Los Robles Regional Medical Center

The Governing Body failed to require hospital policy and procedure regarding humidity be followed or to verify that the use and maintenance of operating room equipment was in accordance with the manufacturers' instructions for use. Refer to A-940 and A-0951. This failure resulted in CDPH declaring Immediate Jeopardy due to the risk posed to patients by the continued use and storage of operating room equipment in the presence of low humidity without checking the manufacturers' recommendations for use of the equipment when the humidity was outside of the manufacturers' recommended range. Refer to the initial comments in A-0000.

The Governing Body failed to develop a quality assurance and performance improvement (QAPI) plan in a timely manner or to use the hospital's QAPI program to follow high-risk areas of concern in surgery such as retained foreign objects. Refer to A-0263.

The cumulative effect of the Governing Body failure to follow CMS guidelines and national standards for the maintenance of the operating room equipment used in the performance of surgical services was an inability to ensure the provision of patient care in a safe environment.

Based on observations, staff interviews, and reviews of administrative documents, professional standards of practice and manufacturer's directions for use, the hospital's QAPI program failed to focus on high-risk and problem prone areas and did not take actions aimed at performance improvement when:

1) The hospital experienced and was aware of several separate facility reported adverse events of surgical retention of foreign objects, and

2) The humidity in the operating rooms (OR's) were out of range during surgical cases and there was no evidence the hospital resolved the problem. (Cross- reference A0951) . Review of the hospital's QAPI program, did not reveal the development or implementation of performance improvement activities that addressed these known high risk , high -volume, and problem-prone areas in the hospital.

These failures placed the patients at risk for poor quality care and possible harm with no systems in place for resolvance and monitoring.

Findings:

1. During review of hospital document, titled, (name of hospital) 2020 Quality and Performance Improvement Program, approved by the Board Of Trustees on 7/22/20, pg. 9 of 20, indicated in part ... 2020 Priorities, are set with consideration to scope and services, population served and high risk and high volume or problem prone processes and associated incidence, prevalence and severity of the problems....

Review of hospital reported 2019 adverse incidents included the following occurrences:

A. Record review revealed that hospital reported a retained foreign object when on 2/15/2019 a patient experienced a retained 4 x 4 gauze sponge requiring the surgical site to be reopened for the removal of the retained sponge.

B. Record review revealed that hospital reported a retained foreign object, when the hospital failed to ensure the surgeon performed a methodical wound exploration during the closing surgical count (counting of all instruments/items used during surgery to ensure no instruments/items are left inside the body) in one patient. On 9/17/20, a surgeon removed a retained object (acorn manipulator tip (instrument inserted internally in to visualize the internal organs measuring 1.5 inches in width and 2.5 inches in length) left from the surgery that took place on 9/11/19.

During a concurrent document review and interview on 3/15/21, at 1 p.m., with CMO, review of Quality Forum quarterly meeting minutes for the calendar year 2020 ( 2/3/20, 5/18/20, 8/3/20,11/10/20) , CMO acknowledged minutes did not reflect any metrics and or performance improvement activities surrounding adverse events of retained foreign objects. CMO also agreed that such events of retained foreign objects are potential high risk events.

During a interview with VPQ, on 3/17/21, starting at 9:40 a.m., VPQ acknowledged she was aware of 2019 adverse events of retained foreign objects,VPQ stated, I wasn't in this role (VPQ) , but I am aware they occurred. VPQ was asked if she had any knowledge of any service, department or sub committee that had tracked any metric or performance improvement activities surrounding retention of foreign objects, VPQ stated, I don't see any included (referencing minutes).

2. Record review and Interviews of the Main ORs and TOSH indicated humidity has been high (an infection control concern) during the warm months. Humidity has been low (fire risk) during the cool months. The humidity has been out of range for which the hospital has no evidence that there was follow up and humidity return to acceptable range while surgical cases were in progress.

During a review of the Environment of Care Committee (ECC) Minutes and concurrent interview with BMD on 3/17/21, at 5:05 p.m., the BMD acknowledged and confirmed, after reviewing the ECC minutes for February 2021, November 2020, September 2020, July 2020, that Bio-med had not been in the hospital to perform an inspection of the OR equipment to ensure equipment had not been impacted by the out of range humidity in the ORs. ECC minutes indicated Bio-med had not performed an out of cycle visit or service to the hospital. If Bio-med had performed an out of cycle inspection service, this would be indicated in the ECC minutes, and minutes don't indicate that.

On 3/17/21 at 5:37 p.m. an immediate jeopardy was called on surgical services (reference COP A940, A951)

During a concurrent facility document review and interview with VPQ, on 3/18/21, starting at 10:05 a.m., review of Quality Forum, Safety, Medical Executive, and Governing Board committee minutes, VPQ acknowledged that data and metrics from Environmental of Care did not track or trend data reflective of OR equipment impacted by out of range humidity levels. VPQ was asked if there were any performance improvement activities occurring in this potential high volume, problem prone area, VPQ stated, That's correct, we were not collecting any data on this .

Based on interview and record review, the hospital failed to ensure the QAPI program reflected the complexity of the hospital's organization and services to include the impact on known sensitive operating room equipment subjected to out of range humidity levels that remained outside of the range recommended by hospital policy and procedure, CMS guidelines, and national standards.

These failures created the risk of the patients receiving poor quality medical care in a unsafe environment. (Cross reference A0940)

Findings:

Record review and Interviews of the Main operating rooms (ORs) and affiliated licensed surgical hospital (TOSH) indicated humidity has been high (an infection control concern) during the warm months. Humidity has been low (fire risk) during the cool months. The humidity has been out of range for which the hospital has no evidence that there was follow up or that humidity returned to acceptable range while surgical cases were in progress. (Cross reference A0951)

During a review of the Environment of Care Committee (ECC) Minutes and concurrent interview with BMD on 3/17/21, at 5:05 p.m., the BMD acknowledged and confirmed, after reviewing the ECC minutes for February 2021, November 2020, September 2020, July 2020, that Bio-med (contracted entity responsible for the equipment maintenance) had not been in the hospital to perform an inspection of the OR equipment to ensure equipment had not been impacted by the out of range humidity in the ORs. ECC minutes indicated Bio-med had not performed an out of cycle visit or service to the hospital. If Bio-med had performed an out of cycle inspection service, this would be indicated in the ECC minutes, and minutes don't indicate that.

On 3/17/21 at 5:37 p.m. an immediate jeopardy was called .

During a concurrent facility document review and interview with VPQ, on 3/18/21, starting at 10:05 a.m., review of Quality Forum, Safety, Medical Executive, and Governing Board committee minutes, VPQ acknowledged that data and metrics from these committees and the Environmental of Care committee did not track or trend data reflective of OR equipment impacted by out of range humidity levels. VPQ was asked if there were any performance improvement activities occurring in this potential high volume, problem prone area, VPQ stated, That's correct, we were not collecting any data on this .

The Hospital failed to ensure the provision of surgical services in accordance with hospital policy and procedure, CMS guidelines, and national standards for the use and maintenance of hospital equipment. In 2018, CMS found the hospital failed to provide a safe environment for the provision of surgical services when operating room humidity remained outside of the range recommended by hospital policy and procedure, CMS guidelines, and national standards. Since then the humidity in the operating rooms continued episodically to go out of the range recommended in the hospital's policy for temperature and humidity in the operating rooms. Surgical procedures continued to be performed thereby putting patients at risk for physical harm from equipment used with humidity out of the recommended range. Refer to A-0951. CDPH declared Immediate Jeopardy on 3/17/21 for the performance of surgical cases in a low humidity environment. Refer to A-0000.

The cumulative effect of the hospital's failure to provide appropriate humidity for operating room equipment used in surgical services or to verify the need to follow any required maintenance or usage recommendations for operating room equipment exposed to out of range humidity was an inability to ensure the provision of patient care in a safe environment.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure a safe and sanitary environment for surgical services and failed to follow policy and procedures and standards of practice based on the Association of Peri Operative Room Nurses (AORN) when:

1. All lap sponges (made of cotton material inserted during an invasive procedure to absorb fluid) were not placed back in the sponge counter bags (bag to collect used sponges in surgical cases) at the end of the procedure in one of one surgical case.

2. A suture (a medical device using a needle with an attached thread to hold tissues together after an injury or surgery) was added to the sterile field while the surgeon was still in the process of closing off the surgical area and not counted in one of one surgical case.

3. One of 16 operating rooms (OR) # 7 (1-9 Main hospital ,10-16- surgical hospital off campus) was not cleaned between surgical cases (2).

4. The humidity in the nine ORs (1-9 ) were out of range during surgical cases from November 2020 to March 18, 2021 with no documented resolvance of out of range values.

5. The surgical team failed to use the sponge counter rack to hang the sponge bags according to manufacture's information for use (MIFUs) during Patient N 104's surgical case on 2/4/21 by hanging the sponge counter bags on top of each other instead of separately.

6. The surgical team ( scrub technician Tech 1 and licensed nurse -LN1) failed to perform a correct sponge count during Patient N104's open heart surgical procedure on 2/4/21 by counting and validating visually all used surgical sponges were returned to the sponge counter bags .

7. The surgical team failed to implement their policy and procedure in regards to ensuring the an intra-operative radiography was read prior to the patient leaving the OR suite for three of 32 sampled patients (Patient N 104, N304 and N305).

8. Equipment in the OR's were not checked for safety and functionality according to manufacturer's instructions for use (MIFU's) when humidity was out of range for long periods of time.

These failures placed surgical patients at risk for retained surgical items (RSI's), surgical site infections, transmission of diseases, fire, burns, injuries, unnecessary second surgical procedures because of the RSIs and possible death.

Findings:

1. During a review of the facility's policy and procedure titled, Sponge/Needle/Instrument Counts, dated 7/18, indicated in part ... All team members are responsible for the prevention of retained surgical items (RSI's) ...establishing a system that accounts for all surgical items opened and used during a procedure constitutes a primary and proactive injury-prevention strategy ... sponges, sharps (needles) and applicable miscellaneous items on the operative field will be counted on every surgical/invasive procedure to prevent (RSI's) in the patient ...instrument counts are to be done on any procedure in which the body cavity or hollow organ is entered, or when the operative site is such that an object could be retained ...counts should occur audibly, and while items are concurrently viewed during the count procedure by two individuals, one of whom must be a registered nurse circulator ...times for sponge, sharps, miscellaneous items, and instrument counts: before the procedure to establish a baseline, before closure of a cavity within a cavity, before wound closure begins, at skin closure or end of the procedure ...sponge counter bags should be used to collect used sponges ...these should be filled from the bottom up and have a solid colored backing so each sponge can be visualized by the entire surgical team ...at the end of the procedure all sponges should be accounted for by placing each sponge in a pocket of the counter bags ...this provides a verification that all sponges are accounted for.

During an observation on 3/18/21, at 8:48 a.m., in the labor and delivery operating room (OR 1), the circulating nurse (LN 3) and the scrub technician (Tech 2) were performing the last sponge count. During the count, 14 lap sponges were audibly counted and visualized in each pocket of the sponge counter bags. The remaining six lap sponges were counted, remained on the sterile field while the surgeon was closing, and were not placed in the sponge counter bag.

During an interview on 3/18/21, at 10:15 a.m., with LN 3 and Tech 2 , LN 3 verbalized Tech 2 placed the 14 saturated lap sponges in a basin. LN 3 verbalized the 14 lap sponges were then placed in the sponge counter bag. When asked about the other six laps that were left on the sterile field, LN 3 verbalized they are also included in the final count. When asked if all of the sponges should be placed in the sponge counter bags at the end of the procedure, LN 3 and Tech 2 verbalized they did not know and was unaware of the hospital policy.

During an interview on 3/18/21, at 10:23 a.m., with the perinatal manager (PM 1), PM 1 acknowledged the hospital policy and verbalized all sponges at the end of the surgical procedure should be placed in the sponge counter bags.

According to The Association of periOperative Registered Nurses (AORN) Guidelines titled: Prevention of Retained Surgical Items (2016) indicated in part ... Using a pocketed bag or other system for separating used radiopaque (block the radiation in order to show up on an x-ray) sponges facilitates the ability to see the sponges for counting ... placement of the separated sponges in a standardized pocket bag system supports a consistent counting method ...use of a pocketed sponge holder system is recommended as part of the Sponge ACCOUNTing System protocol ...the RN (Registered Nurse) circulator should use standard precautions to retrieve sponges, then completely open and separate each sponge before placing it in a pocketed sponge bag system ... separating radiopaque sponges after use minimizes errors caused by sponges sticking together ...place only one sponge in each pocket of the pocketed sponge bag system ...as part of the Sponge ACCOUNTing System, all sponges are placed in a pocketed bag system at the end of the procedure to verify that the sponges are not retained in the patient and to allow the surgeon to visualize the location of the sponges, which is called the Show Me step.

2. During a review of the facility's policy and procedure titled, Sponge/Needle/Instrument Counts, dated 7/18, indicated in part ... Counts should occur audibly, and while items are concurrently viewed during the count procedure by two individuals, one of whom must be a registered nurse circulator ...the circulating nurse is responsible for: counting and recording the sponge, sharps, miscellaneous items, and instruments ...recording results of the final counts on the operative/procedure record ...informing the surgeon/proceduralist and surgical/procedure team of the count results by announcing results audibly at the conclusion of the closing count ...any perioperative team member who assists the surgical team by opening sterile items such as extra sutures or radiopaque sponges onto the sterile field must: count items with the scrub person ...add the counted items to the count documentation (instrument count sheet, whiteboard) and promptly inform the RN circulator about what was added ...using a whiteboard to track counts aids in transparency to the entire surgical team and is a preferred method.

During an observation on 3/18/21, at 8:48 a.m., in the labor and delivery operating room (OR 1), the circulating nurse (LN 3) and the scrub technician (Tech 2) were performing the last sponge count. At 8:51 a.m., LN 3 added a suture to the sterile field while the surgeon was still closing. LN 3 did not perform an additional sharps count with Tech 2.

During an interview on 3/18/21, at 10:17 a.m., with LN 3 and Tech 2, LN 3 acknowledged a suture was added to the sterile field after the final count. LN 3 and Tech 2 both further acknowledged an additional count should have been performed.

According to The Association of periOperative Registered Nurses (AORN) Guidelines titled: Prevention of Retained Surgical Items (2016) indicated in part ... Perform counts of sharps and miscellaneous items: before the procedure to establish a baseline ...when new items are added to the field ...before closure of a cavity within a cavity ...when wound closure begins ...when skin closure begins or at the end of the procedure when counted items are no longer in use.

3. According to The Association of periOperative Registered Nurses (AORN) Guidelines titled: Environmental Cleaning (2019) indicated in part ... All personnel should take precautionary measures to limit the transmission of microorganisms when performing environmental cleaning and handling waste materials ...cleaning and disinfection activities should be performed in a methodical pattern that limits transmission of microorganisms ...cleaning should progress from clean to dirty areas ... cleaning should progress from top to bottom areas ...clockwise or counter-clockwise cleaning may be performed when used in conjunction with clean-to-dirty and top-to-bottom methods.

During an observation in main operating room (OR 7) on 3/16/21, at 10:25 a.m., the surgery orderly (SO 2) was cleaning the OR between patients. SO 2 proceeded to clean starting with the OR lights, then cleaned the operating table (dirtiest), down the column, to the base of table. SO 2, with the same gloves and same cleaning cloth, continued to clean monitors, equipment, mayo stands (a removable instrument tray set on a moveable stand that is positioned over a surgical site and provides a place for sterile instruments and supplies used during surgery), and counter tops to the outer periphery of the room. SO 2 started the cleaning progression from top-to-bottom then went from bottom- to- top. SO 2 continued to progress from clean to dirty then went from dirty to clean.

During an interview with SO 2, the surgery director (SD) and the vice president of surgical services (VPS) on 3/16/21, at 10:55 a.m., they acknowledged AORN guidelines and the cleaning sequences of the OR's. They further acknowledged the cleaning should begin with the cleanest (outer periphery) of the OR and progress to the dirtiest (inner), and the OR table is cleaned last.

During a review of the Operating Room Cleaning Power Point, undated, the power point indicated in part ...Work from clean outside edges to the dirty operating table in the center...scrubbing action is most effective.

During a concurrent interview and record review, on 3/17/21, at 8:35 a.m., with the chief nursing officer (CNO), and VPS, the Operation Room Cleaning Power Point, undated, was reviewed. The CNO verbalized the surgical orderly's are taught to clean top to bottom and cleanest to dirtiest. The CNO and VPS further acknowledged SO 2 did not follow the correct cleaning sequence of the operating room.

4. According to AORN guidelines for Perioperative Practice titled: Design and Maintenance (2012-2019) indicated in part ... The health care organization should create and implement a systematic process for monitoring HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance parameters and a mechanism for resolving variances ...personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the healthcare organization's policy and procedures

During an interview on 3/16/21, at 4:50 p.m., with the facilities manager (FM), FM verbalized if the humidity is low or out of range, the temperature can be adjusted through the temp track system, by increasing the temperature. FM further verbalized you can only adjust the temperature not the humidity.

The facility policy and procedure tilted Monitoring of Temperature and Humidity dated 12/20, indicated in part ... It is the purpose of this policy to name areas required by regulatory standards to monitor relative humidity and to include guidelines for response to those humidity levels found to be out of range ... operating rooms relative Humidity Range is 30% - 60%.

Review of the temperature and humidity logs on 3/17/21 indicated :

Thousand Oaks Surgery Hospital (TOSH) operating room humidity readings for November 2020:

OR 1 - humidity was from 19% -27% on five of thirty days of the month.

OR 2 - humidity was from 21% -28% on five of thirty days of the month.

OR 3 - humidity was from 21% - 28% on five of thirty days of the month.

OR 4 - humidity was from 22% - 26% on three of thirty days of the month.

OR 5 - humidity was from 21% -29% on five of thirty days of the month.

OR 6 - humidity was from 19% - 29% on six of thirty days of the month.

OR 7 - humidity was from 18% - 29% on six of thirty days of the month.

TOSH operating room humidity readings from December 2020:

OR 1 - humidity was from 11% - 28% on fourteen of thirty-one days of the month.

OR 2 - humidity was from 12% - 28% on fourteen of thirty-one days of the month.

OR 3 - humidity was from 12% - 28% on fourteen of thirty-one days of the month.

OR 4 - humidity was from 12% - 29% on thirteen of thirty-one days of the month.

OR 5 - humidity was from 14% - 29% on fourteen of thirty-one days of the month.

OR 6 - humidity was from 13% - 28% on thirteen of thirty-one days of the month.

OR 7 - humidity was from 11% - 29% on fourteen of thirty-one days of the month.

TOSH operating room humidity readings from January 2021:

OR 1 - humidity was from 23% - 28% on three of five surgical days.

OR 2 - humidity was from 24% - 29% on three of five surgical days.

OR 3 - humidity was from 25% - 28% on three of five surgical days.

OR 4 - humidity was from 25% - 29% on two of five surgical days.

OR 5 - humidity was from 26% - 28% on two of five surgical days.

OR 6 - humidity was from 25% - 29% on three of five surgical days.

OR 7 - humidity was from 23% - 27% on three of five surgical days.

TOSH operating room humidity readings from February 2021:

OR 1 - humidity was from 14% - 27% on eight of ten surgical days.

OR 2 - humidity was from 15% - 29% on eight of ten surgical days.

OR 3 - humidity was from 16% - 29% on eight of ten surgical days.

OR 4 - humidity was from 13% - 28% on eight of ten surgical days.

OR 5 - humidity was from 15% - 28% on seven of ten surgical days.

OR 6 - humidity was from 15% - 29% on eight of ten surgical days.

OR 7 - humidity was from 14% - 27% on eight of ten surgical days.

TOSH operating room humidity readings from March 2021:

OR 1 - humidity was from 10% - 28% on four of twelve surgical days.

OR 2 - humidity was from 11% - 28% on four of twelve surgical days.

OR 3 - humidity was from 11% - 29% on four of twelve surgical days.

OR 4 - humidity was from 10% - 28% on four of twelve surgical days.

OR 5 - humidity was from 12% - 26% on three of twelve surgical days.

OR 6 - humidity was from 11% - 29% on four of twelve surgical days.

OR 7 - humidity was from 9% - 27% on four of twelve surgical days.

Labor and Delivery operating room humidity readings from December 2020:

OR 8 - humidity was from 11% - 29% on twenty of thirty-one days.

OR 9 - humidity was from 11% - 29% on nineteen of thirty-one days.

Labor and Delivery operating room humidity readings from January 2021:

OR 8 - humidity was from 20% - 28% on fourteen of thirty-one days.

OR 9 - humidity was from 20% - 28% on fifteen of thirty-one days.

Labor and Delivery operating room humidity readings from February 2021:

OR 8 - humidity was from 18% - 29% on eight of twenty-eight days.

OR 9 - humidity was from 15% - 28% on six of twenty-eight days.

Labor and Delivery operating room humidity readings from March 2021:

OR 8 - humidity was from 13% - 27% on three of eighteen days.

OR 9 - humidity was from 13 - 28% on three of eighteen days.

The temperature and humidity logs indicated on the days the temperature and humidity were out of range the actions taken were no action taken or facilities informed. No other specific resolution or actions were mentioned what were done to address the out of range temperature and humidity.

According to AORN guidelines for Perioperative Practice titled: Design and Maintenance (2012-2019) indicated in part ...A small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period may have clinical significance...based on the risk assessment, corrective measures may include: rescheduling procedures to the areas of the surgical suite where the HVAC system is functioning with in normal parameters, delaying elective procedures, limiting surgical procedures to emergency procedures only, closing the affected OR's.

During an interview on 3/17/21, at 10:00 a.m., with the chief operations officer (COO), the COO verbalized the facility did not have CMS waiver. When asked if the equipment in the OR's is safe to use at a low humidity, and if there is a fire risk assessment done, and if the fire risk assessment includes safety of equipment, the COO verbalized he did not know and would have to follow-up.

The Centers for Medicare & Medicaid Services (CMS) memorandum S&C: 15-27-Hospital, CAH & ASC Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs) stated It has come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms and CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs.

During a concurrent interview and record review on 3/17/21, at 1:35 p.m., with the COO and safety bio-med director (Safety BMD), the facility's Critical Items in the OR & Procedural Areas,dated 7/17/18, was reviewed. The recommended humidity range for the Cautery Machines was 30%-75%. When asked how do you know the cautery machines are safe to use at a humidity lower humidity range, the COO and Safety BMD verbalized they did not know.

During a review of the facility's Fire Risk Assessment, the assessment indicated cautery is an ignition source for fire.

According to the Advancing Safety in Healthcare Technology (AAMI) guidelines titled, Relative Humidity Levels in the Operating Room- Joint Communication to Healthcare Delivery Organizations, dated 1/2015, indicated in part ... Required environmental RH for supplies and equipment is stated in the manufacturer's instructions for use (IFU's) ...it is important for personnel to know and understand the IFU's specific to all supplies and equipment ... relative humidity may affect the operation of some electro-medical equipment used in the OR ...the equipment may malfunction unexpectedly ...too low humidity levels may also impact calibration ...larger electrostatic discharge (ESD) ... a person can become charged and receive an electrostatic shock when coming into contact with medical equipment.

During an interview on 3/17/21, at 4:20 p.m., with the surgical manager (SM), SM was asked when the humidity is low in the operating rooms, is the equipment checked for functionality prior to surgery, SM verbalized she did not know. When asked if any surgical cases had been canceled due to low humidity, SM verbalized no cases had been canceled.

During an interview on 3/17/21, at 5:00 p.m., with SM, SM verbalized the OR circulating nurse does the fire risk assessment before each surgical case. SM verbalized the fire risk assessment is made up of three questions and produces a fire risk score. SM verbalized a score of two is low fire risk and a score of three is a higher fire risk. SM verbalized there is no assessment of the OR equipment in the fire risk assessment. SM further verbalized the OR circulating nurses do not have access to the OR equipment parameters (IFU's).

On 3/17/21 at 5:37 p.m. an immediate jeopardy was called .

5. The facility's policy and procedure entitled, Sponge/Needle/Instrument Counts, revised 7/25/18, and in effect during Patient N104's surgical procedure, was reviewed. Section V, entitled, PROCEDURE set forth the following: l) Sponge counter bags should be used to collect used sponges.

The [Manufacture's name] Surgical Sponge Counter Rack IFUs indicated a double hook (front and back) rack can hold two sets of sponge bags.

During an interview with scrub technician (Tech 1) on 3/16/21 at 11:30 a.m., Tech 1 confirmed during Patient N104's sponge count several sponge bags were against or on top of each other, hanging. The sponge holder (double hook) rack used to hang the sponge bags had a lot of bags hanging, more than two per side or hook.

During an interview with LN 2 on 3/16/21 at 11:45 a.m., LN 2 confirmed performing Patient N 104's CABG surgical procedure sponge counts with Tech 1 on 2/4/21. Three sponge counter bags were used to count the 30 Lap sponges for this procedure. Three sponge counter bags were use to count the 30 ray-tech sponges used for this procedure as well. The six sponge counter bags were all hanging from the double hook rack.

During an interview with surgical manager (SM) on 3/15/21 at 11:11 a.m., SM explained the sponge count practice is to use one double hook sponge rack to hang multiply sponge bags. There is no limit as to how many sponge counter bags can be hang from the double hook rack. SM was asked to provide supporting literature indicating it was okay to hang multiply sponge counter bags from the double hook rack. The hospital was asked on 3/16/21, and 3/17/21 to provide supporting literature/documents supporting their practice. However, the hospital was not able to provide supporting documents indicating it was okay to hang multiply sponge counter bags in the double hook rack.

6. The facility's policy and procedure entitled, Sponge/Needle/Instrument Counts, revised 7/25/18, and in effect during Patient N104's surgical procedure, was reviewed. Section V, entitled, PROCEDURE set forth the following:

a) Counts should occur audibly, and while items are concurrently viewed during the count procedure by two individuals, one of whom must be a registered nurse circulator, referred to as the circulating nurse.

l) Sponge counter bags should be used to collect used sponges. These should be filled from the bottom up and have a solid colored backing so that each sponge can be visualized by the entire surgical team. At the end of the procedure all sponges should be accounted for by placing each sponge in a pocket of the counter bags. This provides a verification that all sponges are accounted for.

The clinical report for patient N 104 was reviewed on 3/15/21 at 12:00 p.m., with the assistance of quality coordinator (QC). The record indicated that on 2/4/21 at 7:30 a.m., Patient N104, a [AGE] year old patient was brought into operating room (CV 1) for a coronary artery bypass graft (CABG) surgical procedure.

The CABG with left radial artery harvest surgical procedure case record, dated 2/4/21, indicated the initial, second and final counts were correct. The counts were performed by scrub technician (Tech 1) and circulating nurse (LN-2). According to case record All sponge counts were correct and all sponges were accounted for. A chest X-ray was performed. Patient left the OR. Patient was in the coronary care unit (CCU when the radiologist communicated to surgeon the chest X-ray showed a C shaped radio-density overshadowing the left side of the chest. Two more chest X-rays were performed in the CCU to confirmed a retained Lap sponge was inside patient's chest.

During an interview with scrub technician (Tech 1) on 3/16/21 at 11:30 a.m., Tech 1 confirmed during Patient N104's sponge final count. He could not see the sponge counter bags clearly. Tech 1 stated I couldn't see all the pockets of each bag. The bags were against or on top of each other, hanging. The angle of the hanging bags was hard to see. [LN 2's name] said all the sponges were there, so I believe that. The sponge holder rack used to hand the sponge bags had a lot of bags hanging. Tech 1 acknowledged and confirmed not counting the sponges audibly and while items were concurrently viewed during the count procedure.

During an interview with LN 2 on 3/16/21 at 11:45 a.m., LN 2 confirmed performing Patient N 104's CABG surgical procedure sponge counts with Tech 1 on 2/4/21. Three sponge counter bags were used to count the 30 Lap sponges for this procedure. The three counter bags were hanging from the rack on top of each other. Bag #1 was located on top or front. Bag # 2 was located in the middle. Bag #3 was located on the bottom or back. According to LN 2, Tech 1 had 4 sponges. Then, she continue counting 5 ...10, on the top counter bag (Bag #1). She slide the top bag (Bag # 1) to the side to continue counting in bag #2. She could not see the entire bag. She could not see the 10 pockets on this bag (Bag # 2). Then, she slide the bag (counter Bag # 2) to the side to continue counting the sponges in bag #3. Because she slide the bags #2 and #3 to the side she was not able to see the 10 pockets on each bag. One sponge was missing in one of the pockets of bags #2 or #3. She did not notice one bag pocket was empty because when she slide the bags to the side she couldn't see the entire bag. She was not able to see whether each pocket had a sponge inside. Furthermore, LN 2 acknowledge that during the final count Tech 1 and her were not counting the sponges out loud or audibly and looking at the sponge being counted, at the same time. LN 2 further confirmed getting the sponge bags from the OR. One of the sponge bags had a missing sponge or empty pocket. The sponges inside the bags were counted and only found 29 Laps sponges. The missing Lap sponge confirmed it was inside the patient's chest.

7. The facility's policy and procedure entitled, Sponge/Needle/Instrument Counts, revised 7/25/18, was reviewed. Section V, entitled, PROCEDURE set forth the following:

Number 8. Sponges and Sharp count safety concepts:

j) For cardiac procedures in which post-operative chest x-rays are obtained before the patient leave the Operating Room, a sponge/sharp count must be performed.

The clinical record for patient N 104 was reviewed on 3/15/21 at 12:00 p.m., with the assistance of quality coordinator (QC). The record indicated that on 2/4/21, Patient N104, a [AGE] year old male was brought into operating room (CV 1) for a coronary artery bypass graft (CABG) surgical procedure.

The CABG surgical procedure case record, dated 2/4/21, indicated Patient N104 left the OR at 12:45 p.m.

The Radiology Report, dated 2/4/21 at 12:24 p.m., indicated a C shaped radio-density overshadowing the left lower chest suspecting a retained Lap sponge was inside patient's chest. The report was signed by the radiologist at 12:53 p.m.

During an interview with MD 1 on 3/17/21 at 10:10 a.m., MD 1 confirmed a chest X-ray was performed on Patient N104 while patient was in the OR on 2/4/21. When the radiologist read the initial chest x-ray and called him, the patient was rolling into the critical care unit's (CCU) room. Furthermore MD 1 explained The protocol is that the patient does not leave the OR until chest x-ray is cleared. In this case, patient left the OR. Then, the radiologist called him to notify him there was something in the patient's chest.

During an interview with chief of surgery (SC) on 3/17/21 at 8:36 a.m., the SC acknowledged and confirmed the standard of practice is for an intra-operative x-ray to be read before the patient leaves the OR.

The facility's policy and procedure entitled, Sponge/Needle/Instrument Counts, revised 7/25/18 indicated patient should remain in the room until the image is interpreted unless the medical condition of the patient requires immediate transfer

Review of closed records on 3/16/2021 at 5:23 PM indicated patient N304 had coronary artery bypass graft (CABG) surgical procedure on 10/16/2020. Operating room records indicated the procedure ended at 3:30 PM, surgeon leaves room at 3:30 PM and the patient leaves room at 3:40 PM. Radiograph taken during surgery was signed and reported by the radiologist at 3:56 PM

Review of closed records on 3/17/2021 at 1030 AM indicated patient N305 had CABG procedure on 10/20/2020. Operating room record indicated the procedure ended at 12:15 PM, the surgeon leaves the room at 12:15 and the patient leaves the room at 12:27 PM, Radiograph taken during surgery was signed and reported by the radiologist at 12:41 PM.

8. On 03/17/21, at 5:37 p.m., an Immediate Jeopardy (IJ) was declared in the presence of the hospital's senior leadership. The hospital failed to monitor and ensure operating rooms (ORs) humidity levels were within acceptable range (30-60 %) in accordance with acceptable professional standards of practice (AORN), and their policy and procedures. In addition, the hospital was not able to demonstrate compliance with manufacturer's information for use (MIFUs) with the use of operating equipment when humidity was out of range in the ORs.

Record review and Interviews of the Main ORs and TOSH indicated humidity has been high (an infection control concern) during the warm months. Humidity has been low (fire risk) during the cool months. The humidity has been out of range for which the hospital has no evidence that there was follow up and humidity return to acceptable range while surgical cases were in progress. Acceptable Humidity range is 30-60%.

July 2019: Main OR

OR 1- humidity was 62% on 7/19/19

OR-2 humidity was from 61-65% on fifteen of 31 days of the month.

OR-3 humidity was from 61-65% on twelve of 31 days of the month.

OR-4 humidity was from 61-65% on six of 31 days of the month.

OR-5 humidity was from 61-65% on nine of 31 days of the month.

OR-6 humidity was from 61-65% on four of 31 days of the month.

OR-7 humidity was from 61-65% on ten of 31 days of the month.

CV-I humidity was from 61-73% on fifteen 31 days of the month.

CV-2 humidity was from 61-66% on fifteen of 31 days of the month.

Cysto- humidity was from 61-65% on nine of 31 days of the month.

Core- humidity was from 61-65% on twenty nine of 31 days of the month.

August 2019: Main OR

OR 1- humidity was from 61-66.2% on six of 31 days of the month.

OR-2 humidity was from 61-64.2% on eleven of 31 days of the month.

OR-3 humidity was from 61-66.4% on eleven of 31 days of the month.

OR-4 humidity was from 61-68% on twelve of 31 days of the month.

OR-5 humidity was from 61-65.6% on nine of 31 days of the month.

OR-6 humidity was from 61-65.2% on nine of 31 days of the month.

OR-7 humidity was from 61-64% on seven of 31 days of the month.

CV-I humidity was from 61-71.4% on fourteen of 31 days of the month.

CV-2 humidity was from 61-65.8% on twelve of 31 days of the month.

Cysto- humidity was from 61-63% on ten of 31 days of the month.

Core- humidity was from 61-67% on nine of 31 days of the month.

November 2019: Main OR

OR 1- humidity was from 8-27% on six of 30 days of the month.

OR-2 humidity was from 8-28% on seven of 30 days of the month.

OR-3 humidity was from 9-28% on seven of 30 days of the month.

OR-4 humidity was from 8-25% on eight of 30 days of the month.

OR-5 humidity was from 7-29% on ten of 30 days of the month.

OR-6 humidity was from 8-27% on seven of 30 days of the month.

OR-7 humidity was from 10-28% on nine of 30 days of the month.

CV-I humidity was from 10-26% on six of 30 days of the month.

CV-2 humidity was from 10-29% on nine of 30 days of the month.

Cysto- humidity was from 8.4-29% on eight of 30 days of the month.

Core- humidity was from 6.5-26.9% on seven of 30 days of the month.

December 2019: Main OR

OR 1- humidity was from 16-29% on five of 30 days of the month.

OR-2 humidity was from 16-27% on five of 30 days of the month.

OR-3 humidity was from 16-27% on five of 30 days of the month.

OR-4 humidity was from 16-28% on four of 30 days of the month.

OR-5 humidity was from 13-23% on four of 30 days of the month.

OR-6 humidity was from 16-27% on six of 30 days of the month.

OR-7 humidity was from 13-29% on six of 30 days of the month.

CV-I humidity was from 13-27% on five of 30 days of the month.

CV-2 humidity was from 17-27% on five of 30 days of the month.

Cysto- humidity was from 18-23% on three of 30 days of the month.

Core- humidity was from 16.7-29% on five of 30 days of the month.

December 2020: Main OR

OR 1- humidity was from 11-27% on twenty one of 31 days of

Based on interview and review of the hospital's certification Intravenous (IV) compounding report from a clean room vendor, the hospital failed to provide evidence the mold which had been found in a fungal air sample near a work table, (inside the segregated compounding room) had been remediated and the air near the table resampled.

Findings:

Review of the hospital's policy and procedure entitled: Compounded Sterile Preparations (CSP); General Provisions, Standard Procedures, and Definitions, dated 5/2014, states: ... Sterile product compounding shall be performed in compliance with current information from USP-NF Chapter 797, State Board of Pharmacy Laws and Regulations ....Interview with the Director of Pharmacy (DOP) and the Clinical Pharmacy Coordinator (CPC) on 6/26/18 at 10:45 am revealed that the Pharmacy's most current copy of their intravenous room certification report showed that the Pharmacy's segregated compounding room (the location where intravenous solutions are prepared for patient administration), had grown 7 colony forming units (CFU) of a mold (Cladosoporium) in an air sample from the right corner of a work table. The hospital Pharmacy staff were unable to provide any additional information in regards to any corrective actions which the hospital had taken to remediate this mold sample obtained the hospital's segregated compounding room.

USP-NF Chapter 797 states the following: ...Regardless of the number of Colony Forming Units (CFUs) identified in the compounding facility, further corrective actions will be dictated by the identification of microorganisms recovered (at least by genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler. Highly pathogenic microorganisms (e.g., Gram-negative rods, ... molds and yeasts) can be potentially fatal to patients receiving Compounded Sterile Products (CSPs) and shall be immediately remedied , regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist. By the hospital continuing to compound CSP at 150 CSPs per day, this put every patient who received a CSP at risk for developing a highly pathogenic infection from these products.

On 6/27/18, at 1:15 p.m., an IJ (immediate jeopardy) was called with the hospital's administration based on the mold, which had been identified in the Pharmacy's segregated compounding room. When the hospital's administration contacted the hospital's previously used hood certification testing company later that day to schedule a new recertification test, the company asked the hospital administrator if anyone from the hospital had kept a copy of the company's recertification report from March 22, 2018. The certification company scanned over a copy of the March 22, 2018 report to the facility. This report was subsequently provided by the hospital CEO (Chief Executive Officer) to the Pharmacy surveyor at 5:35 p.m. on 6/27/18. After the Pharmacy surveyor reviewed the report and determined the information on the report showed the air-sample had been retaken at the same location of the original air sample. The results indicated there was no longer any mold present, the IJ for the Pharmacy portion of the survey was lifted (abated) at 5:55 p.m. on 6/27/18.

Survey not available

Based on interview and record review, Governing Board (GB) failed to ensure the annual Performance Improvement Plan Program (PI) for 2020 was approved timely (approve for use only on 7/22/20), and implemented when:

1. Quality Assurance Program Improvement (QAPI) program was not implemented and put in place

when incidents and adverse events were not fully investigated for implementation of a performance improvement efforts, metrics tracking or reviewed and reported to the GB. There was no evidence to show the GB provided direction regarding the follow-up of adverse events.

This failure created the risk of persistent poor practices and substandard healthcare outcomes to the patients in the hospital. (Cross reference A0940).

Findings:

During a interview on 3/16/21, at 2 p.m., with the VPQ, while concurrently reviewing the Governing Board meeting minutes for calendar year 2020, VPQ acknowledged that the hospital Quality and Performance Improvement Plan,is a annual plan requiring GB to approve. VPQ also acknowledged that the QAPI plan was not approved until 7/22/20. When VPQ was asked what was the cause for delay of the plan, VPQ stated, Possible change in staffing or Covid.

During review of hospital document, titled, (name of hospital) 2020 Quality and Performance Improvement Program, approved by the Board Of Trustees on 7/22/20, pg. 9 of 20, indicated in part ... 2020 Priorities, are set with consideration to scope and services, population served and high risk and high volume or problem prone processes and associated incidence, prevalence and severity of the problems.... Further review of 2020 document indicated in part pg 3 continued to pg 4 of 20, under subhead Goals and Objectives,... To ensure that patient care practices and professional performance are in compliance with the requirements of CMS Conditions of participation...

During interview on 3/18/21, at 9:40 a.m.,with VPQ, while concurrently reviewing GB meeting minutes for calendar year 2020, VPQ acknowledged the minutes from the meetings did not reflect QAPI, patient safety and/or performance improvement efforts regarding hospital's experience with retention of foreign objects. In addition the meeting minutes did not reflect distinct direction for improvement projects for potentially unsafe control of out of range humidity, within the operating rooms.

Based on observations, staff interviews, reviews of administrative documents and professional standards of practice, the hospital's QAPI program failed to focus on high-risk and problem prone areas and did not take actions aimed at performance improvement when:

1. A patient experienced a retained foreign object on 2/15/19 of a 4x4 gauze sponge requiring the surgical site to be reopened for the removal of the retained sponge.

2. A surgeon on 9/11/19 failed to performed a methodical wound exploration during the closing surgical count (counting of all instruments/items used during surgery to ensure no instruments/items are left inside the body) in one patient. An acorn manipulator tip (instrument inserted internally in to visualize the internal organs measuring 1.5 inches in width and 2.5 inches in length) was retained and removed manually on 9/17/20 (6 days later).

These failures placed the patients at risks for non quality surgical services rendered that can be potential for harm secondary to no improvement and follow programs for accountability .

Findings:

During review of hospital document, titled, (name of hospital) 2020 Quality and Performance Improvement Program, approved by the Board Of Trustees on 7/22/20, pg. 9 of 20, indicated in part ... 2020 Priorities, are set with consideration to scope and services, population served and high risk and high volume or problem prone processes and associated incidence, prevalence and severity of the problems....

Review of hospital reported 2019 incidents included the following occurrences:

1. Record review revealed that hospital reported a retained foreign object when on 2/15/19, a patient experienced a retained 4x4 gauze sponge requiring the surgical site to be reopened for the removal of the retained sponge.

2. Record review revealed that hospital reported a retained foreign object, when the hospital failed to ensure the surgeon performed a methodical wound exploration during the closing surgical count (counting of all instruments/items used during surgery to ensure no instruments/items are left inside the body) in one patient. On 9/17/20, a surgeon removed a retained object (acorn manipulator tip (instrument inserted internally in to visualize the internal organs measuring 1.5 inches in width and 2.5 inches in length) left from the surgery that took place on 9/11/19.

During a concurrent document review and interview on 3/15/21, at 1 p.m., with CMO, review of Quality Forum minutes for the calendar year 2020 ( 2/3/20, 5/18/20, 8/3/20,11/10/20) , CMO acknowledged minutes did not reflect any metrics and or performance improvement activities surrounding adverse events of retained foreign objects. CMO also agreed that such events of retained foreign objects are potential high risk events.

During a interview with VPQ, on 3/17/21, starting at 9:40 a.m., VPQ acknowledged she was aware of 2019 adverse events of retained foreign objects,VPQ stated, I wasn't in this role (VPQ), but I am aware they occurred. VPQ was asked if she had any knowledge of any service, department or sub committee that had tracked any metric or performance improvement activities surrounding retention of foreign objects, VPQ stated, I don't see any included (referencing minutes).

Based on interview and record review the hospital failed to ensure there was an effective hospital-wide, data driven QAPI program as evidenced by:

1. The QAPI program failed to set priorities for it's performance improvement activities that focused on high risk activities, when the hospital experienced and was aware of several separate facility reported adverse events, involving retention of foreign objects. These events occurred in calendar year 2019. Review of the hospital's calendar year 2020 QAPI program, did not reflect the development or implementation of performance improvement project(s) that addressed the known high risk activities, in order for the hospital to implement preventative actions. (Cross-ref. A 0283 and A0951).

2. The hospital failed to ensure a effective QAPI program was in place, when they failed to measure, analyze and track hospital operations to provide and ensure appropriate humidity for operating room equipment used in surgical services and to provide any required maintenance of operating room equipment exposed to out of range humidity, to ensure the provision of patient care in a safe environment (Cross Reference A-0940).

4. The hospital's governing body failed to assume responsibility and accountability for ensuring that an ongoing program for effective quality improvement was defined, implemented, and maintained. (Cross Reference A0043, A0940 and A0309).

The cumulative effect of these systemic problems resulted in the hospital's failure to ensure quality health care in a safe environment.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview with the hospital's Clinical Pharmacy Coordinator (CPC),Vice President of Operations (VPO), and review of the clinical record for Patient 1 (P1) the hospital failed to ensure :

A. P1's insulin drip had been administered according to the physician's order, and

B. The insulin drip (medication for high blood sugar - a high alert medication according to the hospital's policy and procedure) contained documentation of an independent double check during the infusion of this patient's insulin drip.

Findings:

A) Record review with the hospital's CPC and the VPO on 7/3/18, at 5:00 p.m. revealed P1 had been admitted on [DATE] and started on an insulin drip on 6/21/18 at 7:49 p.m. The patient's physician had written the following order:

...Regular insulin 0.1 units/kg as intravenous bolus then 0.1 units/kg/hour continuous iv (intravenous) infusion. Target glucose (sugar) reduction rate is 50-75 mg/dl per hour (accuchecks every hour). - - If hourly glucose (blood sugar) reduction is less than 50 mg/dl, double the infusion rate. - - If hourly glucose reduction rate is greater than 75 mg/dl, decrease infusion rate by 50% when blood glucose reaches 250 mg/dl, decrease insulin to 3 units/hr and titrate to maintain blood glucose 150-200 mg/dl as follows (accuchecks every 2 hours): If blood glucose is greater than 400 = call physician, if blood glucose is between 300-399 = increase the infusion rate by 3 units/hour, if blood glucose is between 201-299 = increase infusion rate by 1 unit/hour, if blood glucose is between 150-200 = no change in the infusion rate, if blood sugar is between 100-149 = decrease the infusion rate by 1 unit/hour, if blood glucose is between 75-99 = decrease the infusion rate by 2 units/hour, if blood glucose is less than 75 = stop the infusion and call the physician.

The hospital was unable to provide documentation of P1's insulin infusion rate on 6/21/18 from 7:49 p.m. to 11:26 p.m. (for almost 4 hours of the infusion).

Additionally, based on the physician's order above the following adjustments should have been made, but were not made to P1's insulin infusion rate:

1) On 6/22/18, at 1:45 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 115, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

2) On 6/22/18, at 2:45 p.m., the physician's order indicated P1's insulin drip should have no change to the insulin infusion rate based on the patient's current blood glucose of 158, but the insulin infusion rate had been increased by 2 units/hour by the nurse contrary to the physician's insulin order.

3) On 6/22/18, at 4:45 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 123, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

4) On 6/22/18, at 5:10 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 132, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

5) On 6/22/18, at 6:15 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 131, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

6) On 6/22/18, at 7:15 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 147, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

7) On 6/23/18, at 10:40 a.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 144, but no change was made by the nurse to P1's insulin infusion rate contrary to the physician's insulin order.

8) On 6/23/18, at 11:45 a.m., the physician's order indicated P1's insulin drip should have had no change based on the patient's current blood glucose of 178, but the nurse increased P1's insulin infusion rate by 1 unit, contrary to the physician's insulin order.

B) Review of the hospital's policy and procedure entitled: High-Risk/High-Alert Medications dated 11/2017 reads: Purpose: To identify those medications that have a high likelihood to contribute to medication errors. To establish and implement safety measures for the use of these medications to help prevent the occurrence or errors ...Intravenous High Alert medications shall be infused via a programmable smart pump ...Independent Double Check (IDC) shall be performed by two licensed healthcare professionals on the initial set up of the smart pump, including but not limited to, selection of the appropriate medication from the drug library, data entry of correct concentration, volume to be infused, and rate of infusion ...Documentation of these IDCs shall be required for selected medications .... Under attachment A of the hospital's policy and procedure it states: Insulin (intravenous, subcutaneous), Documentation Required for Independent Double Check. Under Appendix 1, number 3 under Administration, states: Double check per facility policy for proper pump settings when administering insulin drips.

Review of the hospital's: Diabetes Blood Glucose Record, for patient P-1 during the administration of her insulin drip (between 6/22/18 at 7:49 pm to 6/24/18 at 10:30 am), did not demonstrate any documentation of an Independent Double Check for this insulin infusion. This document clearly states the Nurses Signature must be included on this document for each infusion rate and changes.

Based on observation, interview, and document review, the hospital failed to ensure that the pharmaceutical services met the needs of all of their patients as evidenced by their failure to:

1) Compound sterile intravenous medication in a safe and effective manner as outlined in USP-NF 797 (State Board of Pharmacy Regulation). (Refer to A-501)

2) Recalibrate (maintain accuracy) the TempTrak transmitters(monitors) for all of the Pharmacy medication refrigerators. (Refer to A-491)

3) Implement the hospital's established policy and procedure for the investigation of controlled drug losses. (Refer to A-509)

4) Administer a high alert/high risk medication in accordance with the patient's physician order and document in the patient's medical record the independent double check by nursing as outlined in the hospital's policy and procedure. (Refer to A-405)

The cummulative effect of these systemic problems resulted in the inability of the hospital's pharmaceutical services to direct staff in such a manner to meet the pharmaceutical needs of the hospital's patients in accordance with the hospital's policies and procedures, drug references and acceptable standards of practice.

Based on interview with the hospital's Chief Operating Officer (COO) and review of the manufacturer's TempTrak product literature the hospital failed to recalibrate their refrigerator temperature monitoring devices as outlined in the product manufacturer's literature.

Findings:

TempTrak's manufacturer's literature indicated their monitors and transmitters are used to ensure constant temperature and humidity levels are maintained. In the manufacturer's latest literature it reads: ...Under normal use conditions Cooper-Atkins instruments and probes experience insignificant drift and maintain stated accuracy, even over extended time periods. However, thermal and physical stress will cause temperature instruments and probes to drift over time. Therefore, periodic calibration of (company name) instruments and probes or any manufacturer's products is a sound and recommended practice. Periodic calibration is also required by many industry standards and regulations. The only way to be absolutely certain an instrument is accurate is to perform periodic calibration ...(Name of Company) Corporation recommends periodic calibration of instruments and probes against known traceable standards ... initially, annual calibration is recommended, but subsequent frequency may be increased or decreased based upon calibration history or an institution's identified protocol.

Interview with the hospital's Chief Operation Officer (COO) on 7/3/18, at 2:50 p.m., the COO indicated the hospital's oldest pharmacy medication TempTrak transmitter is 4 years old and all the other medication refrigerator TempTrak units are on average 2 to 3 years old. The hospital was unable to provide any evidence that their TempTrak medication refrigerator transmitters had ever been recalibrated. The hospital COO also acknowledged during the interview the facility had no calibration history for any of the TempTrak Pharmacy medication refrigerator units and the facility had not developed an institutional identified protocol.

Based on Interview with the Director of Pharmacy (DOP) ,Clinical Pharmacy Coordinator (CPC), and review of the hospital's Drug Enforcement Administration (DEA) drug loss reports (form DEA 106) the hospital's DOP failed to provide evidence of : .... at minimum participated in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps, as outlined in the hospital's policy and procedure.

Findings:

Interview with the DOP and CPC on 6/27/18, at 11:30 a.m., revealed hospital incidents of drug losses/possible drug diversions. The DOP revealed having not participated in the investigation of the facts to determine the next steps in the corrective action plan with the unit Nurse Managers.

Review of the hospital's policy and procedure entitled: Medication Diversion Prevention guide book, under the section entitled: Director of Pharmacy Role and Responsibility: states: ...ensure all investigative results are summarized, and that recommendations and actions are identified and documented in the MDT meeting minutes...Leads, or at minimum participates in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps.

The following are incidents obtained from the DOP's files which were reported to the DEA and/or the California State Board of Pharmacy, but the hospital's DOP was unable to provide evidence she had lead or at minimum participated in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps with the Unit Nursing Managers for each of these incidents:

1) On 6/2/17, the hospital's Pharmacy reported to the DEA one Traveler Nurse (which had been employed by the hospital had removed one tablet of Oxycodone 10mg with Acetaminophen (Tylenol) from the hospital's Automated Drug Delivery Device (ADDD) on May 22, 2017, but there was no record that this scheduled narcotic medication had ever been administered to a patient or disposed of by waste. This medication was never recovered by the hospital.

2) On 3/27/2017, the hospital's Pharmacy reported to the DEA one 5 milliliter (ml) cup of Guaiatussin with Codeine had been lost by the hospital. This medication was never recovered by the hospital.

3) On 9/12/17, the hospital's Pharmacy reported to the DEA an ampule of the scheduled controlled drug Hydromorphone 1 milligram (mg)/ 1 ml had been removed from the hospital's ADDD system. + of the 1 ml dose of this scheduled narcotic medication had been administered to one patient, but the remainder of this medication had not been documented as wasted nor had this medication ever been found.

4) On 8/19/2017, one of the hospital's Pharmacy Technician's had been filling an ADDD using a medication cart. While the Pharmacy Technician had been filling the ADDD, with his back to the hallway door, an unknown employee entered through the door of the room and walked back out of the room with 5 tablets of the scheduled medication Lorazepam (Ativan) before the Pharmacy Technician was able to get a good luck at the other employee. This medication has never been found by the hospital.

5) On 3/7/18, a Pharmacy Technician had been given 12 ampules of Fentanyl 50 micrograms (mcg)/1ml vials. The facility's report showed that all 12 ampules of Fentanyl had been delivered but 2 ampules of Fentanyl were later found missing by two Physician's during their work-shift from the same ADDD which this Pharmacy Technician had filled earlier. This Pharmacy Technician later resigned from the facility and the missing ampules of the scheduled narcotic medication Fentanyl were never found.

Based on observation, record review, and interview, the facility failed to provide safe anesthetizing locations for the patients they serve as evidenced by;

Relative humidity (RH) levels that were out-of-range and with incomplete and missing documented corrective actions.

RH levels in anesthetizing locations that were not maintained in accordance with equipment instructions-for-use (IFUs).

Failure to calibrate and develop a protocol for calibration of sensors used to monitor RH.

Using a temporary alteration to the heating, ventilating, and air-conditioning (HVAC) system controlling the surgical suite. (Refer to 701).

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure safe quality health care services were provided to patients within acceptable standards of practice.

Based on observation, record review, and interview, the facility failed to maintain the anesthetizing locations. This was evidenced by relative humidity (RH) levels that were out-of-range and with incomplete and missing documented corrective actions, by RH levels in anesthetizing locations that were not maintained in accordance with equipment instructions-for-use (IFUs), by the failure to calibrate and develop a protocol for calibration of sensors used to monitor RH, and by a temporary alteration to the heating, ventilating, and air-conditioning (HVAC) system controlling the surgical suite. This affected all anesthetizing locations in the Main Hospital and TOSH. This could result in the failure to maintain RH within required parameters, by the increased risk of OR equipment failure, by the inability to control RH levels with the hospital's mechanical system, and the decreased reliability of sensors used to monitor ambient conditions in anesthetizing locations.

NFPA 99, Health Care Facilities Code, 2012 Edition.

9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170.

American Society of Heating, Refrigerating and Air Conditioning Engineers, Inc. (ASHRAE) 170, Ventilation of Health Care Facilities, 2008.

Class A surgery: provides minor surgical procedures performed under topical, local, or regional anesthesia without preoperative sedation. Excluded are intravenous, spinal, and epidural procedures, which are Class B or C

surgeries.

Class B surgery: provides minor or major surgical procedures performed in conjunction with oral, parenteral, or

intravenous sedation or performed with the patient under analgesic or dissociative drugs.

Class C surgery: provides major surgical procedures that require general or regional block anesthesia and/or

support of vital bodily functions.

TABLE 7-1 Design Parameters

Function of Space: RH (%)

Classes B and C operating rooms: 30 - 60

Operating/surgical cystoscopic rooms: 30 - 60

Delivery room (Caesarean): 30 - 60

Class A Operating/Procedure room: 30 - 60

On 4/19/13, the Centers for Medicare & Medicaid Services (CMS) released memorandum S&C: 13-25-LSC & ASC titled Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements. The memorandum stated: The 2012 edition of NFPA 99 has adopted the 2008 edition of the American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Addendum D of the ASHRAE standard requires RH in anesthetizing locations to be maintained between 20 - 60 percent. In addition, this ASHRAE standard has been incorporated into the Facility Guidelines Institute (FGI) 2010 Guidelines for Design and Construction of Health Care Facilities, and has been approved by the American Society for Healthcare Engineering of the American Hospital Association and the American National Standards Institute.

Centers for Medicare & Medicaid Services (CMS) memorandum S&C: 15-27-Hospital, CAH & ASC Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs) stated it has come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms and CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs.

Findings:

During a facility tour, record review, and interview with ADM 2 from 6/28/18 to 7/3/18, the temperature and humidity logs were provided and the heating, ventilating, and air-conditioning (HVAC) system for the surgical suite was observed.

All Buildings

6/28/18

At 7:45 a.m., the facility's policy and procedure (P&P) for Monitoring temperature and humidity was reviewed. The policy was effective July 2015 and revised January 2016.

The P&P stated that temperature and relative humidity (RH) levels were continuously monitored by an automated system called TempTrak. Table A on the P&P indicated that an RH range of 20% - 60% was to be maintained in operating rooms (ORs), catheterization labs (Cath Labs), procedure rooms, interventional radiology (IR), and caesarean section (C-Section) Rooms.

The P&P stated that Facilities Management would monitor RH levels through Temptrak and any action taken, in the event RH is out-of-range, would be documented by Facilities.

The P&P stated that in the event RH continued to be out of range, or moisture accumulated on the walls or horizontal surfaces, the room was to be closed.

The P&P also stated mold inspections would be completed weekly or when deemed appropriate based on RH levels to ensure patient safety.

The P&P cites the American Institue of Architects' Academy (AIA) 2006 Guidelines, the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 170, 2012 Life Safety Code NFPA, and the Association for the Advancement of Medical Instrumentation (AAMI) ST79 as references for their P&P.

Main Hospital

6/28/18

1. Temperature and humidity logs provided on 6/28/18 indicated that RH levels fell out-of-range in June 2018 at the following locations:

a. In C-Section Room 1, the RH was recorded as greater than 60% during 14 days of the month. The out-of-range RH levels ranged from 61% to 72%.

b. In C-Section Room 2, the RH was recorded as greater than 60% during 12 days of the month. The out-of-range RH levels ranged from 62% to 76.7%.

c. In Cath Lab 1, the RH was recorded as greater than 60% during 9 days of the month. The out-of-range RH levels ranged from 63% to 68%.

d. In Cath Lab 2, the RH was recorded as greater than 60% during 12 days of the month. The out-of-range RH levels ranged from 62% to 74.7%.

e. In Cath Lab 3, the RH was recorded as greater than 60% during 17 days of the month. The out-of-range RH levels ranged from 61.7% to 78%.

f. In OR 1, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 78%.

g. In OR 2, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 72.7%.

h. In OR 3, the RH was recorded as greater than 60% during 25 days of the month. The out-of-range RH levels ranged from 62% to 75%.

i. In OR 4, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 73.7%.

j. In OR 5, the RH was recorded as greater than 60% during 18 days of the month. The out-of-range RH levels ranged from 61% to 75%.

k. In OR 6, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 74%.

l. In Cardiovascular (CV) 1, the RH was recorded as greater than 60% during 27 days of the month. The out-of-range RH levels ranged from 63.7% to 90.7%.

m. In CV 2, the RH was recorded as greater than 60% during 27 days of the month. The out-of-range RH levels ranged from 62% to 76%.

n. In Cystoscopy (Cysto) Room, the RH was recorded as greater than 60% during 14 days of the month. The out-of-range RH levels ranged from 61.7% to 76%.

o. In IR, the RH was recorded as greater than 60% during 13 days of the month. The out-of-range RH levels ranged from 62.4% to 79.7%.

Under the column for Actions Taken on the log for all the rooms, staff indicated that Facilities was informed and that the mold assessment was current/documented on days the RH was out-of-range. For IR, the staff also indicated that the fire risk assessment was completed on days the RH was out-of-range.

At 8:40 a.m., the Temptrak monitor at the Engineering Office was observed. The 8:30 a.m. readings for RH were:

a. OR 1 - 66.3%

b. OR 2 - 64%

c. OR 3 - 73%

d. OR 4 - 62%

e. OR 5 - 63%

f. OR 6 - 65%

g. OR 7 - 57%

e. CV 1 -77%

f. CV 2 - 78%

All RH levels greater than 60% appeared in a red box on the screen and all RH levels between 20% and 60% appeared in a green box on the screen.

During an interview at 8:49 a.m., FAC 1 stated that Temptrak records the temperature and humidity levels every 15 minutes. He said that the red boxes indicate that levels are out-of-range. He stated that the Facilities only take action if called by staff in the procedural areas and Facilities will try to lower RH by raising the temperature. He stated that the Facilties personnel do not keep a log of all corrective actions taken. ADM 2 stated that a log was kept during business hours.

The Facilities Management Department Service Call Log provided only had corrective actions noted since 6/19/18 and did not address all the instances the RH was out of range and at all locations. One note stated that they received a call from IR at 7:49 a.m., on 6/27/18, with a RH of 79% but that staff declined to change humidity levels. One note stated that Facilities received a call from Special Procedure Rooms 1, 2, and 3 because of high RH but staff declined to raise temps. On 6/26/18, at 7:50 a.m. in Cath Labs 1 and 2, and at 8:10 a.m. in IR, it was noted that staff declined to adjust temperatures to lower RH. Six other entries in the log noted calls received about humidity but there were no documented corrective actions.

During an interview at 8:57 a.m., on 6/29/18, FAC 1 confirmed if staff in the surgical department do not want to make any changes to lower RH then Facilties will not make any changes and procedures would continue with RH levels out of range.

2. At 3:43 p.m., IFUs for two pieces of equipment used in the ORs and other procedural areas were provided. For both equipment, Bovie and Datapad, the operating RH humidity was listed as 30% to 75%. The Bovie was present in all ORs and procedural areas.

The humidity logs indicated that RH went above 75% in the following rooms and on the following days:

OR 1:

a. 6/24/18 - 78%

Cath Lab 3:

b. 6/24/18 - 78%

CV1:

c. 6/5/18 - 77%

d. 6/21/18 - 90.7%

e. 6/22/18 - 77.3%

f. 6/23/18 - 76%

g. 6/25/18 - 76%

h. 6/26/18 - 76%

i. 6/27/18 - 75.7%

j. 6/28/18 - 76%

CV2:

k. 6/27/18 - 76%

l. 6/28/18 - 76%

Cysto:

m. 6/17/18 - 76%

IR

n. 6/4/18 - 76.3%

o. 6/27/18 - 79.7%

p. 6/28/18 - 79%

The facility failed to ensure that RH levels in procedural areas are maintained in accordance with equipment IFUs.

Main Hospital and TOSH:

6/28/18

3. At 10:31 a.m., reading from the Temptrak indicated that Cath Lab 1 had an RH level of 69%.

During a concurrent interview, ADM 2 stated that the sensor in Cath Lab 1 might be broken because the temperature readings were off by 10 degrees when compared with a reading from a handheld device. He said the facility did not compare RH readings from the sensor and another source.

During an interview at 3:10 p.m., on 7/2/18, ADM 2 stated that the facility did not calibrate the Temptrak sensors.

At 10:25 a.m., on 7/3/18, the manual with instructions for Temptrak sensor maintenance and calibration was provided. Temptrak sensors are used throughout the hospital and used to monitor conditions in anesthetizing locations and other critical areas. The manual stated initially, annual calibration is recommended but subsequent frequency may be increased or decreased based upon calibration history or an institution's identified protocol. The facility did not provide a protocol or P&P for maintenance of Temptrak sensors.

During a concurrent interview, ADM 2 and ADM 3 both confirmed that calibration was not conducted and the facility did not establish a maintenance protocol for Temptrak calibration.

Main Hospital

6/28/18

4. During an interview at 8:30 a.m., ADM 2 stated that the HVAC system that controls most of the procedural areas did not have a built dehumidification or humidification system. He said, that as a temporary solution to ongoing high RH levels, the facility would put in portable 12-ton spot coolers that would air-condition air going into the HVAC system and help lower humidity.

During an interview at 9:35 a.m., FAC 2 stated that the facility had tried this spot cooler method before and it worked to lower humidity.

During an interivew at 9:51 a.m., ADM 2 stated that the spot coolers were previously used in Summer 2016, while the HVAC system was undergoing a repair, and one of the side effects was that humidity was lowered.

During an interview at 3:37 p.m., ADM 2 stated that the facility applied for an emergency permit from the Office of Statewide Health Planning and Development (OSHPD) to install the portable spot coolers.

An email dated 6/28/18, at 7:35 p.m., indicated that OSHPD granted the facility authorization to install the spot coolers prior to issuance of a building permit. The email from OSHPD stated this authorization does not waive the plan approval and permit process and authorization to proceed has been granted for project S 5-56-00 via CAN 2-108. Please be sure to comply with the requirement addressed in the CAN.

Code Appliance Notice (CAN) 2-108 states: Such permits shall be limited as to time of service, but shall not be permitted for more than 180 days. The building official is authorized to grant extensions for demonstrated cause.

The spot coolers were installed outside the Southwest Wing and flexible ductwork went from the coolers on the ground floor to the air intake on the roof one floor above.

During an interview at 9:35 a.m., on 7/2/18, ADM 2 confirmed that the spot cooler intervention affects all procedural areas except Cath Labs and C-Section Rooms.

The facility failed to ensure their mechanical ventilation system can adequately maintain temperature and humidity levels in accordance with accepted guidelines and equipment IFUs.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services department met the needs of all of their patients as evidenced by their failure to:

1). Maintain humidity in 10 of 10 Operating Rooms (ORs), two of two of labor and delivery caesarean section rooms (CSR), three of three cardiac catheterization laboratory (CCL-cath lab) rooms, three of three special procedures/gastrointestinal (GI) rooms, one of one interventional radiology (IR) room, and one OR sterile supply room . From 6/1/18 to 6/26/18, the humidity range in the above mentioned areas were from 60.2 % to 90.7%, all above the recommended range. (Refer to A-951 and 701).

2). Ensure medical equipment in the OR's were not exposed to out of range humidity, (Refer to A-951 and 701).

3). Ensure portable empty oxygen tanks were segregated from the full portable oxygen tanks, (Refer to A-951).

4). Ensure 4 towel clamps (instrument use to hold human tissue and/or towels together during surgery) were not sterilized with box locks (where the joint of the instrument connect) in closed positions and ensure two straight scissors and one wire scissor in the GI lab were not sterilized in closed positions. (Refer to A-951).

The cumulative effect of these systemic problems resulted in the inability of the hospital's surgical services department to meet the surgical service needs of the hospital's patients in accordance with the hospital's policies and procedures, and acceptable standards of practice.

Based on observation, interview, and record review, the facility failed to ensure:

1. Recommended Humidity ranges were followed throughout the hospital OR's, procedure rooms and sterile supply rooms.

2. Follow policy and manufacturer guidelines related to surgical equipment in the OR's..

3. Empty oxygen tanks were segregated upon storage from full portable tanks,

4. Ensure sterilization was performed according to ASHRAE guidelines and hospital policy.

These failures had the potential to result in fires, outbreaks of surgical site infections, and compromise to the health and safety of patients.

.

Findings:

1. During an observation on 6/26/18, at 9:00 a.m.,Technician 2 (Tech 2) was recording OR humidity values obtained from a computer onto the OR Humidity Log (report recording daily temperature and humidity).

During an interview with Tech 2 on 6/26/18, at 9:02 a.m.,Tech 2 indicated the out of range OR humidity values/range are reported to licensed nurse 4 (LN 4) and to administration 2 (ADM 2).

Review of the OR Humidity Log report from 6/1/18 to 6/26/18 indicated out of 10 ORs (including the Cysto and the two CV rooms 1 and 2 ) the humidity range were from 61.0 % to 90.7%. above the range of 20-60%.

Further review of the OR humidity logs from 6/1/18 to 6/26/18 revealed the following :

1. In two of two L&D C-section rooms the humidity ranged from 61.3% to 76.7.%.

2. In three of three CC ORs the humidity ranged from 61 % to 76.7.%.

3. In three of three GI ORs the humidity ranged from 61 % to 71%.

4. One of one IR rooms (11) had a humidity range from 62.4% to 76.3.% .

5. One of one CS room had a humidity range from 61% to 65%.

The humidity range documented on the OR humidity log from 6/1/18 to 6/26/18 were above the ANSI and ASHRAE recommended range.

NFPA 99, Health Care Facilities Code, 2012 Edition.

9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170.

American Society of Heating, Refrigerating and Air Conditioning Engineers, Inc. (ASHRAE) 170, Ventilation of Health Care Facilities, 2008.

Class A surgery: provides minor surgical procedures performed under topical, local, or regional anesthesia without preoperative sedation. Excluded are intravenous, spinal, and epidural procedures, which are Class B or C

surgeries.

Class B surgery: provides minor or major surgical procedures performed in conjunction with oral, parenteral, or

intravenous sedation or performed with the patient under analgesic or dissociative drugs.

Class C surgery: provides major surgical procedures that require general or regional block anesthesia and/or

support of vital bodily functions.

TABLE 7-1 Design Parameters

Function of Space: RH (%)

Classes B and C operating rooms: 30 - 60

Operating/surgical cystoscopic rooms: 30 - 60

Delivery room (Caesarean): 30 - 60

Class A Operating/Procedure room: 30 - 60

On 4/19/13, the Centers for Medicare & Medicaid Services (CMS) released memorandum S&C: 13-25-LSC & ASC titled Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements. The memorandum stated: The 2012 edition of NFPA 99 has adopted the 2008 edition of the American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Addendum D of the ASHRAE standard requires RH in anesthetizing locations to be maintained between 20 - 60 percent. In addition, this ASHRAE standard has been incorporated into the Facility Guidelines Institute (FGI) 2010 Guidelines for Design and Construction of Health Care Facilities, and has been approved by the American Society for Healthcare Engineering of the American Hospital Association and the American National Standards Institute.

Centers for Medicare & Medicaid Services (CMS) memorandum S&C: 15-27-Hospital, CAH & ASC Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs) stated it has come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms and CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs.

During an interview with licensed nurse (LN 4), on 6/27/18, at 9:11 a.m., LN 4 confirmed the out of range values for all the ORs and specialty procedural areas. LN 4 stated, There is not a lot we can do to change the high humidity other than to raise the temperature and our surgeons don't like that, they like it cold. The temperature/humidity values are reported to me everyday and almost everyday we do nothing unless there is actual condensation in the room then we shut the room down for the day. Once a week we do mold checks in all the ORs. The mold checks are done by Environmental Services (janitorial services) they physically check all the walls and dark places looking for mold. Humidity has always been high in our ORs, at certain times of the year it's even higher.

2. During an observation on initial tour on 6/25/18, at 3:15 p.m., one cautery machine (equipment used to stop bleeding) was stored in all ORs and a heart-lung/Cardiopulmonary bypass machine (CBM-equipment used to take over the function of the heart and lung during surgery) was stored in CV rooms 1 and 2.

The undated manufacturer's instructions for the cautery machine entitled Force Triad Energy Platform indicated, (page 9-3) the relative humidity range should be 30%-75%.

The undated manufacturer's operating instructions for the CBMs entitled Operating Instructions indicated, relative humidity range of 30%-75%.

Review of the OR daily humidity log on 6/26/18, at 11:54 a.m., dated from 6/1/18 to 6/26/18, indicated CV rooms 1 and 2, the humidity were 61.7 % to 90.7 %. On 9 of those days from 6/1/18 to 6/26/18 the humidity was above 75%. The recorded humidity range were all above the manufacturer's recommendation for the equipment.

During an interview with ADM 2 on 6/27/18, at 9:15 a.m., ADM 2 stated, The hospital follows guidelines for temperature and humidity as recommended by American National Standards Institute (ANSI), American Society for Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), and American Society for Healthcare Engineering (ASHE). ADM 2 further indicated in addition to those guidelines the facility relied on administration 11 (ADM 11) for consult.

ADM 2 provided a copy of the Healthcare Guidelines and Standards published by ANSI/ASHRAE/ASHE Standard 170, dated 2013. The report indicated on Table 7-1 the Relative Humidity range of 20-60% .

Review of the guidelines provided by ADM 2 concur with the humidity range of 20-60 %.

In an interview with ADM 11, on 7/2/18, at 3:22 p.m., ADM 11 stated, It is my understanding that the equipment in the operating rooms should remain at a humidity range, which would allow it to perform in the way it is intended. If we noticed this was not occurring we would contact the manufacturer to determine what ill effects it would have on the equipment over a prolonged time-period as this is what would cause the equipment to malfunction. However, I have not been made aware of or consulted on the humidity being out of range in any of our ORs.

The facility's policy and procedure entitled Monitoring of Temperature and Humidity last revised 6/2016, indicated, It is the policy of the Hospital to ensure safe environmental temperature and humidity levels. Optimum Temperatures for all operating rooms 68-75 degrees Fahrenheit and Relative Humidity range 20-60%. The facility's policy and procedure does not mention the process to notify ADM 11 regarding the use of OR equipment in high humidity areas and out of range himidity in the OR .

On 6/27/18 at 6:50 p.m., the IJ related to the out of range humidity in the 10 of 10 ORs, two of two CSRs, three of three CCL rooms, three of three GI rooms, one of one IR, and one OR sterile supply room was abated when an acceptable action plan was submitted and accepted.

On 6/28/18 at 1:30 p.m. the IJ regarding the out of range humity in the ORs was put back in place when 9 of 10 operating rooms (ORs1, 2,3,4,5,6,Cysto room, CV1 and CV2) continued to be out of compliance with the ANSI/AHRAE humidity recommendations and facility policy and procedure entitled Monitoring of Temperature and Humidity dated 6/16.

On 7/2/18 at 11:15 a.m.,the IJ was abated when all ORs and procedural areas were within recommended humidity levels by ANSI/ASHRAE and faciltiy policy.

3. During an initial observation and concurrent interview with licensed nurse 4 (LN 4), on 6/25/18, at 3:00 p.m., in the surgical suites area an empty E-size portable oxygen tank was found in the storage racks together with the full oxygen tanks. LN 4 observed the empty oxygen tank and stated, The black cap usually indicates it is full, but this oxygen tank is empty and it should not have been in this section.

The facility's policy and procedure titled Portable Oxygen Tank Storage-Safety with revised date 4/2018, indicated, E-size medical cylinder will be segregated in Full, In Use, and Empty storage racks.

4. During an initial observation in the central sterile processing room (area where surgical instruments are cleaned and sterilized) on 6/27/18, at 9:20 a.m., 4 towel clamps (surgical instrument used to clamp towels or hold human tissue together) were found with the lock box closed (where the joints of the instruments connect) inside of a surgical major tray, which was sterilized and prepared for surgical use.

During an observation and concurrent interview with central sterile technician (TECH1) on 6/26/18, at 9:35 a.m., a drawer in the gastrointestinal (GI) room 2 contained two peel pouches with straight scissors, and one peel pouch with a wire scissor, which were steam sterilized in the closed position. TECH 1 acknowledged the instruments were sterilized closed and stated, Yes, they should be in the open position.

An interview with ADM 7, on 6/27/18, at 9:22 a.m., ADM 7 confirmed the finding and stated, Yeah, those lock boxes should have been sterilized opened.

The facility policy and procedure titled Disinfection And Sterilization dated 1/14, indicated, Sterilizing agent must contact all surfaces. Open all lock boxes on instruments