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'S HOSPITAL MEDICAL CENTER 1726 SHAWANO AVE GREEN BAY, WI 54303 June 3, 2014
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, record review and interview, the facility failed to ensure there is a comprehensive infection control program to prevent the potential transmission infectious disease and cross contamination related to using immediate use rather than full sterilization of dental instruments, in 1 of 1 Pts (#1). This deficient practice directly affected Pt #1 and potentially affects all Pts receiving dental care at the facility and lead to an IJ at tag A749.

Findings include:

Review of records and interview revealed the facility had utilized Immediate Use sterilization for dental equipment due to insufficient time and/or lack of sufficient instrument sets, leading to the potential transmission of infectious disease to Pt #1 using an unsterile piece of equipment during a procedure. See A749.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, record review and interview, the facility failed to ensure there is a comprehensive infection control program to monitor and prevent infections and cross contamination and maintain product integrity, in 5 of 5 staff observed (E, F, G, H and W), in 1 of 10 MRs reviewed (1) and in 2 of 2 months of Immediate Use sterilization records reviewed (April and May). This deficiency directly affects Pt #1 and potentially an additional 118 Pts receiving dental surgery between April 2014 and June 2, 2014.

Findings include:

Per review on 6/3/14 at 9:45 AM of facility P&P titled Dress Code for Restricted and Semi-Restricted Areas, dated 4/1/14, states under #8 "Head and facial hair, including sideburns and neckline, are covered...#10 High filtration masks are worn in restricted area where open sterile supplies or scrubbed colleagues are present."

Examples of observations:
Per observation on 6/2/14 at 10:15 AM the following staff are not wearing masks with open sterile instruments on the table: DA E, Anes H, RN G and RN W. The following staff have on skull caps and do not have all hair covered: Anes H, Den F. This is confirmed during observation with Dir D on 6/2/14 at 10:15 AM.

Per observation on 6/2/14 at 10:30 AM, the blanket warmer has a note taped to the front alerting no tubing should be in the warmer, the warmer is set for 135 degrees. Upon opening the warmer, 15 Nasal Endotracheal Tubes are found on top of the blankets. The packaging on the tubes stated for storage "...away from heat..." This is confirmed at time of observation with Dir D on 6/2/14 at 10:30 AM, agreeing the tubes should not be in the warmer.

Examples of Immediate Use (Flashing instruments):

Per interview with C A on 6/2/14 at 1:05 PM, C A was informed by Den B on 5/28/14, after Pt #1 had dental surgery, an instrument that had been cleaned but not sterilized, was used during the procedure. C A stated Pt #1 had to be tested for infection and needs to be retested in six months.

Review of Pt #1's MR on 6/3/14 at 7:05 AM revealed there is a statement in the Post Operative note written by Den B on 5/28/14 C A was informed of the use of an unsterile piece of equipment.

Interview with ST I on 6/2/14 at 10:43 AM, revealed a drill handle was washed, but not sterilized and placed on a case cart next to supplies to be used for the fourth case, at 12:45 PM on 5/28/14, adding there was a different case cart with all sterile supplies for Pt #1's 11:00 AM case ready for use. ST I said when ST I returned to retrieve the handle to place in the Autoclave (Sterilizer) the cart with handle was gone. ST I questioned DA Q about the handle, ST I was told the clean cart with the unwrapped handle was taken for use in the 11:00 AM surgery.

Per interview with Dir D on 6/2/14 at approximately 11:30 AM, the facility has the following inventory of dental instruments: 6 drill handles (one is currently not functional) which are shared with all the dentists; 1 set for DG #1; 4 sets for DG #2; 3 sets for DG #3; 2 sets for DG #4; 3 sets for Den S; 1 set for Den T, and 1 set for Den U. Per Dir D, Den T and Den M rarely perform surgeries at the facility.

Facility records indicate on 5/28/14 Den B working under DG #1 had one set of instruments available to perform four surgeries scheduled at 7:30 AM, 8:45 AM, 11:00 and 12:45 PM. Den V, also scheduled for 5/28/14 procedures, working under DG #4, had two sets of instruments available for four surgeries scheduled at 8:45 AM, 10:00 AM, 11:15 AM and 1:30 PM. The Flash Sterilization Records for 5/28/14 indicate one set of instruments for Den B, was flashed three times, and two set of instruments for Den V, was flashed three times. The records do not indicate if the dental handle is included in with the instruments. This indicates the surgery schedule does not allow for the complete sterilization process and/or there are not enough instrument sets available to perform the scheduled procedures. This is confirmed during record review on 6/2/14 between 11:00 AM and 12:30 PM.

Per review on 6/2/14 between 11:00 AM and 12:30 PM, with Dir D, of facility sterilization records for 4/1/14 through 6/2/14, there is evidence the facility is routinely flashing instruments due to time constraints and/or lack of instrument sets. Per the OR log and Flash Sterilization Records there were 118 dental surgeries performed from 4/1/14 through 6/2/14 and 64 sets of instruments/handles flashed. This is not consistent with the AORN RP: Sterilization VII.a. "Immediate (flash) use steam sterilization should not be used as a substitute for sufficient instrument inventory."

Interview with DA Q on 6/3/14 at 7:35 AM, confirmed the handle used was not wrapped but was on the clean cart with clean "stuff". DA Q stated the instruments are usually in a "turkey roaster" (rigid perforated container for sterilizing), and are not wrapped. The practice of not wrapping the rigid container indicates the instruments are flashed and do not get processed through the full sterilization cycle.

Per interview with SPD Aide M on 6/2/14 at 12:05 PM, a regular load for sterilization requires hand washing instruments, approximately one hour through the washer cycle, drying, wrapping and one hour in the sterilizer resulting in a three hour turnaround time.

Interview with ST J on 6/2/14 at 11:55 AM a usual surgical day starts with wrapped instruments. After they are used, the instruments are taken to SPD for washing, picked up and autoclaved. ST J added "I take all (instruments) to SPD for washing, then pick up to autoclave...always."

Per interview with Dir D on 6/2/14 between 11:00 AM and 12:30 PM, Dir D stated the facility follows AORN SOPs and should not be flashing instruments unless it is an emergency.

Review of credential files on 6/2/14 at 2:25 PM, for Dentists B, F, U and V; and DAs E and R have no documented infection control training for the OR. DA Q's credential file included documentation that DA Q was an ST in 2001 at the facility, but has had no further infection control training. This is confirmed in interview with Mgr X on 6/2/14 at 2:25 PM, stating they get the training upon orientation.
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on record review and interview, the facility failed to ensure an updated H&P to clear the Pt for surgery is on file prior to the procedure, in 2 of 10 MRs reviewed (4 and 10). This deficiency directly affects 2 Pts and potentially affects all 43 Pt receiving surgical services during survey.

Findings include:

Per review on 6/3/14 at 10:00 AM of facility P&P titled Medical Record Regulations dated 5/14, it states under V.5.3.a.4) "The H&P interval note (H&P Update) must be documented... in the case of surgical patients, prior to surgery..."

Pt #4's MR review on 6/3/14 at 8:28 AM revealed Pt #4 had dental surgery on 4/29/14. There is no H&P Interval note, completed by an MD, on file for the procedure. This is confirmed in interview with Dir D on 6/3/14 at 8:28 AM, adding the H&P Interval should be filed prior to the procedure.

Pt #9's MR review on 6/3/14 at 9:10 AM revealed Pt #9 had dental surgery on 2/26/14. There is no H&P Interval note, completed by an MD, on file for the procedure. This is confirmed in interview with Dir D on 6/3/14 at 8:28 AM, adding the H&P Interval should be filed prior to the procedure.
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on record review and interview, the facility failed to ensure patients consent to surgery, including evidence risks and benefits, were discussed prior to their procedure in 3 of 10 MRs reviewed (2, 4 and 10). This deficiency directly affects 3 Pts and potentially affects all 43 Pt receiving surgical services during survey.

Findings include:

Per review on 6/3/14 at 10:00 AM of facility P&P titled Medical Record Regulations dated 5/14, it states under IV.4.1.a.2. "Surgical patients' medical records shall also include the following: a) Informed consent for the procedure performed."

Per interview with Dir D on 6/3/14 at 8:00 AM, the H&P Interval should include documentation of the risks and benefits of the procedure. The consent form signed by the Pt or representative states the risks and benefits were explained, but there is no area for the surgeon to sign attesting to providing risks and benefits.

Pt #2's MR review on 6/3/14 at 8:00 AM revealed the H&P interval, completed on 6/2/14 for a dental surgery performed on 6/2/14, does not include a statement by the surgeon the risks and benefits were discussed with the Pt and/or Pt's representative. This is confirmed in interview with Dir D on 6/3/14 at 8:00 AM.

Pt #4's MR review on 6/3/14 at 8:28 AM revealed the H&P interval, completed on 4/29/14 for a dental surgery performed on 4/29/14, does not include a statement by the surgeon the risks and benefits were discussed with the Pt and/or Pt's representative. This is confirmed in interview with Dir D on 6/3/14 at 8:28 AM.

Pt #10's MR review on 6/3/14 at 9:15 AM revealed the H&P interval, completed on 4/29/14 for a dental surgery performed on 4/29/14, does not include a statement by the surgeon the risks and benefits were discussed with the Pt and/or Pt's representative. This is confirmed in interview with Dir D on 6/3/14 at 9:15 AM.
VIOLATION: OUTPATIENT POST-ANESTHESIA EVALUATION Tag No: A1005
Based on record review and interview, the facility failed to ensure PANs are complete per policy, in 7 of 10 MRs reviewed (1, 2, 3, 4, 5, 6 and 10). This deficiency affects all 7 Pts with MRs reviewed and potentially affects all 43 Pts receiving surgical services during survey.

Findings include:

Per review on 6/3/14 at 10:00 AM of facility P&P titled Medical Record Regulations dated 5/14, it states under V.5.5.b.3.b) "The post-anesthesia evaluation includes documentation of respiratory function, cardiovascular function, temperature, pain, nausea, post-operative hydration and mental status."

Pt #1's MR review on 6/3/14 at 7:05 AM revealed Pt #1 had dental surgery on 5/28/14 under General Anesthesia. The PAN does not include a BP, T, if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 7:05 AM, agreeing the information should be included.

Pt #2's MR review on 6/3/14 at 8:00 AM revealed Pt #2 had dental surgery on 6/3/14 under General Anesthesia. The PAN does not include BP, R, if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 8:00 AM, agreeing the information should be included.

Pt #3's MR review on 6/3/14 at 8:15 AM revealed Pt #3 had dental surgery on 5/28/14 under General Anesthesia. The PAN does not include documentation if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 8:15 AM, agreeing the information should be included.

Pt #4's MR review on 6/3/14 at 8:28 AM revealed Pt #4 had dental surgery on 4/29/14 under General Anesthesia. The PAN does not include a BP, T, if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 8:28 AM, agreeing the information should be included.

Pt #5's MR review on 6/3/14 at 8:40 AM revealed Pt #5 had dental surgery on 3/25/14 under General Anesthesia. The PAN does not include a BP, T, if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 8:40 AM, agreeing the information should be included.

Pt #6's MR review on 6/3/14 at 8:50 AM revealed Pt #6 had dental surgery on 3/25/14 under General Anesthesia. The PAN does not include documentation if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 8:50 AM, agreeing the information should be included.

Pt #10's MR review on 6/3/14 at 9:15 AM revealed Pt #10 had dental surgery on 4/29/14 under General Anesthesia. The PAN does not include documentation if there is N/V and states under pain "adequate analgesia". This does not constitute a complete PAN. This is confirmed in interview with Dir D on 6/3/14 at 9:15 AM, agreeing the information should be included.