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Based on observation, interview and document review, it was determined the Hospital failed to ensure patients' rights were protected. Therefore the Condition of Patient Rights, 42 CFR 482.13, was not in compliance. This has the potential to affect all patients who receive care at the Hospital with a current census of 575 patients.

Findings include:

1. The Hospital failed to ensure protection and confidentiality of patients' records. See A 0147

Based on observations, interview, and document review, it was determined the Hospital failed to ensure protection and confidentiality of patients' records. This has the potential to affect all patients who receive care at the Hospital with a current census of 575 patients.

Findings include:

1. During a tour of the Pediatric Acute Care Unit (Zone 9) with the Charge Nurse (E#35) on 01/22/19 at approximately 1:30 PM, patients' records were hanging unsecured on the wall outside of each patients' room.

2. During an interview on 1/22/19 at approximately 1:30 PM, E#35 stated "We store the charts outside of the rooms for ease of access during rounds. The charts have the face sheet (which includes name, birthday and insurance) electrocardiograms, telemetry strips, and anything that has not been scanned into the electronic medical record." E#35 verbally agreed staff, patients, and families have access to the hallways and the charts outside of the patients' room.

3. During a tour of the Adult Cardiac Intensive Care Unit (Zone 9) with the Manager (E#38) on 01/22/19 at approximately 2:15 PM, patients' records were hanging unsecured on the wall outside of each patients' room.

4. During an interview on 1/22/19 at approximately 2:15 PM, E#38 verbally agreed patients' records were stored in the hallway and were unsecured.

5. During a tour of the Adult Medical Specialty Unit (Zone 7) with the Charge Nurse (E#36) on 1/23/19 at approximately 11:00 AM, patients' records were hanging unsecured on the wall outside of each patients' room.
Pt#6's record was observed to contain personal patient information (name, address, phone number, birth date, insurance information, etc.), a signed blood and a surgical consent form, transfer packet (copy of the patient's record), Advanced Directives, Power of Attorney papers, Vendor Progress Note, and a patient information hand-off tool which included Pt #6's medical information (diagnosis, medications, past medical history, etc.).

6. During an interview on 1/23/19 at approximately 11:00 AM, E#36 verbally agreed patients' records were stored in the hallway and were unsecured.

7. The policy titled "Confidentiality and Privacy" (last reviewed by Hospital 5/30/17) was reviewed on 1/25/19. The policy stated "... employees are responsible for protecting the confidentiality and privacy of the information... Patients have the right to confidential care... every patient can expect any medical or social information whether written, spoken, or computer-generated to be held in the strictest of confidence."

Based on document review and interview, it was determined in 3 of 3 (Medical Doctor-MD#11, MD#12, MD#14) physicians' files reviewed for surgical privileges, the Hospital failed to ensure privileges were granted for the types of surgical procedures performed. This has the potential to affect all patients who receive surgical services with an average of 85 surgical cases per day.

Findings include:

1. The "Bylaws of Professional Staff and Rules and Regulations of The Professional Staff" (dated May 2017) was reviewed on 1/24/19. The Article VII Awarding of Clinical Privileges stated on page 37 "7.1 Exercise of Privileges Except in an Emergency situation, a Professional shall be entitled to exercise only those Privileges specifically granted by the Governing Board..."

2. The Daily Surgery schedule dated 1/22/19 through 1/24/19 and the Clinical Privileges list for physicians were reviewed on 1/22/19-1/24/19. The following patients, procedures and surgeons were noted:

a) On 1/22/19, Pt #61 was scheduled for a Transfemoral Aortic Valve Replacement by MD#11 (Cardiologist).
The current approved Clinical Privileges list for MD #11 dated 8/20/17 lacked documentation that privileges were granted for the Transfemoral Aortic Valve Replacements.

b) On 1/22/19, Pt #62 was scheduled for a Transfemoral Aortic Valve Replacement by MD#11 and MD#12 (Cardio-Thoracic Surgeon). The current approved Clinical Privileges for MD#11 dated 8/20/17 lacked documentation that privileges were granted for the Transfemoral Aortic Valve Replacement. The current approved Clinical Privileges list for MD#12 dated 10/20/17 lacked documentation that privileges were granted for the Transfemoral Aortic Valve Replacement.

c) On 1/23/19, Pt#58 was scheduled for a Robotic Low Anterior Colon Resection with Splenic Flexure Mobilization by MD#14 (General Surgeon). On 1/24/19 Pt#59 was scheduled for a Robotic Hiatal Hernia Repair with Mesh Possible Linx or Gastric Fundoplication by MD#14. On 1/24/19 Pt #60 was scheduled for a Robotic Epigastric and Umbilical Hernia Repair with Mesh by MD#14. The current approved Clinical Privileges list for MD#14 dated 8/16/18 documented privileges were granted for Robotic Surgery, although lacked specific procedures which could be scheduled and conducted Robotically. The procedure list noted "The Core Procedure List" for General Surgeons listed privileges for "Colon surgery... Gastric operations... Laparoscopy... mobilization... Repair of perforated viscous... Splenectomy" although, lacked specific procedures which could be scheduled and conducted.

3. The Surgery Scheduling Coordinator job description was reviewed on 1/25/19. The job description noted the principle duties and responsibilities of the surgery scheduler was to "Schedules Operative and Invasive procedures for future cases... Maintains privileges books for the Operative and invasive areas...Medical Terminology preferred..."

4. During an interview on 1/24/19 at approximately 8:45 AM, Registered Nurse (E#51) stated "I've been asking around why the Transfemoral Aortic Valve Replacements got scheduled if it's not on the privileging sheet. Well, I found out... (pointed to page 3 of MD#11's Delineation of Privileges) this (an abbreviation "TAV/TAVR") is the abbreviation for the Transfemoral Aortic Valve Replacement procedure...." E#51 verbally agreed it was unable to be determined if the TAV/TAVR procedure was checked as an approved procedure on the privileging sheet or if it was the Radiofrequency Ablation written above it. E#51 stated MD#12 was assigned to Pt#62's surgery on 1/22/19 in case of an emergency which required the chest to be opened and not the Transfemoral Aortic Valve Replacement. E#51 verbally agreed the surgery schedule should identify which doctor was scheduled to provide what surgery.

5. During an interview on 1/24/19 at approximately 2:30 PM, Manager Physician Credentialing Office (E#51) stated that the schedulers have a book with the Delineation of Privileges form for each physician in it. E#51 stated that the schedulers were to reference the forms prior to scheduling a procedure. E#51 verbally agreed the schedulers were not required to have medical experience to decipher which procedures and abbreviations were specifically granted prior to the procedure being scheduled and performed. E#51 stated "We need a system that only allows procedures to be scheduled and conducted that are specifically approved so there is not any guess work involved."

Based on document review and interview, it was determined for 1 of 2 (Pt #49) observation patients reviewed for intravenous orders, the Hospital failed to ensure intravenous accesses were ordered. This has the potential to affect all patients serviced by the Hospital which has a census of approximately 575 patients.

Findings include:

1. The following Hospital documents were reviewed on 1/24/19 at approximately 2:00 PM.
a. The Hospital Policy ID: 50989787 titled "Intravenous Therapy" (last reviewed or revised by Hospital 12/13/18) - on page 3, the policy stated "c. Consult Lippincott IV (intravenous) procedures for IV standards."
b. The "Lippincott Procedures- Intermittent infusion device flushing and locking" document stated, " - The procedure Implementation... Verify the practitioner's order or follow Ministry Flush Grid for time intervals for flushing the IV cannula..."

2. Pt#49 Admission date: 1/19/19 to 1/19/19
Diagnoses: Intracranial Hemorrhage/Subdural Hematoma and History of Fall.
Pt #49's record was reviewed on 1/24/19 at approximately 11:20 AM. Nursing documentation stated Pt #49 had two peripheral IV sites started at 10:51 AM. The record lacked orders for the IV sites.

3. An interview was conducted with the Registered Nurse (E#47) on 1/24/19 at approximately 2:00 PM. E#47 reviewed Pt#49's record and verbally agreed the record lacked orders for the IV sites.

Based on document review and interview, it was determined in 1 of 2 (Pt #15) patients' records reviewed, whom received blood transfusions, the Hospital failed to ensure blood was administered as ordered. This has the potential to affect all patients who receive blood at the Hospital.

Findings include:

1. The clinical record of Pt #15 was reviewed on 1/24/19 at approximately 10:50 AM. Pt#15 was admitted on 12/22/19 with Anemia (low blood counts). The Physician's order dated 12/22/18 stated, "transfuse 2 units of blood and conduct Vital signs: Within 30 minutes before initiating transfusion, 15 minutes after start of transfusion, 5 minutes before and after stop of transfusion, and 50-70 minutes after blood completion." Pt #15's record lacked vital signs 30 minutes prior to initiation of the first unit of blood and 50-70 minutes after completion of the first unit of blood. Pt #15's record lacked vital signs 30 minutes prior to initiation of the second unit of blood, 15 minutes after the start of the second unit, 5 minutes before and after completion of the second transfusion, and 50-70 minutes after completion of the second unit of blood."

2. During an interview on 1/24/19 at approximately 10:50 AM, Registered Nurse (E#41) verbally agreed the patient's vital signs were not monitored as ordered by the Physician and they should have been.

Based on document review and interview, it was determined in 3 of 5 (Pt#19, Pt#54, Pt#55) patients' records reviewed for donated organs, the Hospital failed to ensure consents were obtained and placed in the medical record. This has the potential to affect all patients who are potential organ donors.

Findings include:

1. The policy titled "Organ Donation Management Procedure" (last reviewed by Hospital 6/2018) was reviewed on 1/25/19 at approximately 11:00 AM. The policy stated "10. Confirm one of the two following types of consents is present and placed in chart under consents: a. First person consent... b. Consent by legal decision-maker... once Gift of Hope obtains a copy of the consent, scan into the Media tab in EPIC (electronic health record)."

2. The clinical record of Pt#19 was reviewed on 1/24/19 at approximately 11:45 AM. Pt#19 presented to the Emergency Department on 12/21/18 with a brain injury status due to a Motor Vehicle Accident. The Anesthesia Record dated 1/1/19, noted Pt#19's organs were harvested and Pt#19 was subsequently pronounced dead. The record lacked a consent for organ Procurement. A copy of the consent was provided on 1/25/19 upon request to the Gift of Hope, although the copy had not been obtained by the Hospital and scanned into the medical record.

3. The clinical record of Pt#54 was reviewed on 1/25/19 at approximately 11:00 AM. Pt#54 presented to the Emergency Department on 1/19/19 with a brain bleed. The Anesthesia Record dated 1/23/19, noted Pt#54's organs were harvested and Pt#54 was subsequently pronounced dead. The record lacked a consent form for the Organ Procurement.

4. The clinical record of Pt#55 was reviewed on 1/25/19 at approximately 11:15 AM. Pt#55 presented to the Emergency Department on 1/3/19 with a brain bleed. The Anesthesia Record dated 1/5/19 noted, Pt#55's organs were harvested and Pt#55 was subsequently pronounced dead. The record lacked a consent form for the Organ Procurement.

5. During an interview on 1/25/19 at approximately 12:00 PM, Registered Nurse (E#41) verbally agreed the organ procurement consents for Pt#19, Pt#54, and Pt#55 were not completed and placed in the medical record per policy and they should have been.

Based on document review and interview, it was determined for 2 of 2 (Medical Doctor- MD#24, MD#25) Interventional Radiologists reviewed for Level 2 ALARA (as low as reasonably achievable/radiation exposure level) levels, the Hospital failed to ensure ongoing, elevated dosimeter readings were analyzed to determine the potential causes for the elevated results, in accordance with the "ALARA Memorandum". This has the potential to affect all staff with outlying dosimeter results.

Findings include:

1. The Hospital Policy Stat ID: 5741481 titled "Radiation Protection Program- Hazardous Materials" (last reviewed/revised by Hospital 1/22/19) was reviewed on 1/24/19 at approximately 10:55 AM. The policy stated "Page 2-Process:... 6. Personnel who exceed the exposure limits set by the Radiation Safety Committee are contacted and advised."

2. An email, dated 1/25/19, was reviewed on 1/25/19 at approximately 9:30 AM. The email stated the Hospital's ALARA levels were "Level 1- are set to be trigger at 10% of the annual regulatory limit... Level 2- are set to trigger at 30% of the annual regulatory limit..." The email further stated the annual regulatory limits were set by the Illinois Management Agency Division of Nuclear Safety.

3. The ALARA Memorandums for MD#24 and MD#25, dated September 2018 and November of 2018 were reviewed on 1/24/19 at approximately 12:55 PM.

a. The ALARA Memorandums stated "Your dose is above our level 2 limit and indicates a need to review work procedures for possible reduction of exposure. Reduce your exposure..."
b. In September of 2018 the ALARA Memorandums stated that the LDE (lens of the eye radiation dose) levels were Level 1 and stated the SDE (shallow radiation dose equivalent) levels were Level 2.
c. In November of 2018 the ALARA Memorandums stated that the LDE levels and the SDE levels were Level 2.

4. An interview was conducted with the Manager of Diagnostic Radiology and Ultrasound (E#32) and the Director of Radiology (E#40) on 1/24/19 at approximately 10:00 AM. Both had reviewed MD#24's and MD#25's ALARA Level 2 reports. E#40 stated the following:

a. The process for outlying levels (1 or 2) was to notify the affected person of the ALARA results.
b. A level 2 ALARA result would include an "ALARA Memorandum" questionnaire the provider would complete and return to the Hospital.
c. MD#24 and MD#25 were Fellows (physicians who had completed their Residency program and were now actively performing Interventional Radiology procedures) and had begun their Fellowships in July 2018.
d. E#40 stated that they had a meeting with MD#24 and MD#25 and their overseeing physician and asked them to review their questionnaires with emphasis on the types of available resources available to decrease radiation exposure, "as their lens levels (LDE) were reaching levels that concerned us".
e. E #40 stated that the Hospital had not performed any observations as part of the ALARA Memorandum "review of work procedures for possible reduction of exposure" to determine the potential causes for increased radiation exposure when outlying levels occur. "We do not do actual observations."

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on January 22-24, 2019, the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Full Survey Due to a Complaint conducted on January 22-24, 2019, the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

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A. Based on observation, document review, and interview, it was determined the Hospital failed to ensure its' preventive maintenance and equipment safety checks/monitoring processes were followed. This has the potential to affect all patients (current census of 575 patients), staff, and visitors.

Findings include:

1. A tour of the Blood Bank was conducted on 1/22/19 between 11:30 AM and 12:10 PM. The "Blood Bank Daily Equipment Temperature Form 2" dated January 2019 was reviewed. The form lack documentation the Eye Wash Station was checked for the week of January 16, 2019.

2. The policy titled "Department of Laboratory Services" was reviewed on 1/23/19 at approximately 10:00 AM. The policy required, "Eyewash Station 3. Maintenance a. Free flow water from each eye wash must be checked weekly."

3. An interview was conducted on 1/22/19 at approximately 11:40 AM with Blood Bank Lead (E#23). E#23 stated that the eye wash station is to be checked weekly.

4. A tour of the Medical Intermediate Care Unit was conducted on 1/22/19 between 2:00 PM and 3:00 PM. The "Resuscitation Crash Cart Checklist" for cart #4014, dated January 2019 was reviewed. The checklist lacked documentation on 1/18/19 that cart #4014 was checked.

5. The policy titled "Code Blue (Crash) Carts: Adult, Pediatric, and Neonate (last revised by Hospital 9/12/18) was reviewed on 1/23/19 at approximately 9:00 AM. The policy required, "Code Blue cart integrity seal and external components are checked by a designated person daily."

6. An interview was conducted on 1/22/19 at approximately 2:30 PM with the Manager of the Medical Intermediate Care Unit (E#24). E#24 stated that staff did not check the crash cart on 1/18/19 as required.

7. A tour of the offsite pediatric rehabilitation facility was conducted on 1/23/19 between 11:00 AM and 11:45 AM with the Director of Rehab Facilities (E #26) and Children Hospital of Illinois Pediatrics Manager (E #25). A Pediatric Lifepak 500 (Biomed # 20567) Automated External Defibrillator (AED) was available for an emergency in the pediatric workroom. No documentation of daily equipment check performed on the AED was available.

8. The policy titled "OSF Off Campus Response to Emergency/Potential Emergency" (last revised by Hospital 7/13/18) was reviewed on 1/24/19 at 10:00 AM. The policy required "C. Defibrillator/AED ...Daily Check on LifePak 500 &1000" with a log sheet attached for date and signature.

9. An interview with E #25 was conducted during the tour at approximately 11:30 PM. E #25 was not aware of a log for the AED. E#25 stated that biomed takes care of the preventive maintenance.

10. During a tour of Zone 7 Medical Acute Care Unit conducted on 1/23/19 at approximately 9:00 AM, a Sabrina 2 EE lift in the storage room lacked a preventive maintenance label and/or identification tag.

11. A "Work Order" for the Sabrina 2 EE lift, dated 1/23/19, was presented on 1/23/19 at approximately 2:00 PM. There was no documentation of the lift being initially checked and/or put into the Hospital's Medical Equipment Management Plan.

12. During a tour of Zone 1, 1st floor Sonogram/Ultrasound area conducted on 1/23/19 at approximately 3:15 PM, a treadmill in the "Arterial Room" lacked a preventive maintenance label and/or Hospital identification tag.

13. A "Detailed Equipment History Report" was presented and reviewed on 1/25/19 at approximately 8:15 AM for the Ultrasound treadmill. The report listed four work orders (WO) between 1/9/03 and 8/23/12. The report lacked any preventive maintenance until 1/24/19.

14. The Hospital Policy ID: 5123211 titled "Medical Equipment" (last reviewed or revised by Hospital 10/5/18) was reviewed on 1/25/19 at approximately 9:00 AM. The policy stated, "Policy... 4. Medical equipment is maintained and evaluated in accordance with the Medical Equipment Management Plan... Process: 1. For new medical equipment, site supervisor, or manager confers with Biomed to determine if Biomed or contracted company maintains the equipment... 4. Inspect medical equipment prior to use by checking the following... d. Expired PM (preventive maintenance) due date..."

15. During an interview conducted on 1/23/19 at approximately 3:15 PM, The Manager Diagnostic Radiology and Ultrasound (E#32) and the Ultrasound Supervisor (E#33) verbally agreed the treadmill lacked any preventive maintenance label and/or Hospital identification tag.

16. During an interview conducted with the Patient Care Manager (E#34) on 1/25/19 at approximately 8:45 AM, E#34 stated that both the Sabrina 2 EE lift and the treadmill had not been checked before use and had not been put into the Hospital's Medical Equipment Management Plan for ongoing maintenance checks. When asked how the Hospital could ensure that all current equipment had been checked initially and/or placed into the Medical Equipment Management Plan, E#34 verbally agreed they (the Hospital) could not ensure all current equipment had been checked and/or placed into the Medical Equipment Management Plan.

17. During a tour of the Labor and Delivery's 2200 unit on 1/22/19 at approximately 10:30 AM and G 200 unit on 1/23/19 from approximately 1:00 PM to 3:00 PM with Safety Project Manager (E #39) and Registered Nurse (E# 42), the following emergency cart logs lacked documentation of required daily checks:

a) Labor and Delivery emergency cart logs dated September 2018 and November 2018, lacked documentation for 1 of 30 days, October 2018 and December 2018 emergency cart logs lacked documentation for 1 of 31 days.
b) 2200 unit (hall) emergency cart logs dated 9/2/18 and 10/31/18 lacked the signature of staff that checked the crash cart.
c) G 200 unit (adult) emergency cart logs dated October 2018 lacked documentation for 7 of 31 days and in November 2018 the logs lacked documentation for 3 of the 31 days.
d) G 200 unit (peds-Pediatric) emergency cart logs dated October 2018 lacked documentation for 8 of 31 days and in November 2018 lacked documentation for 3 of 31 days.

18. The policy titled "Code Blue (Crash) Carts: Adult, Pediatric and Neonatal (last reviewed by Hospital 9/12/2018)" was reviewed on 1/25/19 at approximately 8:45 AM. The policy required..."Policy:...3. Code Blue cart integrity seal and external components are checked by a designated person daily. a. A log of cart checks is maintained with the cart."

19. During an interview with Patient Care Manager (E# 34 ) on 1/24/19 at approximately 3:30 PM, it was confirmed the above mentioned crash cart on the Labor and Delivery's 2200 unit and G 200 unit weren't checked on those dates and it should have been.


B. Based on observation, interview and document review, it was determined for (1 of 1) Pediatric Intermediate Unit (PIC) patient (Pt #4), the Hospital failed to ensure an electrical item brought from home was checked prior to use in order to ensure item safety. This has the potential to affect all patients (current census of 575 patients), staff, and visitors.

Findings include:

1. During a tour conducted on the PIC unit on 1/22/19 at approximately 1:15 PM, a string of "Christmas" lights were draped around Pt #4's bed in room #410. There was no sticker indicating that the lights had been checked for safety by the bio-med department.

2. During an interview with PIC/PICU (Pediatric Intensive Care Unit Manager) (E #12) conducted during the tour, E#12 stated that the lights were not hospital equipment and were brought in by the patient's mother for visual stimulation. E #12 stated that the item should have been sent to the biomed department to check its safety before it was allowed to be used. E #12 stated that a sticker from biomed would be placed on the item indicating when it was checked and there was no sticker indicating this was done and it should have been.

3. Policy "Patient Supplied Equipment" (last reviewed by Hospital 2/6/2018), was reviewed on 1/23/19. Policy: b. Refer to Process section for appropriate steps when patient supplied electronic or electrical medical equipment is utilized. PROCESS: 3. Clinical staff performs a visual/physical inspection, operational and functional check of patient supplied medical equipment upon patient admission, or when use is initiated using "Evaluation of Patient Supplied Medical Device" form.... 4. Clinical Engineering completes a safety inspection of patient supplied medical equipment upon request or if the device fails the clinical staff visual inspection. 6. Obtain a "Release of Waiver of Liability for Non-Hospital Owned Patient Supplied Medical Device" form.

4. Pt #4's chart was reviewed on 1/24/19 at approximately 10:00 AM. Pt #4's chart lacked documentation of when the lights were placed on Pt #4's bed, staff performing the visual/physical inspection, and completion of the required forms.


C. Based on observation, document review and interview, it was determined the Hospital failed to ensure refrigerator temperatures were checked and monitored per policy. This has the potential to affect all patients who receive care by the Hospital with a current census of 575 patients.

Findings include:

1. During a tour of the Newborn Nursery 2400 Unit on 1/22/19 from approximately 10:30 AM to 11:30 AM and Maternal Fetal Diagnostic Unit on 1/23/19 from 1:00 PM to 3:00 PM with Safety Project Manager (E #39) and Registered Nurse (E#42 ), the following refrigerator temperature logs dated 9/1/18-1/23/19 lacked documentation of the required temperature checks:

a) Newborn Nursery logs dated November 2018 lacked documentation of temperatures for 1 of 30 days and in December 2018 lacked documentation of temperatures for 1 of 31 days
b) 2400 unit logs dated November 2018 lacked documentation of temperatures for 3 of 30 days.
c) Maternal fetal Diagnostic logs dated October 2018 lacked documentation of temperatures for 4 of 31 days and November 2018 logs lacked documentation of temperatures for 2 of 6 days.

2. The policy titled "Food- Nutrition Floorstock Ordering (last reviewed by Hospital 12/12/2018)" was reviewed on 1/25/19 at approximately 8:50 AM. The policy required..." Policy: ....4. A Room Service Ambassador on each unit documents the temperature of the refrigerator and the freezer according to the following temperature guidelines: a. Daily Temperature Checking Form is posted on the refrigerator. Once each day, a Room Service Ambassador checks the temperature of the refrigerator and freezer and document...temperatures on the log..."

3. During an interview with E# 34 (Patient Care Manager) on 1/24/19 at approximately 3:30 PM, it was confirmed the refrigerator temperatures mentioned above weren't checked on those dates and they should have been.


D. Based on observation, document review, and interview, it was determined the Hospital failed to ensure equipment was monitored per manufactures guidelines. This has the potential to affect all patients who receive care by the Hospital with a current census of 575 patients.

Findings include:

1. During a tour of the Oncology Unit and Medical Intermediate Unit on 1/23/19 at approximately 1:00 PM to 3:00 PM, the following "Intelligent Warmers" flashed red lights with ready baths noted in the warmers:

a) The Oncology Unit Intelligent Warmer flashed 3 red lights.
b) The Medical Intermediate Unit included 2 Intelligent Warmers. 1 unit flashed 8 red lights and the 2nd unit flashed 7 red lights.

2. The Instruction Manual titled "Intelligent Warmer (ready bath)" was reviewed on 1/24/19 at approximately 3:40 PM, the manual included "...status indicator- Discard -If Red LED Flashes- Pack has been in the warmer longer than 250 hours and should be discarded..."

3. During the tour, an interview was conducted with Registered Nurse (E #43) and Registered Nurse (E# 44). Both verbally confirmed the red lights were flashing and were unsure what that meant.

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A. Based on observation and interview, it was determined for 1 of 1 circumcision pack for sterilization, the Hospital failed to ensure hinged instruments were open during sterilization, in order to prevent/control infections and communicable diseases. This has the potential to affect all circumcision patients, an average of 87 patients monthly.

Findings include:

1. An observation of the preparation of circumcision instruments for steam sterilization was conducted on 1/23/19 between approximately 1:20 PM and 1:50 PM with the Manager of Sterile Processing (E#29), the Sterile Processing Department Educator (E#30), and the Director of Infection Prevention and Control (E#31). The Lead Sterile Processing Technician (E#28) inspected and packaged a circumcision pill pack for steam sterilization. The circumcision pack included the following hinged devices: six Mosquito (a type of surgical hemostat forceps instrument) hemostat forceps (three straight and three curved), one Iris scissors, and one straight Mayo scissors. E#28 inspected each instrument, then closed each instrument and placed them into a green foam envelope package.

2. During an interview conducted on 1/23/19 at 1:50 PM, E#28 stated that the pack is then placed into the peel-pack (a type of sterilization pack). E#28 stated that all circumcision packs are prepared in this manner (closing of the Mosquito hemostats and scissors and placing them into the foam envelope). E#28 stated, "We don't string them like we do in the larger packs."

3. During an interview conducted on 1/23/19 at 1:55 PM, E#29 stated, "They (the hemostats and scissors) are open when they put them in the pack (green envelope)." E#29 then observed the hemostats and scissors were closed in the pack and E#29 verbally confirmed with E#28 that this was currently how the circumcision packs were processed (the hemostats and scissors were closed, not open) during sterilization. Both verbally agreed there was no way to ensure the sterility of the hemostats and scissors, as they were not open during the sterilization process and should have been.


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B. Based on observation and interview, it was determined the Hospital failed to ensure equipment was properly utilized in order to avoid the potential for cross contamination. This has the potential to affect all patients serviced by the Hospital with a current census of 575 patients.

Findings include:

1. An observational tour of the Operating Room was conducted on 1/23/19 at approximately 11:00 AM with the registered nurse (E#48). In Operating Room #20, the CRNA (certified registered nurse anesthetists) (E#47) dropped a cardiac monitor electrode on the floor during the patient's surgery preparations. E# 47 picked up the electrode from the floor and placed it on the patient's bed and stated "I was going to change the electrode later." Prior to leaving the operating room, E#47 used E#47's feet to push drawers in on Room #20's anesthesia cart.

2. An interview was conducted with E#48 on 1/23/19 during the tour. E#48 verbally confirmed the CRNA shouldn't have put the electrode onto the patient's bed after picking it up off floor without changing the electrode and should not have pushed the anesthesia cart's drawers using feet instead of hands.



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C. Based on observation, document review, and interview, it was determined for 1 of 1 Neonatal Intensive Care Unit (NICU) Milk Lab Room (clean area which is utilized to prepare and store baby milk, to decrease chances of contamination), the Hospital failed to ensure the two Laminar Flow Hoods (utilized for baby milk preparation to decrease chances of contamination) and the Milk Lab room were monitored for compliance with daily cleaning requirements, in order to prevent/control infections and communicable diseases. This has the potential to affect all patients served in the NICU and NIC.

Findings include:

1. On 1/22/19 at 11:30 AM, an observational tour was conducted in the NICU Milk Lab with the Chief Nursing Officer (E#3) and the NICU/NeonataL Intensive Care (NIC) Manager (E #2). The NICU Milk Lab contained a large amount of removable gray fluffy debris/substance on top of both of the Laminar Flow Hoods and on top of one milk refrigerator.

2. On 1/22/18 at 3:00 PM, the document titled, "Laminar Hood Cleaning Log" dated 1/2019 was reviewed. The document required that "...hoods were to be cleaned daily." The Laminar Hood Cleaning Log dated 1/19 stated that the hoods were cleaned on 1/1/19-1/22/19.

3. On 1/22/19 at 3:00 PM the document titled, "NICU...Milk Lab Cleaning". The document required that, "cleaning of Milk Lab daily."

4. During an interview conducted with E#2 on 1/22/19 at 11:35 AM, E#2 confirmed the above findings and stated that the Laminar Flow Hoods and the milk room were to be cleaned daily.


D. Based on observation, document review, and interview, it was determined for 1 of 1 NICU and 1 of 1 Neonatal Intermediate Care Unit (NIC), the Hospital failed to ensure the environment was safe and sanitary in order to prevent/control infections and communicable diseases. This has the potential to affect all patients served in the NICU and NIC.

Findings include:

1. On 1/22/19 at 11: 45 AM, an observational tour of the NICU/NIC was conducted with the Chief Nursing Officer (E#3) and the NICU/NIC Manager (E#2). The following infection control issues were noted:
a. The NICU/NIC's "Clean Holding Room" (storage for clean baby equipment) contained a large amount of removable gray fluffy debris/substance on top of the shelves, floor, vital sign monitors, and the pulse Oximetry machines.
b. The NICU "Family Dining Room" refrigerator's top contained a large amount of removable gray fluffy debris/substance.
c. The NICU's unlocked soiled utility room contained two containers with surgical instruments (scissors, clamps, and tweezers) in a clear solution and two full containers of used sharps, which were accessible to patients and visitors. The two containers of used instrument lacked any biohazard stickers.

2. On 1/22/19 at 11:50 AM the document titled " Housekeeping Daily Worksheet" dated 1/2019 was reviewed. the document stated that the NICU/NIC's Clean Holding Room and the NICU's Family Dining Room is cleaned daily.

3. On 1/22/19 at 11:55 AM, the policy titled, " Instrument Preparation for Items that Require Sterilization" (dated 1/9/19) was reviewed. The policy required that, "...place biohazard sticker on top of instruments. (container)"

4. On 1/22/19 at 12:00 PM, the policy titled "Biohazard Waste Handling" (2/6/18) was reviewed. The policy required that, "Waste that contains blood or other potentially infectious body fluids is considered biohazard waste. You must handle waste appropriately to prevent exposure to patients..."Biohazard waste should be separated from other trash and stored in clearly labeled hazardous waste containers...

5. During an interview conducted with E#2 and E#3 on 1/22/19 at 11:45 AM, E#2 stated that the instruments were used at bedside for baby circumcisions. The instruments which have not been cleaned yet and the sharp containers are stored in the soiled room until they are picked up. E#2 stated, "I am not sure why those instruments are in here." E#2 agreed that patients and visitors could access the soiled room, since it was unlocked. E#3 stated, "we did a risk assessment on leaving the soiled utility room unlocked and it was a low risk."


E. Based on observation, document review, and interview, it was determined for 1 of 1 Pediatric Intensive Care Unit (PICU) and 1 of 1 Pediatric Intermediate Care Unit (PIC), the Hospital failed to ensure the environment was safe and sanitary in order to prevent/control infections and communicable diseases. This has the potential to affect all patients served in the PICU and PIC.

Findings include:

1. On 1/22/19 at 1:06 PM, an observational tour of the PICU/PIC was conducted with the Chief Nursing Officer (E#3) and the PICU/PIC Manager (E#12). The following infection control issues were noted:

a. The PICU/PIC's "Clean Holding Room" contained a large amount of removable gray fluffy debris/substance on top of the blanket warmer.
b. Room 402 contained three crumpled paper towels, 5 medication vial caps, and two latex gloves on the floor next to the trash can.

2. On 1/22/19 at 11:50 AM the document titled " Housekeeping Daily Worksheet" dated 1/2019 was reviewed. The document stated that the "Clean Holding Room is cleaned daily."

3. During an interview conducted with E#12 on 1/22/19 at 1:15 PM, E#12 agreed with the above findings and stated, "I 'm not sure when the clean holding room is cleaned."


F. Based on observation, document review, and interview, it was determined for 1 of 6 Cardiac Catheterization Lab (Cath Lab) rooms, the hospital failed to ensure equipment was thoroughly disinfected in order to prevent/control infections and communicable diseases. This has the potential to affect all patients receiving care in the Cardiac Catherization Lab.

Findings include:

1. On 1/23/19 at 10:15 AM-11:30 AM, an observational tour was conducted in the Cath Lab Department with E#2 and Cath Lab Supervisor (E#20). Following Pt#29's procedure in room #4, the Cardiac Catherization staff conducted a room clean and disinfection. The following infection control issues were noted following the room cleaning:

a. Clear tape and tape residue was on the patient procedure table
b. The two phones in the room were not cleaned and disinfected. Registered Nurse (E#19) used the anterior wall phone during the procedure.
c. The posterior wall phone handle contained a torn paper sticker, which would make it difficult to properly disinfect.
d. The boom arm of the lead shield plate, which is above the procedure table, contained cloth tape wrapped around each end of the shields boom arm.

2. The policy titled, "Cardiac Cath Lab Theater Turnover" (dated 2017) required that, "procedure room should be cleaned after each patient...clean and disinfect...procedure table.. lead shields arm..."

3. On 1/23/19 at 10:30 AM, an interview was conducted with E#2 and E#20. E#2 and E#20 agreed with the above findings and verbally agreed the table, phone and the shield arm could not be adequately disinfected with the tape residue and sticker.


G. Based on observation, document review, and staff interview, it was determined for 1 of 1 Endoscope procedure observed, the Hospital failed to ensure proper hand hygiene practices were followed in order to prevent/control infections and communicable diseases. This has the potential to affect all patients receiving endoscopes at the Hospital.

Findings include:

1. On 1/23/19 at 9:10 AM in Endoscope Room #7, Registered Nurse (E#17) administered Intravenous (IV) Conscious Sedation medications to Pt#28. E#17 gave Pt#28 a dose of IV medications, then touched Pt#28's arm, then touched the computer, then gave Pt#17 another dose of IV medication, without the benefit of a glove change or hand hygiene.

2. The policy titled "Hand Hygiene" (dated 12/4/18) was reviewed on 1/23/19 at 2:00 PM. The policy stated, "Indications for Hand Hygiene, "...AFTER: ...after contact with patients intact skin..."

3. During an interview with Gastro-Intestinal Supervisor (E#16) conducted on 1/23/19 at 9:35 AM, E#16 stated that staff should follow the Hospital's hand hygiene policy.


H. Based on observation, document review, and interview, it was determined for 1 of 1 EKG (Electrocardiogram Unit) and 1 of 1 ECHO (Echocardiogram Unit), the Hospital failed to ensure the environment was safe and sanitary in order to prevent/control infections and communicable diseases. This has the potential to affect all patients served in the EKG/ECHO units.

Findings include:

1. On 1/24/19 at 2:15 PM, an observational tour of the EKG/ECHO Departments were conducted with the EKG Unit Supervisor (E#45) and the ECHO Unit Supervisor (E#46). The following infection control issues were noted:

a. EKG Procedure room #1 contained a large amount of removable gray fluffy debris/substance on top of the EKG monitor.
b. EKG Procedure room #2 contained a large amount of removable gray fluffy debris/substance on top of the EKG monitor.
c. ECHO Procedure room #2 contained a large amount of removable gray fluffy debris/substance on top of the baseboards and wall protector.

2. On 1/25/19 at 11:50 AM the document titled " Housekeeping Daily Worksheet" dated 1/20/2019-1/21/19 was reviewed. The document stated that the EKG and ECHO Department rooms were cleaned daily.

3. During an interview conducted with E#45 and E#46 on 1/24/19 at 2:00 PM, E#45 and E#46 agreed with the above findings and stated that the unit staff clean equipment between each patient and the housekeeping staff clean the rooms daily.


34824


I. Based on observation, document review, and interview, it was determined for 1 of 1 Pediatric Acute Care Unit and 1 of 3 Surgical Unit observations, the Hospital failed to ensure infection control measures were followed to prevent the potential of cross contamination. This has the potential to affect all staff, visitors, and inpatients serviced by the Hospital with an average census of 575.

Findings include:

1. During a tour with Charge Nurse (E#35) of the Pediatric Acute Care Unit on 01/22/19 at approximately 1:30 PM, the couch in Room #629 had multiple cracks which covered approximately 2 feet.

2. An interview was conducted during the tour with the Charge Nurse (E#35). E#35 confirmed the cracks and verbally agreed the couch could not be adequately disinfected with the cracks in the covering and should be replaced.

3. During a tour of the surgical suites on 01/23/19 at approximately 10:00 AM, the arm support on the operating table in Room #14 had ten small (approximately 1/4 inch) rips in the covering.

4. An interview was conducted during the tour with the Supervisor of Neurosurgery (E #22). E#22 verbally agreed the arm support could not be adequately disinfected with the rips in the covering and should be replaced.

5. An observation was conducted with the Director of Surgical Services (E #4) of an Aortic Valve Replacement (Tissue Valve) with Transesophageal Echocardiogram Possible Insertion of Invasive Lines for Pt #41 on 01/23/19 between 11:37 AM and 1:17 PM. The following breeches of infection control were noted:

a. 1135 AM - 11:45 AM, Medical Doctor (MD) #26 donned gloves without performing hand hygiene. Then MD#26 withdrew medication from a vial without cleaning the top with alcohol, administered the medications, touched the bedside monitors, and then withdrew more medication, without the benefit of a glove change or hand hygiene.
b. 11:45 AM - MD#23 entered the room, touched the patient and then donned sterile gloves, without the benefit of performing hand hygiene prior to putting on gloves.
c. 11:55 AM - MD#26 removed gloves then donned sterile gloves, without the benefit of performing hand hygiene.
d. 12:26 PM MD#23 removed sterile gown and gloves, then left the surgical suite, without the benefit of hand hygiene.

6. The policy titled "Hand Hygiene" (last revised by Hospital 12/4/18) was reviewed on 1/24/19 at approximately 1:00 PM. The policy required "Indication for Hand Hygiene: c. Before and after wearing sterile or non-sterile gloves. e. After contact with a patient's intact skin."

7. An interview was conducted with E#4 on 01/23/19 at 1:20 PM. E#4 confirmed the observations and stated that MD#23 and MD#26 failed to perform appropriate hand hygiene per policy and should have followed policy.

8. On 1/23/19 at approximately 11:30 AM, in Operating Room (OR) #13, the Anesthesiologist (MD#22) taped Pt #32's endotracheal tube in place on Pt #32's face and applied tape to Pt#32's eye without wearing gloves. MD#32 then obtained a pre filled medication syringe (propofol 40 milligrams) off the Anesthesia cart and injected the medication into the port of Pt#32's intravenous tubing. MD#32 then applied gloves without performing hand hygiene and secured with tape the ventilator tube to Pt #32's face.

9. An interview was conducted at approximately 11:35 AM with the Manager of Surgery (E#27). E#27 stated that the Anesthesiologist should always wear gloves when providing patient care and should sanitize hands when removing gloves.

Based on observation, document review, and interview, it was determined for 1 of 1 (Pt #29) patient observed during a Cath Lab procedure, the Hospital failed to ensure surgical attire was donned properly. This has the potential to affect all patients receiving Cath lab services.

1. During a tour of the Cardiac Catheterization Lab conducted on 1/23/19 at approximately 10:15 AM, Pt #29 was receiving a Cardiac Catheterization procedure (long thin tube called a catheter is inserted in an artery or vein in the groin, neck or arm and threaded through the blood vessels to the heart). Registered Nurse Cath Lab (E #19) was the circulating nurse assisting during the procedure. E #19's sterile gown was not tied in the back and an area of E #19's scrubs was visible/exposed.

2. The Hospital's policy, "Dress Code for Surgical Areas" (last Reviewed/Revised by Hospital 01/03/2019), was reviewed on 1/24/19. The policy required that; "DEFINITIONS: Restricted area: includes the Operating Room (OR) suite, procedure rooms, and clean core. Surgical attire and hair coverings are required in this area... POLICY: 1. ... Appropriate surgical attire is worn within the surgical environment to provide high level cleanliness and hygiene. 2. Surgical attire is worn in the semi-restricted and restricted areas of the surgical environment...."

3. The Hospital's policy, "Surgical attire, donning/doffing" (last Revised by Hospital August 24, 2018) was reviewed on 1/24/19. The policy required that, "Sterile gowns and sterile surgical gloves are designed to create a barrier to prevent microorganism on hands and clothing from being transferred to the patient and causing a surgical site infection. Sterile gowns and gloves also act as a barrier and protect the hands and clothing of surgical personnel from microorganisms present on the patient. EQUIPMENT...Two-piece scrub suite (pants and top) Sterile gown in the correct size..."

4. An interview was conduced during the tour with Cath Lab Supervisor (E #20). E#20 stated that E #19 should have the sterile gown tied in the back. E #20 then instructed E #19 to tie gown.