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Based on observation, staff interview, and policy and procedure review, the facility failed to ensure the designated Biohazard room was secured according to state and local laws on five (5) of five (5) days of survey.

Findings Include:

Observation on 08/16/2022 at 10:30 a.m., a tour of the designated Biohazard Room with Jennifer Layton, DON, revealed the door to the biohazard area did not have a latch or locking device to secure the biohazard area.

An interview with Director of Nursing (DON) on 08/16/2022 at 10:31 a.m., confirmed the door to the Biohazard room was not secured with a locking device.

An interview with the Chief Operating Officer on 08/19/2022 at 10:10 a.m., confirmed the door to the Biohazard room is not secured with a locking device on the door.

Review of the facility's "Infectious Waste Management" policy dated 08/28/2019 revealed: " ...Infectious waste ... is secured to deny access to unauthorized persons ...".

During Exit Conference on 08/19/2022 at 12:00 p.m., survey findings were discussed, and no further documentation was submitted for review.

Based on observation, staff interview, Policy and Procedure review, and medical record review, facility failed to have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital.

Findings Include:

An interview with Director of Nursing (DON) on 08/17/2022 at 5:20 p.m., confirmed there is no documentation of a Do Not Resuscitate (DNR), withholding of treatment or withdrawal of treatment order for Patient #1, who expired after experiencing a cardiac arrest.

Review of facility's "End-of-Life Decisions (including DNR and withholding of withdrawal of treatment)" policy dated 03/06/2022 revealed: " ...The order for withholding resuscitation measures will be written by the physician ...".

Review of the facility's "Procedure for the Arrangement of the Medical Record" policy dated October 2009 revealed: " ...To assemble the medical record in proper order for permanent filing ...Physicians order ...".

Review of Patient #1 medical record, episode number 126043-0156, admit date of 06/27/2022, through discharge date of 06/28/2022, revealed no documentation of a Do Not Resuscitate, withholding or withdrawal of care order.

During Exit Conference on 08/19/2022 at 12:00 p.m., survey findings were discussed, and no further documentation was submitted for review.

Based on observation, staff interview, document review, and policy and procedure review the facility failed to provide a functional and sanitary environment for surgical services to avoid sources and transmission of infection and communicable diseases by failing to ensure surgical instruments are high-level disinfected or sterilized according to manufacturer guidelines, on two (2) of five (5) days of survey; and failed to ensure walls are maintained in identified clean and sterile areas, on five (5) days of five (5) days of survey; and failed to ensure staff followed manufacturer instructions for cleaning of glucometers on four (4) of five (5) days of survey.

Findings Include:

Observation on 08/16/2022 at 10:15 a.m. in the clean room where endoscopes are disinfected, revealed Scrub Technician (Scrub Tech) #1 failed to use Cidex test strips to verify effectiveness of Cidex high-level disinfectant prior to use in cleaning endoscopes.

Observation on 8/16/2022 at 10:35 a.m., during tour of the sterile storage and processing room with Registered Nurse (RN) #1 present, a wall eight (8) feet by eight (8) feet was found to have a compromised area with missing plaster exposing internal wall structure measuring eight (8) feet by five (5) inches width on door facing area and a space of eight (8) feet wide by four (4) feet tall with peeling paint exposing uncleanable surfaces.

Observation on 08/16/2022 at 5:15 p.m. with the Chief Operating Officer (COO) of the surgical area where the vaginal probes are disinfected, revealed the CIDEX OPA test strips, Lot number 034970, expired on 07/28/2020, with 8 test strips in the container.

Observation on 08/17/2022 at 11:28 a.m. with Director of Nursing, (DON) of finger stick blood glucose testing with RN #2, revealed the glucose monitor was cleaned with an alcohol prep pad.

An interview on 08/16/2022 at 3:10 p.m. with Scrub Tech #1, confirms she is the staff member assigned to disinfect surgery equipment in CIDEX OPA. She also confirms that the log document reveals testing performed with a passing result on the most current entries dated in the month of August 2022. When asked if CIDEX OPA Solution test strips are used to test effectiveness of disinfectant prior to each use she confirms that she has not used the test strips since sometime in May 2022; she further confirms incorrect data entry of performed tests and passing results recorded on disinfection log.

An interview on 08/17/2022 at 10:45 a.m. with the COO confirms measurements of compromised areas on the eight (8) feet by eight (8) feet wall in the sterile storage and processing area to measure five (5) inches thick and eight (8) feet tall to door facing with a second surface area of four (4) feet by eight (8) feet of peeling paint on flat wall surface.

An interview on 08/17/2022 at 11:36 a.m. with the Director of Nursing (DON), confirmed the glucose monitors are cleansed with alcohol prep pads.

An interview on 08/18/2022 at 2:00 p.m. with the Ultrasound Technologist, confirmed the CIDEX OPA test strips, Lot number 034970, expired on 07/28/2020 and were not used in the disinfection of the vaginal probes. Ultrasound Technologist confirmed the vaginal probe was soaked in the CIDEX OPA solution without testing the CIDEX OPA solution effectiveness due to no test strips available.

Review of document titled, "Scope Reprocessing Log Disinfectant CIDEX OPA 14-day solution" revealed: from May 2, 2022, to May 19, 2022, no evidence of disinfectant testing performed before each use; from May 19, 2022, to August 15, 2022, disinfectant testing documented prior to each use with passing results; August 16, 2022, no evidence of disinfectant testing performed prior to each usage.

Review of the facility Policy and Procedure "Care of instruments Scopes and Powered Surgical Instruments", revised date 09/29/2020, revealed: " ... all scopes are processed using ...CIDEX OPA Linrecommendations ...Disinfection Cidex Note: ...TEST with Cidex strips and Log in book, CHANGE Cidex solution if test strip fails ...".

Review of facility guidelines "Department of Surgical Services Sterilization and Disinfection" revealed: " ...26. A high-level disinfectant shall be used if an item is to be disinfected ...a. Products selected for disinfection shall be registered with the EPA. The manufacturer's written instructions shall be followed for use ...".

Review of label on bottle of CIDEX OPA solution revealed: " ...use CIDEX OPA Solution Test Strips to monitor ortho-phthalaidehyde concentration before each use to detect the MEC (0.3%) ... Follow the directions for use provided with the Cidex OPA Solution Test Strips ...".

Review of manufacturer's instructions for CIDEX OPA solution test strips revealed: " ...The CIDEX OPA solution test strips are semi-quantitative chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX OPA solution, is above or below the minimum effective concentration (MEC) established for CIDEX OPA Solution ...CIDEX OPA solution test strips are developed exclusively for monitoring the minimum effective concentration (MEC) of CIDEX OPA solution. It is recommended that CIDEX OPA solution be tested before each usage with the CIDEX OPA solution test strips in order to guard against solution below its MEC of 0.3%...".

Review of surgical technician job description revealed: " ...The surgical technician must have a working knowledge ...and is responsible for the care, cleaning and proper sterilization for all items ...", signed by Scrub Technician #1 on 11/9/2020.

Review of the facility training and education "Reprocessing In-service/Competency for Endoscopes by Olympus" dated March 2021, revealed: " ...Manual High-Level Disinfection ... 2. Test the disinfectant concentration (i.e., MEC) according to the manufacturer's instructions ... Demonstrated ...yes ...", as education provided to Scrub Technician #1.

Review of the Stat Strip Xpress 2 Glucose Hospital Meter System Quick Reference Guide dated 01-2020 revealed: " ...Acceptable cleaning and disinfecting materials ...recommends the use of Clorox Healthcare Bleach germicidal wipes, EPA registration number 67619-12 ...".

Review of the Facility's "Stat strip Xpress Glucose Testing" policy dated 02/14/2022 revealed: " ...Policy: ...Decontamination of Meter ...wipe with Cavi Wipes between patients ...".

During Exit Conference on 08/19/2022 at 12:00 p.m., survey findings were discussed and no further documentation was submitted for review.

Based on observations, staff interview, documentation review, and policy and procedure review the facility failed to ensure staff followed facility policy and procedure for preventing and controlling transmission of infection on two (2) of five (5) days of survey.

Findings Iclude:

Cross Refer to A-0747/482.42 for the facility's failure to ensure staff followed manufacturer guidelines for cleaning equipment, high-level disinfection of instruments, and maintenance of clean and sterile environment.