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1500 FOREST GLEN ROAD

SILVER SPRING, MD 20910

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on staff interviews and the review of 14 medical records, in 1 of 14 medical records the hospital failed to ensure that the provision of care was in accordance with the fully informed consent of the patient as evidenced by:

Patient #1 is a 71 year old female who presented to the ambulatory surgery department (ASD) at Holy Cross Hospital on 11/24/10 for a lumpectomy and breast biopsy. The patient's medical history was significant for lifelong debilitating mental illness. The DSS (Department of Social Services) began proceedings to appoint a guardian for health care but had not completed the process at the time of patient #1's surgery. The pre-surgical nurse during interview on 5/4/11 at 10:30 A.M. stated that the Assisted Living Facility (ALF) delegating nurse informed her that guardianship proceedings were initiated.

The medical record review revealed that patient #1 signed the consent to conditions of admission and consent for surgery. The patient History & Physical was performed on admission by the surgeon. Patient #1 signature on the consent form implied she was given information regarding her health status, diagnosis, risk and benefits of the surgery and prognosis and that the patient could make an informed decision once the information was provided. In addition the hospital sent a physician certificate of incapacity to the ALF for the Primary Care Physician (PCP) signature. The signed form was returned to the hospital and on the morning of the surgery, 11/24/10, the surgeon signed the form (as the second physician) which states "Incapacity of making an informed decision means the inability of an adult patient to make informed decision about the provision, withholding, or withdrawal of specific medical treatment or course of treatment because the patient is unable to understand the nature, extent, or probable consequences of the proposed treatment, is unable to make a rational evaluation of the burdens, risks, and benefits of the treatment, or is unable to communicate a decision." During the hospital investigation the surgeon was interviewed and could not explain why he signed the physician certificate for incapacity. The patient had the surgery and was discharged back to the ALF on the same day.

The hospital has established policies and procedures in place pertaining to surgical services and informed consent. The patient consented to the surgical procedure but the anesthesiology consent was blank. To confuse matters, a physician certificate of Incapacity was completed which stated that patient #1 lack capacity to make her health care decisions. Either the patient had capacity to consent to treatment, which should have included the patient's mental status on the day of the surgery, or the patient lack capacity. The patient's consent was essentially negated by the certificate of incapacity.

MEDICAL RECORD SERVICES

Tag No.: A0450

In 1 out of 14 medical record reviewed (patient#1) a history and physical was incomplete and the pre-anesthetic evaluation was blank which included the anesthesiologist confirmation of informed consent.

Patient #1 is a 71 year old female who presented to the ambulatory surgery department (ASD) at Holy Cross Hospital on 11/24/10 for a lumpectomy and breast biopsy. The surgeon performed the H&P but failed to review the body systems, document the vital signs and mental status nor did he print his name with his pager number or document the date or time he performed the H&P. The surgical consent for breast biopsy lacked the date and time along with the physician's name printed. The anesthesiologist for patient #1 did not complete the pre-anesthetic confirmation of consent. The entire block is blank. The anesthesia post-operative evaluation checklist is also blank but most of the information can be found in other areas of the medical record.

HISTORY AND PHYSICAL

Tag No.: A0952

Based on review of the medical record the hospital failed to ensure that patient #1 had a complete medical history and physical examination documented prior to surgery as evidenced by:

In 1 of 14 medical records reviews (patient #1) the history and physical was incomplete.

Patient #1 presented to the Ambulatory Surgery Department (ASD) at Holy Cross Hospital on 11/24/10 for a lumpectomy, breast biopsy, and axillary dissection. The surgeon performed the history and physical but failed to review the body systems, document allergies, vital signs, pain assessment, or mental status as evidenced by these sections were blank. In addition, the surgeon did not print his name, pager number, or document the date and time he performed the history and physical.

PRE-ANESTHESIA EVALUATION

Tag No.: A1003

Based on review of 14 medical records, in 1 out of 14 medical records reviewed the hospital failed to complete the pre-anesthesia evaluation for a patient receiving anesthesia.

Patient #1 presented to the Ambulatory Surgery Department (ASD) at Holy Cross Hospital on 11/24/10 for lumpectomy, breast biopsy, and axillary dissection. The anesthesiologist for patient #1 did not complete the pre-anesthesia evaluation or confirmation of consent for anesthesia. The entire block is blank. The post-operative evaluation checklist was also blank but most of this information can be found in other areas of the medical record.