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100 HIGH STREET

BUFFALO, NY 14210

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on medical record review and interview, the hospital does not ensure that the patient or patient's representative is given the information needed in order to make "informed" decisions regarding care, as evidenced for 6 of 14 patients whose consent forms were reviewed. (Patients #9, 26 and 33-36)

Findings include:

Medical record review with Staff Nurse #13 on 10/9/12 at 2:30 PM revealed:
- The informed consent form in the paper medical record for Patient #9 was blank. Staff Nurse #13 stated that the system always prints out two forms, so the other form was probably in the patient's room. An informed consent form for hospital admission and treatment was obtained from the patient's room; it was signed by the patient and dated on the day of admission, 10/3/12. The consent was witnessed and signed by hospital staff at that time on 10/9/12.

Medical record review with Unit Nursing Supervisor on 10/10/12 at 3:15 PM revealed:
- The informed consent form for Patient #26 for newborn care did not contain the name of the responsible practitioner.

This finding was verified with Unit Nursing Supervisor on 10/10/12 at 3:15 PM.


Medical record review with Staff Nurse #21 on 10/11/12 at 10:30 AM revealed:
- The paper medical record of Patient #34 contained transfer documentation from another facility, with consent forms (signed by the mother at the other facility) for the baby and the baby's twin (Patient #33) for transfer for a higher level of care. This transfer documentation included the delivery room record, and individually for each baby, neonatal resuscitation flow sheets, cord pH results and transfer forms. The medical record for Patient #33 did not contain any of this documentation. During interview on 10/11/12 at 11:25 AM, Nurse Manager Staff #20 explained that transfer documentation is typically kept in one medical record when twins are born.

Medical record review with Unit Nursing Supervisor Staff #25 on 10/11/12 at 1:45 PM revealed:
- The paper medical record for Patient #35 did not contain documentation of informed consent for treatment. A "Stabilization Team Transport Record" was completed by facility staff on 10/8/12, the day of admission. Unit Supervisor Staff #25 stated that the Stat Team, which is involved in the transfer of a patient from another facility to this hospital, often keeps transfer/consent forms with their records.
During interview on 10/11/12 at 11:25 AM, Staff #20 also confirmed this practice of the Stat Team.

Medical record review with Unit Nursing Supervisor Staff #25 on 10/11/12 at 1:45 PM revealed:
- The informed consent form for Patient #36 for blood transfusion did not contain the name of the responsible practitioner or the legal name of the consenting person.

This finding was verified with Unit Nursing Supervisor Staff #25 on 10/11/12 at 1:45 PM.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on medical record review and interview, the hospital does not ensure that informed consent forms are properly executed and contain all required minimum elements, as evidenced for 10 of 14 patients whose consent forms were reviewed. (Patients #9, 21, 24-26 and 32-36)

Findings include:

Cross-refer to Tag #A-0131 for Patients #9, 26 and 32-36.

Cross-refer to Tag #A-0955 for Patients #21, 24, 25 and 32.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation and interview, the hospital does not maintain all equipment to ensure an acceptable level of safety.

Findings include:

- During facility tour with Plant Operations Manager Staff #5 on 10/10/12, at a medical gas zone valve box on the second floor, a vacuum gauge read 0 psi, indicating no vacuum. The zone valve box signage indicated that it was for "Cardiac Cath, Angio Labs, Nuclear Medicine". Upon entry into the cath lab, it was observed the wall vacuum gauge showed the vacuum was functional.

This finding was verified with Plant Operations Manager Staff #5 on 10/10/12.


- During facility tour with Plant Operations Manager Staff #5 on 10/9/12, on the fifth floor of the Tanner building, the nurse call bells in the male and female restrooms off the corridor did not ring to the nurse's station.

This finding was verified with Plant Operations Manager Staff #5 on 10/9/12.


- During facility tour with Plant Operations Manager Staff #5 on 10/10/12, in room #200M, the toilet stalls in both the male and female restrooms each had a "light" switch labeled "call for nurse". When the switch was flipped, there was no visual or audio alarm indication. There was no nurse call light outside of either door.

This finding was verified with Plant Operations Manager Staff #5 on 10/10/12.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation and interview, the hospital does not maintain all ventilation equipment.

Findings include:

During facility tour with Plant Operations Manager Staff #5 on 10/9/12, it was observed that the exhaust ventilation was not operational in rooms #301A, 301D, 301E and 301F.

These findings were verified with Plant Operations Manager Staff #5 on 10/9/12.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation and interview, the hospital does not disinfect all patient equipment, maintain all surfaces in a clean manner, or sanitize all equipment located in the surgical rooms.

Findings include:

- During facility tour with Plant Operations Manager Staff #5 on 10/9/12, two patient backboards were observed in the "return to EMT" (emergency medical technician) area in the emergency department. Both backboards had disposable tape, which is used to secure the patient's head during transport, still attached to the boards. This tape has the potential to become contaminated.
- During interview on 10/9/12, Plant Operations Manager Staff #5 stated there was no written policy on how equipment from EMTs is to be disinfected before return to use. Additionally, he stated that the facility does not have a method to identify whether or not a backboard in the "return to EMT" area has been disinfected.

These findings were verified with Director of Quality/Patient Safety Staff #2 on 10/10/12.


- During facility tour with Plant Operations Manager Staff #5 on 10/9/12, the following observations were made:
---In the clean supply room for the emergency department, there were many supply items on the floor underneath the storage racks.
---In trauma rooms #3 and 4 in the emergency department, the window blinds were heavily laden with dirt.
---In the kitchen in the dietary department, the floor underneath the tray-line had a layer of dirt on it.
---In the kitchen in the dietary department, Freezer II had numerous cardboard boxes containing food items that were stored on the floor of the freezer.
---In the kitchen in the dietary department, the area behind the dish machine in the dishwashing room was heavily encrusted with dirt.
---In shower room #429, the shower curtain had a heavy build-up of mildew, and the room was odorous. The top hinge to the door of the room was heavily corroded.
---In environmental room #1047, staff had left a towel lying in the floor sink basin. The floor in the room had a heavy accumulation of dirt on it.
---In environmental room #T6 (Tanner 6), the floor sink basin had a heavy accumulation of dirt on it.
---The exhaust grills in rooms #484, 933, 962, 965 and E313 had heavy accumulations of dust.

These findings were verified with Plant Operations Manager Staff #5 on 10/9/12.



- During facility tour with Plant Operations Manager Staff #5 on 10/10/12, the following was observed on the third floor in the NICU (neonatal intensive care unit) (Tanner building):
---The floor in clean supply room #313 had an accumulation of dust on it, and numerous supply items were stored underneath the storage racks for clean supplies.
---The floor in the common area that contained computer work stations had a heavy accumulation of dirt on it.
---The floor in environmental room #E310 was heavily encrusted with dirt.

These findings were verified with Plant Operations Manager Staff #5 on 10/10/12.



- During facility tour with Plant Operations Manager Staff #5 on 10/10/12, it was observed in surgical rooms #1 and 6 that there were arm boards that had a large build-up of adhesive on them, which caused the surface to not be easily cleanable.

This finding was verified with Plant Operations Manager Staff #5 and Director of Quality/Patient Safety Staff #2 on 10/10/12.

INFORMED CONSENT

Tag No.: A0955

Based on medical record review and interview, the hospital does not ensure that the patient is informed who will conduct a proposed surgical intervention, and does not document the legal name of the consenting person, as evidenced for 4 of 14 patients whose consent forms were reviewed. (Patients #21, 24, 25 and 32)

Findings include:

Medical record review with Unit Nursing Supervisor Staff #18 on 10/10/12 revealed:
- The informed consent form for Patient #21 for vaginal delivery and Cesarean section did not contain the name of the responsible practitioner.

This finding was verified with Unit Nursing Supervisor Staff #18 on 10/10/12 at 11:30 AM.



Medical record review with Unit Nursing Supervisor Staff #19 on 10/10/12 revealed:
- The informed consent form for Patient #24 for vaginal delivery and Cesarean section did not contain the name of the responsible practitioner.
- The informed consent forms for Patient #25 for epidural, vaginal delivery and Cesarean section did not contain the name of the responsible practitioner.

These findings were verified with Unit Nursing Supervisor Staff #19 on 10/10/12 at 3:30 PM.



Medical record review with Staff Nurse #21 on 10/11/12 revealed:
- The informed consent forms for Patient #32 for bronchoscopies signed on 7/25/12 and 8/28/12 did not contain the names of the responsible practitioner or the consenting person. The informed consent form for Patient #32 for bronchoscopy signed on 9/18/12 did not contain the name of the responsible practitioner or the legal name of the consenting person.

These findings were verified with Staff Nurse #21 on 10/11/12 at 10:00 AM.