HospitalInspections.org

Bringing transparency to federal inspections

901 NORTH HARRY S TRUMAN DRIVE

LARGO, MD 20774

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on a review of hospital policy, and the records of patients #1, and #8, it is determined that 1) the hospital failed to certify an incapacity for patient #1, obtain a surrogate signature, or in the case of emergency, a second physician signature on two consents, and failed to document the source of a phone consent for patient #1; 2) the hospital failed to conduct an evaluation to certify an incapacity for patient #8 prior to obtaining consent from his surrogate, and 3) documented an incapacity on a consent signed by a Physician Assistant (PA) and Registered Nurse (RN).


Patient #1 was a middle-aged adult with multiple conditions. The patient required a permacath Quinton catheter and anesthesia for placement of that catheter on 9/14/2016. Consent forms for the procedure and anesthesia revealed an RN and a physician signature, but no signature of the patient, or his surrogate. Patient #1 required an arterial line on 9/20. The consent revealed two physician signatures as required for an emergency consent, and also revealed a check box indicating a consent obtained by telephone. A progress note indicated that patient #1's daughter was given the risks and benefits of the arterial line, however, the consent form failed to indicate who consented by phone.


The facility consent form, titled " Consent for Operations and Other Procedures " has a check box to indicate " Lacks decision-making capacity. "


Review of hospital policy, "Withholding, Withdrawing, or Limiting Life sustaining Treatment, 50-6" (reviewed 4/2016), revealed in part, " Note: A competent individual who is able to communicate by means other than speech may not be considered incapable of making an informed decision. " Additionally, the policy describes the process for certifying an incapacity, and has an attached form for one or two physician ' s certifying an incapacity.


Patient #8 was a young adult who was on a ventilator. On 11/7, patient #8 required an CT chest with contrast. The consent was obtained from the patient's sister via telephone. The consent form was signed by two witnesses, one of them a physician. The box indicating he lacked decision-making capacity was checked on the consent, however, a record search for supporting certification documentation by two physician evaluations was not found.


On 11/8, patient #8 required a bronchoscopy, and sedation to perform the bronchoscopy. Review of patient #8's record revealed an RN note of 11/8 at 0713 which stated in part, " Pt (patient) remains alert and oriented, able to communicate needs ...possible bronch and PEG today ... " A 0745 consent for bronchoscopy and sedation revealed the mother's signature, and two witness signatures. The witnesses were a Physician Assistant and what appears to be an RN. No physician signature was noted. Additionally, the box indicating that patient #8 lacked decision-making capacity was checked without any record evidence that a two physicians had examined patient #8 to make this certification. Additionally, the incapacity is in direct contrast of the RN note which stated that patient #8 was alert, oriented and able to make his needs known. Finally, a Physician Assistant and RN have no authority to determine an incapacity.


Based on all documentation, the hospital failed to appropriately manage certifications of incapacity for patients #1 and #8.