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Based on observation, interview, record review, and policy review, the facility failed to:
- Assure that the Infant Security System (ISS) including Magnetic Door Locks (MDL, doors automatically lock when an alarm is activated) were maintained and fully operational to prevent infant abduction from the Maternal Child Unit (MCU, mothers and newborns) and Neonatal Intensive Care Unit (NICU, premature and ill newborns).
- Provide an effective communication process to assure that nursing staff had knowledge of ISS and MDL failures and provide directives until the repairs were made and retested.
- Develop an interim safety and security process to assure that nursing staff had knowledge of ISS and MDL failures and provide directives until the repairs were made and retested.

These deficient practices resulted in the facility's non-compliance with specific requirements found under the Condition of Participation: Patients Rights, A-144.

On 02/24/16, it was determined that an unsafe patient care environment and limited recognition of continued risks to the health and safety of patients, constituted an Immediate Jeopardy (IJ) and placed all patients of the facility at risk. The facility provided an acceptable plan of correction and implemented corrective actions to abate the IJ on 02/24/16 to prevent further risk to patients that included the following:
- On 01/28/16, the date it was discovered, the power to the failed MDLs were restored, validated, and documented.
- In the event of a failure in the system, the facility will conduct an immediate risk assessment and implement an interim security plan until repaired.
- The facility will always put 24/7 presence at doors that do not lock during tests until repaired and retested for function.
- Development of a process to report failures in the ISS, coordinate repairs to the system, Nursing shift-to-shift reports of ISS status, daily Security staff communications, and daily communication from Security to Nurse leaders of the affected area and the Vice President of Operations.
- Education of Security, Plant Operations, and Nursing staff responsibilities was conducted and added to new hire orientation.
- Weekly tests of the ISS including the engagement of the MDLs with reports submitted to the Environment of Care Committee.

Based on observation, interview, and record review, the main campus of the facility failed to:
- Assure that the Infant Security System (ISS) including Magnetic Door Locks (MDL, doors automatically lock when an alarm is activated) in were maintained and fully operational to prevent infant abduction from the Maternal Child Unit (MCU, mothers and newborns) and Neonatal Intensive Care Unit (NICU, premature and ill newborns);
- Provide an effective communication process to assure that nursing staff had knowledge of ISS and MDL failures and provide directives until the repairs were made and retested; and
- Develop an interim safety and security process to prevent infant abduction until failures in the system were repaired and fully operational.
These deficient practices to maintain an effective ISS and MDL, communicate failures, and implement interim safety and security measures for equipment failures until resolution; placed all infants at risk for abduction. The facility delivered approximately 5000 newborns per year. The facility census was 427.

Findings included:

1. Record review of ISS and MDL tests from 07/01/15 to 01/28/16 showed the following:
- 08/17/15: Tests conducted on MCU; no tests on NICU.
- 09/22/15: Tests conducted on MCU; no tests on NICU.
- 10/08/15: Tests conducted on MCU; no tests on NICU.
- 11/24/15: Tests conducted on MCU; no tests on NICU.
- 12/03/15: Tests conducted on NICU and found MDL failures; no tests on MCU.
- 01/12/16: Tests conducted on NICU (in response to a report of MDL failures) and found MDL failures; no tests on MCU.
- 01/14/16: Tests conducted by Security accompanied by an ISS Technician on NICU and found MDL failures; no tests on MCU.

2. Record review of ISS system tests showed an electronic mail document dated 12/04/15 at 3:36 PM from Staff TTT, Security Officer to Staff UUU, Director of Security, showed that she conducted ISS and MDL tests on 12/03/15 and found MDL failures at the following exits on the Fifth Floor NICU:
- Entrance to Five East Nursing Unit;
- Double doors between Room 5409 and the Family Waiting Room, 5001;
- Stair 5ST3A (name of stairwell) across from Southwest nursing station; and
- Stair 5ST1B (name of stairwell, location not identified).

3. Record review of an electronic mail dated 01/12/16 at 9:14 PM from Staff TTT, to Staff UUU, documented that she conducted ISS and MDL tests and found MDL failures in the following exits on the NICU:
- Double doors to elevator 5;
- Double doors in main corridor at Southwest (SW) nurses station;
- Double doors to East rear corridor; and
- Double doors to the SW rear corridor.
Stair 4A was not able to be tested due to too much foot traffic.

4. Record review of a Service Order from the company that installed the ISS and dated 01/12/16 documented that:
- On 01/12/16 at 3:15 PM, a facility staff called to report that there were a lot of communication failures of the ISS and spoke with an ISS Technician;
- The ISS Technician contacted Staff VVV, Director of Plant Operations, who reported that wires were being pulled for the Nurse Call system. The ISS Technician was unable to resolve the problems by remote communication so they scheduled an on-site visit for 01/18/16.
- On 01/14/16, an ISS technician was on-site and performed multiple checks of the ISS and MDL on the NICU.
- He identified multiple ISS failures and made multiple repairs.
- After completing repairs he contacted Staff TTT, Security Officer, and they tested all exits.
- The ISS technician documented MDL failures at Exit 12 (Main Entrance), Exit 7, and Exit 11 and reported that MDL failures were not part of the ISS. (They were the responsibility of the facility's maintenance department).
- Staff TTT would advise maintenance and her supervisor.

5. Record review of an electronic mail dated 01/15/16 at 3:21 PM from Staff TTT to Staff UUU documented that they went and retested the system and found that two stairwell doors (2A and 3A on the fifth floor) had mechanical issues with MDL.

6. Record review of a work order dated 01/15/16 at 3:31 PM showed two malfunctioning door locks on staircases (2A and 3A) on the fifth floor (NICU). There were no records available of other work orders, communications, or retests of the MDL from 12/04/15 (date failures were identified) to 01/28/16 (date of record review).

7. Observation on 01/27/16 from approximately 12:00 PM to 12:25 PM, showed Staff RRR, Security Officer, tested the exit doors on MCU and NICU, and found MDL failures on NICU-Exit 2A and MCU-Exit 2C. (There were no records of tests on MCU since 11/24/15.)

During interviews on 01/27/15 at approximately 12:00 PM:
- Staff PPP, Clinical Support Nurse, stated that she received no report that there had been problems with the MDL on the Fifth floor (NICU) or Sixth floor (MCU);
- Staff N, Director of MCU and NICU, stated that she was not aware that some MDL had not worked;
- Staff WWW, RN, stated that Security was in charge of the ISS and she had no knowledge of problems with the ISS and MDL; and
- Staff DD, RN Team Leader of MCU, stated that she was not aware of problems with the MDL.

During an interview on 01/27/16 at approximately 12:25 PM, Staff N, stated that she just found out that one of her nurses on NICU reported the problem to the ISS installer on 01/12/16.

During an interview on 01/28/16 at approximately 12:26 PM, Staff DD, stated that there was no process to notify nursing staff or to track failures of MDL until they were repaired.

8. Even though requested no documents were submitted that showed repairs and retests of failed MDL on the NICU from 01/15/16 (the date of the work order) to 01/28/16 (the date of the observation), and there were no records of ISS and MDL checks on the MCU from 12/04/15 to 01/28/16.

9. During an interview on 01/28/16 at approximately 1:20 PM, Staff UUU, Director of Security stated that:
- Security conducted full tests (ISS and MDL tests of all exits on both MCU and NICU) one time per month.
- On 01/12/16, a nurse reported that there were ISS failures on the NICU, contacted the ISS, and the installer conducted an assessment of the problems through remote access (computer access through the Internet).
- He instructed Staff TTT, Security Officer, to conduct tests of the ISS on the fifth floor (NICU).
- Security performed no retests of the ISS and MDL from 01/14/16 to 01/28/16 to assure they were fully operational.
- He was not aware that some MDL were still not working and that Staff TTT was responsible.
- He did not provide oversight of Staff TTT related to the ISS and MDL tests and repair.
- There was no preventative maintenance system except for the monthly tests conducted by Staff TTT.
- They had no monitoring or maintenance agreement with the ISS installer.
- When nursing reported problems with the ISS system, they contacted Security, an Officer examined the causes, and usually found they were operator errors.
- He received no other reported problems except for the one that occurred on 01/12/16.
- They were responsible to communicate with nursing staff when there were problems, but the communication was not made in writing.
- There was no document that showed what staff were expected to do from the point when a failure was identified until it was repaired.
- Plant Operations was not involved in tests or failures of the ISS and MDL unless Security submitted a Work Order.
- There was inconsistent communication between Security and Plant Operations regarding the status (fully operational or failures) of the ISS and MDL.

During an interview on 01/28/16 at approximately 1:40 PM, Staff VVV, Director of Plant Operations, stated that:
- Security managed the ISS and MDL.
- There was irregular communication between Security and Plant Operations and they (Plant Operations) did not participate in system tests.
- He assumed the systems were fully operational unless he was notified by Security of needed repairs.
- There was no interim safety/security plan or policy to direct staff what to do when there were failures in the ISS or MDL to prevent infant abduction.

Based on observation, interview, and policy review the facility failed to ensure that staff followed infection control policies and standards when they failed to:
- Perform hand hygiene (wash hands with soap and water or use hand sanitizer) and change gloves after touching a contaminated inanimate objects and prior to administration of medications including intravenous (IV, within a vein) medication for five patients (#2, #4, #5, #6 and #15) of seven patients observed.
- Perform hand hygiene before putting on gloves and inserting a lancet (a small sharp blade) into the newborn's heel to obtain a blood specimen for one patient (#19) of one patient observed.
- Perform hand hygiene and apply a clean pair of gloves after touching a contaminated privacy curtain and her hair; and inserting a needle into the patient's hand to start an IV for one patient (#22) of one patient observed.
- Use an applicator when applying ointment to an infectious wound for one patient (#18) of one patient observed.
- Dispose of outdated foods and label open food containers in the kitchen cooler.
These deficient practices had the potential to increase the risk of cross contamination and placed all patients, visitors, and staff at risk for infection. The facility census was 427.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene," dated 03/2013, showed Hand Hygiene was the most important means for preventing the transmission of infectious organisms, and directed staff to perform hand hygiene:
- Before and after each patient contact;
- After handling patient equipment;
- After removing gloves;
- Before performing any invasive procedure;
- Before and after contact with wounds; and
- When moving from a contaminated body site to a clean body site during patient care.

Record review of the facility's policy titled, "Standard Precautions," dated 04/2014, showed Standard Precautions were based on the principles that all blood, body fluids, secretions, excretions, non-intact skin and mucous membranes may contain transmissible infectious agents; and directed staff to perform hand hygiene between patient contacts and after glove removal; and utilize appropriate barriers to protect themselves from possible exposure to bloodborne pathogens (infectious microorganisms in blood that can cause disease in humans) and other potentially infectious materials.

Record review of the facility's policy titled, "Isolation Guidelines," dated 05/2014, showed the following:
- Isolation Precautions were designed to prevent the spread of microorganisms to patients, personnel, and visitors;
- Patient care processes, including hand hygiene, isolation, and cleaning of portable equipment; included measures to protect the patient from infection or colonization (have microorganisms but no active symptoms).
- Contact isolation was designed to reduce the risk of antibiotic resistive organisms, including Vancomycin Resistant Enterococcus (VRE), by direct or indirect contact with items in the patient's environment.

2. Observation and concurrent interview on 01/26/16, at 9:00 AM, on the 2 East Unit, showed the following:
- Patient #2 was in contact isolation related to having a history of VRE.
- Staff I, Registered Nurse (RN), failed to perform hand hygiene and change gloves after she touched the contaminated computer keyboard in the patient's room, prior to administration of an intravenous medication.
- Staff I stated that the computer keyboard was cleaned one time a day by the housekeeping department and as necessary by the nurse assigned to the patient. Staff I stated that she had not cleaned the keyboard yet that day.

3. Observation on 01/26/16, at 9:15 AM, on the Intensive Care Unit (ICU), showed that Patient #4 was in contact isolation related to having a history of Clostridium difficile (C diff, a bacteria that causes mild to severe diarrhea and intestinal conditions). Staff J, RN, failed to perform hand hygiene when she changed gloves on two separate occasions while caring for the patient and when she administered medications.

4. Observation on 01/26/16 at 9:40 AM, in the ICU showed that Staff K, RN, was in Patient #5's room to administer medication. She put on gloves, typed on the computer keyboard, touched the patient's bare arm, administered oral medication, moved the bedside table, typed on the computer keyboard again but did not change gloves or perform hand hygiene between the times she touched the patient and inanimate objects.

During an interview on 01/26/16 at 9:40 AM, Staff K stated that she should have changed gloves and performed hand hygiene.

5. Observation on 01/26/16 at 9:53 AM, Staff J entered Patient #6's room to administer medications. She administered the patient's oral medications and an injection. She typed on the computer and used the computer mouse, touched the patient's IV tubing, then emptied the urinary catheter bag (a drainage bag that collects and holds urine). She changed gloves after that but did not perform hand hygiene between glove changes.

During an interview on 01/26/16 at 9:53 AM, Staff J stated that she didn't think about performing hand hygiene between glove changes until after the fact but knew she should have done that.

6. Observation and concurrent interview on 01/26/16 at 10:57 AM, ICU, showed that Patient #15 was in contact isolation for VRE. Staff V, RN, put gloves on but failed to perform hand hygiene and glove changes to prevent the possible transmission of infectious organisms by the following:
- Placed medications on contaminated computer keyboard, then touched patient and gave three intravenous medications without glove change;
- Dropped packaged syringe on floor, picked it up and gave intravenous medication without glove change;
- Typed on contaminated computer keyboard, then gave Lovenox (blood thinner) injection in patient's abdomen without glove change;
- Failed to clean her personal stethoscope before and after she entered Patient #15's room; and
- Staff V, stated that typically she wouldn't change gloves in an isolation room, but she would have put a second pair on.

During an interview on 01/26/16 at 3:18 PM, in ICU, Staff Y, Director of Critical Care, stated that she didn't think glove changes were a problem with Staff V in Patient #15's room.

During an interview on 01/26/16 at 3:45 PM, Staff RR, Infection Control RN, stated that she didn't think staff had to perform glove changes after placing medication on keyboard.

7. Observation on 01/26/16 at 1:45 PM, on the Maternal Child Unit, showed Staff GG, RN, while preparing to draw blood on Patient #19, touched the contaminated computer keyboard, and without performing hand hygiene inserted a lancet into the newborn's heel to obtain a blood specimen.

During an interview on 01/26/16 at 1:50 PM, Staff GG, stated that she knew she was expected to use hand hygiene after touching the keyboard but she got nervous and missed it.

8. Observation on 01/26/16 at 3:45 PM, on the Neonatal Intensive Care Unit (NICU, premature and ill newborns) showed Staff HH, RN, while preparing to start an IV on Patient #22, touched the privacy shade, put her fingers in her hair, and without performing hand hygiene, she inserted the needle into the patient's hand.

During an interview on 01/26/16 at 1:55 PM, Staff N, NICU Director, stated that Staff HH should have washed her hands after touching the privacy curtain and her hair.

9. During observation, on the 2 West Unit, of wound care on 01/26/16 at 2:15 PM, Staff MM removed the dressing from Patient 18's buttocks. Staff MM applied ointment to the affected area with a gloved finger and placed the tube of ointment (uncapped) on the computer key board.

During an interview on 01/28/16 at 9:40 AM Staff U, RN Team Leader 2 West, (present during observation) stated that she had discussed the procedure with Staff MM and advised her that she should have used a cotton tip swab to apply the ointment and should not have placed the ointment on the keyboard.

During a telephone interview on 01/28/16 at 10:10 AM, Staff MM, RN, stated that she knew the minute she placed the ointment on the keyboard that she should not have placed it there. Staff MM stated that normally she used a cotton tip applicator to put ointment in the skin.

During an interview on 01/28/16 at 10:15 AM, Staff OOO, Physician Director of Infection Control, stated that he was unaware that nurses used the computer keyboard shelves to set their medications on. He stated that it would be something that needed to be addressed and should be avoided.

10. Record review of the "United States Department of Health and Human Services Food Code," dated 08/2015, stated that a food shall be discarded if the food is not consumed before the expiration date and if it is in a container or package which does not bear a date.

11. Record review of the facility's policy titled, "Food Safety Product Labeling and Dating Guide," revised 07/29/2014, showed that product storage labels must have date of preparation and/or "use-by" date.

Record review of the facility's policy titled, "Food Product Shelf Life Guideline," revised 11/22/2010, showed that salad dressings expired after opened in ten to fourteen days and mayonnaise expired after opened in two months.

12. Record review of the Hazard Analysis Critical Control Point (HACCP, a food safety program), showed that ready-to-eat foods that have been prepared onsite or commercially prepared and opened must be labeled with date to be discarded.

13. Observation on 01/25/16 at 4:45 PM in the facility kitchen dairy cooler showed the following opened containers:
- Mayonnaise with expiration date of 01/20/16;
- Thousand Island Dressing with expiration date of 01/13/16;
- Coleslaw with no expiration date.

During an interview on 01/26/16 at 8:45 AM, Staff A, Director of Dietary Services, in the kitchen office stated that the Executive Chef is expected to walk through all coolers daily to recognize expiration dates.

During an interview on 01/26/16 at 9:15 AM, Staff W, Lead Cook, stated that the coolers are normally checked by a store room person. She also stated that there was a daily check by whoever was assigned and sometimes it was a new employee.

During an interview on 01/26/16 at 10:40 AM, Staff YY, Executive Chef in kitchen #1, stated that there were multiple team members assigned for coolers. He stated that he followed behind them auditing items for expiration. He also stated that he expected his staff to throw away items that were unidentifiable and thought that in the panic of the survey, someone put those opened containers in the back.

During an interview on 01/27/16 at 2:55 PM, Staff B, Executive Chef in kitchen #2, stated that they followed the HACCP policy for food safety.

During an interview on 01/28/16 at 8:47 AM, Staff A, stated that they go by their policy "Food Product Shelf Life Guideline" for expiration dates on individual food items.





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Based on interview, record review, policy review and Agreement review, the facility failed to notify their organ procurement organization (OPO) in a timely manner and failed to allow the OPO to make the determination of medical suitability for organ, tissue and eye donations for seven patients (#16, #49, #50, #51, #52, #53 and #54) of 24 patient OPO records reviewed for organ/tissue procurement. This had the potential to affect all patients who expired in the facility and had previously requested organ donation, by causing their organ(s) to be nonviable (unusable) due to untimely notification. The facility census was 427.

Findings included:

1. Record review of the facility's policy titled, "Organ and Tissue Donation," revised 08/2013, showed the following:
- The OPO will determine suitability based on established criteria.
- An OPO representative will speak with the family about organ donation.
- Contact with the family, by the OPO, should be documented by facility staff in the medical record with donation eligibility noted.

2. Record review of the facility's document titled, "Organ and Tissue Recovery Agreement," dated 01/15/2015, showed the following:
- The donor hospital will provide timely organ referrals to the OPO of all imminent deaths by notifying the donor hotline.
- Timely notification of referrals to the OPO is defined by the facility/vendor agreement as within one (1) hour of the imminent death, cardiac death, and prior to withdrawal of mechanical support.
- Referrals are made timely so that an on-site evaluation can be conducted by the OPO to determine the medical, legal and behavioral suitability of the referral.
- Donor hospitals' staff shall not rule out any patients as potential donors.

3. Record review of Patient #16's Emergency Department (ED) Expiration Check List dated 05/31/15, showed he expired on that date at 9:36 AM. Staff failed to notify the OPO until 11:00 AM, or one hour and twenty four minutes after the patient expired.

4. Record review of Patient #49's Intensive Care Unit (ICU) Expiration Check List dated 07/12/15, showed she expired on that date at 10:00 AM. Staff failed to notify the OPO until 12:57 PM, or two hours and fifty-seven minutes after the patient expired.

5. Record review of Patient #50's ED Expiration Check List dated 07/22/15, showed she expired on that date at 9:47 PM. Staff failed to notify the OPO until the following day 07/23/15 at 10:55 PM, or 25 hours and eight minutes after the patient expired.

6. Record review of Patient #51's ED Expiration Check List dated 03/29/15, showed she expired on that date at 6:34 AM. Staff failed to notify the OPO until 9:44 AM, or three hours and ten minutes after the patient expired.

7. Record review of Patient #52's Emergency Department (ED) Expiration Check List dated 07/06/15, showed he expired on that date at 1:39 PM. Staff failed to notify the OPO until 4:20 PM, or two hours and forty-one minutes after the patient expired.

8. Record review of Patient #53's Emergency Department (ED) Expiration Check List dated 02/06/15, showed he expired on that date at 9:10 AM. Staff failed to notify the OPO until 11:00 AM, or one hour and fifty minutes after the patient expired.

9. Record review of Patient #54's Emergency Department (ED) Expiration Check List dated 03/11/15, showed he expired on that date at 7:20 PM. Staff failed to notify the OPO until 9:52 PM, or two hours and thirty-two minutes after the patient expired.

10. During an interview on 01/26/16 at 3:05 PM, Staff Z, ED Director, stated that the OPO was not notified timely because staff could not reach the family, or next of kin (NOK, family members, relatives), contrary to the facility's Agreement with the OPO that the OPO contact the family.

During an interview on 01/27/16 at 2:54 PM, Staff AA, Regulatory Director and Patient Safety, stated that staff should not delay OPO referral to reach the family/NOK, as the OPO is responsible to contact the family/NOK per Agreement.

During an interview on 01/28/16 at 9:25 AM, Staff AA stated that the timeliness of the OPO notification was not tracked by the facility and they were unaware that the Agreement was not honored.



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