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Based on policy and procedure review, closed medical record review and staff interview, the facility failed to ensure informed consent for surgery and anesthesia was signed and documented in the patient's medical record for 1 of 4 surgery records reviewed (# 9).
The findings include:
Review of Hospital Policy, "Informed Consent", effective date 04/02/2015, revealed "...An informed consent is required for all invasive and non-invasive procedures involving a substantial risk to the patient unless emergent....Documentation of Informed Consent The process of obtaining 'Informed Consent' is the discussion between the treating physician....and the patient that results in the patient's request or refusal to a proposed procedure. Completion of the Informed Consent Form is a document signed by the patient (or legal authority) and witnessed by the physician....to show evidence that the consent had been obtained prior to performance of a procedure....Completion of the Informed Consent Form ....1. A patient identification label should be placed on both sides of the consent form. 2. Identify the specific entity where the procedure will take place....3. As applicable to the specific consent form, the physician name should be entered and the name of the patient or 'myself'. 4. The procedure as designated on the procedure request should be entered. Avoid using abbreviations....6. The date and time of patient and witness consent is to be completed. ..."
Closed medical record review of Patient (Pt) # 9 on 10/14/2015 revealed the patient was admitted on 09/23/2015 with abdominal pain. Review of the History and Physical (H&P), dated 09/23/2015 at 2207, revealed "...Assessment & Plan....1. Acute cholecystitis with calculus (inflamed gallbladder with gallbladder stone)....will get surgical input. ..." Review of Operative Note, dated 09/25/2015 at 0704, revealed "SURGERY DATE: 9/24/2015 PRE-OP DIAGNOSIS: Cholecystitis....Procedure(s): LAPAROSCOPIC CHOLECYSTECTOMY (gallbladder removal through small cuts in abdomen using a scope and video monitor) & OPERATIVE CHOLANGIOGRAPHY (X-ray that shows the anatomy of the bile ducts)....OPERATIVE REPORT: After verification of informed consent, the patient was transferred to the operating suite....General anesthesia was induced (given)....The patient tolerated the procedure well and there were no complications. ..." Review of Anesthesia Pre-procedure Evaluation, dated 09/24/2015 at 1138, revealed "...Anesthesia Plan...Anesthetic plan and risks discussed with patient. Informed consent obtained. ..." Review of "Pre-Incision Documentation" revealed "Timeout Details", dated 09/24/2015 at 1405, which stated "...Timeout Questions....Consents verified? Yes. ..." Review of the Medical record did not reveal Surgery or Anesthesia consent forms signed by Pt # 9 for the laparascopic cholecystectomy surgery done on 09/24/2015.
Interview with Administrative Staff (AS) # 1, on 10/15/2015 at 1700, revealed the policy is to have the informed consents for surgery and anesthesia available on the medical record. Interview revealed AS # 1 believed informed consent was obtained, however, AS # 1 stated "we have had issues with losing documents to scanning." Interview revealed the concern with losing documents was one reason for a process change that took place 10/12/2015. The goal now, interview revealed, is for documents to be scanned into the computer system within 24 hours after they are obtained. Further interview revealed the consents for surgery and anesthesia for the 10/24/2015 surgery were not able to be located, and therefore were not available on the medical record.
NC00110759