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800 ROSE STREET

LEXINGTON, KY 40536

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview, medical record review, review of the facility's policies, and review of patient education materials, it was determined the facility failed to ensure the patient was informed of the need to perform a daily flush of his/her left internal/external biliary drain and right external biliary drain after discharge, at home, for one (1) of twelve (12) sampled patients, Patient #2.

The findings include:

Review of the facility policy, " Patient and Family Education," number A11-130, effective date 12/13/13, revealed the purpose of patient and family education was to give the patient/family information so they could make informed decisions about their care and recovery to regain and maintain good health. The policy further revealed the facility supported patient/family education as an integral component of overall patient care and acknowledged that effective education contributed to desirable patient outcomes. It then stated patient education was interdisciplinary in nature and occurred in every patient care at the point of care, but the responsibility for the coordination of educational needs was with the patient's nurse in an inpatient setting.

Review of the facility policy, "Patient Education by Nurses," number NU08-05, effective date 12/01/15, revealed the Registered Nurse (RN) was responsible for the coordination of the patient's educational needs, and he/she would consult and communicate with other health disciplines to provide effective patient education. Also, discharge education consisted of both new teachings and survival skills specific to the patient's medical condition(s).

Review of the patient education document titled, "Taking Care of Your Biliary Drain Tube," revealed it had information to flush the biliary drain tube to keep it from getting clogged. It also stated to flush twice a day, once in the morning and once in the evening. However, in another section on flushing the drain tube, it stated the physician could instruct the tube be flushed daily. In this section, it did not mention the amount of NS flush to use.

Review of Patient #2's medical record revealed he/she was admitted on 11/29/15 with diagnoses of Acute Cholangitis, Stage III Cancer of the Gall Bladder with Possible Metastasis to the Liver, Chronic Obstructive Pulmonary Disease, and Hypertension. The record further revealed Patient #2, on 12/02/15, had fluoroscopically and ultrasound guided placement of bilateral biliary drainage catheters to treat biliary obstruction by Physician #1. The right catheter was an external catheter. The left catheter was an internal/external catheter. The record further revealed the patient tolerated the procedure well and left the interventional radiology suite in stable condition. Further review of the procedural record revealed, under the "Plan" section, the internal/external drain should be left to external drainage for forty-eight (48) hours or as long as the patient was febrile. After this, the internal/external drain could be capped unless fever, pain, or leaking around external portion of the catheter. The record also stated the internal/external drain should be flushed with ten (10) milliliters (ml) of normal saline (NS) per day in a slow, steady fashion without aspiration, and at patient discharge, an extra collection bag to place the drain to external drainage if needed should be sent home with him/her. Also, the internal/external drain should be changed about every eight (8) to ten (10) weeks. The record further revealed Physician #1 documented in the "Plan" that the external biliary drainage catheter should remain to external bag drainage and be flushed with ten (10) ml of NS per day in a slow, steady fashion without aspiration. The record further revealed there were no physician orders written addressing the "Plan" instructions for the bilateral catheters by Physician #1 (the procedure physician) or Physician #2 (the attending physician). The record then showed Patient #2's biliary catheters were not flushed before his/her discharge on 12/03/15. The record then revealed Patient #2 was discharged on 12/03/15 at 2:30 PM, and RN #2 was his/her nurse at discharge. The record showed RN #2 gave Patient #2, on discharge, a patient education document titled, "Taking Care of Your Biliary Drain Tube."

Additional review of Patient #2's medical record, "Medical Oncology Clinic Note," dated 12/08/15, revealed Patient #2's daughter stated he/she was not provided with saline flushes or any supplies at the time of discharge from the hospital. Therefore, the record revealed, Patient #2 had not been flushing the bilateral biliary drains since they were placed on 12/02/15. The record then stated the drainage in the collection bags had been averaging about one-hundred (100) ml per day. The medical oncologist further revealed Patient #2's drains were flushed at the clinic with normal saline, and he/she was provided with flushes/supplies until more were provided by home health services which were also scheduled for Patient #2 by the oncology clinic. In addition, Patient #2's bilirubin level was elevated at 3.1 which the medical oncologist stated could be due to blockage of the drains because of lack of flushing them.

Interview with RN #1, on 06/08/16 at 1:12 PM, revealed she worked at the Medical Oncology Clinic and had cared for Patient #2 on 12/08/15. She further revealed she had asked Patient #2's daughter about how difficult it was to flush the biliary drains, and the daughter replied she did not know anything about it, and the hospital did not provide any syringes with saline flush. At this clinic visit, Patient #2 was having increased abdominal pain. RN #1 then revealed she instructed the daughter on how to flush the drains and the medical oncologist ordered home health services. RN #1 stated supplies were provided to Patient #2 to last until home health services could see the patient. RN #1 then revealed Patient #2's daughter was upset that she had not been instructed to flush the biliary drains and had not received any supplies from the hospital to do so.

Interview with RN #2, on 06/08/16 at 2:10 PM, revealed he provided care for Patient #2 on 12/03/15 and was his/her discharge nurse. He further revealed at the time of discharge a friend of Patient #2 was with him/her and videotaped RN #2 giving the discharge instructions so Patient #2's daughter could view. RN #2 further revealed since there had been no physician order to flush the biliary drains, and he had not done so, he did not instruct Patient #2 to flush his/her biliary drains after going home. He also stated he did not concern himself with supplies to flush the drains. RN #2 then stated if he had been flushing the drains, he would have ensured Patient #2 knew how to do so and would have ensured he/she had enough flushing supplies to do so initially at home, or until the family could purchase them from an outside source.

Interview with the Patient Care Manager (PCM) of 7 Main, Pavilion H, on 06/08/16 at 2:20 PM, revealed there was not a nursing protocol to flush biliary drains without a physician's order; therefore, if a physician did not write an order to flush the drain, it would not be done. The PCM then stated the standard would be nurses do not flush drains without a physician's order to do so.

Interview with Physician #1, on 06/09/15 at 8:20 AM, revealed he was the physician that placed the biliary drains in Patient #2 on 12/02/15, and the process that was used for outpatients that were exclusively on the Interventional Radiology service, was for staff to retrieve the information from the procedure report on the specific discharge instructions on caring for the drain. Physician #1 further revealed the routine instruction was to do a daily flush with ten (10) ml of NS to help keep the drain from getting clogged. Physician #1 then stated when he was consulted on an inpatient, he again would produce a typed procedure report which would have instructions on how the patient's drain(s) should be managed. He then revealed, he, along with the other interventional radiologists, expected the attending physician to write orders for drain care based on what was written in the procedural report, and he did not typically write or give orders on a patient for which he was a consulting physician. Also, Physician #1 stated he did not expect nursing to look at the report and ask the attending physician about writing a verbal order to cover the instructions. Physician #1 then stated the standard of care was for biliary drains to be flushed because it helped them from becoming occluded which could cause the patient increased abdominal pain and increased bilirubin levels. He also revealed internal/external drains could be capped because they could drain internally. Physician #1 stated even if drains were flushed daily they could still become occluded because bile was very thick; therefore, all drains would need to be changed every eight (8) to ten (10) weeks. He then stated some patients could not flush because of physical limitations. However, he revealed for Patient #2, it would have been preferable for him/her to have received discharge instructions on how to flush the biliary drains and to have been flushing the drains at home.

Interview with the Nurse Coordinator of Procedural Nursing, on 06/09/16 at 11:15 AM, revealed she managed nursing care in the Interventional Radiology Department. She further revealed, for an outpatient receiving placement of a biliary tube(s), at discharge the nurse would read the instructions in the procedural note, give the patient a copy of "Taking Care of Your Biliary Drain Tube," and write the specific instructions of amount of flush and frequency of flush on this form. The Nurse Coordinator also revealed for inpatients, a copy of the educational material was placed in the chart and a verbal report was given to the nurse on the floor about specific physician instructions on caring for the drain(s), so the patient's nurse would be aware of how to care for the drain(s).

Interview with Physician #2, on 06/09/16 at 12:35 PM, revealed he was Patient #2's attending physician. He further revealed, as an internal medicine physician, when he was the attending for a patient that had a procedure done, he looked at the procedure notes to see what that physician had written on instructions for caring for the patient as an inpatient and at discharge, e.g. wound care or care of biliary drains. Physician #2 also stated there should be communication, nurse-to-nurse, at hand-off, or when the patient left the procedure area to go back to the floor. He also revealed the process would be improved with nothing missed, if there were procedural physician to attending physician verbal communication, especially if there were specific instructions on wound or drain care. Physician #2 then stated if there were patient needs at discharge for supplies or equipment, these would usually be sent home with the patient, at least enough for a few days, until he/she could get supplies or an agency, such as home health, could see him/her. Physician #2 revealed for Patient #2, he technically should have written the orders for drain care post-procedure and at home; however, the problem with that was it might take several days or hours to get the typed procedure report on the computer. He then stated communication for this process could be improved on multiple levels: nurse-to-nurse, physician-to-physician; and nurse-to-physician to get the orders so nothing was missed.