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Based on review of facility documents, medical record (MR) and staff interview (EMP), it was determined the facility failed to ensure operating room personnel did not prepare a patient's surgical site with a documented allergy to ChloraPrep (A0144). The failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patient.

On December 22, 2023, the survey team toured the pre-op area and conducted interviews with staff regarding the new allergy communication process, and reviewed the immediate education that was provided to staff to determine compliance for the removal of the immediate jeopardy.

The survey team verified these immediate interventions were implemented and confirmed the facility's IJ was removed on December 22, 2023, at 1033.

Cross reference
482.13 (c)(2) Patient Rights: Care in Safe Setting

Based on review of facility documents, medical record (MR) and staff interview (EMP), it was determined the facility failed to ensure operating room personnel did not prepare a patient's surgical site with a documented allergy to ChloraPrep for one of one applicable medical record reviewed (MR1).

Findings include:

Review on December 21, 2023, of the facility's "Patient rights & responsibilities" brochure, dated June 2021, revealed "... Care delivery You or your legally authorized representative or guardian have the right to: ... Receive efficient and quality care with high professional standards that are continually maintained and reviewed. Expect good management techniques to be implements within this hospital considering effective use of your time and to avoid your personal discomfort ..."

Review on December 21, 2023, of the facility's "Amended and Restated Bylaws of the Medical Staff of Geisinger Wyoming Valley Medical Center Bylaws of the Medical Staff," last approved by the Board of Directors on September 21, 2022, revealed "... Article II Purposes and Responsibilities ... Section 2.2 Responsibilities ... The responsibilities of the Medical Staff are: (a) to account for the professional performance, ethical conduct and appropriateness of patient care rendered by all Practitioners ... Article III Medical Staff Membership ... Section 3.3 Basic Responsibilities of Staff Membership Each member of the Medical Staff shall: (a) Provide his patients with care that is consistent with generally recognized standards of professional performance and efficiency ..."

Review on December 21, 2023, of the facility's "Geisinger Wyoming Valley Outpatient Surgery CenterPoint Patient Safety Program and Plan", last approved February 8, 2023, revealed "Purpose Geisinger Wyoming Valley Outpatient Surgery CenterPoint (GWV OSCP) is dedicated to creating, supporting, and disseminating a culture of safety throughout the organization. ..."

Review on December 21, 2023, of the facility's "Universal Protocol - System Policy," last approved July 22, 2021, revealed "... Policy By ensuring that systems are in place, the following steps, taken together, comprise the Universal Protocol for eliminating wrong site, wrong procedure and wrong person surgery or procedures. ... Responsibilities The attending surgeon or individual performing the procedure oversees the Universal Protocol process. The entire OR/procedural team actively participates in the Time-Out ... Procedure I. Applicability The Universal Protocol is applicable to all invasive procedures as defined above ... II. Mandatory The Universal Protocol includes 3 mandatory elements: pre-procedure verification, marking of the site (see exceptions), and time out. ... III. Pre-Procedure Verification Pre-procedure verification consists of 3 parts: Verification of patient ID, verification of correct site/procedure and verification of available special equipment (implants, etc.), blood products, medications (antibiotics), as required for the patient. A. Verification of patient identification must be completed by utilizing 2 patient identifiers and the consent form. B. Verification of correct site/procedure must be completed by utilizing the correct patient's H&P/office notes, pre-anesthesia evaluation, diagnostic studies including radiology and/or pathology reports, and a properly completed and signed consent form ...VI. Documentation of Universal Protocol A. Primary procedure(s) in the OR: 1. The pre-op nurse shall document in the patient's medical record that the site was marked by the attending surgeon. Refer to the appropriate nursing flowsheets and/or checklists for specific documentation requirements. ... Pre-procedure Verification A. Pre-procedure Verification The Pre-Op nurse shall admit the patient to the Pre-Op/In and Out Unit and perform the following tasks: 1. Ask the patient to state their name and date of birth. Confirm the name and date of birth with the wristband and medical record. 2. Place the wristband on the patient. ..."

Review on December 21, 2023, of the facility's "Duties of the Circulating Nurse in the Operating Room", policy, last approved July 23, 2022, revealed "... Policy The policy of Circulating Nurse Responsibilities is to ensure the surgical suite circulating nurse anticipates, plans for and responds to the needs of the patient, surgeon and other team members. ... Responsibilities ... Assure that a member of the nursing staff will remain with the client at all times because the primary commitment of the surgical nurse is the health, welfare and safety of the client. ... Performs duties to provide the highest level of patient care and safety to maximize patient satisfaction. Safeguards patient from dangers and hazards ..."

Review of MR1 on December 20, 2023, revealed this patient presented to Geisinger Wyoming Valley CenterPoint for a scheduled Arthroscopically Aided ACL (Anterior Cruciate Ligament - a structure that stabilizes the knee joint and prevents forward movement) surgical procedure of the left knee on September 6, 2023, at 1007.

Review of MR1 on December 20, 2023, revealed documentation by CF1, CF2, EMP2 and EMP6 indicating this patient's allergy to ChloraPrep causing severe blistering.

Interview with EMP1 and EMP2 on December 21, 2023, at approximately 1015 confirmed CF1, CF2, EMP2 and EMP6 were operating room (OR) staff present in the room for MR1's surgical site prep and for MR1's surgical procedure.

Review of MR1 on December 20, 2023, revealed a physician order dated September 6, 2023, at 0720 instructing the OR staff to prep MR1's surgical site using Betadine.

Further review of MR1 on December 20, 2023, revealed documentation dated September 6, 2023, at 1325 indicating EMP6 prepped MR1's left upper and lower leg, left ankle, toes, knee and foot with ChloraPrep.

Interview with EMP1, EMP2 and EMP3 on December 20, 2021, at approximately 1030 confirmed the above findings.

Review of MR1 on December 20, 2023, revealed this patient presented to an Outside Hospital (OSH) Emergency Department (ED) on September 9, 2023, with complaint of large fluid filled blisters located around the incision sites and had multiple blisters already erupted with clear / yellow fluid draining from the erupted blisters.

Interview with EMP1, EMP2 and EMP3 on December 21, 2023, at approximately 1100 confirmed the findings noted above for MR1.

Cross reference
482.22 (b)(1), (2), (3) Medical Staff Organization & Accountability
482.51 (b) Operating Room Policies

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure a patient's discharge order was written after completion of the surgical procedure and the patient is determined safe for discharge (A0347). The failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patient.

On December 22, 2023, the survey team reviewed the education documentation the facility provided the practitioners and conducted interviews with staff regarding anticipatory documentation of a patients discharge to determine compliance for the removal of the immediate jeopardy.

The survey team verified these immediate interventions were implemented and confirmed the facility's IJ was removed on December 22, 2023 at 1033.

Cross reference
482.22 (b)(1), (2), (3) Medical Staff Organization & Accountability

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure a patient's discharge order was written after completion of the surgical procedure and the patient is determined safe for discharge for two of two applicable medical records reviewed (MR1 and MR2).

Findings include:

Review on December 21, 2023, of the facility's "Amended and Restated Bylaws of the Medical Staff of Geisinger Wyoming Valley Medical Center Bylaws of the Medical Staff," last approved by the Board of Directors on September 21, 2022, revealed "... Article II Purposes and Responsibilities ... Section 2.2 Responsibilities ... The responsibilities of the Medical Staff are: (a) to account for the professional performance, ethical conduct and appropriateness of patient care rendered by all Practitioners ... Article III Medical Staff Membership ... Section 3.3 Basic Responsibilities of Staff Membership Each member of the Medical Staff shall: (a) Provide his patients with care that is consistent with generally recognized standards of professional performance and efficiency ..."

Review on December 21, 2023, of the facility's "Discharge Criteria" policy, last approved July 8, 2022, revealed "... Policy To ensure all post-anesthesia patients are discharged properly. ... Responsibilities It is the responsibility of the surgeon to assess if the patient has met discharge criteria including bleeding status and provide a discharge to home order. It is the responsibility of the anesthesiologist to assess the patient prior to discharge from the unit, to ensure all discharge criteria are met, and to provide a discharge order from the unit before the patient leaves the postoperative area. ... Procedure 1. All patients receiving anesthesia must be seen by an Anesthesiologist or their designee before being discharged from the Postoperative Area. 2. All patients must be assessed by the surgeon for discharge criteria including bleeding status before discharge. 3. All patients must meet discharge criteria before discharged home ... 5. Any bleeding beyond what is consistent with that expected from the surgical procedure needs further evaluation by the surgeon. ..."

Review of MR1 on December 20, 2023, revealed this patient was admitted to Geisinger Wyoming Valley Outpatient Surgery CenterPoint an outpatient surgery site of Geisinger Wyoming Valley Medical Center on September 6, 2023, for a surgical procedure.

Review of MR1 on December 20, 2023, revealed the following:
MR1's surgery started at 1252.
MR1's surgery ended at 1623.
MR1 was transferred to the Post Anesthesia Care Unit (PACU) at 1625.
MR1 was discharged from the facility at 1729.

Further review of MR1 on December 21, 2023, revealed a Discharge Summary Note documented by CF2 on September 6, 2023, at 1146, indicating after examination of this patient, I have determined this patient is ready for discharge to home when the patient meets criteria. Discharge instructions were given to the patient. Bleeding well controlled at time of discharge.

Interview with EMP1, EMP2 and EMP3 on December 21, 2023, at the time of the medical record review revealed CF2 documented MR1's Discharge Summary Note before MR1's surgery began.

Review of MR2 on December 22, 2023, revealed this patient was admitted to Geisinger Wyoming Valley Outpatient Surgery CenterPoint an outpatient surgery site of Geisinger Wyoming Valley Medical Center on September 13, 2023, for a surgical procedure.

Review of MR2 on December 22, 2023, revealed the following:
MR2's surgery started at 0831.
MR2's surgery ended at 0932.
MR2 was transferred to the PACU at 0937.
MR2 was discharged at 1045.

Further review of MR2 on December 22, 2023, revealed a Discharge Summary Note documented by CF2 on September 13, 2023, at 0806, indicating after examination of this patient, I have determined this patient is ready for discharge to home when the patient meets criteria. Bleeding inspected prior to discharge. Discharge instructions were given to the patient.

Interview with EMP7 on December 22, 2023, at the time of the medical record review revealed CF2 documented MR2's Discharge Summary Note before MR2's surgery began.

Cross reference
482.13 Patient Rights: 482.13 (c)(2) Standard Care in a Safe Setting
482.51 (b) Operating Room Policies

Based on review of facility documents, medical record (MR) and staff interview (EMP), it was determined the facility failed to ensure a physician disclosed the use of ChloraPrep surgical prep on a patient with a documented severe allergy (A0951). The failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patient.

On December 22, 2023, the survey team reviewed the education documentation the facility provided the practitioners and conducted interviews with staff regarding the practitioner ' s responsibility to disclose issues to patients.

The survey team verified these immediate interventions were implemented and confirmed the IJ was removed on December 22, 2023, at 1033.

Cross reference
482.51 (b) Standard: Delivery of Service

Based on review of facility documents, medical record (MR) and staff interview (EMP), it was determined the facility failed to ensure a physician disclosed the use of ChloraPrep surgical prep on a patient with a documented severe allergy for one of one applicable medical record reviewed (MR1).

Findings include:

A request was made of EMP1, EMP2 and EMP3 for a facility policy/procedure/protocol/or guideline medical staff would follow regarding the disclosure of harm or potential harm to a patient that occurs pre-operatively, intraoperatively, and post operatively. None was provided.

Review on December 21, 2023, of the facility's "Amended and Restated Bylaws of the Medical Staff of Geisinger Wyoming Valley Medical Center Bylaws of the Medical Staff," last approved by the Board of Directors on September 21, 2022, revealed "... Article II Purposes and Responsibilities ... Section 2.2 Responsibilities ... The responsibilities of the Medical Staff are: (a) to account for the professional performance, ethical conduct and appropriateness of patient care rendered by all Practitioners ..."

Review on December 21, 2023, of the facility's "GWV Rules and Regulations for use of the Medical Record," last approved by the Medical Executive Committee on May 10, 2023, revealed "GWV Rules and Regulations for use of the Medical Record ... XII. Operative / Procedure Reports An operative/procedure report should include date of procedure, description of procedure, a preoperative diagnosis, post operative diagnosis, name of procedure, name of primary surgeon and assistants, type of anesthesia, drains, estimated blood loss, specimens removed, disposition of each specimen, complications, condition of patient, and signature by the surgeon who performed the surgery/procedure. ..."

Interview with EMP1 and EMP2 on December 20, 2023, at 1500 revealed it is the physician's responsibility to notify the patient and / or responsible party regarding harm or potential harm to a patient that occurs pre-operatively, intraoperatively, and post operatively.

Review of MR1 on December 20, 2023, revealed documentation by CF1, CF2, EMP2 and EMP6 indicating this patient's allergy to ChloraPrep causing severe blistering.

Interview with EMP1 and EMP2 on December 21, 2023, at approximately 1015 confirmed CF1, CF2, EMP2 and EMP6 were operating room (OR) staff present in the room for MR1's surgical site prep and for MR1's surgical procedure.

Review of MR1 on December 20, 2023, revealed this patient presented to Geisinger Wyoming Valley CenterPoint for a scheduled Arthroscopically Aided ACL (Anterior Cruciate Ligament - a structure that stabilizes the knee joint and prevents forward movement) surgical procedure of the left knee on September 6, 2023, at 1007. Further review revealed EMP6 completed a surgical scrub with ChloraPrep to MR1's left knee.

There was no documentation in MR1 indicating CF1 disclosed the use of ChloraPrep surgical prep on this patient to the patient or this patient's responsible party.

Interview with EMP1, EMP2, EMP3 and EMP4 on December 21, 2023, at approximately 0945 confirmed the above information.

Review of MR1 on December 20, 2023, revealed this patient presented to an Outside Hospital (OSH) Emergency Department (ED) on September 9, 2023, with complaint of large fluid filled blisters located around the incision sites and had multiple blisters already erupted with clear / yellow fluid draining from the erupted blisters. MR1 was treated with intravenous Decadron (a medication that reduces swelling and to treat severe allergic reactions) 10 milligrams (mg) / Milliliter (ml) at 1517 and an order to take Benadryl orally when at home.

Interview with EMP1, EMP2, EMP3 and EMP4 on December 21, 2023, at approximately 0950 confirmed the findings noted above for MR1.

Review of MR1 on December 21, 2023, revealed an addendum made by CF1 on September 15, 2023, at 1324 indicating after positioning the patient and leaving the room to scrub, OR nursing inadvertently applied ChloraPrep to the operative extremity despite a previous allergy and blister reaction. MR1 was treated with intravenous Decadron (a medication that reduces swelling and severe allergic reactions) 10 milligrams (mg) / Milliliter (ml) at 1517 and an order to take Benadryl orally when at home.

Interview with EMP1, EMP2, EMP3 and EMP4 on December 21, 2023, at approximately 1000 confirmed the above information.

Cross reference
482.13 (c)(2) Standard Care in a Safe Setting
482.22 (b)(1), (2), (3) Medical Staff Organization & Accountability