HospitalInspections.org

Based on review of facility policy and facility documentation and staff (EMP) interview, it was determined that the facility failed to ensure its grievance policy was followed by failing to send an interim letter within seven days of receipt of a grievance if the grievance could not be resolved within seven days or a final resolution letter once the grievance investigated was completed for three of four grievances reviewed (MR18 and MR19).

Findings include:

Review on October 27, 2020, of facility policy "Patient Complaints and Grievances-Resolution Process," last approved August 2019, revealed "Policy It is the policy of UPMC Susquehanna to promptly investigate and resolve any patient's, or their legal representative's complaint(s) or grievance(s) in a prompt and equitable manner...Procedure: G...All complainants will be notified within 7 days as to the steps being taken to resolve their grievance and that they will receive prompt written notification of the results following completion of the investigations. If the problem cannot be resolved with 7 days, an interim letter will be sent within this time frame to inform the complainant that the investigation may be prolonged, but we will respond in writing when the complaint investigation is completed/resolved..."

Review on October 27, 2020, of the facility's complaint/grievance log from January through September 2020, and four grievance files on behalf of MR18, MR19 and MR20 revealed a grievance was filed on behalf of MR18 on August 25, 2020. The facility had no documentation an interim or final letter had been sent to the complainant. Two separate grievances were filed on behalf of MR19 on August 25, 2020 and September 9, 2020. The facility had no documentation an interim letter had been sent to the complainant for the August 25, 2020 grievance. A final letter was sent on September 10, 2020, for the grievance filed on August 25, 2020. The facility had no documentation an interim letter or final letter had been sent to the complainant for the September 9, 2020 grievance.

Interview on October 27, 2020, at 10:30 AM with EMP1 confirmed MR18 was not sent an interim or final letter regarding a grievance filed on August 25, 2020. EMP1 confirmed that no interim letter was sent to MR19 for the August 25, 2020, grievance and the final letter, sent on September 10, 2020, was not within the seven-day timeframe required by facility policy. EMP1 further confirmed MR19 was not sent an interim or final letter for the complaint filed on September 9, 2020.

Based on review of facility policy and medical records (MR) and staff interview (EMP), and review of medical records (MR), it was determined the facility failed to document a surgical complication in the medical record in one of one applicable medical record reviewed (MR1).

Findings include:

Review on October 30, 2020, of facility policy "Disclosures of Serious Events/Outcomes of Care," dated August 31, 2020, revealed "Policy/Purpose/Scope It is the policy of UPMC to comply with the standards of the Joint Commission and, as applicable, the Pennsylvania Medical Care Availability and Reduction of Error Act ("Mcare"), 40 P.S. §1303.101, et. seq. ...III. Disclosure of Outcomes of Care...A. Joint Commission Standards...3. Reporters and other staff shall notify the attending physician and/or other physicians involved in a patient's care about any Reportable Patient Event that has or could affect the patient's clinical care and shall document the Patient Event in the patient's medical chart...C. Recommendations for Communicating Serious Events and Unfavorable Outcomes...3. The timing, content and persons present at any discussion of an event or condition should be clearly and carefully documented. For example, specific diagnoses and treatment recommendations should be included..."

Review of MR1 on October 30, 2020, revealed no documentation of the bioburden exposure was present in the September 9, 2020, post-operative report. MR1 contained no documentation of the adverse event discussion with the patient with CF2 and EMP1 on September 10, 2020.

Phone interview with EMP1 on October 30, 2020, at approximately 3:30 PM, confirmed MR1 did not contain documentation in the operative report or physician progress notes of MR1's exposure to bioburden during the September 9, 2020, surgery or documentation of the disclosure of the event on September 10, 2020, to MR1.

Based on review of facility documents, medical records (MR) and staff (EMP) interviews, it was determined the facility failed to have the signed "consent for treatment" form for two out of 17 MRs (MR9 and MR15).

Review on October 27, 2020, of facility policy and procedure, "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)," reviewed October 5, 2017, revealed "I. Policy/Purpose/Scope It is the policy of UMPC (including all UPMC facilities providing clinical services) to recognize the individual patient's right to be informed of the content and to sign the Consent for Treatment, payment, and Health Care Operations (TPO) provided to the patient at UPMC. For purposes of this policy, the term "patient" includes a person authorized to consent on behalf of a patient who is a minor or lacks decision-making capacity. ... II. General Consent For Treatment/Payment/Health Care Operations A. The Consent for TPO should be signed by the patient or a person authorized to consent on the patient's behalf. The Consent for TPO form is to be used in accordance with UPMC registration procedures for both inpatients and outpatients. This form includes, but is not limited to: 1. Consent for Medical, Mental Health, Drug and Alcohol Care, and Rehabilitation Services... D. General consent must be obtained prior to any examination, procedure or treatment..."

Review on October 26, 2020, of MR9, revealed no documentation of a signed "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)" form for treatment.

Interview with EMP6 on October 26, 2020, at 2:45 PM, confirmed MR9 with no documentation of a signed "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)" form for treatment. .

Interview with EMP2 on October 26, 2020, at 2:50 PM, confirmed MR9 with no documentation of a Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO) signed form for treatment.

Review on October 27, 2020, of MR15, revealed no documentation of a signed "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)" form for treatment.

Interview with EMP4 on October 27, 2020, at 1:30 PM, confirmed MR15 with no documentation of a signed "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)" form for treatment.

Interview with EMP2 on October 27, 2020, at 1:35 PM, confirmed MR15 with no documentation of a signed "Consent for Treatment and Use and Disclosure of Information for Treatment, Payment, and Health Care Operations (TPO)" form for treatment. EMP2 revealed this document is signed in registration. The patient, or representative, hands this form, as well as the patient's face sheet and name stickers, to the nurses. EMP2 confirmed this process has been in place since the COVID pandemic. Before COVID, the patients used kiosk machines to enter the information. The kiosks are not in use due to the COVID pandemic.

Based on review of facility policies and staff interview (EMP), it was determined that the facility failed to ensure staff followed approved facility policy for the cleaning and disinfection of equipment and for packaging equipment for sterilization in one on one applicable piece of equipment processed in the Sterile Processing Department.

Review on October 27, 2020, of facility policy "Cleaning And Disinfection Of Instruments," last revised May 2019, revealed "...C. All surgical instruments containing bioburden are wiped clean before coming into Decontamination from the surgical rooms. They will come to decontamination, wiped clean of all bioburden, with cannulas flushed. All instrumentation will be sprayed with an instrument spray, which is begun in the OR suite. ...D. Any instrument that was sprayed with the prep solution is hand-washed to remove bioburden...b. All lumens are cleaned with appropriate sized brushes or pipe cleaners under the water surface..."

Review on October 27, 2020, of facility policy "Inspection Assembly and Packaging of Instrumentation," last reviewed May 2019, revealed "...A. All instruments are inspected for cleanliness, proper functioning and alignment before reassembly. a. All cannulated instruments are inspected by holding the cannula to the light to look for organic material and inserting a pipe cleaner..."

Review of facility documentation revealed that during surgery bioburden fell from the distal end of the trocar into the patient's surgical field. The bioburden was retrieved, and the surgical field was flushed. Additional antibiotics were added to the patient's post-op orders.

During an interview on October 27, 2020, at 10:30 AM, EMP5 reported an investigation into the processing of the trocar and cannula occurred. The use of barcode scanning during the cleaning, packaging and sterilization processes provides a record of staff members performing each step in the processing cycle. EMP5 reported OTH1 was responsible for cleaning, packaging and the sterilization of the cannula and trocar involved in the bioburden event. EMP5 confirmed OTH1 did not follow facility policy for cleaning and inspection of the cannula and trocar. EMP1 confirmed, during counseling OTH1 reported since s/he had performed the cleaning of the trocar and cannula, a visual inspection of these instruments was not completed during packaging.