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Based on interviews with key staff on November 17, 2015, it was determined that the facility failed to have developed a written visitation policy.

Finding includes:

The Chief Executive Officer [CEO] stated on November 17, 2015, at approximately 11:10 AM, that the facility did not have a written visitation policy developed.

On November 17, 2015, at approximately 12 noon, the CEO presented the survey team with a written visitation policy dated 11/15.

Based on interviews with key staff on November 17, 2015, at approximately 11:10 AM, it was determined that the facility failed to inform patients and/or support persons of the policies and procedures regarding their visitation rights.

Finding includes:

The Chief Executive Officer [CEO] stated on November 17, 2015, at approximately 11:10 AM, that the facility did not have a written visitation policy developed.

On November 17, 2015, at approximately 12 noon, the CEO presented the survey team with a written visitation policy dated 11/15. This policy was inclusive of the requirements including any clinical restrictions or limitations on such rights.

Based on interviews with key staff on November 17, 2015 at approximately 11:10 AM, it was determined that the facility failed to inform patients and/or support persons of the policies and procedures regarding their visitation rights.

Finding includes:

The Chief Executive Officer [CEO] stated on November 17, 2015, at approximately 11:10 AM, that the facility did not have a written visitation policy developed.

On November 17, 2015, at approximately 12 noon, the CEO presented the survey team with a written visitation policy dated 11/15. This policy was inclusive of the requirements including not to deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability and that patient preferences regarding visitors will be followed.

Based on observations, record review, and interviews with key staff on November 17, 2015, it was determined that the facility failed to ensure that medications were stored according to the manufacturers instructions.

Finding includes:

During a tour at the York Oncology Treatment Center on November 17, 2015, at 10:30 AM, 3 vials of Rituxan 10 ml [milliliter] were found at room temperature and did not feel cold or cool to touch. A review of automated dispensing machine records indicated removal of that medication from refrigeration at 7:30 AM. The manufacturer states Rituxan should be stored under refrigeration. The Director of Pharmacy confirmed that the 3 vials of Rituxan were not being stored properly.

During a tour at the York Oncology Treatment Center on November 17, 2015, at 10:30 AM, the temperature of the medication room was elevated beyond normal room temperature. Upon interview with the Director of Pharmacy, it was confirmed that the room temperature was above normal and there was no documentation to confirm what the current temperature was and that the medications were being stored within accepted limits by the manufacturer's instructions.

During a tour at the Wells Oncology Office on November 17, 2015, at approximately 11:30 AM, a review of refrigeration logs revealed that several continuous temperature recordings were below accepted standards. There was no evidence of corrective action being taken. The Director of Pharmacy confirmed that temperature recordings were outside acceptable standards and no corrective action had taken place.

Based on observations and interviews with key staff on November 16, 2015, it was determined that the facility failed to ensure that drugs and biologicals were controlled to ensure patient safety.

Finding includes:

During a tour of the main pharmacy on November 16, 2015, at approximately 12 PM, multiple 10 milliliter [ml] vials of heparin (defined as high risk per hospital policy) were labeled as 50,000 units (10,000 units/ml -5 ml) were found stored next to the heparin 5,000 unit vials. The recommendations by the Institute of Safe Medication Practice (ISMP) and the American Society of Health-System Pharmacy (ASHP), state methods should be implemented to prevent significant dosing errors in high risk medications. The Director of Pharmacy confirmed that a potential patient safety issue existed and removed the heparin 50,000 units vials immediately from the active inventory to prevent potential error.

Based on observations and interviews with key staff on November 16-17, 2015, it was determined that the facility failed to ensure that dispensing of medications to patients was always under the supervision of a physician or pharmacist and compounding of hazardous medications was done in an area without air flow disruption.

Finding includes:

During a tour of the Emergency Department on November 16, 2015, at approximately 1 PM, an interview with the Emergency Department Director and a Registered Nurse revealed that nursing did dispense limited supplies of medications to patients per order of the Emergency Department physician. State law requires that the authorized provider or a pharmacist must dispense the medication. The Board of Nursing prohibits Nursing from dispensing medication. The Pharmacy Director was present during the interview and confirmed that nursing staff were dispensing medication in the Emergency Department.


During a tour of the York Oncology Treatment Center, on November 17, 2015, at 10:30 AM, it was observed that the medication room where sterile compounding of hazardous medication was occurring, was also an all purpose medication room, and therefore staff would be in and out of the room when sterile compounding of hazardous medication was being done. Appropriate sterile compounding of hazardous medication should be done in an area without disruption of air flow. Laminar Flow Hoods can only provide sterile conditions and prevent increased exposure to hazardous substances when located in areas without disruption of airflow per United States Pharmacopeia (USP), American Society of Health-Systems Pharmacist (ASHP) and Laminar Flow Hood manufacturer.

Based on observations and interviews with key staff on November 17, 2015, it was determined that the facility failed to ensure that unauthorized staff were not accessing areas that were locked.

Finding includes:

On November 17, 2015, at approximately 1 PM, a housekeeping staff member was observed alone in the Medical-Surgical medication room and was later observed re-entering the same medication room by entering the security code into the door lock. Several medications were not secured inside the automated dispensing machine inside of the medication room. The Director of Pharmacy was with the surveyor at the time of the observation and confirmed that the housekeeping staff [unauthorized staff] should not have the access code to the medication room because of the unsecured medications.

Based on observations and interviews with key staff on November 16-17, 2015, it was determined that the facility failed to ensure that all drugs and biologicals were safe to be administered to patients

Finding includes:

On November 16, 2015, during a tour of the Emergency Department, outdated pharmaceutical supplies were found in several treatment rooms:
Treatment Room B

3- 3 ml Unit Dose Sterile Water for nebulizer which expired on "Aug 11" (August 31, 2011)
5- 3 ml Unit Dose Sterile Water for nebulizer which expired on "Feb 13" (February 28, 2013)
6- 3 ml Unit Dose Sterile Water for nebulizer which expired on "6/14" (June 30, 2014)
3- 3 ml Unit Dose Sterile Water for nebulizer which expired on "12/13" (December 31, 2013)
1- 3 ml Unit Dose Sterile Water for nebulizer which expired on "9/14" (September 30, 2014)

Treatment Room C

7- 3 ml Unit Dose Sterile Water for nebulizer which expired on "6/15" (June 30, 2015)
7- 3 ml Unit Dose Sterile Water for nebulizer which expired on "6/14" (June 30, 2014)
16- 3 ml Unit Dose Sterile Water for nebulizer which expired on "7/15" (July 31, 2015)
2- 3 ml Unit Dose Sterile Water for nebulizer which expired on "12/07" (December 31, 2007)
4- 3 ml Unit Dose Sterile Water for nebulizer which expired on "Oct 10" (October 31, 2010)

Treatment Room 4

9- 3 ml Unit Dose Sterile Water for nebulizer which expired on "12/13" (December 31, 2013)

It was confirmed by the Emergency Department Nurse Manager on November 16, 2015, at approximately 3:15 PM, that the items above were expired and then the Manager removed the items from the Emergency Department treatment rooms.

During a tour of the York Oncology Treatment Center on November 17, 2015, at 10:35 AM, a non-labeled syringe filled with red liquid was observed located in the non-hazardous medication refrigerator. The Director of Pharmacy confirmed that the syringe was filled with red liquid and not labeled. The Director of Pharmacy removed the non-labeled syringe immediately and placed it in a sharps container.

During a tour of the hospital's outpatient areas on November 17, 2015 with the Chief Operating Officer (COO), the Trades Coordinator (TC), the Director of Environmental Services (DES), and the Bio-Medical Program Coordinator (BMPC), at approximately 2:40 PM, in the Diabetes And Endocrinology Associates area, there was a room at the end of the hall with no identifying number. A container of One Touch Ultra Blue test strips was observed that had an expiration date of 10/15. This finding was confirmed by the COO at the time of the observation. The COO directed that the container be disposed of at that time.

Based on record review and interviews with key staff on November 18, 2015, it was determined that the facility failed to ensure that a patient's medical record contained evidence of adverse reactions to medications.

Finding includes:

A review of York Hospital's Adverse Event Reports from June 1, 2014 - October 31, 2015, performed on November 18, 2015, at approximately 2 PM, revealed that Patient KK had a reaction to Doxil requiring medication treatment. No evidence of this reaction was entered in the Allergy/Adverse Drug Reaction [ADR] portion of Patient KK's medical record. This information would be essential to prevent future reactions. Several members of the quality team and the Director of Pharmacy confirmed that the adverse reaction was not documented in the patient's medical record.

Based on a tour of the kitchen on November 18, 2015, interviews with key personnel, and information provided by the facility, it was determined that the facility failed to ensure that food was prepared in a sanitary environment.

Finding includes
Maine Food Code, Section 4-903.11(B): Equipment, Utensils. Linens, Single-Service, and Single-Use Articles, states: Clean equipment and utensils shall be stored as specified under (A) of this section and shall be stored: (1) In a self-draining position that allows air drying. The York Hospital policy titled, "Safe Food Handling Procedures", Effective Date 6/96, with last Revision Date 11/15, states, "All pots and pans, & food handling equipment are air dried prior to storage." On November 18, 2015, at approximately 11:20 AM, during a tour of the kitchen with the Food Service Director (FSD), the staff person who was washing pots and pans was observed placing 2 wet steam table pans on a pan storage rack, one on top of the other, in a nestled position which would not allow for water drainage or air drying. This finding was confirmed at the time of the observation by the FSD.

Maine Food Code, Section 3-305.14: Food Preparation, states: During preparation, unpackaged Food shall be protected from environmental sources of contamination. On November 18, 2015, at approximately 11:30 AM, during a tour of the kitchen with the Food Service Director (FSD), the kitchen floor was observed to have areas of floor damage, with recessed areas and peeling paint which created uncleanable surfaces and an unsanitary environment in which to prepare food. This finding was confirmed at the time of the observation by the FSD.

Based on a tour of the facility on November 16, 17, and 18, 2015, interviews with key personnel, and a review of information provided by the facility, it was determined that the facility failed to maintain all buildings covered under the hospital license to ensure safety for all patients.

Finding includes:

On November 16, 2015, during a tour of the hospital with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), stained ceiling tiles were observed; at 11:15 AM, near the air conditioning vent (1 tile) in the Echo Room of the Cardiology area, at approximately 11:45 AM, in the hallway of the Strater Wing near to where 2 beds/stretchers were being stored (1 tile), at approximately 1:55 PM, in the Laboratory Waiting Room (1 tile), at approximately 2:10 PM, in the Emergency Department Bathroom (1 tile), at approximately 2:15 PM, in Patient Room # 1 of the Emergency Department (1 tile), at approximately 2:25 PM, in the Patient Bathroom of the Magnetic Resonance Imaging area (1 tile), at approximately 2:45 PM, near the entrance to the Clean Room of the Pharmacy (1 tile), and at approximately 3:10 PM, in Patient Rooms # 6 (1 tile) and # 8 (1 tile), as well as the Patient Bathroom of the Ambulatory Surgical Unit (1 tile). Stained ceilings/ceiling tiles indicate water leakage and the potential for mold growth. These findings were confirmed at the times of the observations by the COO.

On November 17, 2015, during a tour of the hospital's outpatient areas with the Chief Operating Officer (COO), the Trades Coordinator (TC), the Director of Environmental Services (DES), and the Bio-Med. Program Coordinator (BMPC), a stained ceiling/ceiling tile(s) was observed; at approximately 9:00 AM, in the Waiting Room of the Kittery (Bypass) 1A building (1 tile), at approximately 11:45 AM, in the Waiting Room of Wells Building A (ceiling area), at approximately 12:45 PM, in the Patient Bathroom of York Family Practice at Long Sands (1 tile), at approximately 2:15 PM, in Patient Room # 3 of the Pediatrics practice on the hospital campus (1 tile), at approximately 2:30 PM, and in the Waiting Room of the Internal Medicine practice on the hospital campus (3 tiles). Stained ceilings/ceiling tiles indicate water leakage and the potential for mold growth. These findings were confirmed at the times of the observations by the COO.

On November 16, 2015, during a tour of the hospital with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), high dust was observed: at approximately 12:00 PM, in Patient Room # 263 of the Strater Wing on 2 wall-mounted pictures and on top of the wardrobe; at approximately 12:05 PM, in Patient Room # 259 of the Strater Wing on 1 wall-mounted picture and on top of the wardrobe; at approximately 12:10 PM, in Patient Room # 257 of the Strater Wing on 1 wall-mounted picture; on top of the wardrobe and on the top surface of the over-bed light; at approximately 12:15 PM, in Patient Room # 4 of the Birthing Center on the wall-mounted fan and 1 wall-mounted picture; at approximately 2:05 PM, in Patient Room # 2 of the Emergency Department on the top of the magnetic board and the wood trim on the walls; at approximately 2:10 PM , in Patient Room # 5 of the Emergency Department on the sill over the windows; at approximately 2:15 PM, in Patient Room # 1 of the Emergency Department on the top surface of the window trim and on the top of the air freshener; at approximately 2:20 PM in Patient Room # 4 of the Emergency Department on the top surface of the cabinet and the top surface of the glove box holder; at approximately 3:00 PM in Patient Room # 5 of the Ambulatory Surgical Unit, over 1 wall-mounted picture; at approximately 3:05 PM, in Patient Room # 6 of the Ambulatory Surgical Center, on the top surface of the wall-mounted glove box holder and on the top surface of the wall-mounted mirror frame; at approximately 3:10 PM, in Patient Room # 9 of the Ambulatory Surgical Center, on the top of a wall-mounted picture and a wall-mounted magazine/pamphlet rack; and at approximately 3:20 PM, in Room #1 of the Post-Anesthesia Care Unit on the top of the wall-mounted storage cabinet. Dust may carry infectious organisms and thus, if present, increases a patient's risk of infection. These findings were confirmed at the times of the observations by the COO.

On November 16, 2015, during a tour of the hospital with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), at approximately 2:00 PM in the waste storage room, a cardboard box containing biohazard bags was observed stored on the floor, and more than 4 boxes of waste to be shipped out were, also, observed stored on the floor in the corner of the room. If improperly stored on the floor or under sinks, cardboard boxes can absorb water and create an unsanitary environment. These findings were confirmed at the times of the observations by the COO and the DES.

On November 17, 2015, from 7:30 am to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed cardboard boxes being stored on the floor in the "Garage Room" of the Surgical Suite. Cardboard boxes can absorb water and create an infection control hazard. This finding was confirmed at the times of the observation by the SNM.

On November 17, 2015, during a tour of the hospital's outpatient areas, with the Chief Operating Officer (COO), the Trades Coordinator (TC), the Director of Environmental Services (DES), and the Bio-Med. Program Coordinator (BMPC), at approximately 8:30 AM, in the Laboratory of the Kittery Family Practice, a cardboard box was observed stored under the sink and at approximately 10:05 AM, in the Great Works Clean Storage Room, 4 cardboard boxes of Similac baby formula were observed stored on the floor. Cardboard boxes can absorb water and create an infection control hazard. These findings were confirmed at the times of the observations by the COO.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed a low air vent that was rusty and not easily cleaned in Operating Room # 1 and Operating Room # 3. These findings were confirmed at the times of the observations by the SNM.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed the doors to the Sub-Sterile Room in Operating Room # 1 and Operating Room # 2, to have a rough finish that is not easily cleaned. These findings were confirmed at the times of the observations by the SNM.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed damage to the walls, creating uncleanable surfaces in Operating Room #1, in the area above the mopboard, approximately 4 inches above the floor and in Operating Room #5 on the back wall. These findings were confirmed at the times of the observations by the SNM.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed the door frame to the Sub-Sterile Door to Operating Room #1 to be chipped, creating an uncleanable surface. This finding was confirmed at the times of the observation by the SNM.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed the pads on the operating room tables to be damaged, creating uncleanable surfaces. In Operating Room # 3 the head pad was torn and in Operating Room # 5, the corner seam on the foot pad was coming undone. These findings were confirmed at the times of the observations by the SNM.

Based on observations and interviews with key staff on November 16-18, 2015, it was determined that the facility failed to ensure that all patient care equipment was maintained and supplies were not expired.

Finding includes:

During a tour of the Wells Oncology Office on November 17, 2015 at approximately 11:30 AM, it was observed that the certification of the Laminar Flow Hood expired in August 2015. Upon investigation by the Director of Pharmacy, the Laminar Flow Hood had failed inspection and was waiting replacement of the HEPA filter. It was confirmed by the Director of Pharmacy that the Laminar Flow Hood was still utilized post failure of certification.

During a tour of the Emergency Department on November 16, 2015, at approximately 11:00 AM - 3:00 PM, the following expired medical care devices were observed in the Emergency Department supplies located in treatment rooms and the Clean Supply Closet.
1- 4" x 4" Duoderm dressing which expired on "2014-05" (May 31, 2014)
2 - Idoflex Iodine Pads which expired on "02-2015" (February 28, 2015)
1- Hudson 5.0mm uncuffed endotracheal tube which expired on "03-2013" (March 31, 2013)
15- Tegaderm 6 cm X 10 cm Dressings which expired on "2010-08" (August 31, 2010)
Approximately 120 - 5g Packets white Petroleum Jelly which expired on "May 15" (May 31, 2015)
1 - 12 inch penrose drain which expired on "2014-09" (September 30, 2014)
This finding was confirmed by the Emergency Department Nurse Manager on November 16, 2015, at approximately 3:15 PM, who agreed that the items were expired and removed the items from the Emergency Department.

During a tour of the Emergency Department on November 16, 2015, at approximately 11:00 AM - 3:00 PM, the following was observed in the Emergency Department cabinet located under the Ice Machine:

3- Bottles Gastrografin (contrast medium used for radiological studies) located in drawer marked "Crackers" which contained crackers and other patient snack foods. This was not confirmed at the time of observation; however on November 17, 2015 at approximately 11:30 AM, the Leader of Emergency Services stated "The bottles of Gastrografin were removed for the cracker drawer."

During a tour of the Surgical Suite on November 17, 2015, at approximately 7:30 AM - 11:30 AM, the following expired medical care devices were observed in the "Difficult Intubation Cart" which was located in the Surgical Suite:

1 - "Easy Cap II" capnography adaptor which expired on "2011-10" (October 31, 2011)

1- 7.0 mm cuffed endotracheal tube which expired on "2014-06" (June 30, 2014)

1- 7.5 mm cuffed endotracheal tube which expired on "2014-07" (July 31, 2014)

1- 8.0 mm cuffed endotracheal tube which expired on "2013-10" (October 31, 2010)

2- Lollicain topical anesthetic which expired on "2011-12" (December 31, 2011)

6- 14 gauge X 1 ¼" intravenous catheter which expired on "2012-10" (October 31, 2012)

16 - Portex Fiber optic swivel which expired on "2018-06" (June 30, 2008)

20 - Single Use Biopsy valve which expired on "2014-01" (January 31, 2014)

The Nurse Manager of Surgical Services and the Chief of Anesthesia confirmed on November 17, 2015 at approximately 11:30 AM, that these items were expired and still available for use. The items were removed from the surgical suite by the Nurse Manager of Surgical Services.


On November 16, 2015, during a tour of the hospital, with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), Intravenous (IV) Poles with rusty bases and/or casters, creating an uncleanable surface, were observed; at approximately 11:30 AM, in the Sleep Lab (pole base) and at approximately 1:25 PM in the Computed Tomography (CT) Room (casters). These findings were confirmed at the times of the observations by the COO.

On November 16, 2015, during a tour of the hospital with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), an Intravenous (IV) Pole mounted on a stretcher was observed to be rusty, creating an uncleanable surface, in Patient Room # 2 of the Emergency Department. This finding was confirmed at the time of the observation by the COO.

On November 17, 2015, from 7:30 am to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed rusty casters, creating uncleanable surfaces, in Operating Room # 1 on a rolling stool and a trash hamper, in Operating Room # 2, on a Mayo Instrument Table, and in Operating Room # 3, on an eye stool. These findings were confirmed at the times of the observations by the SNM.

On November 16, 2015, during a tour of the hospital with the Chief Operating Officer (COO), the Trades Coordinator (TC), and the Director of Environmental Services (DES), torn vinyl coverings, creating uncleanable surfaces were observed at approximately 1:15 PM on the ends of the exam table in the Catheterization Laboratory Pacer Room. These findings were confirmed at the times of the observations by the COO.

On November 17, 2015, during a tour of the hospital's outpatient areas with the Chief Operating Officer (COO), the Trades Coordinator (TC), the Director of Environmental Services (DES), and the Bio-Med. Program Coordinator (BMPC), torn vinyl coverings, creating uncleanable surfaces, were observed at approximately 9:45 AM, on 3 floor mats in the Physical Therapy area of the York Hospital of South Berwick, at approximately 10:05 AM, on an exam tables in Room # 2 and in Room # 10 of the Great Works area of the York Hospital of South Berwick. These findings were confirmed at the times of the observations by the COO.

On November 17, 2015, from 7:30 AM to 12:30 PM, during a tour of the hospital Operating Rooms with the Surgical Nurse Manager (SNM), a surveyor observed the pads on the operating room tables to be damaged, creating uncleanable surfaces. In Operating Room #3 the head pad was torn and in Operating Room #5, the corner seam on the foot pad was coming undone. These findings were confirmed at the times of the observations by the SNM.





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On November 17, 2015, during a tour of the hospital's outpatient areas with the Chief Operating Officer (COO), the Trades Coordinator (TC), the Director of Environmental Services (DES), and the Bio-Medical Program Coordinator (BMPC), at approximately 2:40 PM, in the Diabetes And Endocrinology Associates area, in a room at the end of the hall with no identifying number, a container of One Touch Ultra Blue test strips was observed that had an expiration date of 10/15. This finding was confirmed by the COO at the time of the observation. The COO directed that the container be disposed of at that time.

Based on interviews with key personnel and information provided by the facility on November 18, 2015, it was determined that the facility failed to assure proper ventilation, temperature, and humidity controls in the Operating Rooms.

Finding includes:

AORN (Association of PeriOperative Registered Nurses), Inc., state on their web site, updated March 3, 2015, "The recommended temperature range in an operating room is between 68 degrees Fahrenheit and 75 degrees Fahrenheit."

AORN posted on their web site, updated July 18, 2013, "The recommended humidity range in an operating room is 20% to 60%."

On November 19, 2015, at approximately 10:30 AM, the Trades Coordinator (TC) stated the Director of PeriOperative Care reported to him that although they follow the AORN guidelines, they had no written policies or procedures as to how they maintain the temperature, humidity, and air exchanges within the Operating Rooms. Additionally, there was no documentation of temperature and humidity readings or times and number of air exchanges.