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32-36 CENTRAL AVENUE

WELLSBORO, PA 16901

PROVISION OF SERVICES

Tag No.: C1004

Based on the seriousness of the non-compliance and the potential effect on patient outcome, the facility failed to substantially comply with this condition.

The findings were:

485.635 Tag A-1014

The information reviewed during the survey provided evidence the facility failed to ensure compliance with approved facility policies including timely notification and documentation of critical test results/values in three of three applicable medical records (MR) reviewed (MR1, MR2 and MR3); failure to secure an order for suspension/discontinuation of telemetry in one of one MR reviewed (MR1); failure to ensure timely countersignatures in one of three MRs reviewed (MR2); failure to ensure documentation of the condition of a patient on telemetry in one of one MR reviewed (MR1); failure to ensure documentation of an unusual event in one of one MR reviewed (MR1); failure to report an event in the facility ' s electronic event reporting system in one of one MR reviewed (MR1), and; failure to submit an event report to the Pennsylvania Safety Authority in one of one serious events reviewed (MR1).

A discussion took place with the survey team and the facility's administrative staff (EMP1, EMP2 and EMP6) regarding the survey team's concerns related to failure to comply with patient care policies on September 16, 2022, at 1100.

Cross reference
485.635(a)(3)(iii) Tag A-1014

PATIENT CARE POLICIES

Tag No.: C1014

Based on review of facility policy, the medical staff rules and regulations, medical records (MR) and staff (EMP) interview, it was determined the facility failed to ensure compliance with approved facility policies including timely notification and documentation of critical test results/values in three of three applicable MR reviewed (MR1, MR2 and MR3); failure to secure an order for suspension/discontinuation of telemetry in one of one MR reviewed (MR1); failure to ensure documentation of the condition of a patient on telemetry in one of one MR reviewed (MR1); failure to ensure timely countersignatures in one of three MRs reviewed (MR2); failure to ensure documentation of an unusual event in one of one MR reviewed (MR1); failure to report an event in the facility's electronic event reporting system in one of one MR reviewed (MR1), and; failure to submit an event report to the Pennsylvania Safety Authority in one of one serious events reviewed (MR1).

Findings include:

Review on September 12, 2022, of facility policy "Critical Values Results Reporting," approved March 2022, revealed "Purpose: To ensure timely reporting of critical values/results to appropriate care providers to enable provision of timely appropriate treatment to the patient. ...III. Procedure for critical values/results other than lab: A. Imaging - Critical imaging results will be called directly to the ordering provider by the radiologist within 60 minutes of dictation. Refer to the imaging policy "Communication of Critical (Life Threatening) Imaging Results" policy..."

Review on September 12, 2022, of "Communication of Critical (Life Threatening) Imaging Results," approved October 2021, revealed "Policy: UPMC North Central Pa Imaging has developed a process to report life threatening critical results in a consistent and timely manner and to provide guidelines for communicating these critical results to the responsible licensed caregiver. ... Procedure: The Critical (Life Threatening) Results List incorporates the following diagnoses, when such diagnoses are not previously known and/or reported: ...Acute Stroke...Action: There must be direct communication of critical results in person or by telephone to the ordering provider or responsible licensed caregiver. The radiologist will call critical results on inpatients and outpatients at the time of dictation. ...3. All direct communication (or attempted communication) must be documented in the dictated radiology report and must identify who was contacted (name), as well as the date and time of communication. ..."

Review on September 12, 2022, revealed MR1 was ordered an MRI to rule out cerebrovascular accident (CVA) and for visual disturbance. The MRI was completed on August 11, 2022, at 0738 and the results, dictated by CF4 at 0934, revealed multifocal acute infarcts in the right cerebellar hemisphere. There was no documentation within the report or in MR1 of notification of the provider of the critical result. There was no documentation in MR1 to verify the responsible provider was aware of the critical result prior to transport off the unit to an adjacent building for optometry consult at 1045 on August 11, 2022.

Interview with EMP4 on September 12, 2020, at 0930 confirmed there was no documentation of provider notification by CF4 of MR1's acute stoke critical result. EMP4 further confirmed there was no documentation in MR1 to verify the responsible provider was aware of the critical result prior to transport off the unit.

Interview with CF3 on September 16, 2022, at 0930 confirmed s/he was unaware of the MRI finding consistent with acute stroke prior to MR1 being transported from the unit to the adjacent building with telemetry suspended for the optometry consult. CF3 further confirmed the optometry consultation would not have been urgent if s/he had known of the MRI findings consistent with acute stoke.

Review on September 13, 2022, revealed MR2 had an MRI on May 18, 2022, to rule out a CVA. The MRI was completed on May 18, 2022, at 0738 and the results, dictated by CF4 at 0907, revealed acute ischemia left cerebellar hemisphere. There was no documentation within the report or in MR2 of notification of the provider of the critical result.

Interview with EMP5 on September 13, 2022, at 1030 confirmed there was no documentation of provider notification by CF4 of MR2's MRI results.

Interview with CF4 on September 13, 2022, at approximately 1330, confirmed the findings of acute ischemia left cerebellar hemisphere were consistent with acute stroke. CF4 revealed s/he could not recall if a critical result had been called to the provider following MR2's MRI. CF4 further revealed s/he may attempt to notify providers of critical results but is most often too busy to call and the providers of inpatients "should know what is going on with their patients". As for patients in the emergency department, CF4 revealed "half the time when I call the patient is already gone, and I'm too busy". CF4 revealed occasionally s/he will ask a radiology technician to call but does not follow up to see if providers have received the critical results. CF4 revealed that if s/he does notify a provider of a critical result s/he doubts if s/he would remember to go back into the medical record to document provider notification.

Further review on September 12, 2022, of facility policy "Critical Values Results Reporting," approved March 2022, revealed "...1. RN/RT Documentation for critical laboratory or· point of care testing (POCT): ...1. The RN will document the receipt of the critical value and the notification of the provider in the Critical Results Notification Form. ..."

Review on September 13, 2022, of MR3 revealed nursing staff attempted to notify CF2 of a critical lab result on May 19, 2020, at 1142. There was no documentation CF2 returned the call and received the result. Further review of MR3 revealed an attempt by nursing staff to notify CF2 of a critical lab result on May 22, 2022, at 0955. There was no documentation CF2 returned the call and received the result.

Interview with EMP5 on September 13, 2022, at approximately 1130, confirmed there was no documentation in MR3 of a return call from CF2 to receive the critical value on May 19, 2022, or the critical value of May 22, 2022.

Review on September 13, 2022, of facility "Medical and Dental Staff Rules and Regulations," revised January 2022, revealed "...II. Medical Records The attending licensed independent practitioner and/or allied health professional shall be held responsible for the preparation of a complete medical record of each patient. ...III. Practitioner's Orders...(b) All orders for medication and treatment shall be written and signed by a licensed independent practitioner or allied health professional..."

Review on September 13, 2022, revealed MR2 was admitted as an inpatient on May 12, 2022. Documentation by numerous providers throughout MR2's hospital stay revealed MR2 had difficulty with the self-administration of insulin due to failing eyesight. Documentation in MR2 revealed an eye examination by OTH1 on May 17, 2022. A progress note by CF2 on May 18, 2022, documented OTH1 advised further testing with an MRI. Further review of MR2 revealed there was no provider order for an optometry consult.

Interview with EMP5 on September 13, 2022, at 1030 confirmed the documentation by OTH1 in MR2 indicated an examination in OTH1's office on May 17, 2022. EMP5 further confirmed there was no provider order for an optometry consult.

Review on September 12, 2022, of facility policy, "Cardiac Rhythm Monitoring," last reviewed August 27, 2021, revealed "...III. Purpose The purpose of this policy is to establish the minimal criteria necessary to safely manage patients receiving cardiac rhythm monitoring. ... IV. Procedure...6. Cardiac monitoring documentation will be completed in the electronic medical record as per each facility's defined procedures."

Review on September 12, 2022, of MR1 revealed the patient was on telemetry for continuous cardiac monitoring. This was ordered and placed on August 10, 2022, at 2015. A copy of a rhythm strip was uploaded in MR1, and documentation of normal sinus rhythm was recorded at 2257 on August 10, 2022. There were no additional rhythm strips in MR1 prior to removal of telemetry and transport off the unit at 1045 on August 11, 2022.

Interview was conducted with EMP2 and EMP3 on September 12, 2022, at 1020. EMP2 revealed the facility has no defined procedures for cardiac monitoring documentation. However, accepted facility practice is for telemetry strips and documentation of rhythm to occur every eight hours. EMP2 confirmed rhythm strip and documentation of rhythm should have occurred at approximately 0700 on August 11, 2022. EMP3 confirmed there were no additional telemetry documentation after the initial placement on August 10, 2022, at 2257.

Review on September 13, 2022, of facility "Medical and Dental Staff Rules and Regulations," updated January 2022, revealed "...II. Medical Records...(b) Progress Notes...3. ... A progress note documented by a PA must be countersigned by his or her Supervising Physician within ten days, unless the State Board of Medicine has approved changes to the written supervision agreement between the PA and his or her Supervising Physician, in which case the countersignature requirements in the amended written agreement shall apply. ..."

Review on September 12, 2022, of facility policy "Transportation of Patient to A Procedural/Diagnostic Area," last approved January 2021, revealed "...B. Appropriate personnel must accompany patients being transported to a diagnostic or procedural area. ...5. For cardiac monitored patients verify the patient has an order allowing the patient to leave the floor while on the telemetry monitor..."

Review on September 12, 2022, of facility policy "Clinical Alarm Systems/Cardiac Monitor Alarms," last reviewed March 2021, revealed "...Alarm Limits: ...Once initiated, intermittent or discontinuation of monitoring requires a Provider/APP's order..."

Review on September 12, 2022, revealed MR1 was ordered and placed on continuous cardiac monitoring (telemetry) on August 10, 2022, at 2015. There was no order to discontinue telemetry or to permit removal of telemetry prior to transport of MR1 for a consultation in the optometry office.

Interview with EMP3 on September 11, 2022, confirmed there were no orders to discontinue or suspend telemetry prior to transport to the optometry office.

Review on September 13, 2022, revealed CF2 had documented progress notes in MR2 on May 17, 18, and 19, 2022, which OTH3 countersigned on May 30, 2022. Progress notes documented by CF2 on June 2, 2022, and June 4, 2022, were countersigned by OTH3 on July 26, 2022, and August 11, 2022, respectively.

Interview was conducted with EMP4 and EMP5 on September 13, 2022, at approximately 1130. EMP5 confirmed the progress notes of May 14, 15, 17, 18, and 19, 2022, were not signed within the required ten-day time frame. EMP4 confirmed the progress notes written by CF2 required countersignature by OTH3. EMP4 further confirmed there were no changes to the written supervision agreement permitting an extended time frame for countersignature of progress notes.

Review on September 12, 2022, of facility policy "Initial Incident/Event Reporting (IIER)," dated December 31, 2021, revealed "...IV. Definitions...H. Reportable Patient Event: Any Incident, Medication Event, Sentinel Event, Serious Event or Infrastructure Failure. ...K. Patient Safety/Peer Review Committee ("Committee"): A committee or committees consisting of health care providers and hospital administrators and staff who evaluate the safety, quality and efficiency of services ordered or performed by a hospital or other health care provider and/or the compliance of a hospital or other health care facility with applicable standards, laws, rules and regulations. ... M. Reporters: Staff members, physicians, employees, volunteers, students or other persons who gain knowledge of a Reportable Patient Event, Reportable Staff Event or Other Reportable Event. ...P. Serious Event: An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. ...V. Procedure A. Reportable Patient Events 1. Reporting. Unless he or she knows a report of the event has already been made, a Reporter with knowledge of a Reportable Patient Event shall report the event immediately or as soon as reasonably practical, but no later than 24 hours after occurrence or discovery. ... 3. Immediate Communication of Significant Patient Events. When any Reporter gains knowledge of any incident or event that he or she believes has, or if repeated, could compromise patient safety or cause significant patient injury, in addition to completing the IIER, the Reporter shall immediately communicate the event or incident to a member of the Committee. ... 4. Physician Notification. The attending physician and/or other physician(s) involved in the care of the patient should be notified of any Reportable Patient Event that has or could affect clinical care. The patient's medical record and IIER should indicate notification of the physician(s). 5. Documentation in Patient Record. The relevant clinical facts surrounding the Patient Event (and the notification of the event to the attending or other physician(s)) should be recorded in the patient's medical record. ..."

Review on September 12, 2022, of facility policy "Disclosures of Serious Events/Outcomes of Care," dated July 28, 2022, revealed "I. 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... B. General Recommendations for Physician Communications of Outcomes of Care... 3. Notification of significant events or information should be given to the patient as soon as practicable. ...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. ..."

Review on September 15, 2022, of the facility's "Patient Safety Plan," CY2022, revealed "...V. Summaries of Key Elements of Patient Safety Program: A. Internal Reporting System: i. Hospital has in place a system for reporting Reportable Patient Events and Infrastructure Failures 24 hours a day, 7 days a week. ii. The basic elements of the reporting system are: An Initial Incident/Event Report is generated by the individual discovering any Reportable Patient Event. The staff will immediately communicate any significant event that could be a Serious Event, Sentinel Event, and/or Infrastructure Failure to the Nursing Administrative Supervisor. The staff may communicate any potentially Reportable Patient Event to their manager or directly to the Patient Safety Officer. ...K. External Reporting: i. The Patient Safety Officer, in collaboration with the Patient Safety Quality Review Committee, shall oversee all reporting to external organizations. The Patient Safety Officer may delegate the actual creation and forwarding of such reports to one (1) or more Peer Review assemblies or individual members of such Peer Review assemblies or individual members of such Peer Review assemblies Serious Events shall be reported to the Pennsylvania Department of Health and Patient Safety Authority within 24 hours of confirmation of the occurrence of the Serious Event, using the Pennsylvania - Patient Safety Reporting System (PA-PSRS). ..."

Review on September 12, 2022, revealed MR1 was ordered and placed on continuous cardiac monitoring (telemetry) on August 10, 2022, at 2015. There was no order to discontinue telemetry or to permit removal of MR1's telemetry prior to transport for a consultation in the optometry office. A progress note by CF3 at 1400 noted he was called STAT to the optometry office to assist with MR1 who felt a sudden sharp headache and became unconscious. Resuscitation efforts began and MR1 was transported via ambulance to the ED. The efforts were unsuccessful and MR1 was pronounced dead at 1254 with the etiology of the event likely cardiac in nature. Continued review revealed there was no nursing documentation of provider notification regarding the lack of telemetry monitoring during the time MR1 was off the unit in the optometry office. Further review of MR1 revealed following the death, CF3 documented "Additional time with the family postmortem explaining". There was no documentation in MR1 of the content provided or persons present during the discussion of the event.

Interview with EMP7 on September 13, 2022, at 1230 revealed the event occurred on August 11, 2022, and the event was not placed in the facility's [name of electronic reporting system]. EMP7 further revealed the Patient Safety Officer did not become aware of the event until August 16, 2022.

Interview with EMP4 on September 13, 2022, at 1345 confirmed the documentation in MR1 did not address the notification requirements to the physician and family as outlined in facility policy.

Review on September 13, 2022, of a serious event report revealed an event related to a patient transport from the facility to an adjacent building without an order for the discontinuation of telemetry had occurred on August 11, 2022 and was reported to the Patient Safety Authority on August 17, 2022.

Interview with EMP7 on September 13, 2022, at 1230 confirmed the event occurred August 11, 2002, and was reported to the Patient Safety Authority on August 17, 2022.