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Based on record review, a review of facility Medical Staff Bylaws and interview, the facility failed to ensure that requirements of the organized medical staff were followed for 1 of 10 sampled patients (#1).

Findings:

During the review of the medical record of #1, handwritten physician notes by physician A were found in the record with the following dates: 4/28/15, 5/04/15, 5/05/15, 5/07/15, 5/09/15, 5/12/15, 5/13/15, 5/15/15, 5/17/15, 5/18/15, 5/19/15, and 5/21/15. None of these notes were legible.

During an interview of the Director of Risk Management on 12/28/15 at 2:15 PM, a request was made to have the physician read his notes and provide a legible translation. She stated that she had asked the physician to provide a legible translation but he could not understand what he had written. The medical record was incomplete in its comprehension.

The Medical Staff Bylaws read, "All entries in the medical record must be legible.... " The physician did not comply with bylaws regarding medical record entries.

On 12/29/15 at 1 PM, the Director of Risk Management confirmed the medical record was incomplete in its comprehension and the physician did not comply with bylaws regarding medical record entries.

Based on record review and interview, the hospital failed to ensure that a registered nurse (RN) properly supervised the care of a patient with a Fecal Management System for 1 of 10 sampled patients. (#1)

Findings:

Patient #1's physician orders of 5/12/15 at 10:18 AM read, "FMS (Fecal Management System)." A "Flexi-Seal FMS is a temporary containment device, indicated for bedridden or immobilized, incontinent patients with liquid or semi-liquid stool." (Medline).

A nurse's note of 5/12/15 at 3:19 PM read, "FMS placed due to constant diarrhea stools during shift."

The "Patient Treatment Sheet", dated 5/12/15, indicated FMS placement on this day, but it did not specify the anatomical location of placement. The FMS was ordered and inserted but later documentation revealed that the FMS was discovered in the patient's vagina. There is no way of knowing from these specific entries whether the device was or was not inserted in the rectum. There were no additional notes about this device until 5/15/15.

A nurse's note of 5/15/15 at 8 AM read, "Unsure of exact date FMS inserted. On assessment, noticed what appeared to be stool in the vaginal area, on cleaning the patient and checking the rectal tube it was found to be in the pt's vagina. Dr. (A) was called and is coming in to see patient to assess her." A nurse's note of 5/15/15 at 8:50 PM read, "FMS in place found on assessment to be in patient's vagina, Dr. (A) notified. Pt had a colorectal vaginal fistula repair done on the 28th of April. Stool is draining into the FMS tube and is liquid, concerned the fistula has reopened. Will wait for Dr. (A) to assess pt, will discuss with daughter at that time."

Review of the "Guidelines for the Management of Fecal Incontinence with Flexi-Seal SIGNAL Fecal Management System (FMS)," created by the device manufacturer, read, "Gently insert the balloon through the anal sphincter until it is beyond the external orifice and well inside the rectal vault." Thus, the device was made for rectal insertion only. The guidelines made no mention of application involving the vagina. Prior to the two preceding nurse's notes of 5/15/15 at 8 AM and 5/15/15 at 8:50 PM, there was no evidence of physician authorization of the FMS in the vagina, which is not the designated use of this device per manufacturer's guidelines.

On 12/28/15 at 3:50 PM, the Director of Risk Management stated the patient did not have the ability to perform any placement of the FMS in her vagina by herself. As to whether the physician believed the FMS had any medical justification for being in the vagina, during an interview of physician A on 12/28/15 at 4:10 PM, he stated that the device was not initially ordered (by another physician) to be placed in the vagina. Thus, a nurse at some unknown point on or after 5/12/15 and before 5/15/15 at 8:50 PM had inserted the FMS in the patient's vagina instead of her rectum, which was contrary to the device's stated intent or physician orders. This type of placement in the vagina was initially done without physician authorization.

On 12/29/15 at approximately 11:25 AM, the Director of Risk Management stated the incident was reviewed after it was discovered, and through interviews of the staff who cared for patient #1 from 5/12/15 through 5/15/15, learned that the FMS was initially inserted in the rectum. However, she said they were not able to discover the time when it was placed in the vagina.

During an interview of the Director of Risk Management on 12/12/29/15 at 1 PM, she confirmed the findings.

Based on record review, a review of facility Medical Staff Bylaws and interview, the facility failed to ensure that requirements of the organized medical staff were followed for 1 of 10 sampled patients (#1).

Findings:

During the review of the medical record of #1, handwritten physician notes by physician A were found in the record with the following dates: 4/28/15, 5/04/15, 5/05/15, 5/07/15, 5/09/15, 5/12/15, 5/13/15, 5/15/15, 5/17/15, 5/18/15, 5/19/15, and 5/21/15. None of these notes were legible.

During an interview of the Director of Risk Management on 12/28/15 at 2:15 PM, a request was made to have the physician read his notes and provide a legible translation. She stated that she had asked the physician to provide a legible translation but he could not understand what he had written. The medical record was incomplete in its comprehension.

The Medical Staff Bylaws read, "All entries in the medical record must be legible.... " The physician did not comply with bylaws regarding medical record entries.

On 12/29/15 at 1 PM, the Director of Risk Management confirmed the medical record was incomplete in its comprehension and the physician did not comply with bylaws regarding medical record entries.

Based on record review and interview, the hospital failed to ensure that a registered nurse (RN) properly supervised the care of a patient with a Fecal Management System for 1 of 10 sampled patients. (#1)

Findings:

Patient #1's physician orders of 5/12/15 at 10:18 AM read, "FMS (Fecal Management System)." A "Flexi-Seal FMS is a temporary containment device, indicated for bedridden or immobilized, incontinent patients with liquid or semi-liquid stool." (Medline).

A nurse's note of 5/12/15 at 3:19 PM read, "FMS placed due to constant diarrhea stools during shift."

The "Patient Treatment Sheet", dated 5/12/15, indicated FMS placement on this day, but it did not specify the anatomical location of placement. The FMS was ordered and inserted but later documentation revealed that the FMS was discovered in the patient's vagina. There is no way of knowing from these specific entries whether the device was or was not inserted in the rectum. There were no additional notes about this device until 5/15/15.

A nurse's note of 5/15/15 at 8 AM read, "Unsure of exact date FMS inserted. On assessment, noticed what appeared to be stool in the vaginal area, on cleaning the patient and checking the rectal tube it was found to be in the pt's vagina. Dr. (A) was called and is coming in to see patient to assess her." A nurse's note of 5/15/15 at 8:50 PM read, "FMS in place found on assessment to be in patient's vagina, Dr. (A) notified. Pt had a colorectal vaginal fistula repair done on the 28th of April. Stool is draining into the FMS tube and is liquid, concerned the fistula has reopened. Will wait for Dr. (A) to assess pt, will discuss with daughter at that time."

Review of the "Guidelines for the Management of Fecal Incontinence with Flexi-Seal SIGNAL Fecal Management System (FMS)," created by the device manufacturer, read, "Gently insert the balloon through the anal sphincter until it is beyond the external orifice and well inside the rectal vault." Thus, the device was made for rectal insertion only. The guidelines made no mention of application involving the vagina. Prior to the two preceding nurse's notes of 5/15/15 at 8 AM and 5/15/15 at 8:50 PM, there was no evidence of physician authorization of the FMS in the vagina, which is not the designated use of this device per manufacturer's guidelines.

On 12/28/15 at 3:50 PM, the Director of Risk Management stated the patient did not have the ability to perform any placement of the FMS in her vagina by herself. As to whether the physician believed the FMS had any medical justification for being in the vagina, during an interview of physician A on 12/28/15 at 4:10 PM, he stated that the device was not initially ordered (by another physician) to be placed in the vagina. Thus, a nurse at some unknown point on or after 5/12/15 and before 5/15/15 at 8:50 PM had inserted the FMS in the patient's vagina instead of her rectum, which was contrary to the device's stated intent or physician orders. This type of placement in the vagina was initially done without physician authorization.

On 12/29/15 at approximately 11:25 AM, the Director of Risk Management stated the incident was reviewed after it was discovered, and through interviews of the staff who cared for patient #1 from 5/12/15 through 5/15/15, learned that the FMS was initially inserted in the rectum. However, she said they were not able to discover the time when it was placed in the vagina.

During an interview of the Director of Risk Management on 12/12/29/15 at 1 PM, she confirmed the findings.