The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST MARY MEDICAL CENTER 18300 HIGHWAY 18 APPLE VALLEY, CA 92307 Sept. 23, 2013
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to provide documented evidence that all patients with wound VAC (a sealed wound dressing attached to a vacuum machine to promote wound healing) placement were being tracked and that safety indicators were consistently implemented for 5 of 6 patients (Patients 28, 30, 31, 32, 33). This failure had the potential to result in a re-occurrence of dressings being left in wounds which could lead to infection requiring hospitalization and/or surgical interventions.

Findings:

During the entrance conference on September 17, 2013, the Risk Manager was asked for a list of all patients who had wound VAC placement in the hospital between July 1, 2013, and September 17, 2013. A list was provided with 3 patients on September 17, 2013; it noted that Patients 28's wound VAC placement was performed on September 6, 2013, Patient 29 on September 1, 2013, and Patient 33 on August 28, 2013.

During a review of the hospital plan of correction (POC), with completion dates starting June 18, 2013 through September 30, 2013, the following were noted:

"1. June 18, 2013, representative provided additional education to the Perioperative Services staff.

2. June 18, 2013, the Perioperative Services Department implemented a new visual aid process for all wound VAC. The new visual aid process is physically placed on all wound VACs and exhibit proper dressing and sponge quantity. This new visual aid process required the surgeon and/or staff directed by the surgeon (a doctor specializing in operations that involve gaining access to the patient's body, e.g. by making incisions into it, in order to correct faults, repair injuries, or treat diseases) to document the following five (5) elements:

Date wound VAC placed in the patient.
Time wound VAC placed in the patient.
Number of VAC foam dressings placed in the patient.
Color of the VAC foam dressings
Planned date when the VAC foam dressings were to be changed."

A review of the Quality Assurance Performance Improvement (QAPI) monitoring, noted that the tracking process was to be initiated on July 1, 2013, and completed on September 30, 2013. It also noted that the Peri-Operative Services Leadership Team (includes the Perioperative Services Director (PSD) and the Manager of Patient care Services) would conduct monthly direct observations of all cases that were required to have a wound VAC placement to ensure that the visual elements were written on the wound VAC dressing. The would document the results of such audits on the Wound VAC Dressing Tracking Tool for at least three (3) consecutive months and would continue the process monthly until compliance was achieved.

During a tour of the Post Anesthesia Care Unit (PACU) on September 18, 2013, at approximately 11:30 AM, an interview was conducted with the PSD. He was asked to describe the new wound VAC visual aid process that was initiated on July 1, 2013. He stated that the staff in Central Supply attached a laminated card with all of the 5 elements to be tracked on the the wound VAC machine when it was ordered. He stated that the circulating nurses in PACU documented the information on the laminated card that was attached to the wound VAC machine.

During a tour of Central Supply on September 18, 2013, at approximately 11:45 AM, interviews were conducted with two (2) distribution technicians. When asked to see the laminated cards that they attached to the wound VAC machines, Distribution Tech 1 and 2 responded that they were not aware of the laminated cards.

During an interview on September 18, 2013, at 12:05 PM, with the Manager of Patient Care Services, in PACU, she stated that the process was changed because the patients were discharged home with the wound VAC machines that had the laminated cards with the documentation. She stated that the 5 elements were documented directly onto the patient's wound VAC dressing. The circulating nurse in PACU checked off the 5 elements from the wound dressing onto the "Wound VAC Dressing Tracking Tool". A copy of the completed "Wound VAC Dressing Tracking Tool" was requested.

During a review of the information on the "Wound VAC Dressing Tracking Tool", it noted the following sections:

a. Patient's identification - a patient information sticker was attached
b. Dressing timed - yes or no
c. Dressing dated - yes or no
d. Dressing suggested change date - yes or no
e. Number of sponges - yes or no
f. Disposition of patient after leaving PACU - admit or home
g. Color of sponge.

During a review of the completed "Wound VAC Dressing Tracking Tool", on September 18, 2013, it noted that 3 patients had wound VAC placement performed between August 28, 2013, and September 13, 2013. One of the three patients listed on the "Wound VAC Dressing Tracking Tool", did not match the names of the 3 patients that were on the list dated September 17, 2013. The PSD was asked to verify the names of all patients that had wound VAC procedures performed in the hospital from July 1(when the tracking was initiated) to September 20, 2013. A second "Wound VAC Dressing Tracking Tool" was received with 4 additional patients that had wound VAC procedures performed in September 2013, one (1) on September 6, 2013, and three (3) on September 13, 2013.

During an interview on September 20, 2013, at 1:25 PM, with the Physical Therapy Assistant (PTA) 1, she stated that she had been performing wound Vac dressing changes on Patient 33. She confirmed that there was no laminated instructions on the wound VAC machine, and that the wound dressing had only the date and the time when the wound VAC dressing was last changed. (The 5 elements were not documented on the wound VAC dressing per the POC).

During an interview on September 20, 2013, at 1:45 PM, with Registered Nurse (RN) 1, a circulating nurse in PACU, he stated that the information from the "Wound VAC Dressing Tracking Tool", was documented in the computerized medical record, under the section, "Catheter, Drain, Wound VAC."

During a review of 6 wound VAC patients' computerized medical records from August 28, 2013, to September 13, 2013, only one record had all of the five (5) elements documented under the section "Catheter, Drains, Wound VAC." The following patients did not have the 5 elements documented:
Patient 28, was admitted ato the facility on [DATE]. The wound VAC procedure was performed on September 6, 2013.
Patient 30, was admitted to the facility on on [DATE]. The wound VAC procedure was performed on September 13, 2013.
Patient 31, was admitted to the facility on on [DATE]. The wound VAC procedure was performed on September 13, 2013.
Patient 32, was admitted to the facility on on [DATE]. The wound VAC procedure was performed on September 6, 2013.
Patient 33, was admitted to the facility on on [DATE]. The wound VAC procedure was performed on August 26, 2013.
This finding was confirmed on September 20, 2013, at approximately 2:00 PM with Registered Nurse (RN) 7.

During an interview on September 20, 2013, at 2:55 PM, with the PSD, and the Manager of Patient Care Services, the "Wound VAC Dressing Tracking Tool" was reviewed. The PSD was asked if any other patients had wound VAC procedures performed between July 1 and August 27, 2013. He responded that he could not tell if wound VAC procedures were performed on patients prior to August 28, 2013. He stated, "Well, I guess we started tracking on August 28, 2013." He was asked why there was a discrepancy between 1 of the 3 names on the "Wound VAC Dressing Tracking Tool" and the 3 patients that were on the first list received on September 17, 2013. He responded that on September 19, 2013, it was noted that on August 28, 2013, someone placed the wrong patient identification sticker on the "Wound VAC Dressing Tracking Tool". The PSD further stated that he did not know why all 7 patients were not on wound VAC procedure list that was provided on September 17, 2013. During the same interview, the Manager of Patient Care Services stated that she had not reviewed the completed "Wound VAC Dressing Tracking Tool".

During further review of the Wound VAC Dressing Tool with the PSD and the Manager of Patient Care Services on September 20, 2013, at approximately 3:00 PM, the following were noted:
a. For 7 of 7 patients, the number of sponges were not listed
b. For 1 of 7 patient, the color of the of the sponge was not listed
c. There were no dates or times listed on the tracking tool.

The PSD stated that the tracking tool needed to be revised because it allowed the staff to document yes or no, and not the actual date, time, number of sponges, etc. The PSD was asked what protocol was initiated for inpatient wound VAC dressing monitoring. He stated that the protocol for inpatient wound VAC dressing changes had not been developed.

A review of the Performance Improvement (PI) Indicators titled, "Surgical Services - Wound Vacuum Dressing", was conducted with the Director of Risk Management & Privacy Officer, on September 20, 2013, at approximately 3:15 PM. It noted three (3) patients had wound VAC placement performed, one in August 2013 and two in September, 2013. It also noted 100% compliance for all 5 elements of the wound VAC documentation. The Director of Risk Management was asked why only 3 of 7 patients listed on the tracking tool were part of the PI sample, and why September data was already completed. She responded that she did not know why the other 4 patients listed on the Wound VAC Dressing Tracking Tool were not included in the PI sample. The Director of Risk Management stated that she did not know why September 2013, PI data was already analyzed and submitted.

During observation of Patient 33's wound VAC dressing on September 23, 2013, at 9:20 AM, it noted, "chg. (changed) 9/22/13 at 0600." RN 2 stated that she only changed the soiled top dressing, and did not note what information was documented on the dressing she had replaced.

During an interview on September 23, 2013, at 9:43 AM, with PTA 2, he stated that he was familiar with Patient 33, and had performed her wound VAC dressings changes several times. The patient had orders for wound VAC dressing changes three times a week. He stated that he usually placed 2 medium sponges into the wound, and was not aware of the 5 elements to be documented on the wound dressing.