HospitalInspections.org

Based on record review and interviews the hospital failed to ensure medical records included a properly executed informed consent for procedures and treatments specified by the medical staff for 5 of 5 (R1, R2, R4, R6, R8) patient records reviewed for properly executed informed consents. This deficient practice was evidenced by informed consents that were not completed as per hospital policy when information required was omitted in the informed consent, and required information areas were left blank.
Findings:

Review of hospital policy and procedure titled, "Informed Consent" (original date 12/15/14, last reviewed 5/26/15), provided by S5Regulatory as current, revealed the following, in part: "...The Informed Consent discussion sets forth in general terms the nature and purpose of the procedure or procedures; the condition or conditions to be addressed by the procedure(s), together with the known risks, if any, of death brain damage, quadriplegia, paraplegia, the loss or loss of function of any organ or limb, of disfiguring scars associated with such procedure or procedures; the material risk of the procedure(s); unique risks of the procedure particular to the patient; therapeutic alternatives; acknowledgment that such disclosure of information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner...... Informed Consent must be obtained by the provider who will perform the proposed procedure(s)... IV. PROCEDURE: A. All patients or authorized person will sign a general consent for treatment form upon registration ... The general consent does not provide consent for specific procedures... 2. Procedures not included in the general consent that require informed consent include, but are not limited to: a. anesthesia, b. blood/blood product administration, c. chemotherapy, d. moderate sedation/conscious procedural sedation,...k. surgical/invasive procedures.
B. A properly executed informed consent form contains at least the following (Interpretive Guidelines 482.51(b)(2):
1. Name of patient, and when appropriate, patient's legal guardian; 2. Name of hospital; 3. Name of procedure(s); 4. Name of practitioner(s) performing the procedure(s) or important aspects of the procedure(s), as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner...;5. Anticipated Benefits; 6. Material risks of performing the procedure and of not performing the procedure...;7. Side effects and potential problems that might occur during recuperation; 8. Reasonable therapeutic alternative procedures and treatments; 9. Signature of patient or legal guardian; 10. Date and time consent is obtained; 11. Statement that procedure was explained to patient or guardian; 12. Signature of professional person witnessing the consent; and 13. Name/Signature of professional person who explained the procedure to the patient or guardian."

Patient R1
Review of the medical record for Patient R1 revealed she had a Central Venous Catheter placed by a physician 3/25/16 at 3: 55 p.m. Further review revealed her informed consent, signed 3/25/16 at 3:12 p.m., had the following information omitted and/or blank spaces: Name of physician/practitioner who was to perform the procedure, other practitioners that would be participating in the procedure, anticipated benefits, the patient's diagnosis or condition for which the procedure was indicated and recommended, additional risk(s) particular to the patient because of a complicating medical condition (or that there were none), Reasonable Therapeutic Alternatives and risk associated therewith, risks of no treatment. Further review revealed that it could not be determined, by the signature and lack of documentation on the consent, what physician had obtained the informed consent.

Patient R2
Review of the medical record for Patient R2 revealed he had a open reduction and internal fixation of the right proximal humerus 3/29/16. Further review revealed his informed consent for the surgery, signed 3/28/16, had the following information omitted and/or blank spaces: Name of physician/practitioner who was to perform the procedure, other practitioners that would be participating in the procedure, anticipated benefits, additional risk(s) particular to the patient because of a complicating medical condition (or that there were none), Reasonable Therapeutic Alternatives and risk associated therewith, risks of no treatment. Further review revealed that it could not be determined, by the signature and lack of documentation on the consent, what physician had obtained the informed consent.
Review of the Intraoperative Record 3/29/16 revealed that there was a primary surgeon and an attending staff physician in his surgery.

Patient R4
Review of the medical record for Patient R4 revealed she was an 8 year old that had a T&A performed on an outpatient basis 3/39/16. Further review of the Informed Consent, signed 3/29/16 by the patient's legal guardian, did not have the name of the physician who was to perform the surgery or name(s) of any other physicians or practitioners that might participate in the child's surgery. The anticipated Benefits , additional risks (if any) particular to the patient because of a complicating medical condition or that there were none, reasonable therapeutic alternatives and risks associated therewith or risks of no treatment. The signatures of the witness and the physician obtaining the consent were not legible and did not have typed or printed names of either.


R6
Review of the medical record for Patient R6 revealed he had a Joint Aspiration (which joint was not specified) 3/28/16. Further review revealed his informed consent for the surgery, signed 3/28/16 prior to his procedure, had the following information omitted and/or blank spaces: Name of physician performing the procedure, the patient's condition for which the procedure was indicated and recommended, Procedure specific risks, additional risk(s) particular to the patient because of a complicating medical condition (or that there were none), Reasonable Therapeutic Alternatives and risk associated therewith, risks of no treatment. Further review revealed that it could not be determined, by the signature and lack of documentation on the consent, what physician had obtained the informed consent.
Review of the Intraoperative Record 3/29/16 revealed that the surgery was performed by S10MD, whose name was not provided on the informed consent.


R8
Review of the medical record for Patient R8 revealed she received a blood transfusion 3/29/16. Further review revealed her informed consent for Transfusion of Blood or Blood Components , signed 3/29/16 prior to her receiving the blood components, had the following information omitted and/or blank spaces not completed: the patient's condition for which the procedure was indicated and recommended, Anticipated Benefits, additional risk(s) particular to the patient because of a complicating medical condition (or that there were none). Further review revealed that it could not be determined, by the signature and lack of documentation on the consent, what physician had obtained the informed consent.

In an interview 3/29/16 at 5:00 p.m. the findings in the medical records of R1, R2, R6, R8, and R9 were verified again by S5Regulatory. S5Regulatory verified that not all required components of an informed consent were present on the reviewed consents, as required by the policy and procedure. S5Regulatory agreed there should be no areas/lines left blank on an Informed Consent.
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