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Tag No.: A0940
28294
Based on interview and record review, the facility failed to provide surgical services that were organized and consistent with acceptable standards of practice and in accordance with the facility policy by failing:
1. To ensure temperature was monitored in the Sterile Processing Department; and to respond to the "out of range" humidity in the Sterile Prep Room. The relative humidity (RH) was greater than 60% on 41 of the 54 days reviewed (refer to A951);
b. To ensure the room temperatures that fell out of range in the Operating Room (OR), Labor and Delivery OR (OBOR), Cardiac Cath Lab (CC), and Interventional Radiology (IR), were acted upon and further monitored, keeping in mind the normothermia recommendations for the patient (refer to A951);
This resulted in out of range relative humidity and/or temperature not being detected, responded to, acted upon and further monitored when out of range. In addition, this had the potential to result in the development of microorganisms on the sterile supplies and place the patients at risk of developing infections.
2. For Patient 7, to ensure an immediate comprehensive post-operative note was completed by the physician and in Patient 7's record which had the potential to result in individuals caring for Patient 7 not having the information needed to care for the patient (refer to A951);
3. For Patient 1, to ensure the "Pre Procedure Checklist" was completed to include "Site Marked by (physician's name)" and reconfirmed by perioperative staff which had the potential to result in surgery being performed on the incorrect finger (refer to A951); and
4. To ensure the "Medical Staff Privileging Manual," located in Surgical Services, was consistent with the on-line computer program containing physician privileges. This had the potential to result in staff allowing physicians to do procedures which they were not privileged to perform or not allowing physicians to do procedures which they were privileged to perform (refer to A945).
The cumulative effects of these systemic problems resulted in the failure of the facility's surgical department to provide organized, safe, and consistent care and treatment to the patients.
Tag No.: A0945
28294
Based on interview and record review, the facility failed to ensure the "Medical Staff Privileging Manual," located in Surgical Services, was consistent with the on-line computer program containing physician privileges. This had the potential to result in staff allowing physicians to do procedures which they were not privileged to perform or not allowing physicians to do procedures which they were privileged to perform.
Findings:
On July 24, 2012, at 12:25 p.m., an interview was conducted with Surgery Schedulers 1 and 2. They stated in order to confirm a physician's privileges an individual could look at the "Medical Staff Privileging Manual" or the on-line computer program that contained the physician privileges. They stated the on-line computer program for physician privileges, including dates, should match the privileges in the "Medical Staff Privileging Manual." In addition, Surgery Schedulers 1 and 2 stated it was medical staff's responsibility to update and maintain the "Medical Staff Privileging Manual."
A review of the "Medical Staff Privileging Manual" located in Surgical Services indicated Physician 1 had privileges from October 15, 2009, to September 30, 2011, and Physician 2 had privileges from March 31, 2010, to March 31, 2012, which were now expired.
On July 24, 2012, at 12:35 p.m., Surgery Scheduler 1 accessed the on-line computer program for physician privileges, and stated Physician 1 was not in the on-line computer program for physician privileges and Physician 2's privileges would not expire until March 31, 2014.
During an interview with the Director Medical Staff Services (DMSS) on July 24, 2012, at 12:55 p.m., she stated Surgical Services had a "Medical Staff Privileging Manual" and she was not sure as to when the manual had been last updated. When the DMSS was asked about Physician 2's privileges being expired, according to the "Medical Staff Privileging Manual" located in Surgical Services, she stated the "Medical Staff Privileging Manual" in Surgical Services should be updated to match the on-line computer program for physician privileges. The DMSS stated she would need to check her files in regards to Physician 1.
During a subsequent interview with the DMSS on July 24, 2012, at 1:30 p.m., she stated Physician 1 was no longer on the medical staff as of September 20, 2010, and his privileges should have been removed from the "Medical Staff Privileging Manual" located in Surgical Services. In addition, the DMSS stated the facility did not have a policy and procedure in regards to the "Medical Staff Privileging Manual" being updated to match the on-line computer program for physician privileges.
Tag No.: A0951
Based on interview and record review, the facility failed:
1a. To ensure temperature was monitored in the Sterile Processing Department; and to respond to the "out of range" humidity in the Sterile Prep Room. The relative humidity (RH) was greater than 60% on 41 of the 54 days reviewed.
b. To ensure the room temperatures that fell out of range in the Operating Room (OR), Labor and Delivery OR (OBOR), Cardiac Cath Lab (CC), and Interventional Radiology (IR), were acted upon and further monitored, keeping in mind the normothermia recommendations for the patient.
This resulted in out of range relative humidity and/or temperature not being detected, responded to, acted upon and further monitored when out of range. In addition, this had the potential to result in the development of microorganisms on the sterile supplies and place the patients at risk of developing infections.
2. To ensure an immediate comprehensive post-operative note was completed for one of 15 sampled patients (Patient 7) which had the potential to result in individuals caring for Patient 7 not having the information needed to care for the patient.
3. To ensure the "Pre Procedure Checklist" was completed to include "Site Marked by (physician's name)" and reconfirmed by perioperative staff, for one of 15 sampled patients (Patient 1), which had the potential to result in surgery being performed on the incorrect finger.
Findings:
1a. On July 24, 2012, the Humidity Log Sheet for Sterile Processing Department (SPD), dated June and July 2012 was reviewed with Sterile Processing Staff (SPS). Instructions on the log indicated, "Relative Humidity should be between 30% to 60%." The log revealed the RH in the Sterile Prep Room ranged from 53% to 84%, with a high above 60% on 41 out of 54 days. There was no documentation of temperature reading on this log. A request was made for a copy of the temperature log and the Policy and Procedure for monitoring the temperature and humidity specific to the SPD.
On July 24, 2012, at 9:15 a.m., SPS were interviewed. SPS stated Plant Operations (Plant Ops) did not monitor the temperature and humidity in the SPD, like they did for the OR's. She stated the sterile processing staff monitored this area and when a humidity reading falls out of range then Plant Ops should be notified to make adjustments, or to find out if there was a problem. SPS stated they found out the day before that the humidity gauge had not been working correctly, and the readings were probably incorrect. However, at the time of the readings it was not known if the gauge was working or not, and staff should have notified Plant Ops of the high humidity. SPS did not know if Plant Ops was notified and could not find any documention to indicate an action/response to the out of range humidity.
In a concurrent interview with the Director of Surgical Services (DSS), she stated the log instructions were incorrect, and should have indicated that RH should be 35% (not 30 %) to 60%. The DSS also stated the Sterile Processing Department did not have their own policy on monitoring humidity and temperatures, and should have referred to the same policy as the Surgical Department for the correct ranges of humidity and temperature. The DSS further stated, the Sterile Processing Department was not monitoring the temperatures in that area as they should have been.
On July 24, 2012, the facility policy titled, "OR Temperature, Humidity Monitoring," revised January 2012, was reviewed. The RH range was 35% to 60% and the temperature range was 68? F to 73? F within the operating room suite.
On July 24, 2012, at 11:30 a.m., the Director of Plant Ops (DPO) was interviewed. The DPO stated the SPD was responsible to monitor the temperatures and humidity within their department. The DPO stated he was not aware that they were not monitoring temperatures. In addition, he was unable to show if Plant Ops was notified of the high humidity readings in June and July 2012.
b. On July 23, 2012, at 9:30 a.m., RN 1 was interviewed. RN 1 stated Plant Ops monitors and adjusts the temperature and humidity of the OBORs. She stated a report was faxed to the unit every morning for staff to review. RN 1 stated if something fell out of range (too high or too low) then someone from Plant Ops would notify them. She did not know if anything had been reported to OBOR within the past couple of months.
On July 23, 2012, at 9:50 a.m., the Director of Plant Ops (DPO) was interviewed. The DPO stated Plant Ops monitors the temperature and humidity of the ORs, OBORs, and CC (including IR). He stated they print a report every morning and fax it to each department for their review. The DPO stated that if anything was out of range then they would notify the unit involved, and update them when it was back within the acceptable range.
On July 23, 2012, the facility policy, dated January 2012, and titled, "OR Temperature, Humidity Monitoring," was reviewed. The policy indicated, temperature should be maintained in a range between 68 ?F to 73 ?F within the operating room suite. A Memo attached to the policy, dated February 2, 2012, indicated a request to lower the temperature range in the CC and IR to 66 ?F - 70 ?F.
On July 23, 2012, the temperature and humidity reports dated June 1 through July 23, 2012, were reviewed. The reports indicated the temperature was out of range as follows:
-- The main ORs ranged from 60 ?F to 64 ?F on 19 of 53 days reviewed;
-- The OBORs ranged from 60 ?F to 64 ?F on 30 of 53 days reviewed;
-- The CC, including IR, ranged from 61 ?F to 64 ?F on 10 of 53 days reviewed; and
-- The CC, including IR, ranged from 77 ?F to 94 ?F on 10 of 53 days reviewed.
On July 23, 2012, at 11:55 a.m., a follow-up interview with the DPO was conducted. The DPO stated he was aware of the low temperature ranges, and stated the temperature was adjusted per staff request. The DPO stated he was not sure what the action/response was to the high temperatures in the CC/IR areas. The DPO stated his department was working on some high humidity readings around the same time, but was not sure if the high temperature was specifically addressed. The DPO was unable to determine if the staff were notified of the high temperatures that had fallen out of range, and if any action and/or further monitoring was done.
Further review of the policy indicated, "Purpose: To provide a monitoring and feedback system for maintaining appropriate humidity and temperature for the Operating Rooms (OR) and Cardiac Catheterization Rooms as proper functioning of these components minimizes the risk of fire hazard and infection to the patient. Proper ventilation, humidity and temperature in the Operating Room are important for the comfort of the surgical personnel and patients but in also preventing environmental conditions that encourage growth and transmission of microorganisms... The ORs and Cardiac Catheterization Rooms will be adjusted to temperatures as requested by clinical staff keeping in mind the comfort of the surgical staff, normothermia recommendations for the patient..."
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2. On July 23, 2012, the record for Patient 7 was reviewed. Patient 7 was admitted to the facility on July 23, 2012, for a right thoracoscopy, wedge resection and possible lobectomy (internal examination, biopsy, and/or resection of disease or masses within the lung cavities).
Following surgery and recovery, Patient 7 was transferred to a post-surgical unit on July 23, 2012, at 2 p.m.
The "Physician Progress Note Surgical Post-Operative Assessment Note" did not include procedure, findings, surgeon, assistant, anesthesiologist, type of anesthesia, specimens, drains, estimated blood loss, complications or the physician's signature.
There was no immediate comprehensive post-operative note in the record.
During an interview with the Director Medical/Surgical (DMS), on July 23, 2012, at 2:50 p.m., she reviewed the record for Patient 7 and was unable to find documentation of an immediate comprehensive post-operative note. The DMS stated the immediate post-operative physician's note could be written on the physician progress notes, the "Physician Progress Note/Surgical Pre-Operative Assessment Note/Surgical Post-Operative Assessment Note" form, or a physician's dictation of the surgical procedure that was immediately available. The DMS stated the physician's dictation of the surgical procedure had not been done, and an immediate post-operative note should have been in the record prior to the patient leaving the Post Anesthesia Care Unit.
The facility Medical Staff Bylaws with a revised date of September 2011, revealed "... Operative Report - A comprehensive operative note shall be entered in the medical record immediately after surgery to provide pertinent information for use by an individual who is required to attend the patient. ..."
3. On July 23, 2012, the record for Patient 1 was reviewed. Patient 1 was admitted to the facility on July 14, 2012, and had surgery on July 20, 2012, for "partial amputation of right and left fourth finger."
The "Clinical Documentation-Periperative Documentation Pre Procedure Checklist" dated July 20, 2012, at 6:23 p.m., did not indicate "Site Marked by (physician's name) and Reconfirmed By Perioperative Staff" to include the name of the nurse who performed the verification.
During an interview with the Surgery Program Manager (SPM) on July 24, 2012, at 9:20 a.m., she reviewed the record and was unable to find documentation of the surgical site being marked by the physician with verification by the perioperative staff on the "Pre Procedure Checklist." The SPM stated this should have been done by the nurse circulating the surgical case prior to the patient entering the operating room.
During an interview with the Director Surgical Services (DSS) on July 24, 2012, at 1:15 p.m., she stated the "site marked" with verification should be documented on both the "Pre Procedure Checklist" and the surgical intraoperative record. The DSS stated the "Pre Procedure Checklist" should be completed by the pre-procedure nurse, the pre-operative holding nurse, the recovery room nurse when pre-operative holding was closed, and the surgery/circulating nurse.
The facility policy and procedure titled "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery" revised May 2012, revealed "... To establish a standard procedure for identifying the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures. ..."