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Based on a tour of the surgical suite, tours/observations of other areas of the facility and interviews with key personnel on August 10 and 11, 2015, it was determined that the hospital failed to assure that all essential mechanical, electrical, and patient care equipment was maintained in safe operating condition.

Findings include:

1. The following expired/unusable medical care devices were observed on August 11, 2015, between 10:00 AM and 11:00 AM, located in the Pediatric Emergency Cart in the Post Anesthesia Care Unit:
- One (1) uncuffed endotracheal tube, 5.0 mm.
- One (1) uncuffed endotracheal tube, 4.5 mm.
- The endotracheal tube package stated "Sterile unless package opened or damaged".
- Both tubes were found in opened packages in the Pediatric Emergency Cart.
- One (1) 500 ml bag Lactated Ringers Solution with expiration date of "June 2015".
The Lead Nurse Anesthetist confirmed on August 11, 2015, at approximately 11:45 AM, that the above listed items were expired. The items were immediately removed from the Pediatric Emergency Cart.
2. On a tour of the Women's Health area on August 10, 2015, from 11:50 AM to 12:00 PM, in Room MOB252, a Trophon Ultrasound Probe Disinfecting Device did not display a sticker indicating that it had been inspected for patient safety. This finding was confirmed at 12:00 PM, with the Maintenance Director, when he stated that there was no way to know if the item had been inspected.
3. On a tour of the hospital on August 11, 2015, at 9:38 AM, in Room MH2037, there was an Infusion Pump, hospital #702050, that did not display a sticker that it had been inspected for patient safety. This finding was confirmed at 9:40 AM, with the Maintenance Director, when he stated that there was no way to know if the item had been inspected.

Based on a tour of the facility and interviews with key personnel on August 10, 11, and 12, 2015, it was determined that the hospital failed to maintain premises that were clean and orderly.

Findings include:

1. During a tour of Mayo Orthopedics on August 10, 2015, from 11:00 AM to 11:30 AM, the following were observed: The vinyl cover of an exam table in Room MO118 had a 1 inch tear that had been covered over with a clear tape patch, creating an uncleanable surface. The counter cover in Room MO117 had numerous patches of tape residue, creating an uncleanable surface and the wall under the cast cutter had a 6 inch line of deep gouges into the wall, also creating a surface that had been penetrated. These findings were confirmed at 11:30 AM, with the Maintenance Director.

2. In a tour of the Women's Health area on August 10, 2015, from 11:50 AM to 12:00 PM, in Room MOB248, there were 5 cracked floor tiles which created an uncleanable surface. Additionally in Room MOB245 there were gouges into the wall behind the chair and under the window, creating surfaces that had been penetrated. These findings were confirmed at 12:00 PM, with the Maintenance Director.

3. On a tour of the Mayo Psychiatry and Counseling building on August 10, 2015, from 1:20 PM to 1:55 PM, in the enclosed entry-way of the building, there was a stained ceiling tile and a crack in the left wall at the bottom of the stairs, creating an area that could not be sealed. The Maintenance Director stated that the wall looked to have sustained damage from a water leak. These findings were confirmed at 1:55 PM, with the Maintenance Director.

4. On a tour of the Obstetrics area of the hospital on August 10, 2015, at 2:10 PM, in the clean utility room there was an I.V. (intravenous) pole that had rusty wheel casters, creating an uncleanable surface. This finding was confirmed at 2:20 PM, with the Maintenance Director.

5. On a tour of the hospital on August 10 and 11, 2015, high dust was found in the following Rooms: MH2018B, MH2018M, MH2018K, MH2015, MH 208, MH 207, MH206, MH2038, MH2042, MH2043, MH2052, MH2061, MH2064, and MH1065. The presence of dust indicated that the rooms failed to be thoroughly cleaned between patients. These findings were confirmed at the time of the observations, approximately 8:00 AM - 3:00 PM, with the Maintenance Director.

6. On a tour of the hospital on August 10 and 11, 2015, dusty and/or soiled ceiling vents were found in the following locations: Room MH2008, the bathroom in Room MH2006, the bathroom of Room MH2038, Room MH 2039, the bathroom of Room MH2043, Room MH1075, the bathroom in Room MH1037G, and in Room MH1037C. The presence of dust and soiled ceiling vents indicated that the area failed to be thoroughly cleaned between patients. These findings were confirmed at the time of the observations, approximately 8:00 AM - 3 PM, with the Maintenance Director.

7. On a tour of the hospital on August 11, 2015, in Room MH2043, there was a line of gouges in the wall behind both beds in the room, creating uncleanable surfaces. This finding was confirmed at 10:00 AM, with the Maintenance Director.

8. On a tour of the hospital on August 11, 2015, in Room RC111, the Physical Therapy Gym, there was a tear in the vinyl cover of a treatment table that had been patched with tape. This created an uncleanable surface. Additionally there was tape residue on the floor to the right of this table which also created an uncleanable surface. These findings were confirmed at 11:00 AM, with the Maintenance Director.

9. On a tour of the hospital on August 11, 2015, just outside the door to Room MH1037D there was a depression in the floor with 2 broken floor tiles, creating a surface that could not be sealed. This finding was confirmed at 2:10 PM, with the Maintenance Director.

10. On a tour of the hospital on August 11, 2015, in Room MH004, the Morgue, there were 3 large glass bottles labeled " to discard " , 8 plastic bottles, 2 plastic pails, 1 cardboard box containing a Styrofoam cooler, and a Styrofoam cooler stored on the floor. This creates an uncleanable portion of the floor. This finding was confirmed at 2:15 PM, with the Maintenance Director.

11. On a tour of the hospital on August 11, 2015, in Room MH038C, the Central Supply Room, 20 of 20 bins that held patient care supplies contained significant amounts of dust. The presence of dust indicated that the bins failed to be thoroughly cleaned between shipments of supplies. This finding was confirmed at 2:30 PM, with the Maintenance Director.

Based on a tour of the facility and interviews with key personnel on August 11, 2015, it was determined that the hospital failed to assure the safety of the emergency water supply.

Findings include:

1. The State of Maine Food Code, 3-305.12 states food cannot be stored in Mechanical Rooms.
2. 80 gallons of water, for emergency patient use, were observed stored in the Mechanical Room. This was confirmed at on August 11, 2015, at 11:30 AM, with the Maintenance Director.

Based on document review and interviews with key personnel, on August 12, 2015, it was determined that the hospital failed to follow the procedures for reporting drug errors in the administration of drugs.


Findings include:


1. Mayo Regional Hospital Policy, 'Administration of Medications, II. M.' states, "Medication errors shall be reported to the physician and documented in the medical record and in the Occurrence Insight system."

2. A random review of medication error incidents performed on August 12, 2015, revealed that 2 of 4 medical records (DD, FF) did not have documentation that the physician was notified of the patient's medication error. This finding was confirmed by the Vice President of Quality on August 12, 2015, at approximately 8:45 AM, when she stated that there would be no way to know if the physician had been notified.

Based on observations, document review and interviews with key personnel on August 10-11, 2015, it was determined that the hospital failed to assure that all infection control policies were followed.


Findings include:


1. During a tour of the Oncology Clinic on August 10, 2015, at 2:30 PM, biohazardous waste was observed to be discarded in an open general waste container, located in the patient infusion area. This waste consisted of an empty blood unit bag, Intravenous (IV) tubing and the blood transfusion set that all contained visible blood. This was confirmed at the time of observation with the Vice President of Patient Care and the Vice President of Physician Practices. They both confirmed that this observed practice was in violation of hospital policy.

2. During an interview with the Oncology Services Coordinator Registered Nurse on August 10, 2015, at 2:30 PM, she confirmed that she had infused one unit of Packed Red Blood Cells (PRBC's) and had placed the subsequent biohazardous waste in the general trash, which was her practice. She explained that she placed the biohazardous waste in the trash, rather than leave it hanging on an IV pole, and planned to later move it to a biohazardous waste bag.

3. The Vice President of Patient Care immediately provided a copy of the "Waste Disposal- Infection Control Policy IC.ENV.73", which addresses disposal of biohazardous waste. The policy states"...Regulated waste will be put in a leak proof, puncture proof container, or in red plastic bag, and the bag closed in such a way as to deflate any trapped air...Each area of the hospital which has an occasion to generate regulated waste will collect this waste in a properly designated area, in a leak proof, puncture proof container lined with two red plastic bags...The trash container will be covered and have a biohazard sign on it....Regulated waste will be transported separately from non-regulated waste to reduce the risk of leakage from regulated to non-regulated..."

4. During an interview with the Vice President of Patient Care on August 11, 2015, at 9:00 AM, she confirmed that the Oncology Clinic failed to have the proper biohazardous waste container at the time of the observation. She explained that she immediately obtained the necessary plastic biohazardous waste container and placed it in the clinic on August 10, 2015; additionally, the Oncology Services Coordinator Registered Nurse immediately removed the biohazardous waste from the general trash.

Based on record review and interviews with key personnel on August 10 & 12, 2015, it was determined that the facility failed to ensure that all drugs were administered in accordance with written and signed physician's orders in one of five Swing Bed records (Record GG) and one of thirty Inpatient records (Record JJJ).


Findings include:


1. Record GG contained documentation that the patient was admitted to the Swing Bed Unit on August 6, 2015. The medication administration record for this patient indicated that on August 7, 2015, the patient had received one multi-vitamin tablet. Physician orders did not contain orders for this medication. The Vice President of Clinical Operations stated that the physician should have used the form which they had to allow medications to continue over from In-Patient to Swing Unit, on August 10, 2015, at 9:30 AM, and that there was no verbal order.

2. Record JJJ contained documentation that a nurse notified a physician on July 3, 2015, at approximately 6:57 AM, that the patient had aspirated with a sip of water. It was documented by the nurse that the physician stated to thickened liquids, and if patient was to stay at the hospital, then a swallowing evaluation should be ordered. There was no documentation of this verbal order in the physician's orders or on a doctor's order sheet. The Vice President of Clinical Operations confirmed on August 12, 2015, at approximately 10:00 AM, that there was no verbal order related to the thickened liquids or the swallowing evaluation.

Based on review of the medical records, and interviews with key personnel on August 10-12, 2015, it was determined that the facility failed to assure that the medical records of the patients were complete or accurate for seven of thirty-five medical records. (Record LL, Record SS, Record II, Record XX, Record CCC, Record DDD and Record FFF)


Findings include:


1. Record LL contained documentation that stated the patient was admitted on August 8, 2015. The medical record lacked a signed informed consent form and a signed acknowledgement of receipt of the notice of patient rights.

2. Record SS contained documentation that stated the patient was admitted on June 30, 2015. The medical record lacked a signed informed consent form. Record XX contained documentation that stated the patient was admitted on July 9, 2015. The medical record lacked a signed informed consent form. Record DDD contained documentation that stated the patient was admitted on June 30, 2015. The medical record lacked a signed informed consent form. Record FFF contained documentation that stated the patient was admitted on June 27, 2015. The medical record lacked a signed informed consent form.

3. Record II contained documentation that stated the patient was admitted on June 12, 2015. The medical record lacked a signed informed consent form after the patient was admitted to the Swing Bed Unit.

4. Record CCC contained documentation that stated the patient was admitted on July 25, 2015. The medical record contained a signed informed consent and a signed acknowledgement of receipt of the notice of patient rights, which were not signed by the patient until July 27, 2015. The above findings were confirmed on August 10, 11, and 12, 2015, by the Vice President of Clinical Operations between 10:00 AM and 2:00 PM, when she stated that the forms were not signed initially upon admission.

Based on review of the medical records and interviews with key personnel on August 10-12, 2015, it was determined that the facility failed to ensure that informed consent forms for treatment were signed prior to rendering treatment for seven of thirty-five patient records (Record LL, Record SS, Record II, Record XX, Record CCC, Record DD, and Record FFF).


Findings include:


1. Record LL contained documentation that stated the patient was admitted on August 8, 2015. The medical record lacked a signed informed consent form and a signed acknowledgement of receipt of the notice of patient rights.

2. Record SS contained documentation that stated the patient was admitted on June 30, 2015. The medical record lacked a signed informed consent form. Record XX documentation stated that the patient was admitted on July 9, 2015. The medical record lacked a signed informed consent form. Record DDD documentation stated that the patient was admitted on June 30, 2015. The medical record lacked a signed informed consent form. Record FFF documentation stated that the patient was admitted on June 27, 2015. The medical record lacked a signed informed consent form.

3. Record II contained documentation that stated the patient was admitted on June 12, 2015. The medical record lacked a signed informed consent form after the patient was admitted to the Swing Bed Unit.

4. Record CCC contained documentation that stated the patient was admitted on July 25, 2015. The medical record contained a signed informed consent and a singed acknowledgement of receipt of the notice of patient rights, which were not signed by the patient until July 27, 2015. The above findings were confirmed on August 10, 11, and 12, 2015, by the Vice President of Clinical Operations between 10:00 AM and 2:00 PM.

Based on review of medical records for surgical cases and interviews with key personnel, on August 11, 2015, it was determined that the hospital failed to assure that each surgical patient was discharged to a responsible adult unless exempted by the surgeon, in one of five surgical records (Record X).

Findings include:

1. Mayo Regional Hospital Policy 'Post Anesthesia Care Phase Two' states, "The nurse will document the responsible adult accompanying the patient upon discharge".
2. Record X failed to include documentation that the patient was discharged from the hospital to the care of a responsible adult, or documentation that the patient was exempted from this requirement by the practitioner performing the surgical procedure.
3. Record X stated in the Post-Op nursing notes; "Pt [patient] discharged ambulatory to Auto [automobile], Pt [patient] in stable condition." This finding was confirmed by the Operating Room Charge Nurse on August 11, 2015, at approximately 2:00 PM, who confirmed that the record stated; "Pt [patient] discharged ambulatory to Auto [automobile]", and that the nurse failed to follow the policy requiring information identifying the responsible adult accompanying the patient following discharge.

Based on review of the quality program and quality indicators and interviews with key personnel on August 12, 2015, it was determined that the facility failed to ensure that the quality assurance program was effective by requiring that all patient care services and other services affecting patient health and safety were evaluated.


Finding include:


1. In an interview with the Swing Bed Coordinator on August 11, 2015, at approximately 1:30 PM, she stated that her only quality assurance initiative dealt with record review of the activities program. She stated that there were no other quality assurance initiatives being done for the Swing Bed Unit. Additionally, it was confirmed in an interview with the Vice President of Quality on August 12, 2015, at approximately 12:30 PM, when she stated that there was no quality assurance initiatives for the Swing Bed Program.

2. In an interview with the Director of Support Services on August 12, 2015, at approximately 9:00 AM, he stated that there were no quality assurance initiatives being done for Linen Services for the entire year prior to August 12, 2015.

Based on review of medical records and interviews with key personnel on August 10-12, 2015, it was determined that the facility failed to ensure that all patients were informed of their rights regarding their health status and their medical condition for four of thirty patient records (Record LL, Record RR, Record CCC and Record KKK).


Finding include:


Records LL, RR, CC and KKK lacked documentation of a signed acknowledgement of receipt of the notice of patient rights. These findings were confirmed on August 10, 11, and 12, 2015, by the Vice President of Clinical Operations between 10:00 AM and 2:00 PM, when she stated that the records were lacking any documentation that the patients had received their notice of rights and therefore it would not be possible to know if these patients had received their notice.