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Based on interview with hospital employees and review of records the Board of Directors, medical staff, and administrative officials failed to be responsible for ensuring that clear expectations of safety for the provision of care were met.

This failure had the potential to have no preventive measures in place to address equipment maintenance, placing patients at risk for infections and fire during surgical procedures.

Findings:

No contract for the maintenance of the operating room humidifiers was listed on the hospital's list of contracts or documented in the reviews of contracted services contained in the hospital's log of contract reviews. Despite the hospital's problems with controlling the humidity in the operating rooms there was no documentation of a review of the quality of the maintenance of the operating room humidifiers. In an interview on 2/6/20 at 9:30 a.m., the chief nursing officer (CNO) stated that there was no contract for the maintenance of the humidifiers prior to the vendor proposal dated 2/5/20. There was no documentation that the quality assessment performance improvement (QAPI) program had included the preventive maintenance of the humidifiers in their review of services. The QAPI program failed to take appropriate action on the problem of controlling humidity in the operating rooms as was stated they would in their plan of correction from November 2019. During February 2020 the hospital failed to be able to continuously maintain the humidity level in all of the operating rooms within the recommended range and yet the Board of Directors, the medical staff, and administrative officials failed to stop surgery from being performed in the operating rooms. As a result, patients were put at immediate and ongoing risk for possible physical harm caused by the operation of hospital equipment and use of hospital supplies at low humidity without verifying if it was safe to do so. Refer to A-0083, A-0700, and A-0940.

The Condition of Participation was not met when:

The Board of Directors failed to ensure that the hospital's equipment was maintained in a manner that protected the safety of the patients. The hospital's facility maintenance department responsible for the hospital's buildings and equipment (both facility equipment and patient care equipment) did not ensure that all service provided was in compliance with the quality assessment performance improvement (QAPI) requirements. In 2019 the hospital was cited for the failure to document the review of preventive maintenance related to the monitoring of temperature and humidity in the operating rooms. The plan of correction submitted by the hospital administration stated the plan for preventing a recurrence of the deficient practice would be to "Review PM (preventive maintenance) records to ensure all equipment that requires PM is listed." The operating room humidifiers were not included on the list and there was no documentation available regarding review of the preventive maintenance for the operating room humidifiers. Preventive maintenance service performed on the humidifiers on 2/5/20 by an outside vendor showed the presence of waste in the strainers that would require an additional cleaning. The presence of waste in the humidifiers can affect their operation resulting in difficulty in controlling the operating room humidity. Surgery was performed in the operating rooms without restoring humidity to the range recommended by the hospital's policy and national standards or documenting a review of the safety for the use of the hospital's patient care equipment in a low humidity environment. Refer to A-0724 and A-0726.

The cumulative effect of the Board of Directors' failures to ensure the timely maintenance of the hospital's equipment was an inability to provide quality patient care in a safe environment.

Based on observation, interview, and record review, the facility failed to ensure the relative humidity (RH) was maintained within 30%-60% in six of six operating rooms (OR).

This failure had the potential to place patients and staff at risk for accidents, burns, and injuries.

Findings:

According to the Association of Perioperative Registered Nurses (AORN) Guidelines titled: "Design and Maintenance", dated 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 health care organization's policy and procedures ...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 observation on 2/04/20, beginning at 10:59 a.m., inside OR's 2,5, and 6, the humidity readings were as follows:

OR 2 humidity 27.5%
OR 5 humidity 27.5%
OR 6 humidity 24.5%

During a review of the policy and procedure titled, "Practices for Monitoring and Control of Temperature and Humidity in the Operating Room (OR)," dated 1/2020, indicated in part ... "Ensure that temperature and humidity in the OR's are maintained within American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) recommended guidelines ...ASHRAE recommended ranges for humidity are between 30%-60% relative humidity (RH)."

A review of the facility "Daily Temperature and Humidity Reports", dated 2/3/20 the humidity readings were as follows:

OR 2 humidity 24.5%
OR 3 humidity 24.4%
OR 4 humidity 23.7%
OR 5 humidity 24.7%
OR 6 humidity 23.5%
OR 7 humidity 23.6%

On 2/4/20 the humidity readings were as follows:

OR 2 humidity 17.8%
OR 3 humidity 17.6%
OR 4 humidity 17.4%
OR 5 humidity 17.9%
OR 6 humidity 18.0 %
OR 7 humidity 17.7%

The Daily Temperature and Humidity Report (DTHR) indicated the humidity range is to be 30%-60% RH.

During a concurrent interview and record review with the facilities manager (FM) on 2/4/2020 at 4:20 p.m., the FM indicated the humidity readings are taken at 6:00 a.m. before the surgical cases started in OR's 2,3,4,5,6, and 7. The FM acknowledged the humidity readings on 2/3-2/4/2020 were all out of range. The FM indicated receiving email alerts when the heating ventilation air conditioning (HVAC) system is out of range and is currently troubleshooting the problem.

During an observation on 2/05/2020, in OR's 2,3,4,5,6, and 7 beginning at 8:26 a.m., the humidity readings were as follows:

OR 2 humidity 27%
OR 3 humidity 26%
OR 4 humidity 26.5%
OR 5 humidity 26.5%
OR 6 humidity 26%
OR 7 humidity 25.5%

During an interview on 2/5/20, at 8:30 a.m., the surgery manager (SM) acknowledged the OR humidity levels were currently out of range and indicated surgical procedures were still taking place. The SM acknowledged when the humidity levels were low in the ORs there was a risk for fire and the potential for an unsafe environment.

During an interview with the support services vice president (SSVP) on 2/10/20 at 1:40 p.m., SSVP indicated all the OR's were out of range and under 30% humidity for 36 hours.

Review of the computer humidity reports (CHR) for ORs 2,3,4,5,6, and 7 revealed the RH was under 30%, from 10:00 p.m., on 2/2/20, thru 10:00 a.m., of 2/4/20, a total of 36 hours. Further review of the CHR revealed the humidity was under 25% for 25 of the 36 hours.

According to ASHRAE Guidelines titled: "Humidity Control Events in Perioperative Care Areas," dated 2019, indicated in part... "Possible responses to Humidity Control Events...when the lower RH limit is exceeded, there are two responses for the PD (perioperative decision) team to take: 1-If the RH is up to 5% below the lower RH limit for over 6 hours, the facility engineer should take corrective action and adjust the mechanical system to bring the RH up...the PD team should convene if the RH is out of range for more than 12 hours...if the RH is up to 5% below the lower RH limit for more than 24 hours, the PD team should consider halting operations for repairs...2-If the RH is more than 5% below the lower RH limit for more than 2 hours, the facility engineer should take corrective action and convene the PD team ...if the RH is more than 5% below the lower RH limit for more than 8 hours, it is very likely that the mechanical system needs repair...the PD team should consider halting operations until the issue is resolved.

During an interview with SSVP and facilities manager (FM) on 2/5/20 at 8:32 a.m., the SSVP and FM were asked if any outside vendors had been in the hospital to service any systems that supports the operating rooms (ORs) temperature & humidity. The SSVP and FM indicated no repairs or maintenance services had been performed to the systems that support the temperature & humidity in the ORs. The SSVP and FM further indicated no outside vendor had been in the hospital to service any of the systems (e.g. HVAC, humidifiers or steamers) that support the ORs in the hospital.

Based on interview and record review, the facility failed to ensure one out of 30 patient charts reviewed (Patient N 21), had an updated 24-hour history and physical (H&P) on the day of surgery.


This failure of having a no updated H&P placed the patient at increased risk for adverse consequences.


Findings:


During a concurrent interview and record review on 2/5/20, at 9:50 a.m., with licensed nurse (LN 1), Patient N 21's date of surgery was on 1/07/2020. LN 1 acknowledged the surgeon did not complete a physical exam (interval update) or document any changes in health status on the day of surgery. LN 1 indicated the surgeon should have documented the exam.

During a review of the facility's policy and procedure titled: "Medical Record: Surgical Patient Requirement" dated 3/17, indicated in part ... "An H&P must be done no sooner than 7 days prior to admission to the hospital ...an interval update must be signed if the H&P isn't done within 24 hours of surgery."

Based on interview and record, the facility failed to ensure medical records were complete for three out of 30 patients (Patients N 21, N 23, N 25) when the operative reports were not signed by the surgeon.

This failure had the potential for patient's medical records to be incomplete and inaccurate which could affect the planning of quality care.

Findings:

During a concurrent interview and record review on 2/5/20, at 9:55 a.m., with licensed nurse (LN 1), Patient N 21, N 23, and 25's operative reports were reviewed. LN 1 acknowledged the operative reports were not electronically signed by the surgeon and indicated they were an incomplete record and should be signed.

The facility policy and procedure titled: "Electronic Health Information," dated 12/17, indicated in part ... "The electronic signature is used as a means of attestation of the electronic health record entries...properly executed electronic signatures are considered legally binding as a means to identify the author of health record entries, confirm content accuracy and completeness."