible for the quality of medical care in the Hospital...(d) To establish or amend the Hospital Policies and Procedures..."

Based on observation, interview and document review, the hospital failed to provide for an ongoing, comprehensive, hospital-wide Quality Assurance and Performance Improvement (QAPI) Program that included all the elements of the Program when the facility did not ensure:

1. The Perioperative environment (operating rooms, sterile processing room, sterile storage and decontamination room) and shared glucometers (hand-held device used to check patient's blood sugar) were adequately sanitize when the hospital's cleaning produce's "contact time" (also called dwell or wet time; time product must remain wet on surfaces to ensure death of microbes) was not followed per manufacture's instructions and alcohol wipes used to clean the shared glucometers were not effective against blood-borne pathogens (disease causing microbes transmitted through blood) (Refer to A-0749),

2. That staff consistently monitored and/or took corrective action related to temperature levels, humidity, and air exchanges in the Perioperative area (Refer to A-0749),

3. That operating room staff consistently wore appropriate surgical attire, performed antiseptic surgical skin preparation per national standards (clean and sanitize the skin prior to surgery), and performed hand hygiene after touching an unsanitized cell phone during surgery (Refer to 0749), and

4. That policy and procedures existed for monitoring air exchanges in the Perioperative areas and for usage of personal cell phones in the operating room and reflected national standards for sanitizing shared glucometers (Refer to 0749).

These cumulative effects of these systemic problems resulted in the the hospital's governing body, administrative officials and the medical staff's inability to ensure the provision of quality health care and services in a safe environment.

Based on observation, interview, and record review, the facility failed ensure a sanitary environment and an effective infection control program when:

1. The facility did not adequately sanitize the environment when the hospital's cleaning produce's "contact time" (also called dwell or wet time; time product must remain wet on surfaces to ensure death of microbes) was not followed per manufacture's instructions; (Refer to A-0749),

2. Temperature and humidity levels that were outside acceptable parameters in the Perioperative area were not acted upon; (Refer to A-0749),

3. Air exchanges in the Peri-operative area was not monitored when the annual air-balance report was not obtained in 2016; (Refer to A-0749),

4. Licensed staff did not perform antiseptic skin preparation according to professional standards for one patient prior to knee surgery; (Refer to 0749),

5. Surgical staff did not follow national standards when two licensed nurses had bare, uncovered arms in the operating room; (Refer to 0749),

6. Medical staff did not perform hand hygiene after touching an unsanitized personal cell phone during a surgical procedure (Refer to 0749), and

7. Facility shared glucometers were not sanitized per national standards when the devices were cleaned with alcohol wipes: (Refer to 0749).

The cumulative effects of these systemic problems resulted in the facility's inability to provide quality of care in a safe and effective manner.

Based on interview and record review, the hospital failed to ensure the Quality Assurance and Performance Improvement (QAPI) Program was fully implemented when aspects of performance was not identified and tracked related to patient care, services, and safety.These failures led to the potential of the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 5/24/18 at 4:25 p.m., Manager N described the facility's QAPI program and identified various projects currently underway. She stated:

1) The QAPI committee had not been aware the facility's cleaning produce's "contact time" (time need for product to sanitize/kill microbes) was not followed per manufacture's instructions (which could cause the environmrnt to be inadequately sanitized),
2) The QAPI committee had not been aware the temperature, humidity and air exchange within the perioperative department (operating rooms, sterile processing/supplies, decontamination room ) were not consistently being monitored, and
3) The facility had "gaps" related to hospital policy and procedures.

Based on observation, interview, and record review, the facility failed to ensure an effective infection control program and infection control practices were implemented in accordance with hospital policy and nationally recognized standards when:

1. The facility did not adequately sanitize the environment when the hospital's cleaning product's (Eco E23) "contact time" (also called dwell or wet time; time product must remain wet on surfaces to ensure death of disease-causing microbes) was not followed per manufacture's instructions;
2. The Peri-operative environment (surgical area including operating rooms 1 and 2, sterile processing room, sterile storage rooms, and decontamination room) was not monitored per national standards and facility policy when: a) air temperature and humidity levels were outside designated parameters but facility did not document action taken to address them and b) air flow direction (direction air flows into or out of a room) was not monitored in the decontamination room (room where contaminated instruments/devices were taken to be washed) and sterile processing room (room where washed instruments were sterilized);
3. Air exchanges (recommended air volume changes to and from the surgical suite) were not monitored when the annual air-balance report was not obtained in 2016;
4. Licensed staff did not perform antiseptic skin preparation (cleaning the incision site) according to policy and procedure for one patient (Patient 18) prior to knee surgery;
5. Surgical staff did not follow national standards when two licensed nurses had uncovered arms in the operating room;
6. Medical staff did not perform hand hygiene after touching an unsanitized personal cell phone during a surgical procedure;

A situation of IMMEDIATE JEOPARDY (IJ) was identified on 5/17/18 at 16:35 p.m., under §482.42 Infection Control. The Immediate Jeopardy (#1) was abated on 5/21/18 at 5:25 p.m.

7. The facility's shared glucometers (hand-held device used to check blood sugar) were not sanitized per national standards when the devices were cleaned with alcohol wipes (glucometers can be contaminated by a patient's blood after use; alcohol is not shone to be effective against Hepatitis B/C or HIV - disease causing virus's spread through blood).

These failures caused potential for spread of infection among patients, staff and visitors.

Findings:

1. During an observation and concurrent interview on 5/16/18 at 10:45 a.m., Environmental Staff R (ES R) was asked about the products she used to clean and sanitize the Peri-operative areas. She indicated she used E23 to clean the machines and beds. When asked how long the product stayed wet on surfaces (before it dried), she stated it stayed wet probably three minutes.

During an interview on 5/16/18 at 3 p.m., the Infection Control Preventionist (ICP) was asked about E23, the facility cleaning product. The ICP stated E23 had a ten minute "wet time," which indicated the surface being cleaned must be kept wet for ten minutes for it to be sanitized (make clean and hygienic).

During an observation on 5/17/18 at 8:43 a.m., ES R began cleaning Operating Room 2 (OR 2). She used produce E23 and cleaned multiple items including the lights, computers, various machines, vests worn by patients, anesthesia carts, and the walls and floor. She wiped down the following surfaces: at 8:45 a.m. the bed's mattresses; at 8:47 the bed frame; and at 8:49 a.m. the pyxis (cabinet holding medication). The bed frame, bed's mattresses and pyxis appeared dry at the following times: 8:50 a.m. (five minute contact time), 8:50 a.m. (five minute contact time) and 8:54 a.m. (five minute contact time) respectively.

During an interview on 5/17/18 at 9:08 a.m., ES R stated she was finished cleaning OR 2. ES R stated she wiped down the various surfaces one time and stated it took four to five minutes for the mattresses to dry.

Review of facility document titled "Buckeye Eco Neutral Disinfectant (E23)" (undated) indicated E23 "effectively inactivated" Hepatitis B and C, Herpes Type 1 and 2, Influenza A, and Avian influenza when contact time of ten minutes was maintained.

2.a. Online review of AORN document titled, "AORN Facility Reference Center Guidelines for Perioperative Practice: Environment of Care, Part 2" (copyright 2012-2018) indicated, "IV. "The health care organization should create and implement a systematic process for monitoring HVAC (heating,ventilation, and air conditioning) performance parameters and a mechanism for resolving variances." The document indicated HVAC systems control room air quality, temperature, humidity and air pressure of a room. The HVAC system is, "intended to reduce the amount of environmental contaminates (e.g., microbial-laden skin squames [flakes of skin], dust, lint) in the surgical suite by carrying airborne contaminates (the may contribute to infection) away from the sterile field and removing these contaminants through the return duct vents. The restricted areas (operating rooms) are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent.(https://aornguidelines.org/guidelines/content?sectionid=173721980&view=book)

Review of the OR 1 and 2's air temperature monitoring logs (dated 3/1/18 through 5/14/18) indicated readings were outside parameters (below 69° Fahrenheit [F] or above 73°F) on the following occasions: OR 1 air temperatures outside parameters six of twenty times recorded in March, twenty-two of twenty-two times recorded in April, and ten of ten times recorded in May; OR 2 air temperatures were outside parameters thirteen of twenty times recorded in March, twenty-two of twenty-two times recorded in April, and eight of ten times recorded in May. The document indicated temperature was not adjusted, Engineering was not notified, a one hour reassessment was not conducted, and out-of-range resolution and recheck was not conducted on fifty-seven occasions when the temperatures were outside parameters.

Review of the logs for OR 1 and 2 (from 3/1/18 through 5/14/18) indicated the humidity was outside parameters (30-60%) on twenty-four occasions. Staff did not document interventions taken or follow up evaluation on ten of those twenty-four occasions.

Review of facility document titled, "Temperature/Humidity/Air Flow Monitoring Log," subtitled, "Instructions:" indicated, "3. If temperature is out of range, adjust thermostat, if available; recheck in approximately 1 hour... 4. If temperature and/or humidity is outside of posted parameters, the Engineering Department will be notified...5. Document actions taken. 6. If unable to obtain required range before surgeries or procedures, escalate according to department policy..."

During an interview and review of the Temperature/Humidity/Air Flow logs on 5/16/18 at 9:50 a.m., Manager T confirmed OR temperatures had been out of range, as indicated on the logs dated 3/1/18 through 5/14/18. Manager T stated if the temperatures were out of range, it was up to the surgeon to determine if the surgical case would go forward (versus being canceled). Manager T stated she had called surgeons in the past to notify them OR temperatures were out of range. Manager Q was also present for the interview and was asked if any surgical cases had been performed when OR temperatures were out of parameters. Manager Q stated he did not recall.

During an interview 5/16/18 at 11:20 a.m., Manager Q stated the facility followed AORN (Association of PeriOperative Registered Nurses) standards in the OR. Manager Q was asked what expectations he had for staff who identified OR temperatures/humidity outside parameters. Manager Q stated staff should log the information, call the facility (engineer) so they could make adjustments, recheck the reading, and call facility (engineer) again, if necessary. He stated the facility may need to monitor more frequently as monitoring every morning may not be enough. When asked if he was aware the temperature and humidity readings had been outside parameters, Manager Q stated he had been aware and had spoken to Manager U (engineering) and Physician X (a surgeon) regarding the issue.

During an interview on 5/16/18 at 3 p.m., the ICP was asked about temperature and humidity levels in the Perioperative areas. The ICP stated the facility had not notified her regarding temperatures being too high/low, or of humidity issues in the Perioperative areas. When asked if temperatures that were too low in the Perioperative area could increase the humidity level, she stated that was correct. She stated microbes (virus', bacteria, fungus, etc.) could grow if temperatures and humidity levels were elevated.

During an interview on 5/21/18 at 10:20 a.m., Registered Nurse V (RN V) was asked about the temperature in the operating rooms. RN V stated the temperature in the OR's tended to be a little cool and the surgeons wanted it cooler (in the OR's). She stated if the temperature was over 70°F, she would decrease the thermostat to try to get the room to 68°F. When asked if the rooms were ever lower than 68°F, she stated, "Yes, sometimes."

Review of the same logs (from 3/1/18 through 5/14/18) indicated the facility did not monitor OR 1 and 2's temperature/humidity/air flow direction on eleven of thirty-one days in March, eight of thirty days in April and four of fourteen days in May.

Review of facility document titled, "Temperature/Humidity/Air Flow Monitoring Log," subtitled, "Instructions:" indicated, "2. Each day, document time, temperature, humidity, air flow...."

2.b. Review of the Decontamination Room logs (dated 4/1/18 through 5/14/18, a six week period) indicated the air flow direction had not been documented except on one occasion (5/1/18). Review of the Sterile Supply Room (sterile supply storage) logs (dated 3/1/18 through 4/30/18, an approximately eight week period) indicated the air flow direction had not been documented.

Review of facility document titled, "Temperature/Humidity/Air Flow Monitoring Log," subtitled, "Instructions:" indicated, "2. Each day, document ...air flow...."

Review of facility document titled, "Comprehensive guide to steam sterilization and sterility assurance in health acre facilities," subtitled, "3 Design considerations" (dated 2013) indicated, "3.3.7.1 Decontamination area...microbial and particulate contamination is likely to be high in the decontamination area...contaminated aerosols, droplet nuclei, and dust particles can be carried from 'dirty' (decontamination room) to 'clean' areas (sterile storage ) by air currents. Exhausting air directly to the outside (via negative pressure, air flow direction into a room) prevents the reintroduction of contaminants onto clean items...where they would pose a risk to personnel and patients."

Online review of AORN document titled, "AORN Facility Reference Center Guidelines for Perioperative Practice: Environment of Care, Part 2" (copyright 2012-2018) indicated, "IV.g. ...The direction of the airflow from one room to the adjacent area is designed and engineered to minimize the flow of contaminates from clean to less-clean areas....IV.g.2. The pressure relationship of the semi-restricted area to the adjacent area should be based on the use of the area: ...sterile storage-positive (air flows out of the room), decontamination room-negative (air flows into the room).

During an observation of the Decontamination Room and concurrent interview on 5/16/18 at 9:50 a.m., Sterile Processing Technician S (Tech S) was asked what was the room's current temperature and humidity. Tech S read the monitoring device on the wall and stated the temperature was 69.1 F and the humidity was 49 % (facility monitoring log indicated the temperature should bee 60 - 65 F ). Tech S stated that if the measurements were out of range, he would tell Management Staff T or Director Q.

3. During an interview on 5/16/18 at 4:15 p.m., Facilities Manager U was asked to describe how air exchanges were monitored in the Perioperative area. Manager U stated the facility conduced an annual "Air Balance" report for the whole wing (Perioperative area). He stated the last Air Balance Report was done in 2015 or 2016. He stated air exchanges in Operating Rooms 1 and 2 had not been verified (via Air Balance Report) since 2015 or 2016.

Review of facility document (received 5/23/18) titled, "Process for Surveillance of HVAC Systems in Perioperative Services" (undated) indicated "3) At least annually, a certified air test and balance contractor shall check test and balances in the perioperative areas listed above. A written, certified report shall be given to the hospital engineer by the contractor."

Online review of AORN document titled, "AORN Facility Reference Center Guidelines for Perioperative Practice: Environment of Care, Part 2" (copyright 2012-2018) indicated, "IV.c. The minimum number of ACH (air changes per hour) including the percentage of outdoor air should be maintained within the HVAC design parameters...Filtered air minimizes the recirculation of indoor contaminants within the perioperative areas...a higher air change rate may reduce microbial contamination in the OR...IV.c.1. The ACH in a restricted areas should be maintained at 20 total changes per hour...IV.c.2 The ACH in a semi-restricted area are...Sterile storage - 4 total...decontamination room - 6 total..."

4. During an observation and concurrent interview on 5/17/18 at 9:42 a.m., Registered Nurse P (RN P) cleaned Patient 18's knee (surgical skin preparation). RN P used a Chlorhexadine wipe (antiseptic for skin disinfection) and cleaned her knee, then cleaned her leg, then cleaned her foot, and then cleaned the knee again. RN P used one wipe (she did not use a new wipe when she cleaned the knee a second time). Manager Q was asked if it was appropriate for the nurse to clean Patients 18's knee after she had cleaned her foot (using the same wipe). Manager Q stated, "Oh, she did that?"

During an interview on 5/21/18 at 10:20 a.m., Registered Nurse V was asked how nurses performed surgical skin preparation. She stated the anticipated incision site was marked and staff should wipe in concentric circles (working from the anticipated site outward) and proceed from "clean to dirty." She stated for a knee prep, the cleaning would start at the knee, proceed down the leg, and the foot would be last.

During an interview on 5/21/18 at 11:20 a.m., Registered Nurse O (RN O) was asked how she performed surgical skin preparation on a patient's knee. RN O stated she would begin with the incision site, using concentric circles moving outward. She stated she would then clean the tourniquet area (above the knee), then clean the lower legs, then the foot, and lastly the toes.

During an interview on 5/23/18 at 10:05 a.m., Manager Q was asked about proper skin preparation technique for surgery. Manager Q stated staff should begin the skin prep at the anticipated incision site and clean in concentric circles in an outward direction, and then clean the tourniquet area. He stated skin should be prepped from "clean to dirty" (the foot is considered dirtier than the knee). Physician W, who was standing nearby, stated staff would finish the skin prep by cleaning the tourniquet area.

Review of facility polity titled, "Skin Prep in the Operating Room," subtitled "Procedure:" (revised 8/17) indicated, "1.e. Apply the surgical prep progressing from the surgical site to the periphery of the surgical site to prevent reintroducing microorganisms into the incision site," and "1.k. If a tourniquet is used, the cuff, padding, and skin under the cuff should be protected from contact with prep solutions."

5. During an observation on 5/17/18 at 9:36 a.m., RN O and RN P were in OR 1 and Patient 18 was lying on the operating table. Manager Q stated RN's O and P were circulator nurses (RN's who manage patient's nursing care, helps maintain a safe environment and coordinate the needs of the surgical team) for Patient 18's surgery. RN O was wearing a short-sleeved scrub top and her forearms were bare. At 9:39 a.m., RN P removed her scrub coat, which left her forearms bare.

During an interview on 5/21/18 at 10:20 a.m., Registered Nurse V was asked about surgical attire in the operating room. RN V stated the circulator nurse should wear long sleeves and always cover their arms.

During an interview on 5/23/18 at 10:05 a.m., Manager Q was asked about surgical attire in the operating room. Manager Q stated the facility followed AORN surgical standards and stated arms should not be uncovered in the OR.

Review of facility policy titled "Infection Control" subtitled "OR Attire" (reviewed 8/2017) indicated "3.a. ...The human body is a major source of microbial contamination in the OR environment...measures must be taken to control this potential source of pathogens."

Review of facility policy titled "Surgical Attire" (reviewed 7/21/17) indicated surgical attire is "designed to contain skin squames (skin flakes).

Online review of AORN document titled "Guideline Essentials," subtitled "Surgical Attire Top Takeaways" (dated 2015) indicated, "When in the restricted areas (inside the operating room), all nonscrubbed personnel (circulating nurses) should completely cover their arms with a long-sleeved scrub top or jacket." The document indicated a body of evidence that supports covering the arms to help contain skin squames.
(https://www.aorn.org/-/media/aorn/.../surgical-attire/files/keytakeaways_surgicalattire)

6. During an observation and concurrent interview on 5/17/18 at 9:42 a.m., Patient 18 was lying on the operating table and her anesthesiologist (physician who gives anesthesia during surgery), used his cell phone. After he used his cell phone, he began documenting on paper. He did not hand sanitize after using the cell phone. Manager Q stated the device used by the anesthesiologist was his personal phone.

During an interview on 5/23/18 at 10:05 a.m., Manager Q stated the cell phone the anesthesiologist had used on 5/17/18 had not been sanitized prior to use.

Online review of AORN document titled "Guideline Essentials," subtitled "Surgical Attire Top Takeaways" (dated 2015) indicated, "Cell phones...devices are highly contaminated with microorganisms, some potentially pathogenic (disease causing). Researchers recommend regular cleaning of these devices and implementing hand hygiene before and after use." The document indicated, "Personal communication or hand-held electronic equipment should be cleaned with a low-level disinfectant according to the manufacturer's instructions for use before and after being brought into the perioperative setting." (https://www.aorn.org/-/media/aorn/.../surgical-attire/files/keytakeaways_surgicalattire)

A situation of IMMEDIATE JEOPARDY (IJ) was identified on 5/17/18 at 16:35 p.m., under §482.42 Infection Control. The Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and Management Staff N (Director of Quality) were present when the IJ was identified.

A Plan of Action (POA) to abate the IJ was accepted on 5/17/18 at 8:05 p.m. The POA included: 1) No surgical cases would be conducted in the OR's until the POA was implemented in its entirety. Emergency cases would be diverted or transferred (to another hospital). Staff and physicians would be informed, 2) Temperature and humidity logs would be completed daily. Out of parameter results would be acted upon and documented. ICP would monitor for compliance, 3) OR staff and facilities staff would be educated on monitoring humidity and temperatures according to hospital policy, 4) MTB Airbalance (Airbalance evaluation company) would complete an immediate Air Balance Assessment in the Perioperative Suite and provide certification of the results prior to resuming surgical cases, 5) All Perioperative sterile supplies stored in the Anesthesia room and the Sterile Supply Room would be reviewed for package integrity and expiration dates. Compromised/expired packages would be discarded, 6) All environmental OR technicians would receive coaching and education about the dwell/contact/kill times of the disinfectants used in the Operating Rooms. Both Operating rooms would be sanitized using appropriate dwell times under the direct observation of the ICP prior to use. Thereafter, the OR's would be sanitize between and after cases by Environmental staff under the direct supervision of the ICP until competency was achieved, 7) Mandatory education of the hospital's surgical attire policy for all persons entering the OR would be provided prior to staff being allowed to enter the OR. Circulating RN would enforce the policy, 8) All persons entering the OR would attest to the requirement of long sleeved surgical attire in the OR prior to being permitted to enter the OR, 9) All surgical staff would receive education on the hospital policy titled, "Surgical Prep" prior to being permitted to perform surgical prep on a patient, 10) All surgical staff would be required to perform a return demonstration of surgical prep per hospital policy on a mannequin, observed by the Perioperative Services Director or Manager prior to being permitted to perform surgical prep on a patient, 11) Beginning immediately, no cell phones would be allowed in the OR. Hospital policy would be created to reflect the AORN Guidelines regarding non-essential personal equipment not permitted in the OR. All OR staff/physicians would be educated on this polity, 12) Circulating RN would be educated on the policy and required to enforce the policy among staff, vendors, and physicians. The CNO/COO would provide support to the circulating RN to ensure compliance.

An Addendum to the POA was accepted on 5/21/18 at 9:46 a.m. The Addendum included: 1) Beginning immediately, no cell phones would be allowed in the Operating Room, 2) Hospital process would be identified to reflect the AORN guidelines regarding non-essential personal equipment not permitted in the OR, 3) All hospital OR staff (licensed staff, techs, surgeons, physician assistants, and vendors) would be required to read the policy and attest to its contents prior to being allowed into the OR, 4) Circulating RN's would be educated on the policy and be required to enforce it among staff/vendors/physicians. The CNO/COO would provide support to the circulating RN to ensure compliance, 5) all circulating RN's would be required to attest to their enforcement responsibility for this policy, 6) Hospital process would be identified to reflect the new method for cleaning the OR's, 7) All EVS (environmental) staff would be trained to use an EPA rated Hydrogen Peroxide Cleaner/disinfectant to clean throughout the facility, 8) All EVS staff would be required to use an EPA rated Hydrogen Peroxide cleaner/Disinfectant under direct observation of the ICP to validate competency, 9) OR's would be cleaned using the EPA rated Hydrogen Peroxide cleaner/Disinfectant before any procedures were performed in the rooms, 10) Temperature and Humidity logs would be completed seven days per week for the following Perioperative areas: OR 1 and 2, Sterile Processing, Decontamination room, substerile, Sterile storage, and Anesthesia room.

A second Addendum to the POA was accepted on 5/21/18 at 5:25 p.m. The second Addendum included the following steps that staff would take when Perioperative temperature/humidity or airflow were observed to be outside acceptable parameters: 1) Immediately, when an area registers out of range, notify engineering by phone. Note on Temperature/Humidity/Air Flow Monitoring Log (log) in appropriate boxes, 2) Engineering would adjust thermostat to correct either humidity or temperature. Perioperative staff would then recheck these areas in one hour, 3) Note the values at the one hour recheck and place in appropriate area of log, 4) If values not normalized, contact engineering and advise. If values remain out of range, advise engineering and ask for further direction. Log all interventions by engineering in Perioperative Services Environmental Control Adjustments Addendums. Note Date and Time in this form's fields, 5) If Engineering cannot resolve, notify Perioperative Director and Infection Preventionist.

The POA was verified and the Immediate Jeopardy (#1) was abated on 5/21/18 at 5:25 p.m. The CNO, Infection Control Preventionist, and Management Staff N were present when the IJ was lifted.

7. During an observation and interview on 5/29/18 at 11:30 a.m., RN Z and RN F were asked how they sanitized glucometers (shared by patients) after they were used on a patient. RN Z stated she used alcohol wipes to clean the glucometer before and after patient use. RN F stated she cleaned the glucometers with 70 % alcohol or with a germicidal wipe (MicroKill One).

Review of the alcohol wipes label indicated it container 70% alcohol. The labile did not indicate what microorganisms (virus's, bacteria, etc.) the product killed.

During an interview on 5/29/18 at 11:45 a.m., the ICP was asked how facility staff should clean the facility's shared glucometers. ICP stated staff were instructed to use 70% alcohol wipes to clean the glucometers. When asked what organisms the alcohol killed, ICP stated there was no information on the effectiveness of 70% alcohol in killing blood borne pathogens (viruses in the blood that could cause disease like hepatitis A and B and HIV-the virus that caused AID's). When asked if the alcohol product used by the facility was EPA approved, she stated it was not EPA approved.

During an online review of the glucometer's manufacturer's instructions for use on 5/29/18 at 11:45 a.m., the ICP reviewed the cleaning instructions. The manufacturer indicated alcohol and bleach (which kills blood-borne pathogens) could be used to clean the glucometer. The manufacturer's instructions did not include instructions on how to disinfect the glucometer. A request was made to the ICP for a copy of the manufacturer's instructions reviewed online; no copy was provided.

Review of facility document titled "Glucometers," subtitled, "Procedure" (dated 1/8/18) indicated to clean the device thoroughly after each use and disinfect it according to manufacturer's recommendations with an EPA and facility approved disinfectant: "70 alcohol wipes."

Review of facility document titled "Approved Cleaning Agents for (facility name)," dated 9/22/17, indicated a list of "all EPA approved cleaning agents for the hospital." The 70% alcohol product used by the facility was not on the list.

Review of CDC online resource indicated, "whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared." (https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html)

According to the CDC, an underappreciated risk of blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies (e.g., blood glucose meters). Outbreaks of hepatitis B virus (HBV) infection associated with blood glucose monitoring have been identified with increasing regularity. There have been at least 15 outbreaks of HBV infections associated with providers failing to follow basic principles of infection control when assisting with blood glucose monitoring. (https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html)