The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST LUKE'S CORNWALL HOSPITAL 70 DUBOIS STREET NEWBURGH, NY 12550 June 20, 2019
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
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Based on observation document review and staff interview, the facility failed to ensure:
1) proper handling of infectious waste in accordance with its policies and procedures and the New York State Regulation at Title 10 New York Codes, Rules and regulations (NYCRR) 70-2 - Management of Regulated Medical Waste;
2) Hospital staff is trained in proper routine handling and disposal of regulated medical waste.

This failure may place patients, staff and the public at risk for harm.

See Tag A0713.
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VIOLATION: DISPOSAL OF TRASH Tag No: A0713
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Based on observation, document review and staff interview, the facility failed to ensure:
1) proper handling of infectious waste in accordance with its policies and procedures and the New York State Regulation at Title 10 New York Codes, Rules and regulations (NYCRR) 70-2 - Management of Regulated Medical Waste;
2) Hospital staff is trained in proper routine handling and disposal of regulated medical waste.

This failure may place patients, staff and the public at risk for harm.

Findings include:

1. Review of facility policy titled "Infectious Waste Removal, Storage and Transportation," last revised 10/1/2018, notes "Employees shall wear vinyl, latex, or nitrile gloves and cover gown when handling infectious waste bags ... (1) Infectious waste shall be bagged in durable red liners labelled "Infectious Waste." (2) Red infectious waste bags shall be removed from the waste generating area to a centralized collection point in the soiled utility room and placed in rigid leak resistant container labelled 'Infectious Waste,' that is provided for temporary storage. Containers must be covered with a rigid lid at all times ...(3) All Infectious waste must be covered while being transported in a proper container throughout the hospital and may not be co-mingled with municipal waste (Clear bag), needles/sharps, pharmaceutical waste, or chemotherapeutical waste ...(7) If red bags or containers are not used, the bag/container must contain a label that includes the universal biohazard symbol, followed by the term "biohazard"...

During tour of the facility on 6/19/2019 between 11:00 AM and 12:00 PM, the following were observed:

At approximately 11:10 AM, in the Labor and Delivery Unit, a nurse carried a Red Infectious waste bag from the labor and delivery Operating room area into the soiled utility room with no secondary container.

New York State regulation Title 10 NYCRR 70-2.2(m) states, "Transport of regulated medical waste within a facility from the point of generation to the point of storage or treatment shall be by covered cart or other appropriately covered conveyance system marked prominently with signage indicating that the contents are infectious or are regulated medical waste ..."

The soiled utility room serving Labor and Delivery unit was not locked to prevent unauthorized access.

New York State Regulation Title 10 NYCRR 70-2.2(g)(2)(ii) states that each storage area for regulated medical waste shall be designed or equipped to prevent unauthorized access.

In the soiled utility room, red bags filled with regulated medical waste were placed on the floor and not into secondary containers. Regular wastes were co-mingled (not separated) with regulated medical waste.

New York State Regulation, Title 10 NYCRR 70-2.2(g)(2)(vi) states, "each storage area shall be of sufficient size to allow clear separation of regulated medical waste from any other waste, whenever waste other than regulated medical waste is stored in the same area."

During interview with Staff O, Environmental Services (EVS) Director on June 19, 2019 at approximately 11:10 AM, staff acknowledged findings and explained that none of the soiled utility rooms in the facility were locked.


At approximately 11:20 AM, in the hospital hallway, outside of the kitchen, it was observed that Staff P (Environmental Services staff) and Staff Q (Associate EVS) were closing and labeling boxes with red bags containing Regulated Medical Waste. This practice poses a risk for contamination of the area.

At approximately 11:20 AM, EVS staff transported medical waste in boxes and not in appropriate secondary containers (Hard containers) as indicated in the facility's waste manifest.

New York State Regulation, Title 10 NYCRR 70-2.2(b) states, "Containment of regulated medical waste for handling, storage, and treatment shall be accomplished with a primary container for protection from the elements and limiting exposure to employees and the public.

On June 19, 2019 at approximately 2:00 PM, Staff O explained that the facility has been short on secondary containers (rigid leak resistant container), so they were informed to use boxes; this was not documented in the facilities waste manifest.


At approximately 11:30 AM, it was observed at the shed where regulated medical waste was being stored that an environmental service staff member was moving medical waste from a sharps container (secondary container) to a box (secondary container).

New York State Regulation, Title 10 NYCRR 70-2.2(e)(1) states, "Under no circumstances shall regulated medical waste be transferred from one container to another (e.g., for consolidation or loading of a treatments system) in a manner that compromises health and safety of the persons handling the waste ...

Title 10 NYCRR 70-2.2(k) Reusable sharps containers shall not be opened for consolidation or other purposes unless such procedure has been approved as part of the facility's treatment system operation plan."

The staff did not wear a cover gown when handling the infectious waste in accordance with facility's policy and procedures that notes, "Employees shall wear vinyl, latex, or nitrile gloves and cover gown when handling infectious waste bags."

-Some bags in the storage shed containing regulated medical waste were not properly sealed.
-Clean sharps containers were co-mingled with dirty filled medical containers. There was no separation of clean and dirty items.

During interview with Staff S, Environmental Services personnel, at the time of observation, she acknowledged findings and explained that sometimes, regulated medical waste bags come down to the storage area bunny tied, and she has to open them and then goose neck them closed to ensure that the bags are appropriately closed.

At approximately 11:32 AM, it was observed that open boxes, which contained Regulated Medical Waste were moved through the facility to the storage shed by Staff P and Staff Q, Environmental Services Associates. The infectious waste was not covered while being transported in secondary containers. The secondary containers were not of the type indicated in the facility's waste manifest.

An interview with Staff K, Director of Housekeeping, and Staff O on 06/19/2019 at approximately 11:35 AM confirmed these findings.

In the Catheterization Laboratory, at approximately 11:45 AM, it was observed that the soiled utility room serving this area contained both regular waste and regulated medical wastes that were co-mingled (not separated). Regulated medical waste bags were placed on the floor of the soiled utility room and were not placed into secondary containers. A red medical waste bag containing Regulated Medical Waste was placed in a green waste bin with regular waste.

An interview with Staff S and Staff O, on 06/19/2019 at approximately 11:46 AM, they confirmed findings.

In the Operating Room at approximately 12:00 PM, the soiled utility room serving this area contained both regular wastes and regulated medical wastes that were not separated. A clear bag was observed to contain infectious waste that was not bagged in durable red liners and labelled Infectious Waste as per facility policy.

A concurrent interview with Staff R (Vice President, Patient Safety) at approximately 12:00 PM revealed that the clear bag contained Stryker machine's suction tubing used to suck up blood and body fluids during operating room procedures. Staff T and U, Operating Room Nurses reported that at the end of a procedure, the instrument suction tubing is placed in a clear bag with all other waste from the operating room.

New York Regulation, Title 10 NYCRR 70-2.2(d) states, "...the primary container for regulated medical waste, with the exception of sharps, shall be a plastic bag; red in color; and of a strength sufficient to resist ripping, tearing, or bursting under normal conditions of use and handling."

2. Review of facility policy and procedure titled "Needle Box Handling Procedure," last revised 10/1/2018 notes "Sharp Containers (non-wall mounted) when full, secure opening to prevent the container from being overfilled ... Mounted sharps containers will be checked daily by EVS associate. When the container is full and an exchange is needed, notify the Environmental Services Department."

During tour of the Catheterization Laboratory on 06/19/ 2019 at approximately 11:45AM, it was observed that a sharps container was filled above the designated fill line and the lid cover for this sharp container was not closed as per the facility's policy.

An interview with Staff B, Vice President Operations, and O on 06/19/2019 at approximately 11:47 AM confirmed this finding.

On 06/20/2019 at approximately 10:5AM, during tour of the Intensive Care Unit, a wall mounted sharps container inside room 14 was filled above the designated fill line.

Staff B on 06/20/2019 at approximately 10:57 AM acknowledged the finding.


3. Review of facility policy titled "Infectious Waste Removal, Storage and Transportation," and Infectious Waste Handling both revised 10/1/2018 lacked guidance on the following in accordance with New York State Regulation, Title 10 New York Codes, Rules and regulations (NYCRR) 70-2 - Management of Regulated Medical Waste:

On June 19, 2019 at approximately 11:30 AM, it was observed that the shed storing regulated medical waste was quickly becoming overfilled and would be overfilled before the facilities next scheduled pick up.

New York State Regulation, Title 10 NYCRR 70-2.2(g)(1) states, "Each storage area shall be adequate for the volume of regulated medical waste generated between scheduled waste pick-ups by a transporter ..."

On June 19, 2019 at approximately 11:30 AM, it was observed in the storage shed, where regulated medical waste was being stored that an environmental service staff member was moving medical waste from a sharps container (secondary container) to a box (secondary container).

New York State Regulation, Title 10 NYCRR 70-2.2(j) states, "Under no circumstances shall regulated medical waste be transferred from one container to another (e.g., for consolidation or loading of a treatments system) in a manner that compromises health and safety of the persons handling the waste."

On June 19, 2019 at approximately 11:37 AM, it was observed that the storage shed, used to store regulated medical waste, located outside the hospital, had visible openings in the side and roof of the metal structure that could permit access by vermin.

New York State Regulation, Title 10 NYCRR 70-2.2(g)(2)(iii) states, "each storage area shall be designed or located to protect waste from the elements and prevent access by vermin."

On June 19, 2019 at approximately 2:00 PM, Staff B (Vice President of Operations) confirmed that he witnessed the environmental services staff employee consolidating waste and was unsure why he was moving the waste.


4. Review of the Regulated Medical Waste Training records on 06/20/19 at 02:10 PM, revealed that only 126 of the 339 (37%) nurses (RNs and LPNs) received training in the proper disposal of regulated medical waste. Out of 153 Patient Care Assistants, only 26 (17%) received the training.

Review of the training that was conducted by a waste management contractor revealed that four (4) of 46, (0.8%) environmental services employees received training on compliance with regulated medical waste.

The overall findings were brought to the attention of Staff A, President, CEO, and Staff B, who acknowledged findings during the Survey Exit conference on 6/20/19 at approximately 4:00 PM.