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.

ILLINOIS VALLEY COMMUNITY HOSPITAL 925 WEST ST PERU, IL 61354 Aug. 4, 2015
VIOLATION: QAPI Tag No: A0263
Based on document review and interview, it was determined the Hospital failed to ensure identified high risk areas (the use of Immediate Use Sterilization (IUS) related to the lack of an adequate number of surgical instruments) which have the potential to adversely affect patient outcomes was incorporated into its Hospital Wide Quality Assessment Performance Improvement (QAPI) for correction and ongoing monitoring to assure maintenance of correction. The cumulative affect of this systemic action demonstrated the ineffectiveness of the Hospital wide QAPI program in identification of areas requiring immediate corrective action to prevent potential adverse patient outcomes. This has the potential to affect all patients serviced by the Surgery Department, which currently services an average of 302 patients per month.

Findings include:

1. The Hospital failed to ensure identified need for procurement of additional surgical instruments to decrease the utilization of IUS was incorporated into the Hospital Wide QAPI for corrective action and ongoing monitoring. See A-283.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, document review, and interview, it was determined the Hospital failed to ensure its Infection Control program effectively monitored, tracked, and acted upon to ensure the provision of surgical services were performed in a safe environment with an adequate number of surgical instruments subjected to appropriate sterilization in machines which were accurately tested and monitored for safe and sanitary working conditions by trained staff with demonstrated competency to perform sterilization procedures to prevent the potential for cross contamination and post-operative infections. The Hospital further failed to to demonstrate an effective process for monitoring post-operative infections and ensure accurate statistical data for evaluation of the potential for surgical site infections. This has the potential to affect all patients serviced by the Surgery Department which currently services an average of 302 patients per month.

Findings include:

1. The Hospital failed to ensure Immediate Use Sterilization (formerly called Flash sterilization) of surgical instruments was not utilized as a primary form of sterilization in the Surgery Department for convenience and/or due to the lack of an adequate number of surgical equipment. See A-749A.

2. The Hospital failed to ensure compliance with steam sterilization monitoring (biological indications, chemical indicators, and Boxie Dick testing) was performed and documented, in their entirety (dates, times in, times out, initials, results, etcetera). See A-749B.

3. The Hospital failed to ensure compliance with scope sterilization monitoring (chemical preparation, testing for appropriate concentration, and replacement according to manufacturer guidelines) was performed and documented, in their entirety (dates, times, initials, results, etcetera). See A-749C.

4. The Hospital failed to establish and implement a process to monitor the use of Immediate Use Sterilization (IUS/Flash) and scope sterilization and for tracking potential surgical site infections. See A-749D.

5. The Hospital failed to ensure its Infection Control program was able to demonstrate an effective process for accurate surveillance/reporting, measuring, tracking, monitoring of post-operative surgical site infections (SSIs); and that this process was enforced to ensure accurate statistical date was available for evaluation of the potential for SSIs. See A-749E.

6. The Hospital failed to ensure outdated drugs and biologicals were not available for patient use. See A-749F.

7. The Hospital failed to ensure employees who performed steam sterilization and/or scope sterilization, along with the respective biological and/or chemical monitoring requirements for each, had documented initial and ongoing training and demonstrated competency in performing and documenting these functions. See A-749G.

8. The Hospital failed to ensure Administrative staff implemented corrective action to address the identified use of Immediate Use Sterilization (IUS/Flash) as a primary form of sterilization in the Surgery Department related to the lack of an adequate amount of equipment as part of the Hospital's Quality Assessment and Performance Improvement (QAPI) program. See A-756.

An Immediate Jeopardy (IJ) and serious threat to patient safety was created from the cumulative effect of these practices.

An IJ was identified and announced during a meeting on 8/4/15 at approximately 11:35 AM. Present at the meeting were the Chief Executive Officer (E#9), the Vice President of Physician Services (E#10), the Director of Emergency/Intensive Care (E#11), the Director of Materials Management (E#12), the Assistant Vice President of Revenue Cycle (E#8), the Infection Control Coordinator (E#5), and the Director of Surgical Services (E#1) due to the Hospital's failure to ensure Immediate Use Sterilization (formerly called Flash sterilization) of surgical instruments was not utilized as a primary form of sterilization in the Surgery Department for convenience and/or due to the lack of an adequate number of surgical equipment.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on observation, document review and interview, it was determined the Hospital failed to ensure Immediate Use Sterilization (formerly called Flash sterilization) of surgical instruments was not utilized as a primary form of sterilization in the Surgery Department for convenience and/or due to the lack of an adequate number of surgical equipment. This has the potential to affect all patients serviced by the Surgical Services department, which currently performs an average of 302 surgeries per month.

Findings include:

1. An observational tour of the Surgical Department was conducted on 7/28/15 between approximately 11:15 AM and 1:30 PM with the Director of Surgical Services (E#1). There are seven (7) operating rooms (OR) with three (3) "Substerilizing" rooms (one located between OR #1 and #2; one located between OR#3 and #4; and one located between OR#6 and #7) which E#1 stated were used for Flash sterilization and scope reprocessing.

2. The Immediate Use Sterilization (IUS/Flash) logs for the following Substerilizing areas, located in the Surgical Suite were reviewed on 7/28/15 at approximately 1:50 PM with the Director of Surgical Services (E#5) and the following entries were noted:

a. The log for Substerilizing between OR#1 and OR #2, dated 6/1/15 thru 7/23/15 (mainly orthopedic equipment), stated there were approximately nine (9) IUSs/Flashes performed for the following equipment: Approximately three (3) for a positioning tray (used to position the area for orthopedic surgery- Surgery Department has one positioning tray). Approximately two (2) for hip instruments (E#1 stated this is usually a retractor that is used by a certain surgeon). Approximately two (2) for Accuflex Condertone (used for shoulder and knee scopes- Surgery Department has two (2) sets). Approximately two (2) were for eye instruments (Shitts scissor and Senns eye retractor).

b. The log for Substerilizing between OR#3 and OR #4, dated 6/1/15 thru 7/23/15 (mainly general surgery equipment), stated there were approximately twenty-six IUSs/Flashes performed for the following equipment: Approximately four (4) for Laporoscope for Assisted Vaginal Hysterectomy (LAVH) (Surgery Department has two (2) sets and E#1 stated " So if we have 8 cases scheduled, we have to Flash them.";
Approximately two (2) for Septoplasty trays (used for surgery on the nasal septum) of which the Surgery Department has one (1) set; Approximately three (3) for various surgery equipment (a few examples: Myrongotomy tray, Port Closure, Endoscopic Carpal Tunnel Release tray, Kleppingers (used for tubal ligations), and Vascular and Rakes (they have 2 sets of these available for use). E#1 stated "We just don't have enough equipment so we have to Flash it."

c. The log for Substerilizing between OR#6 and OR #7, dated 6/2/15 thru 7/21/15 (mainly eye surgery equipment) stated there were approximately sixty-seven (67) IUSs (40 for I&A- Surgery Department has five (5) eye trays for this type of surgery which is cataract surgery and Loaders used for cataract surgery; 25 for eye instrument trays; 1 for ear tray and 1 for cystoscope).

2. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. When asked if E#5 was aware of the use of IUS/Flash being utilized in the Surgery Department due to the lack of adequate number of surgical equipment, E#5 stated knowledge of the use "but I didn't realize how much (it was being used)." When asked if Administration was aware of the utilization of IUS and the need for more surgical equipment, E#5 stated "It's been brought up and I believe it is a financial issue. I'm not sure."

3. A follow up interview was conducted with E#1 on 7/29/15 at approximately 10:45 AM related to the number of IUS/Flashes being performed. E#1 re-stated "We only do Flash up here (in the Surgery Department). They don't do it downstairs (in Central Sterilizing)." When asked to review the reasoning for doing IUS/Flash sterilization, E#1 re-stated "As I stated yesterday, we just don't have enough equipment.

4. The Infection Control (IC) Meeting minutes, dated August 2014 thru May of 2015, were reviewed on 7/29/15 at approximately 9:30 AM with the Infection Control Coordinator (E#5). The IC Committee meets quarterly and The Chief Nursing Officer was present at all but the last meeting on May 12, 2015. On August 12, 2014, the IC meeting minutes stated under "Item ... Financial... Findings/Discussions ... Immediate Use Sterilization (IUS or Flash) ... (E#1) gave update on "flash pans" that are currently being utilized... Actions/Recommendations ... Additional instrumentation in the budget to avoid minimal IUS." Subsequent Meeting minutes lacked documentation as to any follow up on the need for additional equipment.

B. Based on document review and interview, it was determined the Hospital failed to ensure compliance with steam sterilization monitoring (biological indications, chemical indicators, and Boxie Dick testing) was performed and documented, in their entirety (dates, times in, times out, initials, results, etcetera). This has the potential to affect all patients serviced by the Surgical Services department, which currently performs an average of 302 surgeries per month.

Findings include:

1. The Hospital policy titled "Sterilization" (states revised 7/15; however E#1 stated it should say reviewed 7/15) was reviewed on 7/28/15 at approximately 1:50 PM. The policy stated "Method of Sterilization: 1. Steam: b. Instruments to be flashed are placed unwrapped in tray with a biological indicator... c... A biological indicator with live spores is done on a daily basis. Following sterilization using spore testing, the vial from autoclave is placed in an incubator for 1 hour with the control vial. Positive biological indicator results indicate the sterilizer has malfunctioned..." The policy further stated under "6. Biological Monitoring: a. A chemical indicator is placed in each instrument set or item to be sterilized. b. Any item that is flashed... has an indicator placed inside the instrument tray and on top of tray..."

2. The steam sterilization logs, dated approximately 6/1/15 thru approximately 7/28/15, for three of three Substerilization rooms were reviewed on 7/28/15 at approximately 1:00 PM. The Hospital Surgery Department has three (3) Substerilization Rooms: "A" is located between Operating Room (OR) #1 and #2; "B" is located between OR#3 and #4; and "C" is located between OR#6 and #7. Each Substerilization Room has a steam sterilizer utilized for Immediate Use Sterilization (IUS/Flash) sterilization only. The logs stated the Surgery Department performed IUS on approximately forty (40) days during this time period. The following were noted:

a. Biological Indicator Control testing: Each IUS steam sterilizer would require a biological indicator to be performed at a minimum of daily, unless a new lot number is opened for use, then a new biological indicator control would be required. The "Rapid Biological Indicator" (used for documentation of the biological indicator control test) logs lacked the following documentation:
(1) One out of forty days of biological indicator control testing on each steam sterilizer.
(2) 120 out of 120 (forty days on three steam sterilizers) tests: the "Load Contents" (the biological indicator control and lot number), the "one hour rapid read and 24 hour visual readout", the incubation "Time in/Date/Initials", the incubation "Time out/Date/Initials", and the "24 hour visual check" of the test result and control result.
(3) An interview was conducted with a Unit Clerk/Aide who also performs steam sterilization (E#14) on 7/28/15 at approximately 1:30 PM with the Director of Surgical Services (E#1) present. When asked to describe the process for performing and documenting the biological indicator controls, E#14 stated "I didn't know I had to do that (document the biological indicator control number, time/date/initials in, time/date/initials/out, and one hour rapid read)." E#14 stated "We just do it in the morning, look at it at 1 hour and record it around 24 hours. The control goes into the incubator and always turns out positive."

b. The Substerilizing Immediate Use Sterilization (IUS/Flash) load sterilization logs from approximately 6/1/15 thru approximately 7/23/15 were reviewed on 7/28/15 at approximately 1:00 PM with E#1. The IUS steam sterilization lacked the following documentation:
(1) The logs lacked documentation of four to five or more of the following required elements in 126 out of 126 loads: the time in, time out, who performed the IUS, temperature, why the instrument(s) required IUS/Flash, and which patient the item(s) were used on.
(2) Three out of 136 loads lacked a Steam Chemical Indicator.
(3) An interview was conducted with a Unit Clerk/Aide who also performs steam sterilization (E#14) on 7/28/15 at approximately 1:30 PM with the Director of Surgical Services (E#1) present. When asked why a surgeon's name is written under the "Patient name" column, E#14 stated "We use to put the patient's name there, but for some reason we stopped doing it and were told to put the surgeon's name there."

c. An interview was conducted with E#1 concurrently with sterilization log reviews. When asked if the Surgery Department performs a Bowie Dick test on the steam sterilizers, E#1 stated "We don't have to."

d. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. When asked if E#5 reviewed the biological indicator control logs, the IUS sterilization load logs and monitored the completion of these logs, E#5 stated "No, that would be ... (E#1)'s responsibility. I didn't realize they were not being done."

e. An interview was conducted with E#1 on 7/29/15 at approximately 1:30 PM. E#1 had reviewed the steam IUS logs with the surveyor and verbally agreed the biological indicator logs lacked documentation of the biological indicator control test with lot number, date/time/initials in, date/time/initials out, one hour and 24 hour reads and visual reads. E#1 further verbally agreed the IUS sterilization load logs lacked documentation of the time in, time out, who performed the IUS, temperature, why the instrument(s) required IUS and what patient the instrument(s) was used for.

f. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The interview, review of biological indicator control logs, and review of the IUS sterilization load logs were discussed. E#7 verbally stated E#6 had conveyed the findings to E#7.

C. Based on document review and interview, it was determined the Hospital failed to ensure scope sterilization monitoring (chemical preparation, testing for appropriate concentration, and replacement) was performed and documented, in their entirety (dates, times, initials, results, etcetera). This has the potential to affect all patients serviced by the Surgical Services department, which currently performs an average of 302 surgeries per month.

Findings include:

1. There was no policy or manufacturer guidelines for documentation of chemical monitoring and/or scope sterilization available for review during the survey 7/28/15 thru 8/4/15.

2. An interview was conducted on 7/28/15 at approximately 1:00 PM with the Director of Surgical Services (E#1). E#1 stated the following:

a. There were three (3) automated Steris scope sterilization machines utilized in the Surgery Department. When asked for the scope sterilization logs (for time, temperature, disinfection chemical check, scope identification, leak test, etcetera), E#1 stated "We don't keep any." When asked how they document the scope sterilization, E#1 stated there was a strip (like a cash register strip) on the machine. The strips shown to the surveyor were blank where the strips stated "Operator ID (identification), Load ID, Remarks". The strips further lacked documentation, such as, whether the scopes passed the air leak testing or passed the high level disinfection chemical concentration.

b. When asked if any manual chemical sterilization of scopes was performed, such as with Cidex, E#1 stated "No, we use to but we haven't in a long time."

3. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. When asked if E#5 was aware the Surgery Department was not keeping logs of the scope sterilization process, E#5 stated "No."

4. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The interview, review of scope sterilization strips, and lack of a scope sterilization log were discussed. E#7 verbally stated E#6 had conveyed the findings to E#7.

5. A follow up interview was conducted on 8/4/15 at approximately 11:55 AM with E#1, in which E#1 stated the Surgery Department did utilize Cidex for manual sterilization of scopes during a timeframe when all three automated scope sterilizers were out of working order. When asked where the logs for chemical preparation, testing for appropriate concentration, loads sterilized in this manner, time and temperature, etcetera, E#1 stated "We didn't keep any (logs)."

D. Based on document review and interview, it was determined the Hospital failed to establish and implement a process to monitor the use of Immediate Use Sterilization (IUS/Flash) and scope sterilization and for tracking potential surgical site infections. This has the potential to affect all patients serviced by the Surgical Services department, which currently performs an average of 302 surgeries per month.

Findings include:

1. An interview was conducted with the Director of Surgical Services on 7/28/15 at approximately 12:30 PM. When asked to demonstrate how the Surgery Department would be able to track which IUS item(s) were used on which patient in investigating potential surgical site infections, E#1 stated they (the Hospital) would not be able to tell which item(s) were used on which patient.

2. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. E#5 reviewed the IUS sterilization load logs and the lack of scope sterilization logs. When asked if E#5 was aware the Surgery Department was not keeping logs as to what IUS sterilized instrument(s) and/or what scopes are being utilized for which patient(s), E#5 stated "No, I didn't realize that." When asked how E#5 would be able to investigate a report of a potential surgical site infection utilizing these logs, E#5 stated "I wouldn't be able to tell (what instrument/scope was used on which patient)."

3. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The interview, review of IUS sterilization load logs, and the lack of scope sterilization logs was discussed. E#7 verbally stated E#6 had conveyed the findings to E#7.

E. Based on document review and interview, it was determined the Hospital failed to ensure its' Infection Control program was able to demonstrate an effective process for surveillance/reporting, measuring, tracking, monitoring of post-operative surgical site infections (SSIs) and that this process was enforced to ensure accurate statistical data was available for evaluation of the potential for SSIs. This has the potential to affect all patients serviced by the Surgical Services department, which currently performs an average of 302 surgeries per month.

Findings include:

1. The policy titled "Infection Control" (revised 1/15) was reviewed on 7/30/15 at approximately 11:45 AM. The policy stated "A. 1. Conducts surveillance activities... 7. Prepares a quarterly report of statistical data... "

2. The Infection Control Meeting minutes, dated August 2014 thru May of 2015, were reviewed on 7/29/15 at approximately 9:30 AM with the Infection Control Coordinator (E#5). The minutes lacked any discussion of SSI data collection and analysis as to the follow up with surgeons post-operatively for 30 days for surgical intervention and 90 days for implants.

3. An interview was conducted with E#5 on 7/29/15 at approximately 9:15 AM. When asked to describe the process for accurate surveillance/reporting, measuring, tracking and monitoring of post-operative SSIs, E#5 stated the following:
a. When asked if E#5 was aware of Pt #1's post-op infection, E#5 stated "Not until they (the Director of Surgical Services (E#1) and the Patient Representative (E#6)} told me this morning." E#5 further stated Pt #1's surgeon (MD#1) had not returned the SSI surveillance form for June 2015, as of this date and either the surgeon's office should have contacted E#5 or the surveillance form should have been returned by now.
b. For inpatients: E#5 stated there is a form titled "Infection Control Unit Record" which nurses on the floors and E#5 utilize to collect information on patients admitted with, or who acquire an infection while in the hospital. If the infection is a hospital acquired infection, a second form titled "Patient Infection Record" is completed. These forms are investigated and tracked and compiled on the form titled "Infection Control Committee- Infection Report". The form "is mainly used for inpatients".
c. For Day Surgery and discharged patients: E#5 stated a form letter and a blank "Post-Discharge Surveillance Form" is sent to the surgeons along with a list of the surgeries they performed that month. When asked what the return rate was, E#5 stated approximately 80% all together. When asked if the return rate is evaluated/tracked by provider to assure accurate statistical data, E#5 stated " No, it includes all of them. " When asked to demonstrate the process for sending out the surveillance letters, evaluating the return of the surveillance forms with subsequent follow up if a surgeon does not return the forms, and how these are tracked, monitored, and action taken if necessary, E#5 stated "We trust the offices (surgeon offices) to let us know if an infection occurs." E#5 further stated "I don't keep any of the forms. I put everything together and report it to the committees (Environmental, Quality, Medical Staff, etc.) on a quarterly basis and then I destroy them. I didn't realize I should keep them." When asked if the Infection Control Committee designated physician is notified and involved in assuring the return of the surveillance tracking forms for the surgeons who do not return them, E#5 stated "No, but .... could be."

4. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The interview, review of Infection Control Meeting minutes, and review of the SSI surveillance with E#5 were discussed. E#7 verbally stated E#6 had conveyed the findings to E#7.

F. Based on observation, document review and interview, it was determined 1 of 2 (the Surgical Department) areas toured, in which surgical procedures were performed, the Hospital failed to ensure outdated drugs and biologicals were not available for patient use. This has the potential to affect all patients serviced by the Surgery Department, which currently services an average of 302 patients per month.

Findings include:

1. The following Hospital policies were reviewed:
a. The policy titled "Meaning of Outdates" (last revised 4/13) was reviewed on 7/29/15 at approximately 1:30 PM. The policy stated under "Process: A. Orals/Injections/Topical/Manufacturer Made Products: 1: Multiple dose vials of medication containing a bacteriostatic agent will be considered outdated according to the manufacturers expiration date which is printed on the vial or as recommended by the manufacturer." and gave an example of insulin vials being disposed of 28 days after opening per manufacturers' recommendation.
b. The policy titled "Checking for Outdated Medications" (last revised 4/15) was reviewed on 7/29/15 at approximately 1:30 PM. The policy stated under "Nursing/Ancillary Departments: 1. Ancillary Departments: a. Anesthesia... 2. These departments have the responsibility for checking outdates within their area(s)..."
c. There was no Hospital policy which addressed outdated biologicals.

2. An observational tour of the Surgery Department was conducted on 7/28/15 at approximately 11:15 AM with the Director of Surgery Services (E#1). The following outdated items were observed available for patient use:
a. In the pre-op refrigerator, two open bottles of Tetracaine hydrochloride Ophthalmic solution 5%, dated as opened 6/23/15. The bottles were not labeled as multi-dose. When asked how these are administered, E#1 stated "We take them to the patient and put them in."When asked where this occurs, E#1 stated "We do it in their chair when we bring them back here (the pre-operative) area or, if we are really busy, we'll go to the lobby area and put them in there and then we bring the bottle back and put it back in the refrigerator." When asked if these are approved to be used as multidose medications, E#1 stated she agreed the bottles were not labeled as either single or multidose.
b. In the Tracheostomy Cart in the Surgery Area: four Shileys (sizes 4, 4.5, 5, and 5.5) all expired 5/12 and six pediatric Shileys (sizes 3, 3.5, 5, 4, and 5.5) all expired 5/12.
c. In OR #3: (1) In the Anesthesia Pediatric Cart: eight 24 gauge inch Jelcos (intravenous catheters - seven expired 3/14 and one expired 5/13; five 16 gauge 2 inch Jelcos - two expired 9/08 and three expired 5/13; four 18 gauge 1 inch Jelcos all expired 1/15. (2) In the second drawer of the Anesthesia cart, there was an open Yankauer with bulb tip connected to the suction line observed. (3) In the Anesthesia Emergency Airway Cart: one Cetacaine Spray Topical expired 12/13 and one Soft PVC Nasopharyngeal Airway expired 3/13.
d. In the Scrub Sink between Operating (OR)#3 and OR#4: twenty BD E-Z Scrub (10 expired 2/15, one expired 11/14, and nine expired 9/14).
e. In OR #1: (1) In the Eye Medication Cart- three BD Vistec (one expired 11/12, one expired 3/13, and one expired 3/14). (2) In the unlocked Anesthesia Eye Medication Cart- one one ml vial of Glycopyrrolate 0.2 mg/ml expired 12/13 and one Discofix 4 way Stopcock expired 5/12. (3) In the Eye Suture Cart- one box (3 dozen) 5-0 Prolene suture expired 1/15, box 4-0 PDS II expired 1/15, 2/3 box 5.0 Mersilene expired 7/14, and (4) In the Eye Medication Box (open portable sectioned container ): one 5 ml vial of Ketorolac Tromethamine Ophthalmic Solution 0.5% opened 3/8, one 3 ml Vigamox ophthalmic solution 0.5%, opened 2/12, and one 3.5 gm TobraDex ophthalmic ointment with no date as to when opened.
f. In OR#5 (Eye Room): (1) In the Dr medication box- one open Tetracaine Hydrochloride ophthalmic solution 0.5%, one open Viagmox 0.5% ophthalmic solution, one open 3.5 gm TobraDex ophthalmic ointment, two open 5 ml Aproaclonidine 0.5% ophthalmic solution, one open 5 ml Phenylephrine Hydrochloride 10% ophthalmic solution, and one open 2.5 ml Ciprofloxacin Hydrochloride 0.3% ophthalmic solution all lacked the date as to when they were opened. (2) In the Anesthesia Cart: one open endotracheal tube with stylet in it in the second drawer and several outdated Jelcos- examples: one 14 gauge 2 inch Jelco expired 2/09, one 18 gauge 1 inch Jelco expired 6/07, four 16 gauge 1 inch Jelcos (1 expired 6/05, 2 expired 9/08, and 1 expired 5/13) . (3) In Eye Cart: three 25 gauge Anterior Chamber Cannulas (1 expired 3/10 and 2 expired 10/10).

3. An interview was conducted with the E#1 throughout the tour, E#1 stated outdated drugs and biologicals were not to be available for patient use. E#1 stated all multi-dose vials are to be dated with the date they were opened and initials of the person opening them. E#1 stated "We've always used the eye drop and eye ointment medications for more than one patient." E#1 further stated "We could do better by not taking the eye drops to the lobby to administer them."

4. An interview was conducted with Anesthesia MD#1 on 7/28/15 at approximately 1:20 PM. E#1 was present. When asked who is responsible for checking the Anesthesia carts for outdated supplies, Anesthesia MD#1 stated "Everyone and no one. Anesthesia is responsible for checking all the Anesthesia carts" but does not know how this is done. Anesthesia MD#1 stated each Anesthesia provider can use any of the carts as they are not assigned as they "go from room to room to room."

5. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. E#5 was informed of the findings of the observational tour and stated the following: All open vials were to be dated and initialed when opened and are to be discarded after 28 days; Anesthesia was responsible for checking for outdated biologicals related to Anesthesia services; and each department is responsible for checking for outdated drugs and/or biologicals in their respective departments. E#5 was unaware that there was no Hospital policy on outdated biologicals and stated "I'm sure we have one. They may be looking under the wrong area."

6. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The observations, interviews, and policy reviews, and lack of a policy addressing outdated biologicals were discussed. E#7 verbally stated E#6 had conveyed the findings to E#7. E#7 presented a new unapproved policy titled "Use of Multi-Dose Ophthalmic Medications" which has not been presented or approved as of this date. The unapproved policy addressed the use of Multi-dose ophthalmic medications; however, the ophthalmic solutions and ointment observed in the pre-operative surgical area and in the Operating Rooms were not labeled as multi-dose vials or for use on more than one patient once opened.

G. Based on document review and interview, it was determined the Hospital failed to ensure employees who performed steam sterilization and/or scope sterilization, along with the respective biological and/or chemical monitoring requirements for each, had documented initial and ongoing training and demonstrated competency to assure competence in performing and documenting these functions. This has the potential to affect all patients serviced the the Surgery Department, which currently services an average of 302 patients per month.

Findings include:

1. An interview was conducted with the Director of Surgical Services on 7/28/15 at approximately 11:45 AM, during a tour of the Surgical Department. When asked who performs sterilization of instruments/scopes, E#1 stated the surgery technicians "do it most of the time. The nurses can occasionally if needed." When asked how they are trained and demonstrate competency for this, E#1 stated they receive training and competency upon hire and "we don't do anything else unless we change equipment or something like that." E#1 stated "I pick an infection control topic annually for review, but I don't retrain or watch them (the persons performing steam and scope sterilization and biological/chemical testing) every year."

2. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. E#5 was informed of the lack of documentation of ongoing training and demonstrated competency related to both steam and scope sterilization processes and respective biological and chemical indicators and documentation of such. E#5 was not aware this training and demonstrated competency was not ongoing.

3. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. The interviews related to personnel initial and ongoing training and demonstrated competency in performing steam and/or scope sterilization and respective biological and/or chemical monitoring was discussed. E#7 verbally stated E#6 had conveyed the findings to E#7.

4. On 8/4/15 at approximately 10:30 AM, a request was made to E#1 as to documentation of the initial training and demonstrated competency of the personnel performing steam and/or scope sterilization. As of 8/4/15 at 2:00 PM, none had been provided.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on document review and interview, it was determined the Hospital failed to ensure identified need for procurement of additional surgical instruments to decrease the utilization of Immediate Use Sterilization (IUS) was incorporated into the Hospital Wide Quality Assessment and Performance Improvement (QAPI) for corrective action and ongoing monitoring. This has the potential to affect all patients serviced by the Surgery Department, which currently services an average of 302 patients per month.

1. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. When asked if E#5 was aware of the use of IUS/Flash being utilized in the Surgery Department due to the lack of adequate number of surgical equipment, E#5 stated knowledge of the use "but I didn't realize how much (it was being used)."

2. An interview was conducted with the Chief Nursing Officer (E#7) on 7/29/15 at approximately 2:30 PM, with the Patient Representative (E#6) present. E#7 verbally stated that E7 was aware of the findings and had no further comment related to the lack of a process for monitoring the use of IUS to prevent the use of IUS for convenience and/or lack of an adequate amount of equipment.

3. The "Performance Improvement & Patient Safety" plan for fiscal year 2015 was reviewed on 7/30/15 at approximately 10:00 AM with the Assistant Vice President Revenue Cycle (E#8), also acting as oversight for the Quality Program). The plan stated the vision of the Hospital is to provide a safe environment for patients. The plan further stated the scope of the plan encompassed all services with particular emphasis on high risk areas that could affect a large percentage of the patients and place patients at risk if performed when not indicated or have been, or are likely to be, problematic. The plan further stated an objective of the program was to put in place interventions for prevention of hospital acquired conditions.

4. The Infection Control meeting minutes, dated August 12, 2014 to present; the Surgery Division meeting minutes, dated October 23, 2014 thru April 1, 2015; the Quality and Patient Safety Committee minutes, dated September 23, 2014 thru July 28, 2015; the Environment of Care Committee Minutes, dated August 26, 2014 thru June 15, 2015; the General Medical Staff Committee Meeting minutes, dated September 18, 2014 thru June 18, 2015; the Medical Executive Committee Meeting minutes, dated August 14, 2014 thru July 9, 2015; and the Board of Directors Meeting minutes, dated August 14, 2014 thru June 2, 2015 were reviewed on 7/30/15 thru 7/31/15. There was no documentation that the need for an increased number of surgical instruments due to the use of IUS was reported at the Infection Control meeting August 12, 2014 was communicated up the organizational chain with implementation of corrective action.

5. An interview was conducted with E#8 on 7/31/15 at approximately 1:30 PM. E#8 verbally agreed all the minutes lacked documentation of the need for increased surgical instruments to decrease the use of IUS. When asked the reason for this, there was no answer.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, document review, and interview, it was determined the Hospital failed to ensure the Surgical Services Department put processes in place to provide safe and effective care. The cumulative effect of these systemic practices demonstrates the Hospital's inability to assure the provision of a safe care throughout the surgical continuum of care. This has the potential to affect all patients serviced by the Surgical Department, which currently services an average of 302 patients per month.

Findings include:


1. The Hospital failed to ensure a process was established and implemented for the use and monitoring of Immediate Use Sterilization (IUS- formerly called Flash sterilization). See A-951A.

2. The Hospital failed to establish and implement a fire risk assessment policy/procedure. See A-951B.

3. The Hospital failed to ensure an assessment of Advanced Directive status and failed to address whether Advanced Directives would be followed or suspended during surgical intervention. See A-951C.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


A. Based on observation, document review and interview, it was determined the Hospital failed to ensure a process was established and implemented for the use and monitoring of Immediate Use Sterilization (IUS- formerly called Flash sterilization). This has the potential to affect all patients serviced by the Surgery Department, which currently services an average of 302 patients per month.

Findings include:

1. An observational tour of the Surgical Department was conducted on 7/28/15 between approximately 11:15 AM and 1:30 PM with the Director of Surgical Services (E#1). There were three (3) "Substerilizing" rooms which E#1 stated were used for Flash sterilization and scope reprocessing. When asked if any other form of steam sterilization was performed in the Surgery Department, E#1 stated "No."

2. The Immediate Use Sterilization (IUS/Flash) logs for the three (3) Substerilizing areas were reviewed on 7/28/15 at approximately 1:50 PM with the Director of Surgical Services (E#5). The logs stated approximately 102 IUSs were performed. The following are examples:
Three (3) for a positioning tray (Surgery Department has one positioning tray); two (2) for hip instruments (E#1 stated this is usually a retractor that is used by a certain surgeon); two (2) for Accuflex Condertone (Surgery Department has two (2) sets); four (4) for Laporoscope for Assisted Vaginal Hysterectomy (LAVH) (Surgery Department has two (2) sets); two (2) for Septoplasty trays (Surgery Department has one (1) set); three (3) for various surgery equipment (a few examples: Myrongotomy tray, Port Closure, Endoscopic Carpal Tunnel Release tray, Kleppingers (used for tubal ligations), and Vascular and Rakes (they have 2 sets); forty (40) for I&A- (Surgery Department has five (5) eye trays); and twenty (20) for eye instrument trays.

3. An interview was conducted with the Infection Control Coordinator (E#5) on 7/29/15 at approximately 9:15 AM. When asked if E#5 was aware of the use of IUS/Flash being utilized in the Surgery Department due to the lack of adequate number of surgical equipment, E#5 stated knowledge of the use "but I didn't realize how much (it was being used)."

4. The Infection Control (IC) Meeting minutes, dated August 2014 thru May of 2015, were reviewed on 7/29/15 at approximately 9:30 AM with the Infection Control Coordinator (E#5). On August 12, 2014, the IC meeting minutes stated E#1 had given an update on the use of "flash pans" that were being utilized. The minutes further stated "Actions/Recommendations ... Additional instrumentation in the budget to avoid minimal IUS." There was no documentation as to any follow up on this topic.

5. A follow up interview was conducted with E#1 on 7/29/15 at approximately 10:45 AM. When asked to the reasoning for doing IUS/Flash sterilization, E#1 stated "As I stated yesterday, we just don't have enough equipment. If a surgeon has more surgeries scheduled than we have whatever is needed (surgery equipment or a particular type of equipment which a surgeon prefers to use), then we have to Flash it. They (the surgeons) are not going to wait for it (the item needed for the surgery), so again, we have to Flash it."

6. The Surgery schedule and concurrent steam sterilization logs were reviewed on 7/30/15 at approximately 2:00 PM with the Director of Surgery Services (E#1). The following noted :

a. On 7/13/15 at approximately 5:01 AM and 6:44 AM, IUS was performed. The surgery schedule for that day stated no surgeries were scheduled until 7:00 AM. When asked why this would occur, E#1 had no comment.

b. Examples of uses of IUS use to meet schedule needs: (1) On 6/1/15, there were two endoscopic carpal tunnel releases scheduled (Surgery Department has one tray); (2) On 7/21/15, there were eleven cystoscopic surgeries scheduled (Surgery Department has six scopes); and (3) On 7/23/15, there were three (3) arthroscopic surgeries scheduled (Surgery Department has two trays).

c. Examples of patients in which it was unable to be determined whether the equipment used for the surgery underwent IUS or not:
(1) Pt #1's record was reviewed on 7/28/15 at approximately1:00 PM. Pt #1 was admitted to the Hospital's Day Surgery on 6/2/15 with the diagnosis Lesion of Left Lower Eyelid and underwent Excision of Left Lower Eyelid Neoplasm. The record lacked documentation as to whether the instruments utilized in Pt #1's surgery had been IUS/Flash sterilized or not.
(2) Pt #12's record was reviewed on 7/30/15 at approximately 11:50 AM with E#5. Pt #12 was admitted on [DATE] with Left Hip Pain and underwent a Left Total Hip Arthroplasty on 12/16/14. Internal documentation stated Pt #12 returned to the hospital on [DATE] with worsening of left hip pain, fever, redness of surgical site; required surgical intervention; and that subsequent blood and deep hip wound cultures revealed a sensitive staphylococcus aureus. The IUS log for 12/16/14 stated a "Hip inst (instrument-s)" had undergone IUS. It was unable to be determined if these items were used for Pt #12's surgery.

7. A phone interview was conducted with the Surgery Division Chair (MD#3) on 7/30/15 at approximately 4:40 PM with the Assistant Vice President Revenue Cycle (also acting as oversight for the Quality Program) (E#8) and the Patient Representative (E#6) present. When asked if MD#3 was aware of the use of IUS/Flashing in the Surgery Department, MD#3 stated IUS should only be used for rare situations such as a dropped instrument. When asked if MD#3 was aware of the use of IUS as a primary source of resterilization for Orthopedic instruments, Cystoscopes, and Vascular devices, MD#3 stated "If you use it (IUS/Flash) in the world of orthopedics, you're playing with fire. As far as cysto equipment, you can't Flash that. It (the Flashing) would possibly melt the equipment. You can't get the lumens sterile. You just can't do it. The scope would be hot when it was brought to me and they aren't, unless by chance they (the staff) are cooling it in water or something."

8. An interview was conducted with the Chief Nursing Officer (E#7) with the Patient Representative (E#6) present on 7/31/15 at approximately 11:30 AM. E#7 stated "I'm aware" of the findings and had no further comment.

B. Based on document review and interview, it was determined for 5 of 5 (Pts #1, #2, #3, #4, and #5) surgical patients, reviewed for the assessment of fire risk, the Hospital failed to establish and implement a fire risk assessment policy/procedure. This has the potential to affect all patients serviced by the Surgical Department, which currently services an average of 302 patients per month.

Findings include:

1. Pt #1's record was reviewed on 7/28/15 at approximately 1:00 PM. Pt #1 was admitted on [DATE] with the diagnosis Lesion of Left Lower Eyelid and underwent an Excision of the Left Lower Eyelid Neoplasm under monitored anesthesia care. Intra-operative surgery documentation lacked a fire risk assessment.

2. Pt #2's record was reviewed on 7/29/15 at approximately 2:20 PM. Pt #2 was admitted on [DATE] with the diagnosis Left Adenexal Mass Endometrioma and underwent an Open Left Salpingo-Oophorectomy. Intra-operative surgery documentation lacked a fire risk assessment.

3. Pt #3's record was reviewed on 7/30/15 at approximately 8:30 AM. Pt #3 was admitted on [DATE] with the diagnosis Cataract Left Eye and underwent Phacoemulsification of Cataract with Intraocular Lens Implant of Left Eye. Intraoperative surgery documentation lacked a fire risk assessment.

4. Pt #4's record was reviewed on 7/30/15 at approximately 9:00 AM. Pt #4 was admitted on [DATE] with the diagnosis Left Knee Medial Meniscus Tear and underwent a Left Knee Arthroscopy with Medial Menisectomy. Intraoperative surgery documentation lacked a fire risk assessment.

5. Pt #5's record was reviewed on 7/30/15 at approximately 1:45 PM. Pt #5 was admitted on [DATE] with the diagnosis Perirectal Abcess and underwent an Incision and Drainage of Perirectal Abcess. Intraoperative surgery documentation lacked a fire risk assessment.

6. An interview was conducted with the Director of Surgical Services (E#1) on 7/29/15 at approximately 2:00 PM. E#1 stated there was no Fire Risk Assessment policy/procedure. E#1 stated the Hospital follows AORN (Association of periOperative Registered Nurses) and was aware of the need for a fire risk assessment.

C. Based on document review and interview, it was determined for 3 of 3 (Pts #1, #3, and #4) patients admitted to Day Surgery, the Hospital failed to ensure an assessment of Advanced Directive status and failed to address whether Advanced Directives would be followed or suspended during surgical intervention.

Findings include:

1. The Hospital policy titled "Advance Directives and HealthCare Surrogate Act" (revised 5/13) was reviewed on 7/29/15 at approximately 2:00 PM. The policy stated patients who were scheduled for ambulatory surgery and were 18 years of age or older would be asked if they have an Advance Directive. The policy lacked any reference as to whether a patient's Advance Directive would be followed or suspended during the surgery and lacked any reference as to whether the Advance Directive would be followed or suspended during the surgical intervention.

2. Pt #1's record was reviewed on 7/28/15 at approximately 1:00 PM. Pt #1 was admitted on [DATE] with the diagnosis Lesion of Left Lower Eyelid and underwent an Excision of the Left Lower Eyelid Neoplasm. The record lacked an assessment of Pt #1's Advance Directive status.

3. Pt #3's record was reviewed on 7/30/15 at approximately 8:30 AM. Pt #3 was admitted on [DATE] with the diagnosis Cataract Left Eye and underwent Phacoemulsification of Cataract with Intraocular Lens Implant of Left Eye. The record lacked an assessment of Pt #3's Advance Directive status.

4. Pt #4's record was reviewed on 7/30/15 at approximately 9:00 AM. Pt #4 was admitted on [DATE] with the diagnosis Left Knee Medial Meniscus Tear and underwent a Left Knee Arthroscopy with Medial Menisectomy. The record lacked an assessment of Pt #4's Advance Directive status.

5. A phone interview was conducted with an Admitting/Registration person (E#15) on 7/28/15 at approximately 3:20 PM with the Patient Representative (E#6) present. E#6 verbally stated they (the Admitting/Registration personnel) do not ask patients if they have an Advance Directive.

6. An interview was conducted with the Director of Surgical Services (E#1) on 7/28/15 at approximately 3:45 PM. E#1 stated "We don't ask that (if a patient has an Advance Directive) here (in the surgery suite)." A follow up interview was conducted with E#1 on 7/30/15 at approximately 2:00 PM. E#1 reviewed the records of Pts #1, #3, and #4 (all Day Surgery admissions) and verbally agreed their Advanced Directive status was not assessed and that the Hospital policy does not address whether the Advance Directive will be followed or suspended during the surgical intervention.

D. Based on document review and interview, it was determined for 3 of 3 (Pts #1, #3, and #4) Day Surgery patients, reviewed for discharge from the Day Surgery, the Hospital failed to establish and implement a policy on "Discharge Criteria".

Findings include:

1. Pt #1's record was reviewed on 7/28/15 at approximately 1:00 PM. Pt #1 was admitted on [DATE] with the diagnosis Lesion of Left Lower Eyelid and underwent an Excision of the Left Lower Eyelid Neoplasm. On 6/2/15, there was a physician order "Discharge when "Discharge Criteria" met."

2. Pt #3's record was reviewed on 7/30/15 at approximately 8:30 AM. Pt #3 was admitted on [DATE] with the diagnosis Cataract Left Eye and underwent Phacoemulsification of Cataract with Intraocular Lens Implant of Left Eye. On 7/29/15, there was a physician order "Discharge when "Discharge Criteria" met."

3. Pt #4's record was reviewed on 7/30/15 at approximately 9:00 AM. Pt #4 was admitted on [DATE] with the diagnosis Left Knee Medial Meniscus Tear and underwent a Left Knee Arthroscopy with Medial Menisectomy. On 7/29/15, there was a physician order "Discharge when "Discharge Criteria" met."

4. An interview was conducted with the Director of Surgical Services (E#1) on 7/29/15 at approximately 11:00 AM When asked what the Discharge Criteria was for Day Surgery patients, E#1 "We are an extension of the Medical Surgical Unit and we use their policy."

5. The Hospital policy titled "Discharge of Patient" (revised 10/10) was reviewed on 7/29/15 at approximately 11:30 AM. The policy lacked any direction for Day Surgery patient Discharge Criteria.

6. A follow up interview was conducted with E#1 on 7/30/15 at approximately 2:00 PM. E#1 had reviewed the records of Pts #1, #3, and #4 and had reviewed the Hospital's discharge policy and agreed the policy lacks direction for "Discharge Criteria".