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Based on observation, document review, and interview, it was determined that the Hospital failed to ensure patients' rights were protected. This potentially affects approximately 29 patients on the Hospital census. As a result, the Condition of Participation, 42 CFR 482.13, Patient Rights was not in compliance.

Findings include:

1. The Hospital failed to ensure the parents/guardians were informed regarding the use of the psychotropic medication, prior to administration. See deficiency at A - 131.

2. The Hospital failed to ensure that the Child/Adolescent Behavioral Units (3 North and 3 South) were free of ligature risks. See deficiency at A - 144 A.

3. The Hospital failed to ensure that all Hospital staff followed the policy during a Code Pink Drill.
See deficiency at A - 144 B.

4. The Hospital failed to complete the Notification of Restriction of Rights document, to ensure the appropriate usage of restraint devices. See deficiency at A - 154.

5. The Hospital failed to ensure a Physician's order was obtained for the use of restraint/seclusion. See deficiency at A - 168.


39802

Based on document review and interview, it was determined that for 1 of 4 adolescent clinical records (Pt. #34) reviewed for psychotropic medication usage, the Hospital failed to ensure the parents/guardians were informed of the use of psychotropic medication prior to administration.

Findings Include:

1. The Hospital's policy titled, "Medications and Psychotropic Medications" revised 1/1/16,was reviewed on 9/19/18 and included, "III. Procedure...4...A new informed consent for psychotropic will be initiated for each new psychotropic medication order...The attending physician must complete the informed consent for psychotropic form..."

The following was found at Hospital B:

2. The Hospital's psychotropic medication list was reviewed on 9/19/18 at 10:25 AM, and included Risperidone -antipsychotic.

3. On 9/18/18 at approximately 10 :30 AM, Pt. #34's clinical record was reviewed. Pt. #34 was a 17 year old male who was admitted on 9/10/18, with the diagnoses of autism and schizophrenia. Pt. #34's Physician's order included an order dated 9/10/18, for Depakote (anti-depressant used for bipolar disorder) 500 mg (milligrams) once daily, and an order dated 9/12/18 for Risperidone (antipsychotic) 1 mg 2 times daily (morning/evening). Pt. #34's medication administration record included documentation that the following medications were given: Depakote on 9/11/18 - 9/16/18 and Risperidone on 9/11/18 - 9/14/18. Pt. #34's psychotropic medication consent for Depakote and Risperdal dated 9/10/18 lacked dose, route, frequency, reason for the medication and the physician's signature.

4. On 9/18/18 at approximately 10:40 AM, an interview was conducted with a Registered Nurse (E #30). E #30 stated that a psychotropic medication consent must be completely filled out and signed by the physician and when Depakote is used to treat bipolar disease it is treated as a psychotropic medication and a consent is signed.

A. Based on observation, document review, and interview, it was determined that the Hospital failed to ensure that the Child/Adolescent Behavioral Units (3 North and 3 South) were free of ligature risks. These risks could potentially cause harm to the 15 patients on the census that were on suicidal precautions, as of 9/18/18.

Findings Include:

The following was found at Hospital B:

1. On 9/18/18 between 10:00 AM and 10:45 AM, an observational tour of the 3 North and 3 South (Child /Adolescent) Behavioral Unit was conducted with E #31 (Director, Child and Adolescent Behavioral Unit). The Behavioral Unit had a total of 30 patient rooms:

- In 3 North, there were 12 patients on the census, with 8 patients on suicide precautions (every 15 minute checks for potentially suicidal patients). There were three shower rooms on the unit: 1 inside a patient's room (3N28); and 2 common shower rooms (3N11 and 3N13). The 3N13 shower room had a sign that included, "Do not use." Each of the shower rooms had 1 shower curtain hanging from a ceiling-mounted curtain track using multiple plastic clips. When these shower curtains with multiple clips were drawn together applying approximately 140 pounds of weight, the shower curtains could not be disengaged from the shower track.

- In 3 South, there were 10 patients on the census, with 7 patients on suicide precautions. There were two shower rooms: 1 inside a patient's room (3S46) and 1 common shower room (3S33). Both of the shower rooms had 1 shower curtain each, which was hanging using multiple plastic clips. When these shower curtains, with multiple clips were drawn together applying approximately 140 pounds of weight, the shower curtains could not be disengaged from the shower track.

- All of the 30 patient entry room doors included ligature risks - 3 solid hinges attached to the door frame and solid door. The hinges on the doors were placed approximately 2 and ½ feet from each other. The hinges present a structure to attach linen, cords, or other means of strangulation.

2. On 9/18/18 at approximately 12:00 PM, the Hospital's policy titled, "Suicide Assessment" (revised 1/2016) was reviewed and included, " ... All reasonable efforts must be implemented to protect the potentially suicidal patient from accomplishing his/her plan for self-destruction ..."

3. On 9/18/18 at approximately 12:15 PM, the Hospital's policy titled, "Contraband Policy" (revised 5/2018) was reviewed and included, "It is the policy of (the Hospital) ... to provide a safe ... environment for patients ..."

4. During the tour on 9/18/2018 at approximately 10:45 AM, E #31 stated that the common shower rooms in 3 North and 3 South are used by all patients (including patients on suicidal precautions) for each unit. E #31 said that in 3 North, the door sign in the shower room 3N13 that says, "Do not use" was not because of the shower curtain but due to missing tile issue. E #31 added that the shower curtains in 3 North and 3 South Units will be removed.

5. On 9/18/18 at approximately 12:45 PM, another observational tour of the 3 North and 3 South Units was conducted. During the tour, it was noted that all of the shower curtains had been removed, including the ceiling-mounted curtain tracks.

6. On 9/18/18 at approximately 3:00 PM, E #31 stated that there are plans to replace the doors, which had been purchased by the Hospital.

7. On 9/19/18 at approximately 10:30 AM, interviews were conducted with E #31 (Director of Behavioral Unit) and E #32 (Chief Operating Officer). E #31 stated that the hinges on the patient room doors had been identified as ligature risks. E #31 stated that funds have been allocated, and the door hinges will be replaced in the Fall of 2018. E #31 added that patient and hallway monitoring, as well as video surveillance reviews have been instituted to ensure patients' safety.

8. On 9/19/18 at approximately 11:30 AM, E #32 (Chief Operating Officer) provided an email from a Hospital Contractor dated 9/19/18 that included, "(The Hospital Contractor) will be starting the Behavioral Health work on or before 10/8/18 ..." The scope of work that will be provided by (The Hospital Contractor) including, "Provide and install ligature resistant hinges (full length hinges) on patient room doors ..."


39802


B. Based on document review, observation, and interview, it was determined that the Hospital failed to ensure that all Hospital staff followed the policy during a Code Pink Drill (Infant Abduction). This placed all 11 patients in the Neonatal Unit at risk for abduction.

Findings include:

This was found at Hospital A:

1. The Hospital's policy titled, "Code Pink" (last revised 6/1/16), was reviewed on 9/18/18 and required, "...Code Pink, is an unauthorized removal/exit of an infant/child/youth from the hospital... a 'Code Pink' will be announced to alert the entire hospital to the removal/exit. At this point more staff will respond to lock down the facility and begin a search for the missing patient... Available staff will guard all exit doors... The facility will be locked down and no person will be allowed to leave the institution until the 'All Clear' is given...All staff will assist in the investigation..."

2. A Code Pink Drill Summary, dated 4/30/18 at 7:48 AM, was reviewed on 9/18/18. The summary included, "...announced a Code Pink... [at Hospital A]... All security personnel responded accordingly... No other department responded, except for... food service..."

3. A tour of the 2nd floor Mother/Baby Unit was conducted on 9/18/18, between 9:37 AM and 11:22 AM. The Mother/Baby unit was a locked unit requiring a badge for entry and exit. At approximately 10:41 AM, a Code Pink Drill was called after a monitoring band for an infant patient was cut/removed. The alarm sounded at the nurses' station, located in the middle of the postpartum hallway. At approximately 10:43 AM, an unidentified patient or visitor was let out of the locked unit by the Unit Secretary (E#11). Additionally, the southeast stairway exit (near room #224) in the postpartum hallway was not monitored by staff until approximately 10:45 AM (4 minutes later).

4. A tour of the 6th floor Orthopedic/Medical Surgical Unit was conducted on 9/18/18 at 10:00 AM. At approximately 10:40 AM, a code pink was called overhead in the Hospital. None of the staff responded to the code. The unit secretary made a phone call, "to find out if the code was real," and announced that the code was real. The staff still failed to respond to the Code Pink. When asked what the staff's responsibility was during a code pink drill, the Clinical Educator (E#18) stated, "We watch for any woman carrying a baby and question them. Also, we are on the 6th floor and the nursery is on the 2nd floor, they wouldn't go up to take an abducted patient." After six minutes, at approximately 10:46 AM, a staff member went to one of the stair well exits and another staff stood by the elevator.

5. An interview was conducted with the Mother/Baby Unit Manager (E#10) on 9/18/18, at approximately 10:47 AM. E#10 stated that nobody should leave the unit during a code pink. The unit doors are locked and only staff with a badge can exit. For all other persons, the door must be opened by the secretary at the front desk.

6. An interview was conducted with the Mother/Baby Unit Secretary (E#11) on 9/18/18, at approximately 10:52 AM. E#11 stated that during a code pink, "If any visitors arrive, I let them come in and sit here [in the waiting room] ... I did let that one lady go [exit the unit]. She was a patient... [she was] here since this morning... Typically [persons wanting to exit the unit] are supposed to sit here in the waiting room [until the code pink is cleared]..."

7. An interview was conducted with the Head of Security (E#12) on 9/19/18, at approximately 9:45 AM. E#12 stated that code pink drills are done twice a year in collaboration with the Mother/Baby Unit Manager (E#10) and the Safety Officer. E#12 stated, "All drills are a surprise and all staff on all units are expected to respond as if the code pink is real... Staff are expected to keep an eye on all exit doors [including ones with alarms]... No one should be leaving or coming on the unit during a code pink... Everyone should get involved..." E#12 stated that staff on the floors above should also respond to the code pink and are expected to in case the abductor goes up from the Mother/Baby unit. E#12 stated that timely responses are evaluated on the Mother/Baby unit and at the main entrance. However, no one is posted to evaluate staff responses on any other unit/floor. E#12 stated that (Hospital B) had their first code pink drill this year (on 4/30/18) because "children may arrive at the stand-by ED [emergency department] located there... It was their first time, so not a lot of staff responded... We plan to conduct another drill in response..." No other action plan was implemented. All clinical and non-clinical staff (i.e. secretaries) are required to receive code pink training upon hire and annually.

Based on document review and interview, it was determined that for 1 of 2 (Pt #40) adolescent clinical records reviewed for restraint usage, the Hospital failed to complete the Notification of Restriction of Rights document, to ensure the patient/guardian is aware of why a restraint/seclusion is being used.

Findings include:

1. The Hospital policy entitled, "Utilization of Restraints and Seclusion," (revised 7/13/17) included, "...IV. Special Instructions: Notice of Restriction Rights - Patients on inpatient behavioral health units must be given a Notice Regarding Restriction Rights...whenever they are placed in Restraints or Seclusion and a copy of the Notice must be provided to the patients guardian, parent (if patient is under 18 years of age)..."

The following was found at Hospital B:

2. The Hospital's "Chicago Children's Center for Behavioral Health Restraint/Seclusion Log," for the period of 7/31/2018 to 9/17/2018 was reviewed on 9/18/18 at approximately 2:00 PM. The Log included that Pt #40 was in a restraint device (physical hold) two times on 9/2/18 from 11:04 AM until 11:12 AM and from 11:17 AM until 11:35 AM.

3. The clinical record of Pt #40 was reviewed on 9/19/18 at approximately 10:30 AM. Pt #40 was a 12 year old female, who was admitted on 8/28/18 with diagnoses of bipolar disorder with psychosis and rule out post traumatic stress disease. Pt #40's clinical record lacked documentation of a Notice Regarding Restriction Rights having been completed and sent to the patient's family/guardian, regarding the restraint issues from 9/2/18.

4. On 9/19/18 at approximately 1:15 PM, the Staffing Coordinator for the Adolescent Unit (E #33) was interviewed. E #6 stated that the Restriction of Rights form should have been completed.

Based on document review, and interview it was determined, that for 2 of 2 (Pt. #32 and Pt #40) adolescent clinical records reviewed for seclusion, the Hospital failed to ensure that a Physician's order was obtained for the use of restraint/seclusion.

Findings Include:

1. The Hospital's policy titled, "Utilization of Restraints and Seclusion" (revised 7/13/17) was reviewed on 9/18/18 and included, "...V. Required procedures...5. Restraints and Seclusion Orders must; a. Be initiated in accordance with the order of a physician or other LIP [Licensed Independent Practitioner] for each episode. Once a restraint order is discontinued, a new order is required, even if the patient exhibits the same behavior that resulted in the initial application of Restraints or Seclusion...B. Restraint and Seclusion for Violent and Self Destructive Behavior 1. Emergencies...c. An order for Restraints or Seclusion must be obtained either during the application of the Restraint or Seclusion or immediately - within a few minutes - after the Restraint or Seclusion has been applied..."

The following was found at Hospital B:

2. On 9/18/18 at approximately 9:30 AM, Pt. #32's clinical record was reviewed. Pt. #32 was a 11 year old male who was admitted on 9/14/18, with the diagnoses of autism spectrum disorder, bipolar affective disorder and neurodevelopmental disorder. Pt. #32's nurse's note dated 9/16/18 at 9:51 AM, included, "Pt. [Pt. #32] was placed in seclusino [seclusion] at 7:47 to 6:03 [8:03 AM per Registered Nurse (E #2)] (AM/PM not specified) for agitation. Pt. [Pt. #32] was pacing the halls, going in/out of rooms and hitting staff...Pt. [Pt. #32] was given Haldol (antipsychotic) 2.5 mg (milligrams) with poor results." Pt. #32's nurse's note dated 9/16/18 at 9:53 AM, included, "Pt. [Pt. #32] put into second seclusion from 8:58 to 9:13 (AM/PM not specified) for similar behavior. Pt. [Pt. #32] calmed down but was still hitting at staff and was given thorazine(antipsychotic) 50 mg." Pt. #32's, "Notice Regarding Restricted Rights of Individuals" dated 9/16/18 at 7:50 AM and 8:58 AM. Pt. #32's clinical record contained a Physician's order dated 9/16/18 at 7:58 AM, that included that Pt #32 be placed in locked seclusion once, for 1 occurrence. Pt. #32's medical record lacked a Physician order for locked seclusion on 9/16/18 at 8:58 AM.


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3. The Hospital's "Chicago Children's Center for Behavioral Health Restraint/Seclusion Log," for the period of 7/31/2018 to 9/17/2018 was reviewed on 9/18/18 at approximately 2:00 PM. The Log included that Pt #40 was in a restraint device (physical hold) on 8/30/18 from 2:10 PM until 2:21 PM and two times on 9/2/18 from 11:04 AM until 11:12 AM and from 11:17 AM until 11:35 AM.

4. The clinical record of Pt #40 was reviewed on 9/19/18 at approximately 10:30 AM. Pt #40 was a 12 year old female who was admitted on 8/28/18 with diagnoses of bipolar disorder with psychosis and rule out post traumatic stress disease. Pt #40's clinical record contained a Restriction of Rights notice for the restraint event dated 8/30/18, however the record lacked a physician's order for the restraint usage. Pt #40's clinical record lacked physicians' orders for the documented restraint usages on 9/2/18.

5. On 9/18/18 at approximately 9:45 AM, an interview was conducted with a Registered Nurse (E #29). E #29 stated that if seclusion is discontinued a new physician order must be obtained. E #29 stated that there is not a physician order for Pt. #32's second occurrence of seclusion.

6. On 9/19/18 at approximately 1:15 PM, the Staffing Coordinator for the Adolescent Unit (E #33) was interviewed. E #33 stated that there were no orders for the documented restraint usage and there should have been.

Based on document review, observation, and interview, it was determined that for 1 of 1 patient (Pt. #14) with an intravenous (IV) catheter on the Mother/Baby Unit, the Hospital failed to ensure that IV assessments and care were documented.

Findings include:

1. The Hospital's "Intravenous (IV) Guide to Care and Maintenance: IV, Midline, PICC [peripherally inserted central catheter] Lines, Central Lines, and Implanted Ports" (undated), was reviewed on 9/18/18 and required, "Documenting PIV [peripheral IV] Insertion [should include:]... Placement/Date/Time... Indication/Daily Review of Necessity... Site Preparation/Maintenance... Securement... Patency/Maintenance... Phlebitis [inflammation of the vein]... Infiltration [leakage of IV solution/medication]... Interventions... Extravasation [leakage of damaging IV solution/medication]... Primary RN [registered nurse] is responsible for performing and documenting daily assessment. When should assessments be completed? At least once a shift and as needed... When administering IVF [IV fluids], meds , etc... change of site... What do I assess?... Site/Complications... Dressing... Patency..."

This was found at Hospital A:

2. The clinical record of Pt. #14 was reviewed on 9/18/18 at approximately 10:55 AM. Pt. #14 was a 34 year old female, who was admitted to the Mother/Baby Unit on 9/16/18 for active labor and had a vaginal delivery on 9/17/18. The medication administration record (MAR) indicated that Pt. #14 received continuous IV Lactated Ringers (fluid used to replace fluid and electrolytes in those who have low blood volume or low blood pressure), while in active labor, from 9/16/18 at 8:25 PM to 9/17/18 at 1:45 PM. Pt. #14 also received an infusion of IV oxytocin [hormone that aides with contractions during labor and reduces bleeding after delivery] from 9/16/18 at 10:56 PM to 9/17/18 at 1:45 PM. The record lacked documentation of Pt. #14's IV insertion, assessments and care.

3. During an observational tour of the Mother/Baby unit on 9/18/18, at approximately 10:30 AM, a PIV was observed on Pt. #14's left hand.

4. An interview was conducted with a Registered Nurse (E#17) on 9/18/18, between 10:55 AM and 11:15 AM. At approximately 11:08 AM, E#17 stated that Pt. #14 had a "Hep Lock [IV catheter capped off for later use]." E#17 could not find documentation of the IV insertion nor any IV assessments in Pt. #14's electronic medical record. E#17 stated that assessments are done at least every shift. E#17 stated, "It's [IV insertion] not in the chart... it [IV insertion and assessments] should have been documented... typically IV's are put on at admission... I don't know what time it was put in... she [Pt. #14] did receive IV medications [on 9/16/18 and 9/17/18]..." At 11:10 AM, E#17 entered the placement of the IV catheter and stated that she would put a note that the IV was inserted on an earlier date (9/16/18). E #17 entered the IV catheter insertion note 2 days late (on 9/18/18).

Based on document review and interview, it was determined that, for 1 of 3 patients (Pt. #7), on the Telemetry/ Medical/ Surgical Unit on the 10th floor, the Hospital failed to ensure that a Plan of Care was developed for each patient.

Findings include:

1. On 9/18/18 at 1:50 PM, the Hospital's policy titled, "Assessment - Initial," (approved/ reviewed 9/2/15), was reviewed. The policy required, "III. Procedure... A. 3. All patients will receive nursing care based on plan of care. This assessment will be performed and documented using appropriate template in the Plan of Care... The Plan of Care should be based on Clinical Practice Guidelines, Clinical Practice Model, Nursing Standards of Practice, Standards of Care, and patient outcome expectations." There was no other policy related to Plan of Care."

This was found at Hospital A:

2. On 9/18/18 at 10:20 AM, Pt. #7's clinical record was reviewed. Pt. #7 was a 68 year old female, admitted on 9/12/18, with a diagnosis of metastatic colon cancer. There was no Plan of Care in Pt. #7's clinical record.

3. On 9/18/18 at 10:25 AM, an interview was conducted with the Telemetry Unit Charge Nurse (E #7). E #7 stated that there was no Plan of Care for Pt. #7 and E #7 "was not sure why it's not done."

Based on document review and interview, it was determined that for 1 of 2 (Pt. #5) patients receiving a blood transfusion, the Hospital failed to ensure the blood was transfused (administered - given) within 4 hours.

Findings include:

1. The Hospital's policy titled, "Transfusion Administration of Blood/Blood Component (revised 9/5/17)" was reviewed on 9/18/18 and required, "Blood and/or blood components should be transfused within four (4) hours of the time it was issued or removed from the Blood Bank designated monitored refrigerator. The 4 hour time frame begins when the unit is spiked."

2. The clinical record of Pt. #5 was reviewed on 9/18/18. Pt. #5 was a 47 year old female admitted on 9/17/18 with the diagnosis of chest pain. A physician's order dated 9/17/18 at 6:20 AM, included to transfuse one (1) unit of RBCs (red blood cells). The Blood Transfusion Record included that the unit of blood was started on 9/17/18 at 10:35 PM and stopped on 9/18/18 at 3:00 AM (4 hours and 25 minutes).

3. During an interview on 9/18/18 at approximately 10:55 AM, the Team Leader (E#8) on the Orthopedic/Medical Surgical unit stated, "Blood should be completed within 4 hours."

Based on document review and interview, it was determined that the Hospital failed to ensure clinical records were completed within 30 days of discharge.

Findings include:

1. The Medical Staff Rules and Regulations, dated July 26 2018, were reviewed on 9/18/18 and included, "Practitioners are responsible for completing the medical records of their patients within the thirty (30) days after discharge."

2. A letter, dated 9/18/18, presented on 9/19/18 at 9:15 AM included, "Please be advised as of today September 18, 2018, (Hospital) has a total of 100 delinquent medical records (records incomplete 30 days from discharge)."

3. During an interview on 9/18/18 at 2:45 PM, the Site Manager (E#9) of HIM (Health Information Management) stated, "Any record not completed within 30 days of discharge is considered delinquent. Currently there are 100 delinquent records."

Based on document review, observation, and interview, it was determined, that for 1 of 1 package of frozen potato pancakes (approximately 40 potato pancakes), the Hospital failed to assure that food was labeled with the receipt date or expiration date, affecting the safety of 253 patients on census on 9/19/18.

Findings include:

1. On 9/19/18 at 3:15 PM, the Hospital's policy titled, "Food Receiving and Storage - Food and Non- Food Products..." (effective 7/2016), was reviewed. The policy required, "III. Procedure... B. Storage: 1. The following general storage principles are utilized in the food and nutritional services department. a. All food when received should have the date of delivery stamped on the case... For those products that do not have an expiration and/or date of delivery, they will be stamped with the date of receipt..."

This was found at Hospital A:

2. On 9/19/18 at 10:45 AM, an observational tour was conducted in the Dietary Department. One package of approximately 40 potato pancakes was found in the freezer. The package lacked a label with either a receipt date or expiration date.

3. On 9/19/18 at 11:15 AM, an interview was conducted with the Director of Dietary (E #27). E #27 stated that the potato pancake package should have been labeled.

Based on observations 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 9/18 - 9/20/18, the facility failed to provide and maintain a safe environment for patients, staff and visitors.

Based on observations 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 9/18 - 9/20/18, the facility failed to comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

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

Based on document review, observation, and interview, it was determined that for 2 of 3 emergency/crash carts (CC#1 and CC#2) in the Mother/Baby Unit, the Hospital failed to ensure that medication and supply expiration dates were checked daily per policy.

Findings include:

1. The Hospital's policy titled, "Crash Carts/Defibrillators" (revised 6/15/16) was reviewed on 9/19/18 and required, "Crash cart is to be checked on each shift...Stickers with earliest expiration date are on the cart... Nursing also checks supplies sticker for expiration dates of supplies. Cart will be returned to the department for restocking if reaching expiration date..."

This was found at Hospital A:

2. On 9/18/18, a tour of the Mother/Baby Unit was conducted between 9:37 AM and 11:22 AM. There were 3 crash carts on the unit, 2 neonatal crash carts (CC#1 in the nursery and CC#2 in the operating room [OR] area) and 1 adult crash cart (CC#3). CC#1's daily check logs, did not include documentation that the expiration dates were checked for medications for the period of 6/1/18 to 9/18/18 and supplies for the period of 5/1/18 to 9/18/18. CC#2's daily check logs did not include documentation that the expiration dates for the supplies and\or medications were checked for the period of 5/11/18 to 9/18/18. Both CC#1 and CC#2 did not have stickers present on the cart to indicate when the earliest supply or medication would expire.

3. An interview was conducted with the Mother/Baby Unit Manager (E#10) on 9/18/18 at approximately 10:00 AM. When asked about the expiration date of medications and supplies for neonatal crash cart (CC#1), E#10 stated that the cart should be labeled with an expiration date. E#10 confirmed that there was no sticker/label on the nursery's neonatal crash cart (CC#1).

4. An interview was conducted with the Mother/Baby Unit Team Leader (E#16) on 9/18/18, between approximately 10:20 AM and 10:28 AM. E#16 stated that crash carts should have two stickers, one with the earliest expiration date of medications and the other for supplies. E#16 stated, "The crash carts are sent down to pharmacy if the expiration dates are coming up... If a cart is missing the expiration date stickers, it should also be sent down to pharmacy [to be checked and labeled with expiration dates]..." E#16 confirmed that the OR neonatal crash cart (CC#2) did not have any stickers with expiration dates and stated, "It [expiration dates] should have been checked."

Based on observation, document review, and interview, it was determined that the Hospital failed to ensure an effective Infection Control Program, that included adherence to infection control practices. Placing an approximately 23 surgical patients and 4 patients at risk for cross contamination. As a result, it was determined that the Condition of Participation 42 CFR 482.42 Infection Control was not in compliance.

Findings include:

1. The Hospital failed to ensure visitors were instructed to wear personal protective equipment (PPE) (gown and gloves) in a contact precaution room. See deficiency at A749-A.


2. The Hospital failed to ensure equipment and surgical instruments were thoroughly cleaned, thus creating the potential for surgical instrument contamination, affecting the safety of approximately 23 patients undergoing surgical procedures each day. See deficiency at A-749-B.

3. The Hospital failed to ensure that physicians followed hemodialysis attire and hand washing policies when assessing patients in the dialysis treatment area. See deficiency at A 749 - C.

4. The Hospital failed to ensure PPE (personal protective equipment) was properly worn while in one Patient's (Pt #12) contact isolation room. See deficiency at A 749 - D.

5. The Hospital failed to ensure that 1 of 1 Operating Room Surgical Technician (E #22), followed proper infection control procedures for hand hygiene and glove hygiene. See deficiency at A 749 - E.

A. Based on document review, observation, and interview, it was determined that, on the Telemetry/ Medical/ Surgical Unit on the 10th Floor, for 1 of 4 patients (Pt. #7) on contact precautions (isolation), with visitors in the isolation room, the Hospital failed to ensure visitors were instructed to wear personal protective equipment (PPE) (gown and gloves) in a contact precaution room.

Findings include:

1. On 9/18/18 at 12:30 PM, the Hospital's policy titled, "Isolation Procedures," (approved 7/19/18), was reviewed. The policy required, "III. Procedure... P. Visitors are educated on the use of PPEs when visiting a patient on isolation..."

This was found at Hospital A:

2. On 9/18/18 at 9:40 AM, an observational tour was conducted in the Telemetry/ Medical/ Surgical Unit on the 10th floor. There was a contact precautions sign posted to the door of Pt #7's. The Patient (Pt. #7) was lying in bed and Pt. #7's Brother and Daughter were also in the isolation room, without wearing PPE.

3. The Contact Precautions sign posted to the door included, "Contact Precautions... Visitors: See Nurse Before Entering Room... Gloves: Wear when entering the room... Gown: Wear when entering the room..."

4. On 9/18/18 at 10:03 AM, an interview was conducted with Pt. #7's Brother and Daughter. Pt. #7's Brother stated that he had not read the Contact Precaution sign and no one told him about wearing PPE. Pt. #7's Daughter stated that she was aware of contact precautions, but choose not to wear PPE.

5. On 9/18/18 at 10:20 AM, Pt. #7's clinical record was reviewed. Pt. #7 was a 68 year old female, admitted on 9/12/18, with a diagnosis of metastatic colon cancer. The clinical record did not contain documentation that anyone in Pt. #7's family was educated on the use of PPE.

6. On 9/18/18 at 10:25 AM, an interview was conducted with the Telemetry Unit Charge Nurse (E #7). E #7 stated that the clinical record did not include documentation that Pt. #7's Daughter or Brother had been educated on the use of PPE.

B. Based on document review, observation, and interview, it was determined that for 3 of 3 shelves, 2 of 2 surgical case carts, 2 of approximately 20 scissors, and 2 of approximately 30 wire brushes, the Hospital failed to ensure equipment and surgical instruments were thoroughly cleaned, creating the potential for surgical instrument contamination, affecting the safety of approximately 23 patients undergoing surgical procedures each day.

Findings include:

1. On 9/19/18 at 2:40 PM, the Hospital's policy titled, "Decontamination," (approved/revised 2/22/18) was reviewed. The policy required, "...IV. Definitions... C. Cleaning - means removal of contamination from an item to the extent necessary for further processing or for the intended use... cleaning consists of the removal... of adherent organic and inorganic soil... debris from the surfaces... that prepares the items for safe handling and/or further decontamination... V. Procedure... C. Preparation... 10. Manually brush instruments with stiff brush and then rinse debris form instrument..."

This was found at Hospital A:

2. On 9/19/18 at 3:40 PM, the Surgical Cleaning Brush Manufacturer's "Instructions for Use," (dated 5/4/18), was reviewed. The instructions included, "Steps for Use of Product... recommends that brushes are cleaned and disinfected at least daily, preferably between each use in order to limit the chance for cross contamination..."

3. On 9/19/18 at 9:30 AM, an observational tour was conducted in the Surgical Reprocessing Area and the following was found:

- In the sterile storage room, 3 of 3 top shelves contained dust/dirt. Containers and packages of sterile instruments were placed on the storage shelves.

- In the reprocessing area, near the cart washer, 2 of 2 clean surgical case carts contained paper stickers and tape residue. The 2 carts had gone through the cart washer, but were not clean.

- In the reprocessing area, in the clean instrument area, 1 of approximately 10 Mayo scissors (type of surgical scissors) and 1 of approximately 10 Metz scissors (type of surgical scissors) contained tape residue. Both scissors had been cleaned and were available for packaging and sterilization.

- In the decontamination area, at the cleaning sink, 2 of approximately 30 wire brushes contained debris. Wire brushes were used to clean surgical instruments before being sterilized. Wire brushes were not single use, but were reused.

4. On 9/19/18 at approximately 10:25 AM, interviews were conducted with the Manager of Sterile Processing (E #20) and the Manager of Infection Prevention (E #25). E #25 stated that the shelving in the sterile storage room should be clean and the surgical case carts should not contain tape and tape residue. E #20 stated that the Mayo and Metz scissors should not contain tape residue and the 2 wire brushes with debris would be disposed of.

C. Based on document review, observation, and interview, it was determined that for 1 of 1 Physician (MD #1), the Hospital failed to ensure that physicians followed hemodialysis attire and hand washing policy when assessing patients in the dialysis treatment area.

Findings include:

1. On 9/19/18 at 3:00 PM, the Hospital's policy titled, "Infection Control Policy for Hemodialysis," (approved/reviewed 8/2/15) was reviewed. The policy included, "... II. Definitions: A. Universal precautions... means the wearing of nonporous articles such as medical gloves... III. Procedures: A. Universal precautions are followed when dialyzing any patient... Protective coat is worn during the entire procedure..."

2. On 9/19/18 at 3:05 PM, the Hospital's policy titled, "Hand Hygiene," (approved 7/18/18) was reviewed. The policy included, "... III. Procedures: A. 1. If hands are not visibly soiled, use an alcohol based hand-rub for the routine decontamination in the following situations - Before and after direct contact with patients skin and/or clothing..."

This was found at Hospital A:

3. On 9/19/18 at 1:25 PM, an observational tour was conducted in the Dialysis Treatment Area. At 1:30 PM, a Physician (MD #1) entered the Dialysis Treatment Area and went to dialysis station #2, where a patient was receiving hemodialysis. MD #1, dressed in a suit and not wearing a cover gown, did not wash his hands or put on gloves. MD #1 spoke with the Patient and auscultated (listened to) the Patient's chest with a stethoscope. MD #1 did not disinfect the stethoscope or his hands when he left station #2. MD #1 went to the nurses station and touched one computer and then moved to and touched another computer. Approximately 2 minutes later, MD #1 disinfected his hands.

4. On 9/19/19 at 1:35 PM, an interview was conducted with the Manager of the Intensive Care Unit and Hemodialysis (E #14). E #14 stated that staff and physicians are expected to wear cover gowns and gloves when caring for patients receiving hemodialysis and MD #1 should have disinfected his hands when he removed his gloves and left the dialysis station.


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D. Based on document review, interview and observation, it was determined that for 2 of 2 Registered Nurses (E #13 and E # 15), the Hospital failed to ensure PPE (personal protective equipment) was properly worn in one Patient's (Pt #12) contact isolation room.

Findings include:

1. On 9/18/18 at approximately 2:00 PM, the Hospital's Contact Precautions signage posted outside isolation rooms indicated "Gown - Wear when entering the room. Must be removed before leaving the room."

This was found at Hospital A:

2. On 9/18/18 at approximately 9:45 AM, the Registered Nurse (E #13) was observed entering Pt #12's isolation room. E #13 was observed wearing the isolation gown on inside Pt #12's contact isolation room. E #13's isolation gown was not worn all the way and was not tied in the back. E #13 was observed leaving the isolation room and removing the isolation gown outside Pt #12's contact isolation room.

3. On 9/18/18 at approximately 9:50 AM, the Registered Nurse (E #15) was observed inside Pt #12's isolation room. E #15 's isolation gown was open and not tied in the back. E #15 was trying to tie his isolation gown in the back while standing next to E #15's bed. E #15 stated, "I'll get it eventually."

4. On 9/18/18 at approximately 9:50 AM, an interview was conducted with the Intensive Care Unit Manager (E #14). E #14 stated that E #13 and E #15 should have put the isolation gown on completely prior to entering Pt #12's contact isolation room.


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E. Based on observation, document review, and interview, it was determined that for 1 of 1 Operating Room Surgical Technician (E #22), the Hospital failed to ensure that proper infection control procedures were followed for hand hygiene and glove hygiene.

Findings include:

This was found at Hospital A:

1. On 9/19/2018 at approximately 10:20 AM, an observational tour of the Hospital's inpatient Surgical Department was conducted. In OR (operating room) #7, where a sterile field was being prepared, E #22 was observed opening sterile packages without wearing gloves, and was observed dropping sterile equipment on the floor, a total of 4 times, while trying to place them on the sterile field. E #22 then picked up 2 pieces of the contaminated equipment, discarded, and then proceeded to open new sterile packages without performing hand hygiene and/or donning gloves.

2. On 9/19/2018 at approximately 11:30 AM, the Hospital's policy titled, "Aseptic Technique-Principles and Patterns" (revised 1/27/2016) was reviewed and required, " ...II. Procedure ...3. Surgical hand antisepsis using either an antimicrobial soap or an alcohol-based hand rub with persistent activity is recommended before donning sterile gloves ...D. Tables are sterile only at the table level. 1. Suture and any other items falling over the table edges are discarded. The scrub person does not touch the part of the item hanging below the edge of the table ..."

3. On 9/19/2018 at approximately 2:30 PM, the Hospital presented a document from Elsevier Clinical Skills titled, "Skills-Surgical Packs: Distribution to Sterile Field (Perioperative)" and required, " ...Procedure 1. Perform hand hygiene and don head covering, mask ...Perform surgical scrub and don a sterile gown and sterile gloves. 2. Prepare the sterile field as close as possible to the time of use. 3. Ensure that each item's sterility and integrity are maintained when items are distributed to the sterile field. 11. If the sterility of an item is in doubt, consider it contaminated and discard the item."

4. On 9/19/2018 at approximately 2:30 PM, the Hospital presented the "2018 Edition Guidelines for Perioperative Practice-AORN" and included, "pages 36-37, III. a.4. Hand hygiene should be performed after contact with patient surroundings, including; the floor or items that have come in contact with the floor."

5. On 9/20/2018 at approximately 11:00 AM, an interview was conducted with the Operating Room Nurse Manager (E #23). E #23 stated, " ...if the surgical technician is setting up for surgery they are not scrubbed and they are not required to wear gloves while opening sterile packages. The table being set up is considered sterile at table (waist) level, if the tech drops anything, they can bend down and pick up and throw away and no hand hygiene is required." E #23, also stated, "If we don't have a hospital policy on any process or procedure related to the Surgical Department, we refer to the 2018 AORN Guidelines (Association of periOperative Registered Nurses)."

Based on observation, interview, and document review, it was determined that for 1 of 1 Certified Registered Nurse Anesthetist (CRNA-E #21) and 1 of 1 Surgeon (E #24) in the inpatient OR (operating room), the Hospital failed to ensure adherence to surgical attire, as required.

Findings include:

This was found at Hospital A:

1. On 9/19/2018 between 10:20 AM and 10:30 AM, an observational tour of the Hospital's inpatient Surgical Department was conducted. In OR (operating room) #7, a sterile field was opened and ready for use. E #21 and E #24 were observed with approximately 1-4 inches of hair exposed on the sides and backs of their heads.

2. On 9/19/2018 at approximately 10:45 AM, an interview was conducted with the Nurse Manager (E #23) of the Operating Room. E #23 stated, " ...everyone entering the operating rooms are expected to cover all hair on head and face."

3. On 9/19/2018 at approximately 11:20 AM, the Hospital's policy titled, "Surgical Attire" (revised 1/27/2016) was reviewed and required, "...II. Procedure ...All persons entering the semi-restricted and restricted areas of the Operating Room Suite must adhere to the dress code ...3. Persons entering ...will cover all head and facial hair ...7. All personnel will cover head and facial hair. A clean ...head cover that confines all hair and covers scalp skin will be worn ..."