HospitalInspections.org

Based on record review and interview, the physician did not implement the facility's informed consent policy for 1 of 1 patient (Patient #4) who had a shaved biopsy in that: reasonable alternative to the proposed procedure was not discussed; there was no witness signature on the consent; and there was no documentation why an oral consent was given.

Findings included:

Policy: Admin 5-06 "Consent for Medical Treatment or Surgical Procedures" revised 8/2011 pages 2, 3, 7, 8, and 9 required, "B) Informed Consent: 2) Complete informed consent process includes discussion of the following...d) Reasonable alternative to proposed care, treatment, or service...3) Includes documentation of the above discussion and placement of the appropriate completed consent forms in the medical record...9) The witness must be present with the Responsible Provider when the consent form is obtained. The witness's signature indicates that the witness saw the patient/Surrogate Decision-maker and the Responsible Provider sign the form. C) Procedure for Obtaining Consent...10) An oral consent may be taken by the Responsible Provider. The "signature of the patient" line is left blank. Indicate the reason the oral consent is given. One (1) witness is required."

On 03/13/12 at 10:09 AM, Physician #8 wrote a "Dermatology Consult Note" which reflected dermatology was consulted because the primary team was "concerned for basal cell carcinoma." Physician #8's "Assessment & Plan" included "1. Skin neoplasm, uncertain behavior: Agree with primary team and think that basal cell carcinoma is highest on DDx (differential diagnosis) --- shave biopsy was performed today, results will be available in 7-10 days." The "Shave Biopsy Procedure Note" reflected "...After verbal informed consent (explained risk-scar, bleeding, infection, pain-and benefits-diagnosis) was obtained and time out performed Personnel #13 (patient care assistant) who interpreted the conversation..." The PCA did not sign the oral consent.

In an interview on 03/28/12 at 10:58 AM and 11:45 AM, Physician #9, the dermatology faculty and Physician #10, dermatology medical director were told of the findings. Both physicians confirmed the findings.

Based on record review and interview, the physician did not implement the facility's informed consent policy for 1 of 1 patient (Patient #4) who had a shaved biopsy in that: reasonable alternative to the proposed procedure was not discussed; there was no witness signature on the consent; and there was no documentation why an oral consent was given.

Findings included:

Policy: Admin 5-06 "Consent for Medical Treatment or Surgical Procedures" revised 8/2011 pages 2, 3, 7, 8, and 9 required, "B) Informed Consent: 2) Complete informed consent process includes discussion of the following...d) Reasonable alternative to proposed care, treatment, or service...3) Includes documentation of the above discussion and placement of the appropriate completed consent forms in the medical record...9) The witness must be present with the Responsible Provider when the consent form is obtained. The witness's signature indicates that the witness saw the patient/Surrogate Decision-maker and the Responsible Provider sign the form. C) Procedure for Obtaining Consent...10) An oral consent may be taken by the Responsible Provider. The "signature of the patient" line is left blank. Indicate the reason the oral consent is given. One (1) witness is required."

On 03/13/12 at 10:09 AM, Physician #8 wrote a "Dermatology Consult Note" which reflected dermatology was consulted because the primary team was "concerned for basal cell carcinoma." Physician #8's "Assessment & Plan" included "1. Skin neoplasm, uncertain behavior: Agree with primary team and think that basal cell carcinoma is highest on DDx (differential diagnosis) --- shave biopsy was performed today, results will be available in 7-10 days." The "Shave Biopsy Procedure Note" reflected "...After verbal informed consent (explained risk-scar, bleeding, infection, pain-and benefits-diagnosis) was obtained and time out performed Personnel #13 (patient care assistant) who interpreted the conversation..." The PCA did not sign the oral consent.

In an interview on 03/28/12 at 10:58 AM and 11:45 AM, Physician #9, the dermatology faculty and Physician #10, dermatology medical director were told of the findings. Both physicians confirmed the findings.