HospitalInspections.org

Based on observation, interview, and record review, the facility failed to develop and implement policies and procedures to include identifying biohazardous waste areas and the security of identified storage areas for pharmacertical services; and the facility failed to ensure the posting of clear signage identifying biohazardous areas, where chemotherapy medications were stored, prepared, and administered, and areas of biohazardous waste disposal. Findings include:

A review of the facility's policy and procedure titled, Chemotherapy Drugs-Guidelines for Safe Handling and Preparation, effective date of 12/21, showed, "Policy: Many chemotherapy (cytotoxic) drugs have been demonstrated to be mutagenic and carcinogenic. The handling, preparation, and administration of these substances shall be conducted in a manner to minimize the number and size of any inadvertent exposure to the drugs. Purpose: These guidelines are intended to promote an awareness of the potential hazards involved with chemotherapy drugs and to establish basic safety procedures for handling and preparing these agents..." The policy and procedure did not address signage to be posted, identifying biohazardous areas where chemotherapy medications were stored, prepared, and administered.

A review of the facility's policy and procedure titled, Waste Management Plan, last reviewed 12/27/21, showed, "Policy: [name of facility] shall comply with federal, state, and local agencies in regard to waste management. Purpose: The purpose of [name of facility] waste management program is to establish, implement, monitor, and document safe management of infectious, hazardous, and normal waste... This policy outlines specific procedures to be strictly followed by all personnel responsible for waste management..." The policy and procedure did not address signage to be posted, identifying biohazardous waste areas, or the security of those storage areas.

During an observation and interview on 5/12/22 at 8:40 a.m., staff member AA stated chemotherapy medications were stored in the cancer center medication room. Staff member AA stated chemotherapy medications were mixed in the room, inside a biological safety cabinet (a ventilated enclosure), and then placed into a biohazard bag before administration. She stated emptied or used vials and syringes with trace amounts of chemotherapy medications, were placed in a biohazard bag or container for disposal after usage. No hazardous area signage was posted in that area.

During an observation and interview on 5/12/22 at 8:55 a.m., off the hallway containing various offices and meeting rooms, was a room with a door ajar, which contained several boxes lined with red and yellow biohazard waste bags pertaining to pharmaceutical services. The room had a second door which could be entered from an adjacent hallway and contained patient changing areas. Neither door had a hazardous areas sign posted. Staff member E stated the waste disposal room doors should be closed and was unsure if they should be locked to limit access. She stated there had not been signage posted on the doors, signifying a biohazardous waste area.

Based on observation, interview, and record review, the facility failed to develop and implement policies and procedures which addressed the secure storage of medications and biologicals used in emergency drug boxes and failed to ensure all medications and biologicals were kept in a secured or locked storage for use in patient care areas in the Emergency Department and the Intensive Care Unit. This deficient practice had the potential to affect any patient receiving care and staff providing care in the Emergency and Intensive Care Units. Findings include:

A review of the facility's policy and procedure titled, Emergency Drug Boxes, dated 6/2020, showed, "Policy: Nursing units and identified ancillary units will be provided with an emergency drug box containing medications. Purpose: To provide emergency medications when delivery from the usual Pharmacy source would cause unnecessary delay in patient treatment." The policy and procedure did not address the locked or secure storage of medications identified in the emergency drug boxes.

A review of the facility's policy and procedure titled, Maintenance of Drug Storage Areas and Emergency Drug Carts, dated 8/2020, showed, "Policy: Drug storage shall be maintained in accordance with state and federal regulations. Purpose: To assure that all medications kept at approved storage areas are authorized in that area, free from deterioration, in date, and properly labeled." The policy did not address the secure or locked storage of medications identified in the emergency drug boxes.

During an observation on 5/10/22 at 12:59 p.m., located with or near the cardiac, pediatric, and trauma carts in the emergency room, were eight separate plastic boxes, which contained medications for emergency response administration. Each box was closed with a red zip tag. The boxes were not locked or secured within the patient care room in a manner to prevent unmonitored access to the following medications:

1. In the box titled, Seizure Kit, contained:

- two diazepam rectal 2.5 mg syringes,
- two diazepam rectal 10 mg syringes,
- two lorazepam 2 mg/ml vials.

2. In the box titled, RSI Kit, contained:

- one etomidate 20 mg injection,
- one propofol 10% 20 ml vial,
- two midazolam 2 mg/2 ml vial.

3. In the box titled, Clot Box, contained:

- one Nitrostat 0.4 mg "Tab25's",
- one Procardia 10 mg capsule,
- one Ascriptin 325 mg tablet,
- one lidocaine 100 mg injection,
- one lidocaine 0.4% 500 ml IVPB,
- one TNKase 50 mg kit,
- one Dopamine 400 mg IVPB,
- one Nitroglycerin 50 mg IVPB,
- one D5W 250 ml, and
- one heparin 25,000 U/500 ml IVPB.

4. Located with the cardiac, pediatric, and trauma crash carts were three separate medication boxes titled, Anaphylaxis Kit, which each contained:

- two phenytoin 100 mg injections,
- two dexamethasone 4 mg/ml vials,
- one dextrose 50% 50 ml,
- two diphenhydramine 50 mg injections,
- two Epinephrine 1:1000 per 1 ml injections,
- one Glucagon 1 mg injection,
- two naloxone 0.4 mg/ml vials,
- two Solu Medrol 125 mg injections, and
- one sterile water for injection 10 ml vial.

5. Located with the cardiac and trauma crash carts were two separate medication boxes titled, Adenocard/Nitrostat Kit, which each contained:

- three adenocard 6 mg/2 ml vials,
- one Nitrostat 0.4 mg tablet, and
- four aspirin 81 mg tablets.

During an interview on 5/10/22 at 1:15 p.m., staff member S stated although the trauma room was directly across from the nurse's station in the emergency department, patients and their representatives may be left unattended with the curtains pulled in the patient care area. She stated the medication kits were developed for quick access to certain emergent medications during an emergency situation since it could be time consuming to access the medications from the Omnicell. Staff member S stated the red plastic zip tags on the kits were not itemized and were not used as a locking system to prevent unauthorized access, only to know when the kit had been entered.

During an observation on 5/10/22 at 1:45 p.m., located with the crash cart in the ICU were five separate plastic boxes which were closed with red zip tags, they were not locked, and were not secured in a manner to prevent unmonitored access to the following medications:

1. In the box titled, Seizure Kit, contained:

- two diazepam Rectal 2.5 mg syringes,
- two diazepam Rectal 10 mg syringes,
- two lorazepam 2 mg/ml vials.

2. In the box titled, RSI Kit, contained:

- one etomidate 20 mg injection,
- one propofol 10% 20 ml vial,
- one midazolam 2 mg/2 ml vial,
- one midazolam 2 mg/2 ml vial.

3. In the box titled, Clot Box, contained:

- one Nitrostat 0.4 mg "Tab25's",
- one procardia 10 mg capsule,
- one Ascriptin 325 mg tablet,
- one lidocaine 100 mg injection,
- one lidocaine 0.4% 500 ml IVPB,
- one TNKase 50 mg Kit,
- one Dopamine 400 mg IVPB,
- one Nitroglycerin 50 mg IVPB,
- one D5W 250 ml, and
- one heparin 25,000 U/500 ml IVPB.

4. In the box titled, Anaphylaxis Kit, contained:

- two phenytoin 100 mg injection,
- two dexamethasone 4 mg/ml vials,
- one dextrose 50% 50 ml,
- two diphenhydramine 50 mg injections,
- two Epinephrine 1:1000 per 1 ml injections,
- one Glucagon 1 mg injection,
- two naloxone 0.4 mg/ml vials,
- two Solu Medrol 125 mg injections, and
- one sterile water for injection 10 ml vial.

5. In the medication box titled, Amiodarone/Cordarone Kit, contained:

- six cordarone 150 mg tablets,
- two D5W 25 ml IVPB,
- one 0.9% NaCl 20 ml vial,
- one 30 ml syringe,
- two 10 ml syringes...

During an interview on 5/10/22 at 1:50 p.m., staff member D stated there currently were no patients admitted in the ICU. She stated the medication kits were designed for quick access to certain medications during an emergent situation. She stated the red tags on the kits were not used as a lock but used to know when the kit had been opened. She stated although the ICU currently did not have any patients there was still access to the area by various staff, not just the ICU nursing staff.

Based on observation, interview, and record review, the facility failed to develop and implement policies and procedures which addressed the secure storage of Schedule medications to include Schedule III, IV, and V; and the facility failed to ensure Schedule IV medications were locked and stored in a secure manner to prevent unmonitored access ¹ in the facility's ICU and Emergency departments. This deficient practice had the potential to affect all patients who received care in the ICU and Emergency departments. Findings include:

A review of the facility's policy and procedure titled, Emergency Drug Boxes, dated 6/2020, showed, "Policy: Nursing units and identified ancillary units will be provided with an emergency drug box containing medications. Purpose: To provide emergency medications when delivery from the usual Pharmacy source would cause unnecessary delay in patient treatment." The policy and procedure did not address the locked storage of Scheduled medications identified in the emergency drug boxes, or the secure storage.

A review of the facility's policy and procedure titled, Maintenance of Drug Storage Areas and Emergency Drug Carts, dated 8/2020, showed, "Policy: Drug storage shall be maintained in accordance with state and federal regulations. Purpose: To assure that all medications kept at approved storage areas are authorized in that area, free from deterioration, in date, and properly labeled." The policy did not address the locked storage of Scheduled medications identified in the emergency drug boxes, or their secure storage, and did not address the secure storage of Schedule III, IV, and V medications.

During an observation on 5/10/22 at 12:59 p.m., located near the crash cart in the ER were two separate plastic boxes which were closed with red zip tags, they were not locked and were not secured within the patient care room in a manner to prevent unmonitored access to the following Schedule IV ¹ medications:

1. In the box titled, Seizure Kit, contained:

- two diazepam rectal 2.5 mg syringes,
- two diazepam rectal 10 mg syringes,
- two lorazepam 2 mg/ml vials.

2. In the box titled, RSI Kit, contained:

- one propofol 10% 20 ml vial, and
- two midazolam 2 mg/2 ml vial.

During an interview on 5/10/22 at 1:15 p.m., staff member S stated although the trauma room was directly across from the nurse's station in the emergency department, patients and their representatives may be left unattended, with the curtains pulled, in the patient care area. She stated the medication kits were developed for quick access to the medications during an emergent situations since it could be time consuming to access the medications from the Omnicell. Staff member S stated the red plastic zip tags on the kits were not itemized and were not used as a locking system to prevent unauthorized access, only to know when the kit had been entered.

During an observation on 5/10/22 at 1:45 p.m., located with the ICU trauma cart were two separate plastic bins, which were closed with red zip tags, they were not locked and were not secured within the patient care area in a manner to prevent unmonitored access to the following Schedule IV ¹ medications:

1. In the box titled, Seizure Kit, contained:

- two diazepam rectal 2.5 mg syringes,
- two diazepam rectal 10 mg syringes, and
- two lorazepam 2 mg/ml vials.

2. In the box titled, RSI Kit, contained:

- one propofol 10% 20 ml vial, and
- two midazolam 2 mg/2 ml vial.

During an interview on 5/10/22 at 1:50 p.m., staff member D stated there currently were no patients admitted in the ICU. She stated the medication kits were designed for quick access to certain medications during an emergent situation. She stated the red tags on the kits were not used as a lock but used to know when the kit had been opened. She stated although the ICU currently did not have any patients, there was still access to the area by various staff, not just the ICU nursing staff. Staff member D stated they developed the kits not considering that the Schedule III, IV, and V medications should also be locked.

¹ The Federal Register. Federal Register :: Request Access. (n.d.). Retrieved May 16, 2022, from https://www.ecfr.gov/current/title-21/chapter-II/part-1308/subject-group-ECFRf62f8e189108c4d#subject-group-ECFRf62f8e189108c4d

Based on observation, interview, and record review, the facility failed to develop and implement policies and procedures to include the posting of signage to identify hazardous radiation areas; and failed to ensure clear signage was posted in the X-Ray and Computed Tomography machine locations, identifying hazardous radiation areas ¹. This deficient practice had the potential to affect all patients and staff utilizing the radiation services. Findings include:

A review of the facility's policy and procedure titled, Radiation Safety, last reviewed on 2/10/22, showed, "Policy: To provide a schedule and establish minimum standards for monitoring equipment and personnel with regard to radiation safety. Purpose: Protection of the public (patients) and hospital personnel." The policy and procedure did not include the posting of signage to identify hazardous radiation areas.

During an observation on 5/11/22 at 2:20 p.m., signs were posted on the X-Ray and CT rooms that showed, "DO NOT ENTER Examination in Process." There were no signs posted to identify a hazardous radiation area.

During an interview on 5/11/22 at 2:32 p.m., staff member T stated when X-Ray and CT rooms were utilized, the room doors were closed and the walls had lead in them. He stated he was not aware of when or if radiation signage was ever posted on the X-Ray or CT rooms, to identify hazardous radiation areas.

¹ Alara | nrc.gov. (n.d.). Retrieved May 17, 2022, from https://www.nrc.gov/reading-rm/basic-ref/glossary/alara.htm

Due to the manner and degree of the deficient practice, the facility failed to meet §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Program.

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

- develop and implement policies and procedures to ensure the proper infection control practices were utilized during the reprocessing of colonoscopes during routine colonoscopies;

- ensure the safe transport of contaminated scopes (See A-749);

- ensure sterilization room unilateral workflow (See A-749);

- ensure the proper storage of clean endoscopes to limit contamination (See A-749);

- ensure the completion of risk assessment and quality assurance processes for microbiologic surveillance of endoscopes (See A-749);

- ensure the mitigation of bloodborne pathogens by performing hand hygiene prior to donning gloves for a peripheral intravenous initiation (See A-749); and,

-ensure to properly disinfect and/or dispose of blood contaminated items and surfaces (See A-749).

Based on observation, interview, and record review, the facility failed to: develop and implement policies and procedures to ensure proper infection control practices were utilized for the reprocessing of colonoscopes during routine colonoscopies to ensure the safe transport of contaminated scopes; failed to ensure sterilization room unilateral work flow; failed to ensure the proper storage of clean endoscopes to limit contamination; and, failed to ensure the completion of risk assessment and quality assurance processes for microbiologic surveillance of endoscopes. This deficient practice had the potential to affect all patients receiving care and services for endoscopic procedures; the facility also failed to ensure the mitigation of bloodborne pathogens by not performing hand hygiene prior to donning gloves for a peripheral intravenous initiation and failed to properly disinfect and/or dispose of blood contaminated items and surfaces for 1 (#28) of 32 sampled patients. Findings include:

1. Reprocessing of Flexible Endoscopes:

A. Safe Transport of Contaminated Scope

A review of the facility's policy and procedure titled, Cleaning and Disinfecting of Operating Room and Endoscopy Flexible Endoscopes, dated 4/2022, showed, "...B. After use, decontaminate by the following procedure: ...5. Take endoscope to GI cleaning room..." The facility's policy and procedure did not address the sanitary transport of a contaminated scope between two non-adjoining rooms ¹.

During an observation on 5/11/22 at 10:10 a.m., staff member CC performed bedside disinfection of a colonoscope after the completion of a colonoscopy. She then looped the tubing up in her hand and carried the scope in a suspended manner from the procedure room, into a main thoroughfare, and into the scope processing room. Staff member CC did not transport the scope in a horizontal position to limit debris contamination from the scope and did not transport the contaminated scope in a closed container to the processing room.

During an interview on 5/11/22 at 11:22 a.m., staff member H stated they did not utilize a covered container to transport the contaminated scopes from the procedure room to the scope processing room since the processing room was next to the procedure room. She stated the hall which connected the two rooms was a common hallway used by OR, PACU, and SDS staff and patients.

¹ Guideline summary: Processing flexible endoscopes - apic.org. (n.d.). Retrieved May 16, 2022, from https://apic.org/Resource_/TinyMceFileManager/Implementation_Guides/10_AORNGuidelineProcessingFlexibleEndoscopes.pdf

- "...After precleaning at the point of use, contaminated flexible endoscopes and accessories should be transported to the endoscopy processing room... Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart. The container or cart must be leak proof, puncture resistant, and large enough to contain all contents. The container should be of sufficient size to accommodate the endoscope when the endoscope is coiled in large loops. The transport cart or container must be labeled with a fluorescent orange or orange-red label containing a biohazard legend. Flexible endoscopes should be transported in a horizontal position and not suspended..."

B. Reprocessing Room Workflow

During an observation on 5/11/22 at 10:10 a.m., the endoscope sterilization/reprocessing room door was open into the hallway. Immediately outside the reprocessing room was a cabinet which contained medical supplies and PPE. Immediately outside the reprocessing room next to the cabinet was an uncovered garbage bin. Immediately inside the reprocessing room was the reprocessing unit, then next to the unit was an L-shaped counter space with a sink used to leak test and soak the contaminated scopes at the far end of the room. The reprocessing room did not have a clear delineation between the clean and contaminated areas and did not have a unilateral or "one way" workflow established ². Staff member CC carried by hand the suspended and coiled contaminated endoscope into the reprocessing room. She passed the cabinet and staff outside in the hall. The scope was brought into the reprocessing room, carried past the sterile processor and placed into the decontamination sink. Staff were observed back tracking from the entrance of the reprocessing room from the contaminated area to the clean area. The room only had one entrance and there was not a separate area with an exit, different from the entry.

During an interview on 5/11/22 at 11:22 a.m., staff member H stated the room, which was utilized to reprocess endoscopes, did not have directional airflow that maintained negative pressure, and/or proper ventilation for maintenance of chemicals and equipment. Staff member H stated the room used to reprocess the endoscopes was not delineated between clean and contaminated spaces. The contaminated scope was brought in through the main hallway into the room and was carried past the clean equipment and sterilizer in order to place the scope in the decontamination sink.

² Centers for Disease Control and Prevention. (2018, December 27). Flexible endoscope reprocessing. Centers for Disease Control and Prevention. Retrieved May 16, 2022, from https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

- "...Physical Setting: The reprocessing area should be in a space that is separate from the patient procedural area. Review the physical setting to ensure a "one way" workflow that separates contaminated workspaces from clean workspaces. If a separate room is used for manual cleaning of endoscopes, ensure a directional airflow that maintains negative pressure within that room relative to adjoining spaces. Ensure that heating, ventilation, and air conditioning parameters are appropriate for the chemicals and equipment in use."

C. Storage of Clean Scopes to Prevent Contamination

During an observation and interview on 5/11/22 at 10:10 a.m., in the procedure room was a cabinet along the far wall which was labeled "scopes". Inside the cabinet were several different flexible endoscopes and colonoscopes. On the inside door of the cabinet which the various scopes were hanging, were other metal bioscopic wires which were not specific attachments for the scopes ³.

During an observation and interview on 5/11/22 at 11:22 a.m., next to the decontamination sink was a tall metal pole with hooks at the top. Staff member H stated the clean endoscope was hung from that pole to dry after it was removed from the sterile processor. Immediately outside the reprocessing room, on top of a cabinet, which was located in the main thoroughfare, was a colonoscope which had just been removed from the sterile processor. It was laying coiled and uncovered on top of a white cloth towel. Staff member H stated they had just removed that scope from the sterile processor and it was waiting to be brought into the procedure room for the next scheduled colonoscopy. She stated other times the scope would be hung from the metal pole inside the reprocessing room. She indicated to a pole which was situated next to the sink where the scopes were decontaminated and manually cleaned and inspected. She stated they only had two adult colonoscopes which were reprocessed between each colonoscopy. Stating they could complete anywhere between six to eight colonoscopies twice a week.

³ Guideline summary: Processing flexible endoscopes - apic.org. (n.d.). Retrieved May 16, 2022, from https://apic.org/Resource_/TinyMceFileManager/Implementation_Guides/10_AORNGuidelineProcessingFlexibleEndoscopes.pdf

- "...Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Cabinets used for the storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing area in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room... Flexible endoscopes should be stored in a drying cabinet. If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes. Flexible endoscopes that have been mechanically processed should be stored in a cabinet that is either designed and intended by the cabinet manufacturer for horizontal storage of flexible endoscopes or of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without touching the bottom of the cabinet. Flexible endoscopes should be stored with all valves open, and removable parts should be detached but stored with the endoscope. Flexible endoscopes and storage cabinets should be visually inspected for cleanliness before endoscopes are placed into or removed from storage..."

D. Risk Assessment and Quality Assurance for Microbiologic Surveillance of Flexible Endoscopes

During an interview on 5/11/22 at 11:11 a.m., staff member H stated they had completed an Adenosine triphosphate protein (ATP) Testing QA of the OR and GI lab in June 2019. She stated this was done to preform periodic monitoring and testing of equipment used in the GI lab to verify the effectiveness of the endoscope cleaning process. The ATP testing was used to identify potentially pathogenic material still present on scopes after sterilization. She stated the ATP testing which was completed in June of 2021 was of their old scopes which were no longer in use. She stated the two current adult colonoscopes, which were currently being used by the facility, were instated July of 2021. She stated the new scopes were not currently in a QA Surveillance program by the facility (4).

(4) Guideline summary: Processing flexible endoscopes - apic.org. (n.d.). Retrieved May 16, 2022, from https://apic.org/Resource_/TinyMceFileManager/Implementation_Guides/10_AORNGuidelineProcessingFlexibleEndoscopes.pdf

- "A multidisciplinary team that includes infection preventionists, endoscopists, endoscopy processing personnel, microbiologists, laboratory personnel, risk managers, and other involved individuals should evaluate the need to implement a program for regular microbiologic surveillance cultures of flexible endoscopes and mechanical processors. The multidisciplinary team should establish the methods and frequencies for microbiologic surveillance culturing of flexible endoscopes and mechanical processors...

- Incorporating a verification program into your current practices can help identify trends and gaps in your cleaning and disinfecting processes. Whenever you implement an enhanced testing or verification program, it's a good idea to have a backup inventory of scopes available in the event still-dirty scopes need to be removed from service. "

2. Hand Hygiene

A review of the facility's protocol referenced from their Nursing Reference Center, titled, How to Insert a Peripheral Intravenous Cannula the Over-the-Needle Technique, showed, "...Perform hand hygiene and don nonsterile gloves and other PPE as necessary..."

During on observation on 5/11/22 at 8:43 a.m., staff member I listened to patient #28's heart and lungs with a stethoscope. She then donned gloves and initiated a peripheral IV insertion. Staff member I did not perform hand hygiene after completing the patient assessment and before donning gloves prior to starting the peripheral IV.

During an interview on 5/11/22 at 9:26 a.m., staff member I stated it was important to perform hand hygiene prior to donning gloves when starting a peripheral IV. She stated she had performed hand hygiene upon entry to the patient's care area, but not after completing his physical assessment and starting the IV.

During an interview on 5/11/22 at 9:30 a.m., staff member H stated it was the expectation of staff to perform hand hygiene either by using soap and water when visibly soiled or ABHS when not, prior to initiating a peripheral IV insertion.

3. Blood-Borne Pathogen

During an observation on 5/11/22 at 8:43 a.m., staff member I initiated a peripheral IV insertion for patient #28. After the needle was withdrawn from the IV cannula, staff member I activated the safety device on the needle and disposed of the needle into the sharp's containers. The cannula hub which had blood contaminate was removed from the luer lock and placed back inside the clean field with the remaining clean IV supplies. Staff member I then removed the luer lock cap and disposed of it, leaving blood spatter on the clean field with the remaining IV supplies of tape and gauze.

During an observation on 5/11/22 at 9:20 a.m., the clean field with the blood spatter from the luer lock cap, which held the remaining IV supplies of tape and gauze, was still sitting on the over-the-bed table for patient #28.

During an interview on 5/11/22 at 9:26 a.m., staff member I stated the clean field was left at the patient's bedside so when they removed the peripheral IV they could use the clean tape and gauze which remained in the package. She stated all blood contaminated equipment and supplies should be properly disposed of and any blood spatter cleaned as soon as possible.

During an interview on 5/11/22 at 9:30 a.m., staff member H stated it was the expectation that all blood spatters be cleaned with the appropriate disinfecting wipes and disposed of per facility policy.