HospitalInspections.org

Based on observation and interview, building systems construction and physical plant maintenance deficiencies were present. Specifically, (1) 6 doors lacked self-closing devices and/or had devices that did not fully close and latch the door, as required for the room type. (2) Clean supplies were stored under unprotected sanitary drainpipes. (3) The Ambulatory Surgical Unit (ASU) Endoscopy Soiled Decontamination room and Clean room had incorrect ventilation pressures and there was no physical separation between the soiled and clean room where the clean endoscope cabinet was located. (4) An Environmental Services (EVS) room lacked exhaust ventilation. Improper design, construction, and maintenance of the physical plant and building systems can result in potential harm to patients and staff.

Findings related to (1) include:

-- Per observation on 8/4/2021 between 9:00 am and 12:00 pm, the following room doors were either missing self-closing devices and/or door closers were present but did not close and completely latch the door as required: the morgue, mechanical room, laundry room, EVS room #108, Emergency Department (ED) EVS room, and the operating room (OR) suite EVS room.

Findings related to (2) include:

-- Per observation on 8/4/2021 at 9:00 am, the Materials Management Clean Supply Storage room had newly installed, unprotected sanitary drainpipes running above the clean supplies stored on multiple rows of shelves.

Findings related to (3) include:

-- Per observation on 8/4/2021 at 11:30 am, the ASU Endoscopy Soiled Decontamination room and Clean room had incorrect ventilation/air pressures (i.e., the required air pressures were reversed so the soiled room had positive supply pressure (instead of negative exhaust), and the clean room had negative exhaust pressure return (instead of positive supply air). Additionally, there was no separation between the soiled and clean work room where the clean endoscope storage cabinet was stored, approximately three feet, from the soiled decontamination sink.

Findings related to (4) include:

-- Per observation on 8/4/2021 at 11:45 am, the ASU EVS room lacked exhaust ventilation (no ceiling vent observed) to provide the required negative air pressure.

During interview of Staff A, Director of Plant Operations, on 8/4/2021 between 9:00 am and 12:00 pm, he/she acknowledged all the above findings.

Based on observation and interview, regulated medical waste (RMW) trash was improperly stored in a multi-function room that lacked required exhaust ventilation. Lack of dedicated storage for RMW and no exhaust ventilation for negative pressure creates an infection control risk.

Findings include:

-- Per observation on 8/4/2021 at 9:45 am, the morgue room (housing a refrigerated cooler unit) contained several red bags of RMW waste and two boxes of full sharps containers stored behind a curtain at the back wall of the room. There was no exhaust ventilation observed in the room.

-- During interview of Staff A, Director of Plant Operations on 8/4/2021 at 9:45 am, he/she acknowledged the above finding.

Based on observation and interview, cleaning supplies were improperly stored in a cabinet (not a separate room or closet with proper exhaust) in the basement corridor. Corridor storage creates a safety risk to patients and staff needing to exit during an emergency.

Findings include:

-- Per observation on 8/4/2021 at 10:45 am, a cabinet located in the basement corridor (across from the staff lounge) was used to store the main supply of environmental services cleaning supplies and chemicals (e.g., gallons of bleach, cleaning chemicals, Windex and soap).

-- During interview of Staff B, Director of Environmental Services/Housekeeping on 8/4/2021 at 10:50 am, he/she stated this was the permanent main storage location for their department supplies and acknowledged this finding.

Based on document review and interview, Ambulatory Surgery Unit (ASU) staff did not report inadequate humidity readings in procedure and sterile rooms as required by hospital policy and procedure (P&P). Uncorrected humidity readings in surgical and storage areas creates a patient safety risk.

Findings include:

-- Review of the hospital's P&P titled "Temperature and Humidity Monitoring," last approved 3/2020, indicated that required relative humidity (in procedure and sterile rooms) should be between 30%-60%. The P&P states that unacceptable ranges should be reported to Plant Operations by Director of Surgical Services or ASU staff immediately.

-- Per review of the daily ASU Room Temperature and Humidity logs from 12/2020 to 6/2020, most days showed a humidity reading of less than 30% relative humidity. There were five instances where a note was added that maintenance was notified but no follow up documentation was available.

-- During interview of Staff C, ASU Nurse Manager, on 8/5/2021 at 3:30 pm, he/she was not aware of any reports regarding the unacceptable humidity readings.

-- During interview of Staff A, Director of Plant Operations, Staff D, Director of Ancillary Services and Staff E, Facilities Consultant on 8/6/2021 at 11:00 am, they stated they were unaware of any reports regarding low humidity issues in the ASU spaces and acknowledged the above findings.

Based on observation, document review and interview, the hospital did not ensure there was a system in place to effectively maintain and monitor the environmental status of the Compounding Sterile Products (CSP) room in compliance with United States Pharmacopeia (USP) 797 requirements, as referenced in the hospital policy and procedure (P&P). Specifically, staff were not adequately monitoring the CSP room. The hospital lacked P&P of all required CSP room environmental monitoring operations. The pharmacy staff job descriptions/pharmacist services contract lacked an outline of duties related to CSP room. The hospital lacked documentation of pharmacy staff training regarding the CSP room use/operations/cleaning. This can lead to unsafe medication handling and patient harm.

Findings include:

-- Per observation on 8/4/2021 at 3:00 pm, the CSP room computer screen, that monitors the environmental status (temperature, humidity, pressure, particle count, etc) of the pharmacy rooms, was flashing red warnings indicating error status.

-- Per review of hospital P&P titled "Cleaning the Compounded Sterile Products (CSP) Room," revised 5/2020, USP 797 is the hospital's referenced national standard for compliance. The P&P outlines requirements for daily and monthly cleaning of the CSP room and requirements for documenting pressure monitoring, temperature, and humidity.

-- Per review of the "Clean Room Pressure Monitoring Form," dated 2021, for the months of May, June, July and August, pharmacy staff were documenting daily pressure readings from the manual pressure gauges in the CSP room. However, no other documentation of manual testing for the temperature, humidity, particle count, etc. was completed in past 4 months as a substitute while the CSP computerized monitoring system was in error status. Electronic monitoring alarms were not functioning to notify staff if the above readings fell out of acceptable range, and manual testing was needed for all above parameters to replace the inactive computerized monitoring.

-- Per review of the hospital's job description for the pharmacy technician title, there were no specific job duties or competencies listed for operating, cleaning, and monitoring the CSP room per USP 797 requirements. Additionally, the supervising pharmacist's contract lacked description of required services related to CSP room and competency requirements for operating a compliant CSP room under USP 797 standard.

-- Per interview of Staff F, Supervising Pharmacist on 8/4/2021 at 3:00 pm, he/she indicated the CSP room monitoring system was not functioning for a while (at least 4 months). He/she also indicated there was no other manual testing completed by pharmacy staff of the CSP room in place of the computerized monitoring that was not completely functioning. Staff G, Pharmacy Technician also indicated that no other manual testing of the above readings was done by staff in place of the computerized monitoring system that was in error status.

-- Per interview of Staff D, Director of Professional Services, Staff A, Facilities Supervisor and Staff E, Facilities Consultant on 8/6/2021 at 2:00 pm, all acknowledged the above findings and also confirmed there is no documented training or competencies at this time as required by USP 797 for the current pharmacy staff operating and monitoring the CSP room.

Based on medical record (MR) review and interview, in 3 of 3 surgical patients (Patient's #1, #2 and #3) MRs reviewed, anesthesia consent forms and/or informed consent forms lacked the name of the anesthesiologist providing anesthesia services and the date and/or time the consents were obtained by the provider, anesthesiologist or patient. This could lead to improperly executed consent forms.

Findings include:

-- Per review of Patient #1's MR, date of service 5/13/2021, his anesthesia consent form lacked the name of the anesthesiologist providing the anesthesia, the date and time the anesthesiologist obtained the consent and the date and time the patient signed the consent form.

-- Per review of Patient #2's MR, date of service 6/24/2021, his anesthesia consent form lacked the date and time the anesthesiologist obtained the consent and the date and time the patient signed the consent form.

-- Per review of Patient #3's MR, date of service 7/2/2021, his anesthesia consent form and informed consent form (for the procedure) lacked the date and time he signed the forms.

-- During interview of Staff C, Ambulatory Surgery Unit Nurse Manager, on 8/5/2021 at 3:30 pm, he/she acknowledged the above findings.

Based on observation, interview and document review, hospital staff did not ensure all visitors entering the hospital were screened appropriately for potential exposure to COVID-19 including assessment of symptoms/illness based on New York State (NYS) guidance and the hospital's current screening process. This lack of screening could lead to transmission of COVID-19.

Findings include:

-- Per observation on 8/4/2021 at 8:30 am, Staff H, Door Screener, checked the temperatures of the 3 NYS Department of Health surveyors entering the hospital. He/she did not ask any screening questions e.g., symptoms, travel, contact with a person with COVID-19 or in quarantine, etc. Staff H acknowledged the findings at the time of observation.

-- Review of the hospital's document titled "Entry Screening Plan COVID Response (Patient and Vendors)," updated 1/15/2021, indicated all non-staff persons entering the facility will be screened upon arrival and added to the screening log ... . "COVID Visitor Screening Questions" include:

1. What service are you here for?

2. Have you had any of the following symptoms in the past two weeks:
a. Fever or chills
b. Cough
c. Shortness of breath or difficulty breathing
d. Fatigue
e. Muscle or body aches
f. Headache
g. New loss of taste or smell
h. Sore throat
i. Congestion or runny nose
j. Nausea or vomiting
k. Diarrhea

3. Have you traveled outside of NYS or to an area at high risk for COVID?

4. Have you been in contact with someone who has COVID-19 or has been in quarantine in the past 2 weeks.
If they answered yes to any of the above, visitor should be considered a potential positive (COVID).

Based on document review, observation and interview, nursing staff did not ensure the ACCU-CHEK Inform II Meter (hand held machine used to check a patient's blood glucose) was appropriately transported after use and that the counter where the contaminated meter was placed was disinfected after use. This could lead to increased transmission of infection to patients and/or staff.

Findings include:

-- Review of the hospital's policy and procedure (P&P) titled, "Glucose Monitoring with ACCU-CHEK Inform II Meter," last reviewed 9/2020, indicated supplies (ACCU-CHEK meter, testing strips, lancet, alcohol prep) should be brought to the patient's room. After patient testing the meter should be placed on a level surface. Use a Clorox Germicidal Wipe or Sani-Cloth to disinfect by gently wiping the surfaces three times vertically and three times horizontally. Allow the surfaces of the meter to remain damp with disinfecting solution for one full minute. Dry the unit thoroughly.

-- Per observation of Staff I, Licensed Practical Nurse (LPN), on 8/4/2021 at 12:00 pm, he/she brought glucose testing supplies into a patient's room and placed them on the bedside table. After aseptically performing the glucose test, Staff I placed the ACCU-CHEK meter under his/her arm, removed gloves and washed hands. Staff I then carried the meter and test strip container to the nurse's station where the supplies are stored and placed them on the counter. Staff I applied one glove and cleaned the meter and test strip container with Oxiver Wipes. Staff I did not clean the counter where the contaminated supplies were first placed. Staff I stated he/she does not use Clorox Germicidal wipes because it could ruin the meter. He/she confirmed these findings at the time of observation.

-- Per observation of Staff J, LPN, on 8/4/2021 at 12:10 pm, he/she returned to the nurse's station with the ACCU-CHEK meter and test strips and placed them on the counter. Staff J applied gloves and cleaned the meter and test strip container with Oxiver Wipes. Staff J did not clean the counter where the contaminated supplies were first placed.

-- During interview of Staff K, Acute & Swing Bed Nurse Manager, on 8/4/2021 at 12:15 pm, he/she acknowledged the above findings and indicated only Clorox Germicidal Wipes or Sani-Cloth should be used to clean the meter and the counter where disinfection was done.

Based on observation and interview, the facility lacked required signage posted. Specifically, Emergency Medical Treatment and Labor Act (EMTALA) and Patient's Rights signage was not posted conspicuously in the emergency department (ED). This lack of signage does not ensure all individuals entering the ED are aware of their rights.

Findings include:

-- Per observation on 8/4/2021 at 10:15 am during a tour of the ED, there were no EMTALA or Patient Rights signage posted at the ED entrance, ED ambulance entrance or in ED patient rooms/bays.

-- During interview of Staff L, ED Nurse Manager, on 8/4/2021 at 10:15 am, he/she acknowledged the above findings.

Based on document review and interview, the hospital did not ensure that its emergency preparedness (EP) policies and procedures (P&P) addressed all required elements, as specified in the Centers for Medicare and Medicaid Services (CMS) Appendix Z for Critical Access Hospital (CAH) providers. Also, several EP P&P lacked detail. Lack of comprehensive EP P&P place patients and staff at risk to be unable to safely respond to emergencies.

Findings include:

-- Per review of the hospital's EP Plan, last approved May 2020, it lacked the following elements:

- System to track the location of on-duty staff and sheltered patients in the hospital's care during and after an emergency.
- Safe evacuation from the hospital, which includes staff responsibilities and needs of the patients.
- Means to shelter in place for patients, staff, and volunteers who remain in the facility with site specific locations.
- System of medical documentation that preserves patient information, protects confidentiality of patient information and secures and maintains the availability of records.
- Use of volunteers in an emergency or other emergency staffing strategies.
- Role of the hospital under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
- Process for how emergency medical system assistance can be obtained when needed.

-- Review of the EP Plan also revealed several EP P&P did not provide sufficient details and site-specific information for response during an emergency. Examples include:

- Water Emergencies (flooding) EP P&P lacked details specific to flooding inside and outside the building (i.e., pipe bursts, sprinkler system, frozen pipes), community water disruptions (e.g., loss of water or pressure, boil water orders from community or municipality, etc.).
- Fire Response EP P&P lacked details such as the building layout, locations of exits, locations of life safety equipment (e.g., fire extinguishers, pull stations to activate alarm, fire/smoke walls for horizontal evacuation or temporary use during a full evacuation, locations of shelters, etc.) outside meeting places after evacuation and code phrases.
- Power Outage EP P&P did not address generator use or failure including flashlights or other tools used to assist in evacuation during low light or darkness.

-- During interview of Staff M, EP Coordinator, and Staff D, Director of Ancillary Services, on 8/6/2021 at 12:00 pm, they acknowledged the above findings.