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351 S PATTERSON AVE

SANTA BARBARA, CA 93111

GOVERNING BODY

Tag No.: A0043

The hospital's governing body failed to assume full responsibility for determining, implementing, and monitoring policies governing the hospital's total operation. The governing body failed to ensure that the hospital:

1. Provided a comprehensive quality assessment performance improvement (QAPI) program for surgical services that included patient safety goals by maintaining temperature and humidity in compliance with national standards (refer to A-0748 and A-0951).

2. Maintained the physical plant and overall hospital environment in a manner that ensured the safety and well-being of patients (refer to A-0724).

3. Implemented and maintained an ongoing, proactive, comprehensive quality assessment performance improvement (QAPI) program, which included the monitoring and implementation of QAPI studies in an effort to improve the quality and safety of the patient care services provided (refer to A-0263).

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

CONTRACTED SERVICES

Tag No.: A0083

Based on interview with hospital staff and review of documents the hospital failed to ensure the governing body was responsible for all services furnished in the hospital whether or not they were provided through formal contracts, joint ventures, informal agreements, shared services, or lease arrangements.

Findings:

Review of the governing body meeting minutes revealed evaluations of services provided by outside resources did not include those provided by all outside services. The quality assurance and performance improvement program did not include reviews of services considered to be non-clinical. In an interview on 11/14/2019 at 2 p.m. the hospital's VP stated only "clinical" contracts were reviewed.

CONTRACTED SERVICES

Tag No.: A0084

Based on interview with hospital staff and review of documents the hospital failed to ensure that patient care services, and all other services, provided under contract were subject to the same hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by the hospital.

The governing body failed to ensure that all services provided by an outside resource were provided in a safe and effective manner.

Findings:

Review of the documentation of QAPI evaluation of services furnished to the hospital by outside providers revealed that not all arrangements had been reviewed. In an interview on 11/14/2019 at 2 p.m. the hospital's VP stated only "clinical" contracts were reviewed. The contract with the vendor monitoring the temperature and humidity in the operating rooms was considered "nonclinical" and was not reviewed for quality.

CONTRACTED SERVICES

Tag No.: A0085

Based on interview with hospital staff and review of records the hospital failed to maintain a complete list of all contracted services, including the scope and nature of the services provided. Two of two requested contracts were not on the hospital's list of contracts.

Findings:

Review of the hospital's list of contracted services revealed that it did not include the arrangements with an outside vendor for monitoring the temperature and humidity in critical and semi-critical areas or the maintenance of the HVAC system. In an interview on 11/14/2019 at 2 p.m. the hospital's VP stated the list did not contain services provided under purchasing group contracts.

QAPI

Tag No.: A0263

The hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. The hospital's governing body failed to ensure that the program reflected the complexity of the hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

The hospital failed to:

1. Maintain a quality assessment and performance improvement (QAPI) program that incorporated all contracted services (refer to A-0083, A-0084, and A-0085).

2. Develop a QAPI program that included specific quality indicator data, focusing on high risk, high volume, or problem prone areas (refer to A-0748).

3. Implement a QAPI program reflected the hospital's services, involved all departments, and focused on indicators to improve health outcome and provide quality patient care and services (refer to A-0951).

4. Maintain a QAPI program which evaluated and monitored the safety of its services, and the quality of patient care, with data collection and analysis, leading to the implementation of preventive improvement plans (refer to A-0308).

5. Ensure the QAPI program was implemented and evaluated by the governing body which was responsible for establishing expectations for safety (refer to A-0309).

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

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on interview with hospital staff and review of documents the hospital's governing body failed to ensure that the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services (including those services furnished under contract or arrangement).

Findings:

Review of the QAPI program documentation revealed that not all services provided by outside resources had been reviewed. There was no documentation of review of services provided by the HVAC vendor or the company monitoring the temperature and humidity in the operating rooms. In an interview on 11/14/2019 at 2 p.m. the hospital's VP stated that only certain contracts were reviewed, but not those obtained through a purchasing group, such as the HVAC agreement.

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on interview with hospital staff and review of documents the governing body failed to ensure that the hospital's quality assurance and performance improvement (QAPI) program was implemented and maintained.

Findings:

Review of documents revealed the governing body had not required the QAPI program:

1. To identify and review the safety and efficacy of all services provided by outside resources (refer to A-0083 and A-0084).

2. To review and implement policies and procedures which were consistent with national guidelines for patient safety (refer to A-0748).

3. To respond and take appropriate action to alerts received when the humidity in the operating rooms was out of range (refer to A-0951).

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on interview and record review, the hospital failed to ensure the preventive maintenance (PMs) were being performed to the temperature and humidity monitoring system as recommended.

This failure puts the temperature and humidity monitoring system at risk of not being maintain to function properly.

Finding:

During a facility state licensing survey from 11/4/19 to 11/7/19, the {Manufacture's Name} temperature & humidity monitoring system was reported to be down intermittently from 11/4/19 at 11/6/19, by the facilities manager. The facility was not able to provide temperature and humidity recordings for their operating rooms ORs when requested.

During a review of the October and July 2019 preventive maintenance (PM) service report and concurrent interview with the facilities manager (Admin 10) on 11/15/19 at 9:15 a.m., Admin 10 reported the temperature and humidity monitoring system gets a preventative maintenance service every month as per the planned service agreement. Upon review of the PMs service reports, the reports did not indicate the {Manufacture's Name} temperature & humidity monitoring system was work on, or what was performed on the system. Overall, the report was unclear what was done on the monitoring system during those visits. Admin 10 was asked how does he ensures that the monitoring system representative performs the appropriate preventative maintenance work on the system, if the reports did not indicate the type of work performed on the PM visits. Admin 10 acknowledged the PMs reports provided were not specific to demonstrate that the temperature and humidity monitoring system received preventive maintenance in order for the system to function appropriately. Furthermore, Admin 10 acknowledged, the facility has been having problems with their ORs temperature and humidity and problems with their heat ventilation and air conditioning (HVAC) handlers.

The facility policy and procedure titled "Preventive Maintenance of Non-Patient Related Equipment", dated 01/18, indicated "To ensure proper operation of all non-patient related equipment by providing regularly scheduled preventive maintenance in accordance with...recommendations ..."

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

The hospital's infection control program failed to ensure the provision of a safe environment needed to avoid sources and transmission of infections and communicable diseases. The hospital's infection control program did not identify a problem when the humidity levels in the operating rooms were allowed to exceed the level recommended by national guidelines despite repeated notifications of the problem (refer to A-0748 and A-0951).

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

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observation, interview and record review the facility failed to:
1. Implement the policy and procedure for temperature and humidity control in the operating rooms (ORs).
2. Ensure patient care technicians (PCTs) were competent to perform a room turn-over (cleaning of surgical rooms) between cases.

These facility's failure had the potential to put surgical patients at risk for surgical site infections.

Findings:

According to AORN Guidelines titled: "Safe Environment of Care, Part 2 (2017)": "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 health care organization's policy and procedures."..."The temperature range for sterile storage is maximum 75° F and humidity maximum of 60 %."..."The operating/procedure room temperature is 68°F to 73°F and the humidity range is 20% to 60%."

During an observation on 11/13/19, beginning at 3:32 p.m., the temperature and humidity were as follows:

OR 3 temperature 64°F and humidity 72%
OR 4 temperature 62.5°F and humidity 74.5%
OR 5 temperature 61°F and humidity 71%
OR 6 temperature 62.5°F and humidity 68.5%
OR 7 temperature 62.5°F and humidity 70.5%

During an interview with the surgery services manager (Admin 6) on 11/13/19, at 5:08 p.m., Admin 6 acknowledged the out of range temperature and humidity in ORs 3,4,5,6 and 7. Admin 6 explained she had gotten email alerts but had yet to take action.

During an interview with vice president (Admin 1) on 11/13/19 at 5:15 p.m., Admin 1 acknowledged temperature and humidity control in the ORs is a concern and further indicated the facility policy and procedure on temperature and humidity is not adequate.

Review of the temperature and humidity logs for OR 2 dated 11/13/19 revealed the temperature and humidity were out of range from 5:10 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 3 dated 11/13/19 revealed the temperature and humidity were out of range from 5:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 4 dated 11/13/19 revealed the temperature and humidity were out of range from 5:20 a.m. to 6:20 p.m.

Review of the temperature and humidity logs for OR 5 dated 11/13/19 revealed the temperature and humidity were out of range from
12:00 a.m. to 4:00 a.m. and from 5:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 6 dated 11/13/19 revealed the temperature and humidity were out of range from 7:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 7 dated 11/13/19 revealed the temperature and humidity were out of range from 7:20 a.m. to 5:30 p.m.

Review of the OR surgery schedule dated 11/13/19 indicated surgical cases were scheduled for OR's 3,4,5,6, and 7 beginning at 7:15 a.m. until 2:00 p.m.

During an interview with the director of infection control (Admin 14) on 11/15/19, at 9:15 a.m., Admin 14 indicated there are temperature and humidity concerns at this time, and was aware they were not within range on several dates. Admin 14 indicated moving forward infection control would be more involved.

The facility policy and procedure titled "Temperature and Relative Humidity Record" dated 1/18, indicated in part ... "To ensure the proper temperature and relative humidity are maintained in designated areas ...operating room benchmarks: temperature 68°F-73°F and relative humidity 30-60%...record temperature and humidity readings ...ensure that temperature and humidity and airflow in the operating rooms must be maintained within acceptable standards to inhibit growth, prevent infection and provide patient comfort ...the relative humidity level in the operating rooms will be maintained at 30-60% RH to maintain compliance with joint Commission and infection control standards ...the surgical staff will verify that the OR is within the requirements for the temperature, humidity at the beginning of each procedure ...temperature and humidity should be monitored by the surgical staff and Facilities/Engineering ...Engineering will notify the department of alarm conditions outside of the required temperature and humidity range ...the affected department will ensure rooms temperatures are within 68-73 degree range ...alternate room use will be considered ...upon notification of temperature and/or humidity outside of the range, the notified department and Engineering will make an attempt to return the room to range."


16739

In an interview on 11/13/2019 at 12:30 p.m. the maintenance supervisor stated he received an email from the vendor software program each time the temperature or humidity was out of range. He stated he took no action on the notifications while the room was being used and only adjusted the levels after the staff had left for the day.


35399

2. During a review of patient care technician PCT 1's (2018) Competency Summary and concurrent interview with the infection preventionist (IP) administrator (admin 14) on 11/15/19 at 10:30 a.m., admin 14 was asked that from an IPs prospective, if s/he was involved in ensuring the PCTs were competent to perform surgical room turn-over (cleaning of a surgical room) between cases or if she oversaw the surgical competencies for the PCTs. Admin 14 indicated, she was not involved in doing that. It was shared with Admin 14 that during an observation in operating room (OR) six on 11/05/19 at 9:40 a.m., the patient care technicians (PCT 1) and (PCT 2) were cleaning the operating room between patients. PCT 2, with gloves, removed the biohazard trash and dirty linen, left the OR, touching the OR door without changing gloves. PCT 2 came back into the OR with the same dirty gloves and continued to clean. PCT 1 was cleaning from top- to- bottom method. After cleaning the step stool on the floor, PCT 1 discarded the cleaning wipe, did not change the dirty gloves and began touching the clean operating table. There were concerns regarding the room turn over competencies for the PCTs in the surgical area. Admin 14 acknowledged not being involved in ensuring the PCTs were competent to perform OR room turn-over and was not able to provide any evidence ensuring the PCTs were competent with every step in the room turn-over process as per the Association of periOperative Registered Nurses (AORN) guidelines, the surgical guidelines the facility had adopted.

During an interview with the surgical manager (Admin 6) on 11/15/19 at 10:45 a.m., it was shared with admin 6 there was a concern regarding the surgical PCTs not being competent to perform a room turn over during patients' cases. Admin 6 acknowledged this and stated "I know there are concerns regarding the PCTs room turn over cleaning practices. I agree my staff competencies need to be more specific and I have to make sure the PCTs are competent with cleaning."

SURGICAL SERVICES

Tag No.: A0940

The hospital failed to provide surgical services in accordance with acceptable standards of practice in such a manner as to ensure the health and safety of patients. Acceptable standards of practice include maintaining compliance with applicable Federal and State laws, regulations and guidelines governing surgical services or surgical service locations, as well as, any standards and recommendations promoted by or established by nationally recognized professional organizations. The hospital failed to provide a safe environment for the provision of surgical services when the humidity was allowed to remain out of the recommended range (refer to A-0748 and A-0951).

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

SURGICAL PRIVILEGES

Tag No.: A0945

Based on interview and record review the facility failed to have a supervising surgeon evaluate and sign the annual competencies for two of two Registered Nurse First Assistants (a peri-operative registered nurse who functions in an expanded role) (RNFA 1 and RNFA 2).

This failure had the potential for adverse outcomes in surgical cases when RNFA's are providing care and are not signed off as competent to do so.

Findings:

A review of the RNFA job description indicated in part..." The RNFA is a peri-operative nurse who works in collaboration with the surgeon and health care team members to achieve optimal patient outcomes...the RNFA must have acquired the necessary knowledge, judgement, and skills specific to the expanded role of the RNFA clinical practice... intraoperatively, the RNFA practices at the direction of the surgeon and does not function as a scrub nurse...performs clinical duties as prescribed by the Medical staff scope of practice for physician assistants... intra-operative surgical first assisting, including but not limited to: using instruments/medical devices, providing exposure handling and or cutting tissue, providing hemostasis (to stop blood loss), and suturing (thread and needle to sew tissue back together)."

During an interview with surgery services manager (Admin 6) on 11/19/19 at 12:07 p.m. indicated the RNFA's under direct supervision, assist the surgeon in the operating room. Admin 6 indicated that the surgeons keep a record of the RNFA's surgical privileges and competencies. Admin 6 further indicated the she and the surgeon signs off on the annual evaluations.

During a review of the Cottage Health System (CHS) Supervisory agreements indicated that RNFA1 and RNFA 2 are Allied Health Professionals (AHP). The agreement further indicated in part... "both the physician and the AHP are responsible for adhering to the generally accepted standards of heath care...the AHP and supervising physician agree to participate in the monitoring, peer review and quality improvement programs of CHS."

During a review of RNFA 1 and RNFA 2's annual competencies and concurrent interview with Admin 6 and the director of nursing (Admin 13) on 11/15/19 at 8:44 a.m. acknowledged both competencies were not signed by a supervising surgeon and indicated they should be.

The facility policy and procedure titled "Authorization of Clinical Assistants to Provide Services" dated 12/14, indicated in part... "Clinical assistants must be qualified by academic education and clinical experience or other training specified in the approved scope of practice or job description to provide patient care services in a clinical or supportive role...Clinical assistants provide services only under the supervision of a member of the medical staff...to be eligible to provide clinical services consistent with this policy, clinical assistant must: have demonstrated clinical competence in his or her discipline consistent with the level of education and experience set forth in the relevant job description."

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and record review, the facility failed to ensure a safe and sanitary environment for surgical services when:

1. Temperature and humidity in the operating rooms (ORs) were out of range.

2. One laryngeal mask airway (A laryngeal mask airway (LMA) - also known as laryngeal mask- is a medical device that keeps a patient's airway open during anesthesia or unconsciousness) and two LMA combination tubes (used during an airway management emergency) were not sterilized.

3. Temperature and humidity in the operating rooms (ORs) were out of range, during surgical cases, and there was no evidence of any actions taken to resolve the problem.

4. There was no implementation of a back up plan when the {Manufacture's Name} temperature & humidity monitoring system was down.

5. The preventive maintenance (PMs) were not being performed to the temperature and humidity monitoring system as recommended.

These facility failures had the potential to put surgical patients at risk for surgical site infections and transmission of disease.

Findings:

According to AORN Guidelines titled: "Safe Environment of Care, Part 2 (2017)": "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 health care organization's policy and procedures."..."The temperature range for sterile storage is maximum 75° F and humidity maximum of 60 %."..."The operating/procedure room temperature is 68°F to 73°F and the humidity range is 20% to 60%."

1. During an interview with surgery services manager (Admin 6) and facilities manager (Admin10) on 11/13/19, at 10:53 a.m., Admin 10 indicated the facilities staff monitor temperature and humidity in the OR before cases start each morning, and receive email alerts throughout the day when temperature and humidity are out of range. Admin 6 indicated the OR staff adjust the temperature in the OR based on physician request.

During a review of the temperature and humidity logs for OR 4 on 11/6/19 and concurrent interview with Admin 6 on 11/13/19 at 11:15 a.m., Admin 6 acknowledged the temperature and humidity was out of range from 9:40 am until 7:30 p.m., and surgical cases continued during those hours.

During an observation on 11/13/19, beginning at 3:32 p.m., the temperature and humidity were as follows:

OR 3 temperature 64°F and humidity 72%
OR 4 temperature 62.5°F and humidity 74.5%
OR 5 temperature 61°F and humidity 71%
OR 6 temperature 62.5°F and humidity 68.5%
OR 7 temperature 62.5°F and humidity 70.5%

During an interview with Admin 6 on 11/13/19, at 5:08 p.m., Admin 6 acknowledged the out of range temperature and humidity in ORs 3,4,5,6 and 7. Admin 6 explained she had gotten email alerts but had yet to take action.

During an interview with Admin 1 on 11/13/19 at 5:15 p.m., Admin 1 acknowledged temperature and humidity control in the ORs is a concern and further indicated the facility policy and procedure on temperature and humidity is not adequate.

Review of the temperature and humidity logs for OR 2 dated 11/13/19 revealed the temperature and humidity were out of range from 5:10 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 3 dated 11/13/19 revealed the temperature and humidity were out of range from 5:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 4 dated 11/13/19 revealed the temperature and humidity were out of range from 5:20 a.m. to 6:20 p.m.

Review of the temperature and humidity logs for OR 5 dated 11/13/19 revealed the temperature and humidity were out of range from
12:00 a.m. to 4:00 a.m. and from 5:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 6 dated 11/13/19 revealed the temperature and humidity were out of range from 7:20 a.m. to 6:00 p.m.

Review of the temperature and humidity logs for OR 7 dated 11/13/19 revealed the temperature and humidity were out of range from 7:20 a.m. to 5:30 p.m.

Review of the OR surgery schedule dated 11/13/19 indicated surgical cases were scheduled for OR's 3,4,5,6, and 7 beginning at 7:15 a.m. until 2:00 p.m.

The facility policy and procedure titled "Temperature and Relative Humidity Record" dated 1/18, indicated in part ... "To ensure the proper temperature and relative humidity are maintained in designated areas ...operating room benchmarks: temperature 68°F-73°F and relative humidity 30-60%...record temperature and humidity readings ...ensure that temperature and humidity and airflow in the operating rooms must be maintained within acceptable standards to inhibit growth, prevent infection and provide patient comfort ...the relative humidity level in the operating rooms will be maintained at 30-60% RH to maintain compliance with joint Commission and infection control standards ...the surgical staff will verify that the OR is within the requirements for the temperature, humidity at the beginning of each procedure ...temperature and humidity should be monitored by the surgical staff and Facilities/Engineering ...Engineering will notify the department of alarm conditions outside of the required temperature and humidity range ...the affected department will ensure rooms temperatures are within 68F-73F degree range ...alternate room use will be considered ...upon notification of temperature and/or humidity outside of the range, the notified department and Engineering will make an attempt to return the room to range."


34445


2. According to the Centers for Disease Control and Prevention (CDC) "A Rational Approach to Disinfection and Sterilization-Guideline for Disinfection and Sterilization in Healthcare Facilities "2008, indicates in part "Semi-critical items contact mucous membranes or non-intact skin. This category includes respiratory therapy and anesthesia equipment ...These medical devices should be free from all microorganisms ..."

During an observation in operating room (OR) one, and concurrent interview with administrator (Admin 6) on 11/13/19, at 12:15 p.m., Admin 6 acknowledged and confirmed a LMA stored ready for use on an OR cart in a sterilization peel pouch, did not include a chemical indicator or change of color indicator (red to brown) to suggest sterilization was performed. Admin 6 took the item (LMA) to check with the sterile processing staff.

During an interview with sterile processing department technician (SPD Tech 1) on 11/13/19, at 3:10 p.m., SPD Tech 1 explained the process of cleaning and sterilizing LMA's. SPD Tech 1 explained LMA's should be sterilized and you place an indicator (chemical) inside the peel pouch with the LMA and the indicator should have a color change to a dark blue color, and the peel pouch steam indicator will change to brown in color after sterilization. When asked if the LMA brought to her by Admin 6 appeared to be sterilized, SPD Tech 1 replied "No"

During an observation of the contents in a difficult airway cart and concurrent interview with SPD Tech 1 on 11/13/19, at 3:23 p.m., SPD Tech 1 acknowledged and confirmed two packages with LMA combination tubes had no chemical indicator and the peel pouch had no steam indicator color change. When asked if these items were safe for use, SPD Tech 1 replied "No."

The facility policy and procedure titled "Cleaning/Sterilization of Intavent Laryngeal Mask Airway" dated 10/16, indicated in part "Purpose: To provide consistent guidelines for the cleaning and sterilization of the Laryngeal Mask Airway (LMA) in facilities within the Cottage Health System to prevent cross contamination between patients. D. Peel package the LMA with the appropriate steam chemical indicator and the outside with the size of the LMA. E. The LMA may be steam sterilized in a flash, pre-vacuum or gravity cycle ..."


35399

3. The facility policy and procedure titled "Temperature and Relative Humidity Record" dated 1/18, indicated in part ... "To ensure the proper temperature and relative humidity are maintained in designated areas ...operating rooms ... ...ensure that temperature and humidity and airflow in the operating rooms must be maintained within acceptable standards to inhibit growth, prevent infection and provide patient comfort ...the relative humidity level in the operating rooms will be maintained at 30-60% RH to maintain compliance with ... infection control standards ...temperature and humidity should be monitored by the surgical staff and Facilities/Engineering ...Engineering will notify the department of alarm conditions outside of the required temperature and humidity range ...upon notification of temperature and/or humidity outside of the range, the notified department and Engineering will make an attempt to return the room to range."

During an interview with facilities manager (Admin 10) on 11/14/19 at 3:13 p.m., Admin 10 explained he reviews the {Manufacture's Name} temperature & humidity monitoring system daily at 6:00 a.m., to check if the designated rooms (e.g. operating rooms & SPD ...) temperature and humidity are within acceptable range. Then, he does not check the monitoring system, unless he receives an email alert indicating a designated room's temperature or humidity is out of range. However, there is no specific or designated frequency as to when he checks his email messages. According to Admin 10, he becomes aware that a room's temperature or humidity is out of range when he gets notify by the surgical staff. At that point, the surgical staff or him adjust the temperature or humility gauges to bring the temperature or humidity back to range.

The following {Manufacture's Name} temperature & humidity monitoring system email alerts were reviewed with Admin 10:

On 11/1/19, there were six alert emails indicating the humidity in ORs 1-6 were out of range (62.8% -65.3%).
On 11/3/19, there were ten alert emails indicating the humidity in ORs 2-7 were out of range (62.0% -68.3%).
On 11/4/19, there were five alert emails indicating the humidity in ORs 2,4, 5, 6, & 7 were out of range (61.1% -65.7%).
On 11/5/19, there were six alert emails indicating the humidity in ORs 2,4,5, 6, & 7 were out of range (61.5% -67.5%).
On 11/6/19, there were four alert emails indicating the humidity in ORs 4,5, 6, & 7 were out of range (62.8% -73.4%).
On 11/7/19, there were six alert emails indicating the humidity in ORs 2-7 were out of range (61.1% -68.7%).
On 11/8/19, there were six alert emails indicating the humidity in ORs 2,& 4-7 were out of range (61.1% -70.4%).
On 11/9/19, there were seven alert emails indicating the humidity in ORs 2-7 were out of range (62.0% -73.8%).
On 11/10/19, there was one alert email indicating the humidity in OR 5 was out of range (66.6%).
On 11/11/19, there were ten alert emails indicating the humidity in ORs 2-7 were out of range (62.0% -69.2%).
On 11/12/19, there were seven alert emails indicating the humidity in ORs 4-7 were out of range (62.0% -68.3%).
On 11/13/19, there were 14 alert emails indicating the humidity in ORs 2- 7 were out of range (62.0% -71.7%).
On 11/14/19, there were ten alert emails indicating the humidity & Temperature in OR 3 was out of range (65.3% -65.8% and Temperature > 78.5 degrees).

Admin 10 was asked to share documentation of the interventions performed for the above email alerts indicating the OR temperature and/or humidity were out of range. Admin 10 stated "I don't have any documentation of what was done, the location or when it was done to bring the temperature or humidity back to range." Admin 10 was asked that if he does not have any documentation or evidence as to what was done to bring the rooms temperature or humidity back to range. How do I know that the problem with the temperature or humidity was even addressed, or that the email alert was even acknowledged and action was taken to address the problem? Admin 10 stated "I don't know. I don't have anything." Facility was not able to provide any evidence that the {Manufacture's Name} temperature & humidity monitoring system email alerts were addressed and an action was taken to resolve the problem.

4. According to AORN Guidelines titled: "Safe Environment of Care, Part 2 (2017)": "The health care organization should create and implement a systematic process for monitoring of Heating, ventilation and air conditioning (HVAC) performance parameters and a mechanism for resolving variances. The operating/procedure room temperature is 68°F to 73°F and the humidity range is 20% to 60%."

The facility policy and procedure titled "Temperature and Relative Humidity Record" dated 1/18, indicated in part ... "To ensure the proper temperature (68-73 F) and relative humidity are maintained in designated areas ...operating rooms...the relative humidity level in the operating rooms will be maintained at 30-60% RH to maintain compliance with ... infection control standards.

During an interview with administrator (Admin 10) on 11/14/19 at 3:15 p.m., Admin 10 was reminded the reason for him not providing the ORs temperature and humidity logs when requested on 11/4/19 for the state licensing survey. Admin 10 explained that the {Manufacture's Name} temperature & humidity monitoring system vendor representative was working on the monitoring system software on 11/4/19. Admin 10 was reminded that on 11/7/19, when he was interview in the basement, while we were viewing the monitoring system to obtain the "live" temperature and humidity recordings. He was asked that if the monitoring system was down, how they were monitoring the ORs temperature and humidity. Admin 10 had indicated, he did not know and that there was no back up plan. Therefore, he was not able to provide ORs temperature and humidity recordings for 11/4/19 to 11/6/19. Admin 10 acknowledged that the facility failed to develop and implement a backup plan when their temperature & humidity monitoring system was down, while the vendor representative was working on the monitoring system software.

5. The facility policy and procedure titled "Preventive Maintenance of Non-Patient Related Equipment", dated 01/18, indicated "To ensure proper operation of all non-patient related equipment by providing regularly scheduled preventive maintenance in accordance with...recommendations ..."

During a facility state licensing survey from 11/4/19 to 11/7/19, the {Manufacture's Name} temperature & humidity monitoring system was reported to be down intermittently from 11/4/19 at 11/6/19, by the facilities manager. The facility was not able to provide temperature and humidity recordings for their operating rooms ORs when requested.

During a review of the October and July 2019 preventive maintenance (PM) service report and concurrent interview with the facilities manager (Admin 10) on 11/15/19 at 9:15 a.m., Admin 10 reported the temperature and humidity monitoring system gets a preventative maintenance service every month as per the planned service agreement. Upon review of the PMs service reports, the reports did not indicate the {Manufacture's Name} temperature & humidity monitoring system was work on, what was performed on the system. Overall, the report was unclear what was done on the monitoring system during those visits. Admin 10 was asked how does he ensures that the monitoring system representative performs the appropriate preventative maintenance work on the system, if the reports did not indicate the type of work performed on the PM visits. Admin 10 acknowledged the PMs reports provided were not specific to demonstrate that the temperature and humidity monitoring system received preventive maintenance in order for the system to function appropriately. Furthermore, Admin 10 acknowledged, the facility has been having problems with their ORs temperature and humidity and problems with their heat ventilation and air conditioning (HVAC) handlers.

POST-OPERATIVE CARE

Tag No.: A0957

Based on record review and interview the facility failed to have PACU (Post Anesthesia Care Unit - area in medical facilities providing care for patients recovering from surgery) staff initiate and implement a postoperative care plan for three of 14 sampled medical record reviews (Patient 315, 402, and 411).

This facility failure had the potential to result in unmet care needs and undermine expected patient outcomes.

Finding:

The facility policy and procedure titled "Standard of Nursing Practice in the PACU" dated 5/17, indicated in part ..."Goal: to provide a framework for nurses practicing in all phases of peri-anesthesia care...7. The professional peri-anesthesia nurse develops and coordinates the implementation of a dynamic plan of care based on analysis of the individual patient assessment. 8. the professional peri-anesthesia nurse continuously evaluates the patients progress toward the desired outcomes and revises the plan of care and interventions as necessary..."

The facility policy and procedure titled "Standards of Patient Care" dated 6/17, indicates "...Care plans are interdisciplinary and may be developed and edited by other disciplines. Nursing retains the responsibility to ensure care plans are developed per patient need."

During a review of the medical record for Patient 315 and concurrent interview with medical/surgical manager (Admin 7) on 11/14/19, at 10:35 a.m., Admin 7 acknowledged and confirmed there were no care plans initiated at all for Patient 315 while receiving care in the in the post anesthesia care unit (PACU). Admin 7 stated "It looks like the (PACU) nurse did not initiated any care plans for this patient (Patient 315)."


40904


Record reviews for Patient 402 and 411 on 11/14/19, indicated that there were no care plans initiated in the PACU after surgery.

During an interview with Admin 7 on 11/14/19, at 4:20 PM, she confirmed there were no care plans initiated on both patients since there was nothing seen in the medical records. She further states "If we can't find them in the electronic record, then there's probably none...I agree that they are essential and necessary for every patient, but I really cannot speak to it since it is not my unit."

During another interview with Admin 6 on 11/15/19, at 9:35 AM, she further confirms Patients 402 and 411 had no care plans initiated in the PACU. She states "Yes, they had none...I checked them myself. It doesn't matter whether you guys are here or not. Going forward, I might suggest a hard stop in the electronic record. No excuses...it just has to be done."

The facility policy and procedure (P&P) titled "Nursing Documentation of Patient Care," dated 2/17, indicated in part "...Patient Care Planning - initiated by an RN...nursing retains the responsibility to ensure care plans are developed per patient need...includes the plan of care, goals and disciplines involved with care...completed at minimum each shift..."

The facility P&P titled "Standards of Patient Care," dated 6/17, indicated in part "...Patient plan of care includes cost-effective interventions to achieve the expected goals/outcomes that are of value to the patient...initiated by an RN...plan of care is based on needs identified...the written plan of care is based on the patient's goals and the timeframe's, setting, and services required to meet those goals..."

OPERATING ROOM REGISTER

Tag No.: A0958

Based on interview and record review, the facility failed to provide a complete and accurate register of operations for each surgical procedure performed. This failure had the potential to result in the inability to look back at surgical procedures for specific data.

During an interview with surgery services manager (Admin 6) on 11/13/19, at 12:00 p.m., Admin 6 was asked to provide the operating room (OR) log or register. Admin 6 was unfamiliar with what this was and what contents were needed.

During a record review of the OR log provided dated 10/1/19 to 10/31/19, the log was incomplete and missing: type of anesthesia used, pre-operative and post-operative diagnosis, OR personnel, complications if any and operative time.

The facility policy and procedure titled "Medical Record: Surgical Patient Requirement" dated 3/17, indicated in part " ...6. A register of operations shall be maintained including the following information for each surgical procedure performed ... 2.) Date and time of the operation and the operating room number 3.) Preoperative and postoperative diagnosis 4.) Name of surgeon, assistants, anesthesiologists, scrub and circulating personnel 5.) anesthetic agents used ..."