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295 VARNUM AVENUE

LOWELL, MA 01854

INFORMED CONSENT

Tag No.: A0955

Based on record review and interview, the Hospital failed to ensure that before surgery, a properly informed consent for one patient (Patient #1) in a total sample of ten, included all possible risks of surgery were discussed.

Findings include:

1.) The Hospital's policy and procedure related to informed consent indicated that informed consent included the risks and consequences of the proposed treatment.

2.) Patient #1's surgical consent, dated 1/14/14, indicated that Patient #1's Mother consented for a laparoscopic left ovarian cystectomy (performing surgery through small incisions using a scope placed into the abdomen for the surgical removal of a fluid filled sac that develop on the ovary). The surgical consent did not indicate Attending Physician #1 explained/discussed with Patient #1's Mother the possible risk of removing Patient #1's ovary and fallopian tube.

3.) Attending Physician #1's operative Report, dated 1/14/14 at 7:18 A.M., indicated Patient #1's left ovary was torsed (rotated) two full times and the left ovary was massively enlarged to 20 centimeters (cm) from 11 cm. Based on theses additional surgical findings, a left salpingo-oophrectomy (removal of an ovary and the fallopian tube) was performed.

4.) Attending Physician #1 was interviewed at 10:50 A.M. on 3/6/14. Attending Physician #1 said that he did not explain to Patient #1's Mother, that Patient #1 could loose an ovary during the surgery. Attending Physician #1 said he wished he had explained the risk to the Patient #1s Mother.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on medical record review and staff interviews, and review of hospital policies and procedures on 3/6, 3/10, and 3/11/2014, the hospital failed to assure that policies and procedures (i.e., triage and re-assessment of patients) governing medical care in the Emergency Department (ED) were adhered to by staff for one patient (Patient #1) in a total sample of ten ED patients because Patient #1, who was in pain, was not re-assessed while waiting to be seen by an ED provider.

Findings include:

1.) Hospital policies and procedures related to triage (the process of rapidly determining the order in which individuals presenting to the emergency department will be seen by a medical care provider based on their need for immediate medical treatment), indicated that patients will have a primary assessment and be assigned an emergency severity index (ESI) score from 1-5.

ESI 1 (patient requires immediate life-saving intervention)

ESI 2 - (patient with a high risk situation and requires a bed, the patient may have severe pain)

ESI 3 - (patient without a high risk situation, but may need many resources)

ESI 4 - (patient without a high risk may require 1 resource)

ESI 5 - (patient without high risk situation and no resources needed). All patients will have a secondary comprehensive triage.

The policies and procedures indicated that all patients will have a re-assessment as needed.

The policy and procedure did not have guidelines for an "as needed" re-assessment. An as needed re-assessment could be not at all. The policy and procedure indicated the goal for re-assessment is to assure that patients waiting to be seen will have access to ongoing information and evaluation. The triage re-assessments will be documented in the record.


2.) Family Members #1 and #2 were interviewed at 10:30 A.M. and 11:30 A.M. on 3/5/14. Family Member #1 said Patient #1 waited curled on the Emergency Department floor with severe abdominal pain for an hour and a half before being seen by the physician without anyone re-evaluating the patient.

3.) The Emergency Department Primary Triage Note, at 12:56 P.M. on dated 1/13/14, indicated that Patient #1 complained of abdominal pain and had a large cyst in her ovary per her primary care physician. Patient #1 was assigned an ESI score of 2.

4.) The secondary comprehensive triage, performed 3 minutes later at 12:59 P.M. indicated Patient #1's pain was assessed using the Wong/Baker scale (a pain scale for children using faces with assigned numbers of 2, 4, 6, 8, and 10 to determine the amount of pain). The triage record indicated no score using the Wong/Baker method.

5.) Nurse # 2 was interviewed at 11:40 A.M. on 3/6/14. Nurse #2 said there were no available beds in the Emergency Department so Patient #1's Mother was given a vibrating pager and was asked to wait in the Emergency Department's waiting area. However, while Patient #1 was waiting to be evaluated by an Emergency Department provider, there was no re-assessment of Patient #1's pain.

6.) The next re-assessment of Patient #1, who according to triage needed to be placed into a bed, was not until 2:15 P.M, 1 hour and 19 minutes after arrival to the Emergency Department, when Patient #1 was evaluated by the Emergency Department Physician Assistant. Therefore Patient #1, who was in pain, did not receive an additional evaluation/re-assessment as indicated by policies and procedures. The Family Member did not receive ongoing information while waiting with Patient #1.