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Based on record review and interview, it was determined the Hospital failed to notify in writing, for one (Patient #7) patient out of a total sample of 10 patients, the outcome of the Hospital's resolution of Patient #7's complaint.

Findings include:

The Hospital policy and procedure titled Patient Complaint Resolution and Response Policy, dated 1/5/17, indicated the Hospital will provide the complainant a final written response to include the steps taken on behalf of the patient to investigate the complaint, the result of the investigation, the date of completion and the contact information for the individual whom the complainant can respond for questions regarding the case.

Patient #7's complaint, dated 8/10/19, indicated concerns with the care received from two medical providers at the Hospital and Medical Center.

The Surveyor interviewed the Director of Risk Management at 12:15 P.M. on 10/22/19 while reviewing Patient #7's complaint file. The complaint file indicated that a medical review was performed and that no issues were identified with the medical care provided. The Director of Risk Management said the Patient Liaison attempted to get in touch with Patient #7 several times but was unsuccessful and a letter was sent.

A Hospital letter addressed to Patient #7, dated 8/22/19, indicated the Patient Liaison attempted to speak with Patient #7 by telephone without success and requested that, if Patient #7 wanted to, he/she could contact the Patient Liaison. The letter did not include the required elements as outlined and required in the Hospital's complaint/grievance policy.

The Surveyor asked the Director of Risk Management if a letter was sent to Patient #7 with the resolution of Patient #7's complaint. The Director of Risk Management said there was no letter sent because Patient #1 had not called Hospital's Patient Liaison back.

The Hospital was out of compliance for the Condition of Participation for Surgical Services.

Findings include:

The Hospital failed to ensure for one (Patient #1) patient out of 10 sampled patients that care was provided following established policies governing safe surgical care.

Refer to Tag: A-0951

Based on interviews and record review, the Hospital failed to ensure for one (Patient #1) patient out of 10 sampled patients that care was provided following established policies governing safe surgical care.

Findings include:

The Hospital policy titled Universal Protocol, dated 3/5/18. The Universal Protocol indicated that for "time out" procedures that involve anatomical sites that have laterality, the side or location is written out fully on the procedure schedule and on all relevant documentation. The words "right', "left" or "bilateral" will be used.

The Hospital's policy titled Guidelines for Disclosure of Adverse Patient Events, dated 6/7/2018, indicated that a disclosure documentation of an adverse event includes: the patient's condition before, during, and after the event, notification of providers, time, date, and place of discussion, expression of empathy to patient, summary of questions and concerns raised by patient and/or family.

Surveyors reviewed the Hospital policy titled Informed Consent,dated 3/2/17. The Informed Consent policy did not indicate that laterality needs to be included in the written consent and the words "right", "left" or "bilateral" are not required.

The Informed Consent for Thorocentesis document, dated 3/27/09, has 9 paragraphs indicating that the individual signing understands the procedure and risks associated with the procedure with a blank line for the patient to sign. There are two blank lines in the first sentence of the first paragraph for the practitioner obtaining consent to write their name and the laterality (right or left ) on the blank lines.

Review of Patient #1's medical record indicated that Patient #1 had developed fluid on his/her left lung that required a thorocentesis procedure. Thorocentesis procedures are routinely performed at the bedside by a clinician. On 9/23/19, Patient #1 signed a consent for a left lung thoracentesis (a procedure to remove fluid or air from around the lungs). Physician Assistant (PA) #1 (who's scope of practice includes performing a Thoracentesis) performed an ultrasound on both lungs of Patient #1. PA #1 then performed a right lung thoracentesis (not left lung as consented) on Patient #1 on 9/23/19 at 11:35 A.M. PA #1 then performed a left lung thoracentesis on Patient #1 on 9/23/19, at 1:13 P.M. PA #1 entered a Significant Event note on 9/23/19, at 3:42 P.M. The Significant Event note indicated that bilateral thoracentesis procedures were performed with improvement of the lung and did not include the elements of disclosure.

The Surveyors interviewed PA #1 on 10/21/19 at 12:48 P.M. PA#1 said that Patient #1 signed a consent for a left lung thoracentesis and then used the ultrasound machine to image both the left and right lung. The consent did not include any information allowing an additional procedure to be performed. PA #1 said that although the procedure planned was a left lung thoracentesis, he performed a right lung thoracentesis. PA #1 said that he did not conduct an appropriate "time out" (Universal Protocol) which is required prior to performing an invasive procedure. PA #1 said that he notified his attending and then disclosed the wrong side procedure to the patient and consented for the right lung thoracentesis. PA #1 said that although the procedure was performed on the wrong lung, he did note during ultrasound that there was fluid in the right lung that was drained.

The Surveyors interviewed the Director of Risk Management on 10/21/19 at 1:15 P.M. The Director of Risk Management said that Hospital leadership had met and discussed the event on 10/16/19 at 12:00 P.M. The Hospital leadership identified that the Hospital's Universal Protocol was not followed and Hospital leadership was addressing this in the form of a re-education communication from the Department Chiefs to their appropriate staff. The Director of Risk Management said that the nurse was not in the room for the "time out" as required by the Hospital's Universal Protocol. The Director of Risk Management said that the staff nurse uses the signed Procedural Consent document as the verifying document to identify the correct patient and the correct procedure for the "time out".

The Surveyors interviewed Medical Intensive Care Unit (MICU) Nurse #1 on 10/22/19 at 9:15 A.M. MICU Nurse #1 said that when a bedside procedure is performed in the MICU, the nurses use the patient's Informed Consent as the verifying document required to perform the time out.

The Surveyors interviewed the Interim Chief of Medicine/Chief of Quality Officer on 10/22/19 at 11:01 A.M. The Interim Chief of Medicine/Chief of Quality Officer acknowledged that the Informed Consent document does not meet the requirements of a verifying document according to the Universal Protocol policy. The Interim Chief of Medicine/Chief of Quality Officer acknowledged that the Informed Consent document should not be used as a verifying document to perform a "Time Out", because it did not identify the side/site/laterality of the procedure being performed.

The Surveyors interviewed the Chief Nursing Officer on 10/22/19, at 11:40 A.M. The Chief Nursing Officer acknowledged that the Informed Consent document does not meet the requirements of a verifying document according to the Universal Protocol policy. The Chief Nursing Officer said that the Informed Consent document should not be used as a verifying document to perform a "Time Out".