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Based on policy review, medical record review, and interview, the facility did not ensure nursing staff documented the removal/discontinuation of restraints in accordance with facility policy for 4 out of 21 patients (Patient #47, 48, 37 and 38).

Findings include:

Review of policy "Restraints," last revised 05/06/19 revealed upon discontinuation of a restraint, the registered nurse (RN) will complete the restraint discontinuation powerform for the actual date/time the restraint was discontinued.

Review on 11/15/19 of the Buffalo General Medical Center (BGMC) medical record dated 7/26/19 to 08/02/19 for Patient #47 revealed on 07/29/19 at 05:46 AM, a two point wrist, non-violent restraint was initiated. The last nursing restraint monitoring note was documented on 07/30/19 at 04:00 AM. There is no documentation to indicate the date/time the restraint was discontinued.

Review on 11/15/19 of the BGMC medical record dated 08/03/19 to 08/22/19 for Patient #48 revealed on 08/03/19 at 07:23 PM, a vest/torso, non-violent restraint was initiated. The last nursing restraint monitoring note was documented on 08/04/19 at 12:00 AM. There is no documentation to indicate the date/time the restraint was discontinued.

Interview on 11/15/19 at 02:20 PM with Staff #12, Corporate Quality Improvement Project Coordinator, confirmed these findings.

Review on 11/22/19 of the Oishei Children's Hospital (OCH) Emergency Department (ED) medical record dated 11/15/19 to 11/16/19 for Patient #37 revealed on 11/15/19 at 11:17 AM, a four point violent/self-destructive restraint was applied. There is no documentation to indicate the date/time the restraint was discontinued.

Review on 11/22/19 of OCH ED medical record dated 09/21/19 to 09/24/19 for Patient # 38 revealed on 09/21/19 at 10:32 PM, four point violent/self-destructive restraints were applied. At 11:27 PM, the ED provider ordered to discontinue the restraints. There is no documentation to indicate whether the restraint was discontinued.

Interview on 11/22/19 at 01:30 PM with Staff #5, OCH Chief Quality & Safety Officer, and Staff #10, RN Electronic Medical Record Coach Manager, confirmed these findings.

Based on policy review, document review and interview, the facility does not ensure adverse patient events are analyzed.

Findings include:

Review of policy "Corporate Event Reporting" effective 08/13/18 and attachment "STARS Event Responsibility (LE.8-C)" dated 07/16 indicates a "Stars" a web-based event report must be entered for an event that occurred or could occur resulting in an unintentional adverse development in a patients condition. Follow-up activities (including investigations, corrective actions, disciplinary actions, process improvement recommendations and other analysis) in response to the events will be conducted by the responsible manager/designee and will be documented under "review" and/or "attachment" sections. If an investigation was performed, add a new note in the "notes" section. Each "Event Owner and Event Reviewers will convert the event to "closed" when no further action is required on their part. Risk Management will view all events and Quality Directors will view Quality & Patient Safety events, adding notes in the "notes" section if applicable. It is the managers responsibility to follow-up, investigate and take appropriate action regarding the event.

Review on 11/15/19 of the confidential Stars Event Report revealed on 04/08/19 at 09:00 AM, Patient #12 was undergoing a surgical procedure in the Gates Vascular Institute (GVI) operating room. A multi-use Morris retractor screw/blade fell apart in her chest, but staff were able to retrieve the blade and screw. A staff member from the sterile processing department was notified and retrieved the retractor. The event was assigned to multiple staff members for review. There are no attachments. The event review dated 04/09/19 at 12:00 AM revealed Patient #12 had no injuries from the event, no follow-up was needed, but the investigation is in progress. There is no documentation indicating an investigation took place, what actions were implemented to ensure this retractor was safe for use/removed from service/staff education on assembling, and if the investigation was completed.

Interview on 11/18/19 at 11:54 AM with Staff #1, Manager of Regulatory Affairs, revealed there is no other documentation related to this event. The manager reviewed the event with the technician but did not document the discussion.

Review on 11/15/19 of the confidential Stars Event Report revealed on 06/24/19 at 02:00 PM, Patient #44 was undergoing a cardiac stress test at DeGraff Memorial Hospital and experienced a medical emergency. Staff attempted to place Patient #44 on a Zoll for monitoring/defibrillation, however, none of the code carts in Radiology came stocked with Zoll pads. Patient #44 was transferred to the emergency department. The event was assigned to multiple staff members for review. There are no attachments. The event review dated 07/08/19 at 12:00 AM revealed Patient #44 had no injuries from the event, no follow-up was needed and the investigation was complete. There is no documentation indicating if an investigation took place or what actions were implemented to ensure Zoll pads are available for medical emergencies in the cardiac stress testing/Radiology area.

Interview on 11/15/19 at 02:22 with Staff #1, Manager of Regulatory Affairs, verified this finding.

Review on 11/15/19 of the confidential Stars Event Report revealed on 05/02/19 at 02:55 PM, Patient #39 was having a procedure performed in the operating room at Oishei Children's Hospital (OCH), when the physician brought in and implanted a product from an outside source. The event was assigned to multiple staff members for review. There are no attachments, documented actions/investigations, or explanation of the event in the report. The "review" section does not indicate if the event was reviewed and if the investigation was completed.

Review on 11/15/19 of the confidential Stars Event Report revealed on 06/22/19 at 01:00 PM, a staff member at Buffalo General Medical Center came across an opened narcotic package of Percocet, and took it to the Pharmacist. The event was assigned to multiple staff members for review. There are no attachments, but there is a note from the Pharmacist review indicating "will review with staff member, believe this was just a package." No further explanation of the event is documented in the report. The event review dated 07/01/19 at 12:00 AM indicates the investigation is complete.

Review on 11/15/19 of the confidential Stars Event Report revealed alarm issues for Patient #22 on 06/10/19 at 01:00 AM (MFSH), and for Patient #40 on 07/08/19 at 08:55 AM (OCH). In both cases, the "review" section does not indicate if the event was reviewed and if the investigation was completed.

Interview on 11/22/19 at 02:21 PM with Staff #1, Manager of Regulatory Affairs, verified these findings.

Based on a Life Safety Code Validation survey, completed on November 27, 2019, at Kaleida Health, the condition for Physical Environment is not met. See Form CMS-2567 Life Safety Code report for cited deficiencies.

Based on observation, policy review, and interview, the facility does not ensure the safety and security of sharps containers.

Findings include:

Review of New York Codes, Rules and Regulations on Regulated Medical Waste, Part 70 and Management of Regulated Waste, Subpart 70-2 (10 CRR-NY 70-2.2) indicates that "Each primary container holding regulated medical waste shall be secured and situated so as to prevent leakage or preclude loss of contents during handling, storage and/or transport."

Review of policy "Regulated Medical Waste," last reviewed 09/30/19 indicates sharps containers are to be rigid, leak proof, puncture resistant, closable, labeled, and kept in an upright position.

Observation on 11/13/19 at 11:05 AM at Buffalo General Medical Center (BGMC) revealed the sharps container, located in room #4 of the Medical Intensive Care Unit, was filled to the top of the container, above the"fill line." Interview with Staff #8, Director of Facilities, verified this finding.

Observation on 11/14/19 at 10:50 AM, in BGMC operating rooms #3 and #4 revealed that the sharps containers (one in each room), located on the floor next to the anesthesia machines, were not secured or placed in a safety securing device to prevent tipping and spillage of contents. At 11:00 AM in BGMC CT scan room, three large red sharps container boxes were full, not completely closed, and not secured or placed in a safety device to prevent tipping or spillage of biohazardous contents. Interview with Staff #41, Director Surgical Services and Staff #287, Senior Clinical Lab Technician, verified these findings in the CT area.

Observation on 11/21/19 at 10:40 AM, at Millard Fillmore Suburban Hospital revealed two sharps containers, located on work tables in the lab, were not secured or in anti-tipping devices. Interview with Staff #84, Director Plant Operations, verified this finding.

Based on observation and interview, the facility did not maintain 2 of 3 patient mattresses at Millard Fillmore Suburban Hospital (MFSH) to be free from tears and missing material, preventing the mattresses from being adequately decontaminated.

Findings include:

Observation on 11/19/19 at 01:15 PM, at MFSH revealed that the patient bed mattresses in room #201 and room #210 were torn and missing vinyl material, leaving foam exposed.

Interview on 11/19/19 at 01:15 PM with Staff #84, Director Plant Operations, verified these findings.

Based on policy review, observation, and interview, the facility did not ensure that staff provided care in accordance with acceptable infection control standards.

Findings include:

Review of policy "Standard & Transmission Based Precautions," last revised 08/13/18 revealed the following:
- Hand hygiene must be performed before and after glove use.
- Health care workers will use appropriate barriers including gloves and other PPE (personal protective equipment) to prevent skin and mucus membrane exposure when contact with blood, body fluids, excretions, secretions, non-intact skin and mucus membranes is anticipated.
- Gloves are to be worn when touching blood, body fluids, mucous membranes or non-intact skin of all patients, handling items soiled with blood or body fluids. Changed after each patient contact and between procedures.
- Workstations/computers on wheels and/or medication carts may be brought into the patient room and must be wiped with hospital approved disinfectant upon leaving the room.
- When a patient is on contact precautions, a gown and gloves are worn upon entry into the room, then are removed immediately prior to leaving the room and hand hygiene is performed.

Review of policy "Hand Hygiene," last revised 10/14/19 revealed hand hygiene is to be performed before/after touching a patient, before/after clean/aseptic procedure (prior to donning gloves) and after touching patient surroundings. Gloves are to be changed and hand hygiene is to be performed during patient care if moving from a contaminated body site to a clean body site.

Review of policy "Food Service Infection Control," last revised 04/22/19 revealed gown and gloves will be worn upon entering any contact precautions rooms.

Review of policy "Dialysis Infection Prevention and Control," last revised 05/06/19 revealed mask/face shield, gloves and gowns must be worn during the initiation of hemodialysis.

Review of policy "IV Care and Maintenance," last revised 09/30/19 revealed prior to initiating a central venous catheter dressing change, hand hygiene is performed, and clean gloves are donned. A sterile field is prepared. The old dressing is removed, and the site is assessed. Clean gloves are then removed, hand hygiene is performed, and sterile gloves are donned.

Review of policy "Glucose Testing Using Abbott FSPP Meter," last revised 09/30/19 and "Cleaning and Equipment Classification for Patient Use/Department Specific Equipment," last revised 04/18/19 revealed the blood glucose meter/point of care testing device cleaning is the responsibility of the staff member following each patient use.

Observations at Buffalo General Medical Center (BGMC) revealed the following:
- On 11/13/19 at 10:30 AM on the 8th floor in room 818, Staff# 38, Dietary, entered the room of Patient #4, who was on contact precautions, with a computer on wheels and PPE gown not fully closed. Upon exiting the room, Staff #38 did not disinfect the computer on wheels.
- On 11/14/19 at 02:30 PM in the acute dialysis unit, Staff #30, RN was wearing a mask that was not covering her nose while initiating dialysis through a central line catheter for Patient #5.
- On 11/15/18 at 08:30 AM in the Medical Intensive Care Unit room #1, Staff #39, RN did not have the PPE gown fully closed while providing care for Patient # 7, who was on isolation. At 10:15 AM in the Neuro Intensive Care Unit room #7, Staff #45, RN did not have the PPE gown fully closed while in Patient #10's room, who was on isolation. At 12:00 PM in the Vascular Interventional Suite, Staff #40, RN removed Patient #11's chest dressing and placed it on a gauze wrapper on the windowsill of the patient's room. After the dressing change was complete, Staff #40, RN removed gloves, washed hands, then picked up the old dressing and gauze wrappers without gloves, and discarded the items in the garbage can.

Interview on 11/15/19 at 03:30 PM with Staff #1, Manager of Regulatory Affairs; Staff #2, Senior Director of Accreditation Services; and Staff #9, Chief Quality & Patient Safety Officer at BGMC, verified these findings.

Observations at Oishei Children's Hospital (OCH) revealed the following:
- On 11/19/19 at 10:50 AM, Staff #72, RN entered Patient #24's room #J1003, who was on contact precautions, with gown untied and hanging off of shoulders. Between 02:00 PM to 03:00 PM in the Neonatal Intensive Care Unit, room #J413, Staff #74, RN did not have her PPE gown fully closed or tied four (4) times when entering Patient #34's room, who was on isolation. At 02:30 PM, Staff #56, Dietary Aide, entered Patient #34's with gown untied and open in back.
- On 11/21/19 at 10:30 AM in the 11th floor treatment room, Staff #267, RN, performed a central venous catheter dressing change on Patient #254. Staff #267, RN, set up the sterile field and removed the old dressing from the patient's neck with non-sterile gloves. Staff #267, RN, then removed non-sterile gloves and donned sterile gloves without performing hand hygiene.
- On 11/22/19 at 09:00 AM in Emergency Department Room #7, Staff #73, RN, was opening drawers in the computer workstation, gathering supplies for finger stick, and utilizing the keyboard and mouse on the computer while wearing clean gloves. With same gloves on, Staff #73 performed a finger stick on Patient #29. Staff #73, RN, did not don clean gloves or perform hand hygiene prior to performing the finger stick. Staff #73, RN then placed the glucometer back on the docking station without disinfecting the machine per policy.

Interview on 11/22/19 at 01:30 PM Staff #1, Manager of Regulatory Affairs, Staff #2, Senior Director of Accreditation Services, and Staff #5, Chief Quality & Patient Safety Officer at OCH, verified these findings.

Based on policy review, medical record review, and interview, a Surgical & Anesthesia services policy/procedure related to fire risk assessment and fire safety protocol and evacuation, has not been developed. In addition, nursing staff do not follow surgical services policies related to pre-procedure skin assessments for 2 of 5 surgical patients (Patient #26 and 32), pre-procedure skin preparations for 1 of 5 surgical patients (Patient #32), and specimen collection for 1 of 5 surgical patients (Patient #26).

Findings include:

Review of system wide Surgical and Anesthesia Services policies revealed no evidence of a policy and/or procedure related to performing a fire risk assessment or for the evacuation of the operating room in the event of a surgical fire.

Review on 11/18/19 of the Buffalo General Medical Center (BGMC) medical records for Patient #137, #138 and #139 with a surgical date of 11/15/19 revealed intraoperative nursing documentation of a fire risk assessment with questions to determine risk scoring. If high risk scoring (3) was determined, interventions included: oxygen delivery less than or equal to 3 liters per minute if possible and stopping supplemental oxygen at least 1 minute before and during cautery use. Corresponding documentation in the intra-operative anesthesia record, where the type and rate of oxygen administration is decided and performed by anesthesia personnel, is not present.

Interview on 11/18/19 at 10:45 AM with Staff #1, Manager of Regulatory Affairs and Staff #3, VP Quality & Patient Safety, verified these findings.

Review on 11/18/19 of the BGMC medical record of Patient #139 with surgical date of 11/15/19, revealed nursing documentation of a high fire risk score of (3) due to the following criteria being met: surgical site above the xiphoid, oxygen administered by face mask or nasal cannula, and ignition source of electrocautery present. Under the plan and intervention section, the checkbox regarding oxygen to be administered at 3 liters per minute or less, if possible, was not checked off. Under the section listing interventions when electrocautery is used with an open oxygen delivery system, the checkbox to stop supplemental oxygen at least 1 minute before and during cautery use was not checked off. Although these interventions are included on the nursing documentation, the implementation would be under the control of anesthesia personnel, in collaboration with the surgeon.

Interview on 11/18/19 at 11:00 AM with Staff #11, Accreditation Manager and Staff #41, Director of Surgical Services, verified the above finding.

Review of policy "Specimens - Care, Collection, Handling and Disposition - OR Procedures," last reviewed 10/14/19 indicates the circulating/relief circulating registered nurse will document the surgical specimen slip unique number on the perioperative record once it has been determined a specimen will be obtained. The number of specimens will be documented on the perioperative report. The specimen will be handed off to the circulating nurse as soon as possible. The surgeon will be verbally asked to identify the specimen, and it will be sent to pathology.

Review of policy "Pre-Operative Skin Preparation," last revised 07/15/19 indicates it is the responsibility of the registered nurse (RN) to assess the surgical site for appropriate skin preparation in conjunction with the provider. The patient's skin condition shall be assessed at the surgical site before skin preparation begins. Skin preparation should be documented and include, but not limited to, skin prep dry time in minutes.

Review of policy "Use of Electrosurgical Unit - ESU," last revised 07/15/19 indicates the patient's skin condition will be assessed before and after the use of ESU.

Review on 11/22/19 of the Oishei Children's Hospital (OCH) medical records/Nursing Operating Room Reports revealed the following:
- On 11/19/19, Patient #26 underwent a Tonsillectomy and Adenoidectomy with nasal cautery using an electrosurgical unit (ESU). The pathology specimen was signed off at 01:08 PM, and the post op cautery pad skin assessment was signed off at 01:09 PM, both prior to the initiation of the procedure at 01:32 PM.
- On 11/20/19, Patient #32 underwent an excision of a lesion under the left eye using an electrosurgical unit (ESU). The nursing operative report indicates the procedure started at 05:37 PM and ended at 05:40 PM. However, the pre & post skin assessments are both signed off post treatment at 05:49 PM. The pre procedure skin preparation for Betadine solution is signed off post procedure at 05:50 PM and does not include a dry time.

Interview on 11/22/19 at 01:30 PM with Staff #5, Chief Quality & Safety Officer, verified these findings.

Based on policy review, medical record review, and interview, the post anesthesia evaluation does not include assessment of vital signs for 1 of 8 surgical patients at Oishei Children's Hospital (OCH) (Patient #27).

Findings include:

Review of policy "Standard of Care Post Anesthesia-PACU Phase I," last revised 09/30/19 indicates all patients who receive anesthesia care will be admitted to the Post Anesthesia Care Unit (PACU) or alternative areas by specific direction of the anesthesiologist responsible for the patient's care. Sign out by the Anesthesia team is mandatory prior to discharge. Once discharge criteria is met, an attending Anesthesiologist/post anesthesia evaluation note will discharge the patient from the PACU. Discharge criteria includes, but is not limited to vital signs: respiratory rate, oxygen saturation, blood pressure, cardiac rate/rhythm, and temperature.

Review on 01/22/19 of the OCH medical record for Patient #27 revealed on 11/20/19, he underwent a Tympanomastoidectomy. A pre-anesthesia evaluation is performed at 12:44 PM using vital sign measurements from 10:24 AM. The surgical procedure starts at 01:28 PM and ends at 03:56 PM. The post-operative evaluation is performed at 05:39 PM by another physician using the pre-procedure vital sign measurements from 10:24 AM & 11:56 AM, listing height, weight and body mass index measurements. The assessment does not include temperature, pulse rate, blood pressure, SpO2 monitoring or respiratory rate of Patient #27. There is no evidence the physician reviewed post procedure vital signs.

Interview on 11/22/19 at 01:30 PM with Staff # 5, Chief Quality & Safety Officer, verified these findings.

Based on policy review, medical record review, and interview the facility does not ensure Emergency Department (ED) patients are reassessed following triage in accordance with facility policy for 4 of 4 patients at Millard Fillmore Suburban Hospital (MFSH) (Patient #14, 15, 16, and 18) or that Human Immunodeficiency Virus (HIV) and/or Hepatitis C Virus (HCV) testing is obtained for 3 of 4 patients who did not decline testing during triage at DeGraff Memorial Hospital (DMH) and MFSH (Patient # 41, 43 and 152).

Findings include:

Review of policy "Patient ESI/Triage Process" last revised 01/14/19 indicates a 5 level ESI Triage Classification System is utilized. For a Level 3-Yellow/ESI classification, the goal is to evaluate 100% of these patients within (1) hour of arrival. Patients that are not evaluated by a provider within the target time frame for that triage category need to have a reassessment done by an ED registered nurse (RN) and have that reassessment documented on the nursing record. A change in the triage category may be necessary based on that assessment.

Review on 11/22/19 of MFSH ED medical records revealed the following " Level 3-Yellow/ESI" patients were not reassessed by nursing staff when the provider evaluation exceeded the one-hour target time:
- On 11/13/19 at 06:53 PM, Patient #18 presented to the ED and was triaged. At 09:00 PM, Patient #18 was evaluated by the provider. There is no documentation to indicate the patient was reassessed by nursing prior to the provider evaluation.
- On 11/19/19, Patient #14 presented to the ED and was triaged at 09:29 PM. On 11/20/19 at 02:30 AM, Patient #14 was evaluated by the provider. There is no documentation to indicate the patient was reassessed by nursing prior to the provider evaluation.
- On 11/19/19 at 10:18 PM, Patient #16 presented to the ED and was triaged. At 11/20/19 at 04:00 AM, Patient #16 was evaluated by the provider. There is no documentation to indicate the patient was reassessed by nursing prior to the provider evaluation.
- On 11/20/19 at 01:49 AM, Patient #15 presented to the ED and was triaged. At 06:32 AM, Patient #15 was evaluated by the provider. There is no documentation to indicate the patient was reassessed by nursing prior to the provider evaluation.

Interview on 11/22/19 at 01:45 PM with Staff #13, Registered Nurse, verified findings.

Review of policy "HIV Testing, Reporting, and Prevention" last revised 8/13/18 revealed that testing will be offered as part of routine care with patients having the right to decline testing.

Review on 11/14/19 of the DMH ED medical record for Patient #41 dated 10/29/19 revealed the patient did not decline HIV or HCV testing. There is no evidence to indicate testing was done.

Review on 11/14/19 of the DMH ED medical record for Patient #43 dated 11/7/19 revealed the patient did not decline HCV testing. There is no evidence to indicate testing was done.

Review on 11/22/19 of the MFSH ED medical record for Patient #152 revealed the patient did not decline HIV testing. There is no evidence to indicate testing was done.

Interview on 11/22/19 at 02:00 PM with Staff # 4, Chief Quality and Safety Officer confirmed these findings and indicated that ED patients who meet the criteria, are routinely asked if they would like to receive HIV and HCV testing during triage. If the patient is agreeable to testing, a corresponding order is to be entered and testing is carried out.