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Based on observations, record reviews, interviews, review of the hospital's policies and procedures, the hospital's governance failed to ensure sufficient leadership oversight and intervention into the hospital's sterile processing activities during an extended period of significant managerial and staff turnover with a concomitant increase in surgical site infections, and the governance failed to ensure that the Emergency Department operated in a responsible manner to ensure the safety of those patients.

The findings are:

Cross Reference to A 0063: The hospital failed to ensure contracted employees are adequately trained and evaluated in areas that the contracted employee is assigned to ensure patient safety in the hospital's emergency department.

Cross Reference to A 0084: The hospital failed to ensure contracted employees are adequately trained and evaluated in areas that the contracted employee is assigned to ensure patient safety for the suicidal patients housed in the hospital's Emergency Department.

Based on observations, record reviews, interviews, review of the hospital's policies and procedures and procedural logs, the governing body in accordance with hospital policy failed to ensure that specific patient care requirements for patients in the emergency department were met and failed to ensure staff in the central processing area adhere to specific requirements in sterilization processes for patients receiving services in the Operating Room.

The findings are:

Cross Reference to A 0144: The hospital failed to ensure patients in its emergency department and operating room receive care and services in a safe setting.

Cross Reference to A 0385: The hospital failed to ensure a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care for patients assessed as high risk for suicidal intervention in the emergency department.

Cross Reference to A 0940: The hospital failed to ensure central processing personnel followed the hospital's policies and procedures for Immediate Use Steam Sterilization (IUSS) logs and Steam Sterilization and failed to ensure staff was appropriately trained in sterile processing.

Based on interview and record review, the hospital failed to ensure contracted employees are adequately trained and evaluated in areas that the contracted employee is assigned to ensure patient safety in the hospital's Emergency Department.


The findings are:


On 6/23/17 at 11:47 a.m., a telephone interview was conducted with Security Officer (SO) 1 who was assigned as the primary SO on duty on 6/17/17 to 6/18/17 from 10:00 p.m. to 06:00 a.m. SO 2 was assigned for break relief from 0340 a.m. - 0405 a.m. SO 1 revealed he/she was scheduled patient watch in the back of the Emergency Department for patient rooms 5, 6, and 7. Patient 20 who was on suicide watch was located in room 7 in the emergency department at the start of the shift. During the telephone interview, SO 1 reported, "When I arrived on duty, the patient was laying on the bed. The patient wanted to go to the bathroom, but the technician gave him a jug to pee in. The patient was a 1 on 1 watch, and I was sitting outside of the room, but I could see the patient. At 3:40 a.m., I went on break for about 20 minutes, and was relieved by another security officer. When I returned from break, the relieving officer was sitting outside of the room 7. When the other officer left, I could hear something moving around in the room so I pushed the door open. When I looked in the room the patient was standing next to the sink with a cord wrapped around his neck. He had something hooked to his chest, and he had removed it, and that was what was wrapped around his neck. There was a technician sitting behind me on a computer, and the technician and nurse came into the room and removed the cord from around the patient's neck. We snatched everything from the room and moved the patient to room five in the emergency department because the patient was getting wild. Then, another guard was watching him because he was bigger than me." When Security Officer 1 was asked about training for suicide patients, Security Officer stated, "I have been trained that if a patient is on watch for every ten minutes, you can sit outside the door, if they are 1 on 1. I sit within arms distance and still document every ten minutes to what they are doing. I normally work at another hospital in the lobby greeting people. I have not had training for the sitting with suicide patients in an emergency department. I always just sit in the lobby to greet people."

On 6/23/17 at 12:54 p.m., during an interview with the Program Security Manager revealed, " The security agency is staffed by employees from Security Services. All of the security officers are required to do hospital training specific to Cardiopulmonary Resuscitation, and non-violent crisis interventions, and courses to include overview of responsibilities and arrest powers. The security training is for three days. If an officer will be armed, they are required to have a fourth day of training to learn hand cuffing, pepper foam usage, weapons manipulation and instruction, and then to the shooting range to qualify. Once the officer is hired, they are assigned to their site. The hospital orientation is 1 day prior to post training onsite with the trainer. They are also required to take a HIPAA class, EMTALA training, patient restraints, and working in the Emergency Department. The security officers are responsible for completing the operational logs and the 10 minute observations sheets. The responsible officer should know why the patient they are observing is in the hospital, for example suicidal, homicidal, psychiatric, etc.... If a patient is a 1 to 1 watch, the officer should be in arms length of the patient. The room door should never be closed and has to remain open at all times, as well as lights, they are to remain on at all times during our watch. If the lights go out, it is documented. The officer must document every ten minutes on the Flowsheets, and at the end of the shift, nursing gets a copy of the ten minute sheet, and the report is scanned to the security office."

On 6/23/17 at 1:15 p.m., review of Security Officer (SO) 1's Training Checklist revealed: The employee was hired on 1/12/17. There were no initials of the security office recorded for any of the training materials listed on the sheet. Based on the training forms, there was no evidence that Security Officer 1 completed any training.

On 6/23/17 at 1:25 p.m., review of SO 2's Training Checklist revealed: The employee was hired 3/27/17. Page 1 of the training form was initialed by the trainee and the trainer for the training items listed numbers 1-19. None of the education items listed were related to observations of suicidal/ homicidal patients or the level of care between the 1:1 observation and the every 10 minute observations for these patients. Pages 2, 3, and 4 of the training form were not signed or initial by either the trainee or the trainer.

On 6/23/17 at 1:35, review of SO 2's witness statement revealed, "S/O (2) relieved S/O(1) in Gold Zone 7 at 0340. A nurse was present when I was there and S/O (1) was on a break. The nurse stated that the door would not stay open so I propped open the door with a stool so I could see in room. The nurse had cut the lights out in gold 7 when S/O 1 returned it was 0405 and I left gold zone.

On 6/23/17 at 2:00 p.m., review of SO 3's written voluntary statement revealed, "Since being hired on 1/12/17, SO 1 has not been trained to conduct patient watches. On June 17, 2017, Officer (SO 1) agreed to assist in this hospital to cover open posts."

On 6/23/2017 at 3:00 pm, Nurse Educator 1 and Nurse Educator 2 reported that there is no training or education provided for contract security staff in the hospital. Both Nurse Educators reported that since security is a contract service, that it is the responsibility of the security company to train their employees. Both Nurse Educators reported that there is no system in place for the hospital to ensure that security personnel is appropriately trained to perform duties required in indirect patient care.

Based on observations, record reviews, interviews, review of the hospital's policies and procedures, review of the hospital's personnel data, review of the hospital's sterilization data, the hospital failed to ensure its staff followed the hospital's policies and procedures to ensure protection and promote safety for patients requiring suicide watch and patients receiving services in the hospital's emergency department and surgical department.

The findings are:

Cross Reference to A 0144: The hospital failed to ensure patients in its emergency department and surgical department receive care and services in a safe setting.

Based on observations, record reviews, interviews, review of the hospital's policies and procedures, review of the hospital's logs, the hospital failed to ensure patients in its emergency department and surgical department receive care and services in a safe setting.

The findings are:

Cross Reference to A 0392: The hospital patients failed to receive care and services in accordance with the hospital's policies and procedures and Standards of Practice for its emergency department for 1 of 31 patient charts reviewed for care and services in that the services received did not meet the level of care that the patient was assessed as needing upon admission to the emergency department. (Patient 18)

Cross Reference to A 0395: The emergency department staff failed to ensure the safety and well being of patients admitted to the department expressing suicidal/homicidal ideas or behaviors in failing to supervise contractual security staff in the performance of their duties resulting in potential harm to the this patient and other patients admitted with suicidal/homicidal ideas.

Cross Reference to A 0951: The hospital failed to ensure biological indicator results for loads processed for "Immediate Use Steam Sterilization (IUSS)" and standard sterilization processes and failed to ensure the competencies of its staff assigned these duties.

Based on observations, record reviews, and interview, the hospital failed to ensure that all patients were free from restraints for 1 of 7 patients in the sample with continued bilateral wrist restraints after the physician's order expired. (Patient 7).

The findings are:

Observations on 6/21/17 at 1:26 p.m. in the Intensive Care Unit (ICU) Room 254 revealed Patient 7 (P7) wearing bilateral wrist restraints. In an interview on 6/21/17 at 1:26 p.m., Manager 4 verified bilateral wrist restraints were utilized by P7. Review of P7's electronic record at 1:27 pm revealed a physician's order dated 6/19/17 at 17:44 p.m. for bilateral wrist restraints. The stop date for the order was 6/21/17 at 11:21 a.m. Observations verified the restraint was still in use at 1:26 p.m. on 6/21/17. In an interview on 6/21/17 at 1:27 p.m., Registered Nurse (RN) 2 verified P7's physician's order for bilateral wrist restraints expired at 11:27 a.m. on 6/212/17 and that P7 was in restraints without a physician's order. Record review confirmed P7 was in bilateral restraints from 11:21 am to 1:37 p.m. without a physician's order.

Based on record review and interview, the hospital failed to ensure the physician's order specified the type of restraint and the duration of restraint for 1 of 10 patients in the sample reviewed for restraints. (Patient 9)



The findings are:


Review of Patient 9's (P9) chart on 6/21/17 revealed an order with a start date/time of 6/18/17 18:00 and a stop date/time of 6/21/17 06:04 (Critical Care Invasive Airway Protection Restraint Guideline). Record review revealed the type of restraint to be used was not documented on the physician's order.

Review of the hospital's policy, titled, "Use of restraints for Airway Protection PGR", issued on 11/01/15, page 2 Procedures Steps, Guidelines, or Recommendation, number 3, reads, "The Critical Care Airway Protection Restraint Guideline provides an order for wrist restraints only."

Review of the hospital's policy, titled, "Non-Violent Restraint PGR", issued on 4/19/17, page 7, section 4.2.3., reads, "Each airway protection guideline order encompasses one episode of artificial airway use; therefore, there is no longer a need for a daily order to continue the restraint if the patient remains in continuous restraints."

In an interview on 6/22/17 at 12:01 p.m., Registered Nurse 3 (RN 3) stated orders for Critical Care Invasive Airway Protection Restraint starts from the beginning of the order and continues with daily assessment for need until there is no need for the restraint. RN 3 stated these orders do not have ending dates and times and does not need to be renewed daily. In an interview with RN 4 on 6/22/17 at 12:07 p.m., RN 4 revealed orders for restraints are to be renewed every 24 hours.

Based on observations, record reviews, interview, and review of the hospital's policies and procedures, the hospital failed to ensure a physician's order was obtained to continue bilateral wrists restraints for 1 of 10 patients in the sample reviewed for restraints. (Patient 7)

The findings are:

Observations on 6/21/17 at 1:26 p.m. in the the Intensive Care Unit (ICU) Room 254 revealed Patient 7 (P7) with bilateral wrist restraints. In an interview on 6/21/17 at 1:26 p.m., Manager 4 verified bilateral wrist restraints were being utilized by P7. Review of P7's electronic record at 1:27 p.m. revealed a physician's order dated 6/19/17 at 17:44 p.m. for bilateral wrist restraints (Critical Care Invasive Airway Protection Guideline). The stop date for the order was 6/21/17 at 11:21 a.m. Observations on 6/21/17 at 1:26 p.m. revealed that P7 was in bilateral restraints and record review confirmed P7 was in bilateral wrists restraints from 11:21 a.m. to 1:37 p.m. without a physician's order.

Review of the hospital's policy, titled, "Non Violent Restraint PGR", issued on 4/19/17, page 5 section 4.1.1., reads, "A written/electronic or verbal order or telephone order shall be obtained immediately before, during or immediately after application from an authorized physician, NP, PA or Second Year or Higher Resident. Failure to obtain an order within 30 minutes is viewed as an application of restraint without an order. Page 6, section 4.1.11 reads, A new order is required if restraints have been discontinued and the patient's behavior re-escalates, even if it occurs in the original time frame..."

In an interview on 6/21/17 at 1:27 p.m., Registered Nurse 2 verified P7's physician's order for bilateral wrist restraints expired at 11:27 a.m. on 6/212/17.

Based on observations, record reviews, and interview, the hospital failed to ensure verbal/telephone orders for restraints were signed within 24 hours for 1 of 10 patients reviewed for restraints (Patient 2), and failed to ensure that each order for restraint used to ensure the physical safety of non violent or non-self-destructive patients were renewed every 24 hours for 3 of 10 patients in the sample reviewed for restraints. (Patient 2, 9 and 11)


The findings are:


Review of Patient 2's (P2) record revealed a verbal/telephone physician order dated 6/19/17 16:00 for a Vest due to patient climbing out of bed. The stop date/time was 6/20/17 16:00. The physician order was not signed by the physician until 6/21/17 at 06:35. Review of the hospital's policy, titled, "Medical and Dental Staff Rules and Regulations", issued on 4/18/16, page 10, reads, "The responsible practitioner must electronically sign all verbal and telephone orders promptly." In an interview on 6/23/17 at 12:45 p.m., Medical Director 2 verified "promptly" meant that orders should be signed within 24 hours. Review of Patient 2's (P2) record on 6/22/17 revealed a physician order for a vest or papoose restraint with a start date/time of 6/20/17 14:16 and a stop date/time of 6/21/17 23:59. The restraint indication noted altered level of consciousness and unable to follow commands. Record review revealed the physician order exceeded 24 hours and a new order was not obtained after the initial 24-hour order.

Review of Patient 9's (P9) record on 6/21/17 revealed a physician order with a start date/time of 6/20/17 02:00 and a stop date/time of 6/21/17 07:22. Record review revealed that the order exceeded 24 hours and a new order was not obtained after the initial 24-hour order.

Review of Patient 11's (P11) record on 6/22/17 revealed an order for wrists restraint with a start date/time of 6/17/17 20:00 and a stop date/time of 6/21/17 11:10. Record review revealed that the order exceeded 24 hours and a new order was not obtained after the initial 24-hour order.

Review of the facility policy titled "Non Violent Restraint PGR", issued on 4/19/17, page 6 section 4.1.5. reads, "The restraint order sheet/electronic order for "Non-Violent/Non-Self Destructive Behavior" is completed as follows: 4.1.5.1. Time limit-Initial order is valid for a maximum of 24 hours. 4.1.8. says,The initial restraint order must be authenticated by a physician, NP, PA or Second Year or Higher Resident within 24 hours. In the event that a patient's condition warrants continued restraint, the restraint order must be renewed on the day after initiation within 24 hours of the initial order. Subsequent orders will be obtained every calendar day until restraints are discontinued."
Review of the facility policy titled "Non Violent Restraint PGR", issued on 4/19/17, page 7 section 4.2.3. reads, "each airway protection guideline order encompasses one episode of artificial airway use; therefore there is no longer a need for a daily order to continue the restraint if the person remain in continuous restraints,

In an interview on 6/22/17 at 12:01 p.m., Registered Nurse 3 (RN 3) stated that orders for Critical Care Invasive Airway Protection Restraint starts from the beginning of the order and continues with daily assessment for need until there is no need for the restraint. He/she stated that these orders do not have ending dates and times and does not need to be renewed daily. Interview with RN 4 on 6/22/17 at 12:07 p.m. revealed that orders are to be renewed every 24 hours.

Based on observations, record reviews, interviews, and review of the hospital's policies and procedures, the hospital failed to ensure that patients received care and services in accordance with the hospital's policies and procedures and acceptable standards of practice for 2 of 31 patient charts reviewed for care and services.

The findings are:


Cross Reference to A 0386: The hospital failed to ensure a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care for patients assessed as high risk for suicidal intervention in the emergency department.

Based on record reviews, interview, and review of the hospital's policies and procedures, the hospital patients failed to receive care and services in accordance with the hospital's policies and procedures and Standards of Practice for its emergency department for 1 of 31 patient charts reviewed for care and services (Patient 18).


The findings are:


On 6/21/2017 at 2:15 pm, review of Patient 18's chart revealed the patient presented to the emergency department complaining of a cough and congestion, and verbalized suicidal thoughts while in the emergency department. Review of the nursing documentation and the physician documentation revealed that the patient's level of care received was not at the level of care for patients per the hospital's policies and procedures and the patient's level of care decision when triaged at (Level 2).

On 6/21/2017 at 2:15 pm, review of Patient 18's chart revealed the patient presented to the hospital's emergency department on 01/10/2017 at 1340 (1:30 pm) via a wheel chair with a chief complaint of cough. Review of the triage notes showed the triage registered nurse recorded the patient's vital signs as: Temperature - 98.3 DegF( Degrees Fahrenheit), Pulse - 89 bpm (beats per minute), blood pressure - 134/89, Pulse Oxygen Saturation - 95%(percent). Review of the triage note revealed the triage nurse documented, "c/o (complained of cough) and congestion. Possible etoh (Ethyl Alcohol) intoxication. Disruptive, yelling, cussing at FAST desk. Verbed SI (Suicidal Ideation) in lobby when getting angry." Review of the triage notes showed the patient's acuity level was assigned as a 2 using the ESI scale. ( The Emergency Severity Index (ESI) is a five-level tool for use in emergency department (ED) triage. Experienced ED nurses use the ESI to rate patient acuity, from level 1 (most urgent) to level 5 (least resource intensive). The ESI is unique among triage tools, by including both acuity and resource needs in the system of categorizing ED patients.)
Review of the nursing documentation in Patient 18's chart revealed documentation by the triage nurse on 1/10/2017 at 13:53 (1:53 pm) that revealed the nurse assessed the patient in the following areas: risk precautions - Abuse - No Indications; pregnant - n/a (not applicable); Respiratory - 18. There was no further documentation of an assessment of the patient at 13:53(1:53 pm). The patient's chief complaint was cough and congestion but there was no documentation of an assessment of the patient's respiratory system that the respiratory rate. There was no documentation of the patient's suicidal/homicidal risks related to the triage nurse's documentation that the patient verbalized SI in the lobby. There is no documentation that the patient's oxygen saturation level at 95 % was further assessed in this 44-year-old patient with a complaint of cough and congestion. The documentation of the patient's assessment is not reflective of the patient's presenting symptoms of cough, congestion, or suicidal ideation. There was no documentation of physician orders for the patient for observational watch related to the patient's verbed suicidal threat.

Review of the next documentation by nursing on 1/10/2017 is timed between 16:02(4:02 pm) and 16: 06(4:06 pm) and revealed Patient 18's vital signs were: Temperature - 97.5, pulse - 80, blood pressure - 142/78, respirations - 18, and Pulse Oxygen Saturation - 96%.
The registered nurse documented the following assessments: 16:02 - Affect - Flat, Withdrawn; Behavior Comment- intoxicated; Activity/Behavioral State - Sleeping , Lethargic; 16:06 Orientation- LOC(Level Of Consciousness) - Lethargic; Neurological Comment - intoxicated; Neurological Documentation; EENT Review- System WNL (Within Normal Limits); Respiratory - WNL; 16:06 Renal - Urinary Documentation; 16:06 Reproductive - WNL; 16:06 Integumentary System - WNL; Musculoskeletal Comment - intoxicated; 16:02 Activity. Behavioral State - Sleeping / Lethargic; Affect - Flat/Withdrawn; Eye Contact - Poor; Speech Patterns- Slurred; Appearance - psychosocial - grossly Unkempt; Behavior Comment - intoxicated. There was no documentation related to the patient's presenting system of cough, congestion, or suicidal ideation. There was no documentation of observation in the patient's chart related to the patient's verbed threat of suicidal ideation.

Review of the nursing documentation showed that ton 1/10/2017 at 17:49 (5:49 pm), the registered nurse documented, " Up in chair, Other: pt(patient) sitting in chair refuses to get up and lay in the bed. security watch in progress." There was no other documentation related to a security watch or orders for a security watch in the patient's chart. On 1/10/2017 at 18:23 (6:23 pm), the registered nurse documented the respiratory rate was 18, but no other vital signs are documented. There is no further documentation by the registered nurse for this patient.

Further review of Patient 18's emergency department chart revealed an entry by the physician on 1/10/2017 at 16:46(4:30 pm) for services rendered at 16:32 (4:32 p.m.) which is the first entry by a physician for this patient triaged at a level 2 acuity. The physician documented the patient's chief complaint as:" c/o/cough and congestion. Possible etoh intoxication. Disruptive, yelling, cussing at FAST desk. Verbed SI in lobby when getting angry." In the section labeled, "History of Present Illness", the physician recorded," 44-year-old gentleman history of alcoholism presenting today for depression and alcohol intoxication. The patient is from ..... Florida coming in with 4 bags of luggage. He is acutely intoxicated and actually has a bottle of Vodka that is almost strength with him. States he's been drinking the bottle today. It started any information out of this individual as he just sits there and pains his head. The nursing staff said he was yelling and cursing at the triage desk and was requesting to be evaluated. Triage has also stated that he may have suggested suicidal ideation at the triage as well. He has no complaints today otherwise. He is refusing to speak with me." The physician recorded that a 10-point review of systems was performed and negative unless stated above. Review of the section labeled "Physical Exam" revealed a listing of the vital signs obtained in triage, "General Appearance" - "intoxicated. refusing exam. Rest of exam unable to be performed due to refusal by patient." In the section labeled "Medical decision Making", the physician recorded: Ordered: CR Chest 1 view Portable, Intoxicated gentleman presenting today for what I believe was originally cough and congestion and then turned into depression and suicidal ideation. He has a bottle of Vodka with him that he was drinking on in triage. He also has 4 bags of luggage with him. He is refusing all of evaluation. We will keep him here until he sobers and reassess. His vitals are stable."

Review of the medical orders in Patient 18's chart revealed a chest x-ray order on 1/10/2017 at 16:21(4:21 pm) and reason is documented as: Stat, Cough, alcoholic, r/r(rule out) pna (pneumonia), portable". There were no other medical orders for the patient until the code was called on 1/10/2017 at 19:14(7:14 pm).

Review of the physician's addendum recorded by the physician on 1/10/2017 at 20:13:39 revealed "I was called to the room just after 7 PM and after the patient was found in cardiac arrest. he was blue in color. Compressions were immediately initiated and ACLS protocols were followed....Time of death was 2002 hours."

On 6/23/2017 at 10:00 am, an interview was conducted and the patient's chart was reviewed with Registered Nurse (RN) 26. RN 26 verified the patient was triaged at a level 2 in the ESI scale where Level 1 is the most urgent and Level 5 least urgent). RN 26 verified there was no documentation addressing the patient's verbalized suicidal ideations during triage, no physician orders for suicide watch or any other medical orders upon admission, minimal documentation by nursing for this patient triaged at level 2, and minimal documentation related to the patient's respiratory symptoms by nursing.

Hospital policy, titled, "Palmetto Health: Emergency Department Guidelines of Care, effective 04/04/2017, reads, "1. Assessment, Observation and Documentation ,
1.1 An Initial Assessment is to be completed on all patients that present to the Emergency Department to be seen.
1.2 Upon arrival to treatment area vital signs(Temperature, Blood Pressure, Respiratory Rate, Pulse Rate, and Oximetry) are to be taken and documented at least every 4 hours or more frequently for higher acuity patients or per physician orders.
1.3. A full systems review is to be completed and documented on arrival to treatment area for ESI 1, 2, and 3. A problem - focused assessment (based on the patient complaint) will be documented on arrival to the treatment area for ESI 4 and 5.

Hospital policy, titled, Suicide and Homicide Observation Policy, with an effective date of 01/19/2016, reads, " Policy Statement, Palmetto Health is committed to providing a safe and secure environment to all patients, visitors, and staff. Upon admission the patient will be assessed for the potential risk of self-harm and/or harm towards others. When a patient's verbal and/or nonverbal actions indicate a potential for harm to self or others, the appropriate actions, including specific observations, will be initiated. The need for a specific intensity of observation is continually assessed throughout the inpatient stay by direct observation and feedback."

Based on observations, record reviews, and interviews, nursing failed to ensure the appropriate level supervision to ensure the safety for 1 of 1 patient assessed by nursing staff in the hospital's emergency department as a positive risk for suicidal behavior (Patient 20). The emergency department staff failed to ensure the safety and well-being of patients admitted to the department expressing suicidal/homicidal ideas or behaviors in failing to supervise contractual security staff in the performance of their duties resulting in potential harm to this patient and other patients admitted with suicidal/homicidal ideas.


The findings are:


On 06/21/2017 at 11:00 a.m., review of Patient 20's emergency department chart revealed the 38-year-old patient presented to the hospital's emergency department on Saturday, 06/17/2017 at 07:28 am and was triaged on 06/17/2017 at 07:43 am. Review of the registered nurse triage notes revealed the patient's chief complaint was documented as "Mental Health Complaint". The triage nurse documented "pt(patient) friend bropught[sic] pt in stats[sic] the pt wants to harm himself. Patient sates[sic] wanting to take pills, ambu to room from triage patient took pills our of pooket[sic] and took approx (approximately) 2 - 4 pills from seroquel bottle." Review of the patient's triage notes revealed the nurse documented the patient's vital signs as: 98.2 degrees Fahrenheit, pulse 115 bpm (beats per minute(high), blood pressure 125/85, and pulse Oxygen saturation level 100 % (percent). The triage nurse documented the short version of the Columbia - Suicide Severity Rating Scale (CSSRS) which showed the patient had exhibited suicidal thoughts, a wish to be dead, idea with(w) - Method No intent, Idea w- intent No Plan, Suicide Intent w- plan, suicide behavior within the past month. Review of the triage level acuity revealed a level one (1) using the ESI Scale for Acuity.

Review of nursing documentation in the patient's chart dated 06/17/2017 at 07:50 am revealed, "Calm Environment. MD (Medical Doctor) Notified, Security notified, Security Watch Initiated, 1:1 With Staff . Pt verbalizes SI (Suicidal Ideation) with plan. Pt. States, "I just want end it." Pt states he took 5 of his seroquel pills."

Review of a clinical note, titled, "Assessment & (and) Referral Clinical Note", dated 6/17/2017 at 11:52 am revealed, "Pt. Presents as sedated and PET is unable to complete an assessment at this time. Nursing staff reported that after pt. was triaged and being escorted to a Gold Zone room that he ingested an unknown amount Seroquel 300mg (Milligrams) tablets but what he may have actually taken is unknown as he was walking he took the pills....".

Review of the nursing documentation in the patient's chart revealed a nurse note dated 06/18/2017 at 3:32 am that revealed RN 38 (emergency department Charge Nurse per review of the emergency department's staff assignment sheet dated 6/17/2017) gave RN 39 a report on Patient 20.

Review of the patient's emergency department chart in the section labeled "Activity" revealed the nurse documented on 6/18/2017 at 04:14 am that physician was made aware of of recent incident with patient. The nurse recorded,"He gave verbal order for cardiac monitor to be removed. He was in to eval (evaluate) post incident. No further orders obtained at this time."

Review of a nurse note labeled"Emergency department Note:" dated 6/18/2017 at 03:46 am was electronically entered on 6/18/2017 at 04:43 am. revealed RN 39 documented, "pt 1;1 with security. nurse instructed guard door needed to be opened more to better visualize the patient, as guard was sitting in the doorway."

Review of the patient's chart revealed a note dated 06/18/2017 at 04:14 am documented by RN 38 that reads, "This Charge Nurse was called into room by nurse tech as well as monitor tech who saw patient was no longer on the monitor at this time. Upon my arrival I entered the room and immediately removed the cardiac cable that had previously been plugged into the spacelab and was monitoring patient. Once cord was removed it was also detached from patient chest. I assessed patient neck, and chest and no evidence of ligature marks or bruising was noticed. Pt was able to speak in full sentences and was cursing at me. I explained to patient that he was going to be moved to room 5 where there was no cardiac monitor. I explained to him that he would no longer be able to have the lights off. nor would he be able to the door cracked shut. I explained to security at this time the same. Patient became angry and began cursing at me. Dr. informed of above incident and gave verbal order to d/c (discontinue) the cardiac monitor, and to evaluate patient at this time. Will cont (continue) to closely monitor at this time."

Review of a record of the incident dated 6/18/2017 at 4:14 am revealed, "Pt was in room 7 and was on monitor as he had overdosed on Seroquel as he was being wheeled into the ED (emergency department). Pt has been a 1/1/ watch since his arrival to the ED. Approx 0414, ....RN who was watching monitors notified ....RN that the patient in 7 was off the monitor. She went directly to the room and I was subsequently I was called immediately to the room as the patient had unplugged the cord from the monitor and wrapped it around his neck in an attempt to harm himself. The monitor cord was immediately removed and then he was immediately removed from that room and placed in room 5 where there was no monitor. I have notified security that that this patient is not allowed to have his room lights turned off and that his door must remain open at all times.....".

On 6/23/2017 from 12:00 to 12:54 pm, review of the observations documented on the contracted security company's observation form for Patient 20 for 06/17/207 - 06/18/2017 revealed the contracted security personnel ( Security Officer 1) was assigned for suicide watch at the 1:1 level. Review of the documentation revealed Security Officer 1 was relieved for break on 6/18/2017 from 0330 am - 0407 am by Security Officer 2. There was no documentation of observations of Patient 20 by Security Officer 2 during this period. Review of Security Officer 1's documentation from 0330 - 0404 which was the period that Security Officer 1's was absent, "Patient got up out bed had something tied around his neck nurse came in and Officer.... and removed objects out of his room."
Review of Security Officer 1's witness statement dated authenticated and dated 06/18/2017 at 04:31 am revealed "Upon returning from break around 0400, I heard patience[sic] moving around in Room. I got up to check on him, and then I found him standing up next to sink with a cord wrapped around his neck. Another Officer and I along with nurses went/came inside to remove cord and take other objects out of the room....". In an interview on 6/23/2017 at 11:45 am with Security Officer 1, Security Officer 1 verified that she was assigned for suicide watch 1:1 from 10 pm to 6:00 am on 6/17 -18, 2017. Security Officer 1 reported that he/she went on break for about 20 minutes and was relieved by security Officer 2 during that shift. Security Officer 1 stated that during the shift, she sat outside the the patient's room with the door open and he/she could see the patient from the door. Security Officer 1 stated that she documented on the sheet every 10 minutes while she was son duty. Security Officer 1 reported that when he/she returned from break, Security Officer 2 stated she heard something moving around . I opened the door and saw him (patient) standing by the sink. Security Officer 1 stated a nursing technician was sitting outside the room at the computer behind her. Security Officer 1 stated that they snatched everything from the room and moved the patient to room 5 because he was getting wild and another security guard was watching him. Security Guard 1 stated that she usually worked at another health care facility in main lobby greeting people, and had received no training in observations for patients on suicide precautions." Review of Security Officer 1's training record with the security company verified Security Officer 1 had not completed any training for working with suicidal/ homicidal patients since her hire on 1/12/2017. Security Officer 1 reported that he/she had not received a report from the nursing staff relative to the patient's care.

On 6/23/2017 at 1:00 p.m., review of Security Officer 2's witness statement revealed, "....relieved S/O (security officer)(1) in Gold Zone 7 at 0340 a nurse was present when I was there and s/o was on break. The nurse stated that the door would not stay open so I propped open the door with a stool so I could see in room. The nurse had cut the lights out in gold 7 when the s/o returned it was 0405 and I left gold zone. Patient was laying in bed when I was there between 0340 to 0405 Nurse was doing vitals on patient. When nurse left room she stated to S/O (Security Officer 1) that the door would not stay open so Security Officer (1) propped door open with a sitting stool. Nurse had turned out the lights in patient room goldzone 7 and patient was lying quietly in bed." The witness statement was signed and dated 6/18/2017 at 0445 am. On 6/26/2017 at 1:15 p.m. revealed Security Officer 2 had no documentation of training for working with suicidal/homicidal patients in the file.

On 6/23/2017 at 1:10 p.m., review of Security Officer 40's witness statement relevant for the incident that occurred on 6/18/2017 revealed, "I conducted checks on the officers assigned to patient watch during the shift and found all were positioned in the doorway of the patients room with the door open and patient in view."

On 06/23/2017 from 10:30 a.m. until approximately 11: 15 a.m., Registered Nurse(RN) 26 was interviewed. RN 26 verified that he/she was the triage nurse on duty on 06/17/2017 on the 07:00 a.m. shift when the patient presented to the emergency department with a friend. RN 26 reported that he/she obtained the patient's vital signs and was escorting the patient and friend to emergency department room 4. RN 26 stated that he/she was in front of the patient and the patient's friend was behind the patient as they walked to the room. RN 26 reported that when she arrived at the door to the room and turned, he/she saw the patient remove a bottle from the pocket of he/s her pants, uncapped the lid, and removed pills from the bottle and swallowed them. RN 26 stated that she thought it was 2 to 4 pills and the bottle was labeled Seroquel. RN 26 stated the physician of the patient's actions and the patient was placed on a cardiac monitor and one- (1)-to-one (1) security watch. RN 26 explained that 1 to 1 security watch required a sitter be within arms reach of the patient at all times. RN 26 explained that the patient was not placed in the hospital emergency department's blue zone dedicated for patients presenting to the emergency department with psychiatric and/or behavioral problems because that area of the emergency department was closed and since the patient was placed on the monitor related to the ingestion of the pills in the bottle, the patient was placed in room 4 which is also used for patients admitted with coronary symptoms.

On 6/23/2017 at approximately 11:20 am to 11:30 am, observations were made in the Gold Zone of Patient Room 4, Room 7, and Room 5. Patient Room 4 had multiple equipment and items to meet the emergent needs of patients presenting with coronary or other critical issues. Patient Room 7 was equipped to handle the less critical issues. Patient Room 5 had no equipment and was designed for the safety of patients expressing suicidal/homicidal ideas.

Review of the hospital's policy effective 10/21/2015, titled, "Suicide and Homicide Observation PGR", reads, " Suicide and Homicide Observation Policy"
1. Nursing Assessment [Evaluation of Suicide Risk (Reference Text)]
1.1 The RN will assess each patient for potential risk of self - harm and/or harm towards others upon admission and as a part of the nursing assessment and system review by direct observation.
1.2 Information gathered through the Suicide Risk section of the Risk Precautions section within the Nursing Admission History form helps to determine the need for suicide/homicide observations.

2. Physician Orders
2.1 If the patient exhibits suicidal/ homicidal behavior and/or has a positive risk assessment for suicide/homicide, the nurse should notify the attending physician for further direction.
2.1.1 Suicide or homicide observation must be ordered by the physician. In emergent situations, registered nurses may place the order to be signed by the physician at a later time
2.1.2 A physician's order is required to discontinue suicide and homicide precautions.

2.2 If the patient is placed on suicide/homicide observations, then a psychiatric consult should be obtained.

3. Observation Levels:

3.1 There are two suicide/homicide observation levels that are used on behavioral care units.
3.1.1.1 Suicide/Homicide 1:1 Observations - Staff must remain within an arm's length of the patient at all times. Observation are made on the patient's location and activity. Documentation is made every 10 minutes on the observation record, including times when the patient is sleeping and using the bathroom. This type of observation is used when a patient admits to having suicidal/homicidal thoughts, has an active plan or has recently attempted suicide prior to admission.

The Emergency Severity Index (ESI) is a five-level tool for use in emergency department (ED) triage. Experienced ED nurses use the ESI to rate patient acuity, from level 1 (most urgent) to level 5 (least resource intensive). The ESI is unique among triage tools, by including both acuity and resource needs in the system of categorizing ED patients.

Based on record reviews, and interviews, the hospital's Infection Control Program had insufficient Infection Control Oversight specific to its sterilization processes in the hospital's Central Processing area in the surgical department.

The findings are:

Cross Reference to A- 0749- The hospital failed to ensure complete, accurate data was documented on Immediate Use Steam Sterilization (IUSS) logs and Steam Sterilization logs and failed to ensure staff was appropriately trained in sterile processing.

Cross Reference to A- 0756- The hospital failed to ensure oversight of infection control measures in the Central Sterile Processing Area.

Based on review of the hospital's central processing records for biological indicators for loads processed, interviews, review of the hospital's policy and procedures, and review of the hospital's infection control guideline and practices, the hospital failed to ensure biological indicator results for loads processed for "Immediate Use Steam Sterilization (IUSS)" and standard sterilization processes and failed to ensure the competencies of its staff assigned to these duties.


The findings are:

On 6/21/17 from 2:45 to 4:00 p.m., review of the hospital's IUSS logs revealed :

5/15/17:
Sterilizer # 1-4: no name of the operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, and no pass or reject for the Attest load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 7-9: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 12: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 14-16: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load, no pass or reject for the knee box;
Sterilizer 17-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 20-21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no or reject for the Attest load;
Sterilizer 23-24: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load.

5/31/17:
Sterilizer 1-3: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Biologic load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 7: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 12: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14-17: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 18-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no time of day for the biologic load.

6/6/17
Sterilizer number absent: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 16-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, and no time of day; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load.

6/13/17
Sterilizer 1-4: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Peel pack load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 7: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 9: no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14-16: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, and no pass or reject for the biologic load;
Sterilizer 19: no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no cycle time, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer number absent; no cycle time and no pass or reject for a cycle at 18:10.

6/19/17
Sterilizer 1: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, and no time of day, and no cycle time for the biologic load;
Sterilizer 2: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 4: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 5: no name of operator for in/out times, no cycle time, no time of day, and no pass/reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass/reject for the biologic load;
Sterilizer 6: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 7: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 8: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load.

6/20/2017
Sterilizer 1 showed a failed indicator strip timed at 12:30 am and the test was marked as "pass". The test was not repeated. On 6/21/17 at 3:25 p.m., Sterile Processing Supervisor (SPS) 1 reported, "The test should have been repeated immediately before continued use of the sterilizer."

6/21/17
Sterilizer 3: no name of operator for out time, no cycle time, and no pass/reject for the dart test;
Sterilizer 5 showed a failed indicator strip, but the test was marked as "pass" at 1:41 a.m.. The test was not repeated until 9:30 a.m. During an interview with SPS 1 on 6/21/17 at 3:34 p.m., SPS 1 revealed, "The test should have been repeated immediately before continued use of the sterilizer."

On 6/21/2017 at 3:35 pm, the findings were verified with SPS 1 during review of the records. SPS 1 stated, "Everything must be completely filled out, including the name of the operator who starts and stops the loads, the OR number, the time of day, the date, the cycle time, the pass or reject, and the type of test."

On 6/22/17 at 8:40 a.m., Compliance Officer 1 revealed, "We don't have to attach the indicator strips to the paperwork if they are marking the pass or fail results on there. They are changing the paperwork today with staff and educating on changing the dart test because it's a separate cycle."

On 6/22/17 at 12:00 p.m., the Chief Nursing Officer (CNO) revealed," On the biological tests we follow AAMI standards and AORN for the results of the indicators. The results can be recorded on the paper in place of attaching the strips." (AAMI - Association for the Advancement of Medical Instrumentation) (AORN - The Association of preoperative Registered Nurses)

On 6/22/17 from 5:30 pm to 6:45 p.m., review of the hospital's Steam Sterilization Logs revealed missing data on the following days:
5/2/17
Sterilizer 4:
Load 3- no Fluorescent/Visual Controls,
Load 6 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator".

5/3/17
Sterilizer 2:
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator",
Load 6 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator",and no initials and no date at completion of cycle;
Sterilizer 3:
Load 4 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no Time, no date or initials for the "out of incubator", and no date at completion of cycle;
Load 5 - no Biological indicator time or +/- result;
Sterilizer 4:
Load 2 - no Biological indicator time or +/- result,
Load 6 - no pressure result.

5/4/17
Sterilizer 1 missing Accept/Reject results, initials and date of cycle.

5/5/17
Sterilizer 1, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Time, time and initials for the "out of incubator", and Accept/Reject result; Sterilizer 2, load 2 missing Fluorescent/Visual Controls, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Time, date, time and initials for the "out of incubator"; load 5 missing Biological indicator +/- result, load 6 missing pressure result; Sterilizer 3, load 1 missing pressure result, load 3 missing Fluorescent/Visual Controls, load 5 missing date, time and initials for the "out of incubator"; Load 6 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator".

5/15/17
Sterilizer 1, load 2- Bowie Dick missing initials; load 3 missing Fluorescent/Visual Controls, load 4 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator", load 7 missing Biological indicator time and +/- result, Fluorescent/Visual Controls; Sterilizer 4, load 2 missing Accept/Reject result and initials at end of cycle; load 3 missing Fluorescent/Visual Controls, load 4 missing Fluorescent/Visual Controls,load 5 missing Fluorescent/Visual Controls,
load 6 missing Fluorescent/Visual Controls.

5/16/17
Sterilizer 1, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, load 3 missing Fluorescent/Visual Controls; Sterilizer 2, load 1 missing Accept/Reject result, load 2 missing pressure result, load 3 missing Fluorescent/Visual Controls, load 5 missing Fluorescent/Visual Controls; Sterilizer 3, load 2 missing Biological indicator time and +/- result, load 3 missing pressure result, Fluorescent/Visual Controls, Pass/Reject result, load 4 missing Fluorescent/Visual Controls,
load 5 missing Fluorescent/Visual Controls, load 6 missing Fluorescent/Visual Controls.

5/17/17
Sterilizer 1, load 1 missing initials, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator", Mfg, Lot No, Initials, and date; Sterilizer 3, load 1 missing initials, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Mfg, Lot No, Initials, and date, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls; Sterilizer 4, load 8 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, and pressure.

5/18/17
Sterilizer 1:
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls;
Sterilizer 2:
Load 1 - no Accept/Reject result;
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator";
Sterilizer 3:
Load 1 - no pressure result, no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no Accept/Reject result;
Sterilizer 4:
Load 2 - no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls,
Load 6: no pressure result, no Biological indicator time or +/- result, no Fluorescent/Visual Controls;
Unknown Sterilizer ID:
Load 1 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls.

5/19/17
Sterilizer 4:
Load 2- no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls, no Mfg, Lot No., no initials or date,
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date or initials for the "out of incubator".

5/22/17
Sterilizer 3
Load 5 - no pressure result, no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Sterilizer 4:
Load 5 - no Fluorescent/Visual Controls,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date or initials for the "out of incubator",
Load 7 - no Fluorescent/Visual Controls,
Load 8 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result.

5/23/17
Sterilizer 1: no Bowie-Dick Test,
Load 1 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result,
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Sterilizer 3:
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result, no Mfg, Lot No., no initials or date;
Sterilizer 4:
Load 2 - no Fluorescent/Visual Controls.

5/24/17
Sterilizer 2: no date,
Load 1 - no Accept/Reject result and initials;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result, no time, no date, or initials for the "out of incubator",
Load 4 - no Fluorescent/Visual Controls,
Load 5 - no Fluorescent/Visual Controls;
Sterilizer 3: no date
Load 1 - no Accept/Reject result or initials;
Load 2 - no Accept/Reject result, no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Load 3- no time or initials for "in incubator", no Fluorescent/Visual Controls,
Load 4 - no Fluorescent/Visual Controls;
Sterilizer 4:
Load 1- no Accept/Reject result;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time or initials for "out of incubator",
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date, or initials for "out of incubator."

5/25/17
Sterilizer 1:
Load 1 - no Accept/Reject result,
Load 3 - no Fluorescent/Visual Controls;
Sterilizer 2:
Load 1 - no Accept/Reject result,
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date, or initials for "out of incubator",
Load 4 - no Fluorescent/Visual Controls;
Sterilizer 3:
Load 1- no Accept/Reject result,
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/-;
Sterilizer 4:
Load 1- no pressure result or Accept/Reject result;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- ,
Load 4 - no Fluorescent/Visual Controls,
Load 5 - no Fluorescent/Visual Controls,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/-, no time, date, or initials for "out of incubator";
Sterilizer 4:
Load 8 - no Fluorescent/Visual Controls or Biological indicator time or +/- result.

5/26/17
Sterilizer ID absent with no date, no Bowie-Dick Test,
Load 1 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result,
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, and no time, date, or initials for "out of incubator."

5/28/17
Sterilizer 2:
Load 1- no Accept/Reject result;
Load 2 - no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls or Biological indicator time or +/-, no Accept/Reject result;
Sterilizer 4 - no Accept/Reject result, no Fluorescent/Visual Controls, or Biological indicator time or +/-.

5/30/17
Sterilizer 3:
Load 1 - no Accept/Reject result or initials;
Load 2 - no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/-;
Sterilizer 2:
Load 1 - no Accept/reject result or initials;
Load 2 - no Biological indicator time or +/-; no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls or Biological indicator time or +/- ;
Load 4 - no Fluorescent/Visual Controls.

5/31/17
Sterilizer 1:
Load 3 - no Accept/Reject result;
Sterilizer 3:
Load 8- no Fluorescent/Visual Controls or Biological indicator time or +/-;
Sterilizer 4:
Load 2- no Fluorescent/Visual Controls or Biological indicator time and +/-;
Sterilizer 3:
Load 1 - no initials,
Load 2 - no Biological indicator time or +/-;
Load 4 - no Biological indicator time or +/-;
Load 5 - no Biological indicator time or +/-.

6/8/17
Sterilizer 3:
Load 2- no Biological indicator time or +/-;
Load 3- no Biological indicator time or +/-, no time, date, or initials "out of incubator"

6/9/17
Sterilizer 3: Load 3- no Biological indicator time or +/-;
Load 4 - no Fluorescent/Visual Controls or Biological indicator time and +/-.

6/12/17
Sterilizer 2: Load 1- no Accept/Reject result;
Load 2 - no Biological indicator time or +/-;
Load 3- no Biological indicator time or +/-;
Load 5- no Biological indicator time or +/-;
Load 6 - no Biological indicator time or +/-;
Sterilizer 3: Load 1- no Accept/Reject result;
Load 2 - no Time/Temp/pressure results under "Exposure";
Load 5 - no time, date, or initials for "out of incubator."

6/13/17
Sterilizer 3: Load 6- no time, date, or initials for "in incubator", no time,date, or initials for "out of incubator", no Time/Temp/Pressure under "exposure", no Accept/Reject result, no Fluorescent/Visual Controls or Biological indicator time or +/-, no Mfg, Lot No, no Initials, or date.

On 6/14/17
Sterilizer 2: Load 1- no initials;
Load 4- no Fluorescent/Visual Controls and no Biological indicator time or +/-;
Sterilizer 3: Load 1- no initials; Load 4 - no Fluorescent/Visual Controls or Biological indicator time or +/-.

On 6/16/17:
Sterilizer 4: Load 3 had no time, date, or initials for "out of incubator", no Mfg, no Lot No, no Initials, or date;
Load 6: no time, date and initials for "out of incubator";
Load 8: no time, date and initials for "in incubator", no time, no date or initials for "out of incubator", no Time/Temp/Pressure under "exposure", no Accept/Reject result, no Fluorescent/Visual Controls or Biological indicator time and +/-, no Mfg, Lot No, no Initials, or date.

On 6/21/17:
Sterilizer 2: Load 2 had no Biological indicator time or +/- indicator.

On 6/22/17 at 6:30 p.m., the findings were verified with SPS 2 who reviewed the information with the surveyor.
On 6/23/17 at 12:45 p.m., Manager 2 revealed, "Everything on these logs should be completed. The OR(Operating Room) staff marks the pass/reject results and places a patient sticker on here. The sterile processing staff is responsible for the remainder of the data."

On 6/23/17 at 12:25 p.m., Manager 2 in the Operating Room revealed, "The Director of Sterile Processing left in May 20017, and there really hasn't been any one managing or monitoring central processing since she left. "

On 6/23/2017 at 1:00 pm, the Chief Medical Officer reported that there had been 4 interim directors in the operating room since December 2016.

Hospital policy, titled, "Perioperative Services Guideline for Equipment and Instrument Sterilization PGR", reads "....4.3 Air removal testing (Bowie Dick) performed on the first cycle daily and documented....4.11 Load print out is monitored and reviewed and signed at the end of each cycle to ensure all parameters of temperature, time, and pressure were effectively met....5. Immediate Use Steam Sterilization (Operating Rooms/ORs): 5.6 Load print out is monitored and reviewed and signed at the end of each cycle to ensure all parameters of temperature, time, and pressure were effectively met....5.7 Documentation of each cycle includes date and time of cycle, operator, items sterilized, cycle parameters, chemical indicator verified, patient identification, and reason for sterilization....5.9 All sterilizer documentation is reviewed for process verification..."

Manufacturer guidelines for VERIFY Integrating Indicator- Instructions for Use: reads, "...3. Examine the Verify Integrating Indicator to determine that the dark bar has passed the red FAIL area and reached the green PASS area. This is your assurance that sterilizing conditions have been met. 4. If the dark bar did not reach the green PASS area, it is the indication that sterilizing conditions have not been met. the entire pack must be reprocessed according to standard hospital procedures for reprocessing packs..."

Review of AAMI guidelines: 10.3.2 Sterilizer records, reads, "....For each sterilization cycle, the following information should be recorded and maintained: a) the lot number; b) the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towel packs, type/name of instrument sets); c) the exposure time and temperature, if not provided on the sterilizer recording chart; d) the name or the initials of the operator; e) the results of the biological testing, if applicable; f) the results of the Bowie-Dick testing, if applicable; g) the response of the CI placed in the PCD (BI challenge test pack, BI challenge test tray, or CI challenge test pack), if applicable; and h) any reports of inconclusive or nonresponsive CIs found later in the load..."

AORN Sterilization and Disinfection guidelines, reads, "...VII.g..Documentation of cycle information and monitoring results should be maintained in a log...VII.g.1. Immediate use steam sterilization records should include information on each load, including the items processed, the patient on whom the items were used, the type of cycle..., the cycle parameters used (e.g., temperature, duration of cycle), monitoring results, the date and time the cycle was run, the operator information (ie., person who initiated the cycle, person who retrieved the item from the sterilizer), and the reason for IUSS..."

Review of the hospital's Infection Prevention Plan and Risk Assessment, effective January 2017, revealed at "2.6 Cleaning, Disinfection &(and) Sterilization (JC Standard 02.02.01 EP2), 2.6.2 Decontamination & Sterile Processing
Bullet 1. Process Monitoring: IUSS monitoring/reporting: The IP department should, routinely receive reports of IUSSS(Including implantable).
Bullet 2. Addendum June 15, 2017: IP will collaboratively audit processes and documentation. Findings will be communicated to SPD manager/team. Improvement goals will be established by SPD leaders. Compliance results will be reported to the infection Prevention and Control Committee and the Quality and Safety Cabinet." Review of the hopsital's infection control department data for surgical site infections based on the infection control data for FY 2016 showed increasing trends in surgical site infections for FY 16. Staff turnover increased as well.

Based on review of Central Sterile Processing records and interview, the hospital failed to ensure oversight of infection control measures in the Central Sterile Processing Area in an extended period of significant managerial turnover in its central processing area and an increase of its surgical site infections.


The findings are:


On 6/23/17 at 12:25 p.m., Manager 2 in the Operating Room revealed, "The Director of Sterile Processing left in May 2017, and there really hasn't been any one managing or monitoring central processing since the Director left."

On 6/23/2017 at 1:00 pm, the Chief Medical Officer reported that there had been 4 interim directors in the operating room since December 2016.

Review of the hospital's Infection Prevention Plan and Risk Assessment, effective January 2017, revealed at "2.6 Cleaning, Disinfection & (and) Sterilization (JC Standard 02.02.01 EP2), 2.6.2 Decontamination & Sterile Processing
Bullet 1. Process Monitoring: IUSS monitoring/reporting: The IP department should, routinely receive reports of IUSSS(Including implantable).

Bullet 2. Addendum June 15, 2017: IP will collaboratively audit processes and documentation. Findings will be communicated to SPD manager/team. Improvement goals will be established by SPD leaders. Compliance results will be reported to the infection Prevention and Control Committee and the Quality and Safety Cabinet." Review of the data for surgical site infections based on the infection control data for FY 2016 showed increases in surgical site infections.

Based on review of the hospital's central processing records for biological indicators for loads processed, interviews, review of the hospital's policy and procedures,and review of the hospital's infection control guideline and practices, the hospital failed to ensure biological indicator results for loads processed for "Immediate Use Steam Sterilization (IUSS)" and standard sterilization processes and failed to ensure the competencies of its staff assigned these duties.

The findings are:

Cross Reference to A 0951- The facility failed to ensure its staff followed the hospital's policies and procedures for Immediate Use Steam Sterilization (IUSS) processes and documentation failed to ensure staff was appropriately trained in sterile processing.

Based on review of the hospital's central processing records for biological indicators for loads processed, interviews, review of the hospital's policy and procedures,and review of the hospital's infection control guideline and practices, the hospital failed to ensure biological indicator results for loads processed for "Immediate Use Steam Sterilization (IUSS)" and standard sterilization processes and failed to ensure the competencies of its staff assigned these duties.


The findings are:

On 6/21/17 from 2:45 to 4:00 p.m., review of the hospital's IUSS logs revealed :

5/15/17:
Sterilizer # 1-4: no name of the operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, and no pass or reject for the Attest load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 7-9: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 12: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 14-16: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load, no pass or reject for the knee box;
Sterilizer 17-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load;
Sterilizer 20-21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no or reject for the Attest load;
Sterilizer 23-24: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Attest load.

5/31/17:
Sterilizer 1-3: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Biologic load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 7: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 12: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14-17: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 18-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no time of day for the biologic load.

6/6/17
Sterilizer number absent: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 16-19: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, and no time of day; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load.

6/13/17
Sterilizer 1-4: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load; no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the Peel pack load;
Sterilizer 3-6: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 7: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 9: no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 14-16: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, no time of day, and no pass or reject for the biologic load;
Sterilizer 19: no name of operator for in/out times, no time of day, no cycle time, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 20: no name of operator for in/out times, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer 21: no name of operator for in/out times, no cycle time, no time of day, and no pass or reject for the dart test; no name of operator for in/out times, and no time of day for the biologic load;
Sterilizer number absent; no cycle time and no pass or reject for a cycle at 18:10.

6/19/17
Sterilizer 1: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, and no time of day, and no cycle time for the biologic load;
Sterilizer 2: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 4: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 5: no name of operator for in/out times, no cycle time, no time of day, and no pass/reject for the dart test; no name of operator for in/out times, no time of day, no cycle time, and no pass/reject for the biologic load;
Sterilizer 6: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 7: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load;
Sterilizer 8: no name of operator for in/out times, no cycle time, and no time of day for the dart test; no name of operator for in/out times, no time of day, and no cycle time for the biologic load.

6/20/2017
Sterilizer 1 showed a failed indicator strip timed at 12:30 am and the test was marked as "pass". The test was not repeated. On 6/21/17 at 3:25 p.m., Sterile Processing Supervisor (SPS) 1 reported, "The test should have been repeated immediately before continued use of the sterilizer."

6/21/17
Sterilizer 3: no name of operator for out time, no cycle time, and no pass/reject for the dart test;
Sterilizer 5 showed a failed indicator strip, but the test was marked as "pass" at 1:41 a.m.. The test was not repeated until 9:30 a.m. During an interview with SPS 1 on 6/21/17 at 3:34 p.m., SPS 1 revealed, "The test should have been repeated immediately before continued use of the sterilizer."

On 6/21/2017 at 3:35 pm, the findings were verified with SPS 1 during review of the records. SPS 1 stated, "Everything must be completely filled out, including the name of the operator who starts and stops the loads, the OR number, the time of day, the date, the cycle time, the pass or reject, and the type of test."

On 6/22/17 at 8:40 a.m., Compliance Officer 1 revealed, "We don't have to attach the indicator strips to the paperwork if they are marking the pass or fail results on there. They are changing the paperwork today with staff and educating on changing the dart test because it's a separate cycle."

On 6/22/17 at 12:00 p.m., the Chief Nursing Officer (CNO) revealed," On the biological tests we follow AAMI standards and AORN for the results of the indicators. The results can be recorded on the paper in place of attaching the strips." (AAMI - Association for the Advancement of Medical Instrumentation) (AORN - The Association of periOperative Registered Nurses)

On 6/22/17 from 5:30 pm to 6:45 p.m., review of the hospital's Steam Sterilization Logs revealed missing data on the following days:
5/2/17
Sterilizer 4:
Load 3- no Fluorescent/Visual Controls,
Load 6 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator".

5/3/17
Sterilizer 2:
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator",
Load 6 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator",and no initials and no date at completion of cycle;
Sterilizer 3:
Load 4 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no Time, no date or initials for the "out of incubator", and no date at completion of cycle;
Load 5 - no Biological indicator time or +/- result;
Sterilizer 4:
Load 2 - no Biological indicator time or +/- result,
Load 6 - no pressure result.

5/4/17
Sterilizer 1 missing Accept/Reject results, initials and date of cycle.

5/5/17
Sterilizer 1, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Time, time and initials for the "out of incubator", and Accept/Reject result; Sterilizer 2, load 2 missing Fluorescent/Visual Controls, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Time, date, time and initials for the "out of incubator"; load 5 missing Biological indicator +/- result, load 6 missing pressure result; Sterilizer 3, load 1 missing pressure result, load 3 missing Fluorescent/Visual Controls, load 5 missing date, time and initials for the "out of incubator"; Load 6 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator".

5/15/17
Sterilizer 1, load 2- Bowie Dick missing initials; load 3 missing Fluorescent/Visual Controls, load 4 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator", load 7 missing Biological indicator time and +/- result, Fluorescent/Visual Controls; Sterilizer 4, load 2 missing Accept/Reject result and initials at end of cycle; load 3 missing Fluorescent/Visual Controls, load 4 missing Fluorescent/Visual Controls,load 5 missing Fluorescent/Visual Controls,
load 6 missing Fluorescent/Visual Controls.

5/16/17
Sterilizer 1, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, load 3 missing Fluorescent/Visual Controls; Sterilizer 2, load 1 missing Accept/Reject result, load 2 missing pressure result, load 3 missing Fluorescent/Visual Controls, load 5 missing Fluorescent/Visual Controls; Sterilizer 3, load 2 missing Biological indicator time and +/- result, load 3 missing pressure result, Fluorescent/Visual Controls, Pass/Reject result, load 4 missing Fluorescent/Visual Controls,
load 5 missing Fluorescent/Visual Controls, load 6 missing Fluorescent/Visual Controls.

5/17/17
Sterilizer 1, load 1 missing initials, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, time, date and initials for the "out of incubator", Mfg, Lot No, Initials, and date; Sterilizer 3, load 1 missing initials, load 2 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, Mfg, Lot No, Initials, and date, load 3 missing Biological indicator time and +/- result, Fluorescent/Visual Controls; Sterilizer 4, load 8 missing Biological indicator time and +/- result, Fluorescent/Visual Controls, and pressure.

5/18/17
Sterilizer 1:
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls;
Sterilizer 2:
Load 1 - no Accept/Reject result;
Load 2 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no time, no date or initials for the "out of incubator";
Sterilizer 3:
Load 1 - no pressure result, no Biological indicator time or +/- result, no Fluorescent/Visual Controls, no Accept/Reject result;
Sterilizer 4:
Load 2 - no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls,
Load 6: no pressure result, no Biological indicator time or +/- result, no Fluorescent/Visual Controls;
Unknown Sterilizer ID:
Load 1 - no Biological indicator time or +/- result, no Fluorescent/Visual Controls.

5/19/17
Sterilizer 4:
Load 2- no Fluorescent/Visual Controls,
Load 3 - no Fluorescent/Visual Controls, no Mfg, Lot No., no initials or date,
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date or initials for the "out of incubator".

5/22/17
Sterilizer 3
Load 5 - no pressure result, no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Sterilizer 4:
Load 5 - no Fluorescent/Visual Controls,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date or initials for the "out of incubator",
Load 7 - no Fluorescent/Visual Controls,
Load 8 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result.

5/23/17
Sterilizer 1: no Bowie-Dick Test,
Load 1 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result,
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Sterilizer 3:
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result, no Mfg, Lot No., no initials or date;
Sterilizer 4:
Load 2 - no Fluorescent/Visual Controls.

5/24/17
Sterilizer 2: no date,
Load 1 - no Accept/Reject result and initials;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result, no time, no date, or initials for the "out of incubator",
Load 4 - no Fluorescent/Visual Controls,
Load 5 - no Fluorescent/Visual Controls;
Sterilizer 3: no date
Load 1 - no Accept/Reject result or initials;
Load 2 - no Accept/Reject result, no Fluorescent/Visual Controls, no Biological indicator time or +/- result;
Load 3- no time or initials for "in incubator", no Fluorescent/Visual Controls,
Load 4 - no Fluorescent/Visual Controls;
Sterilizer 4:
Load 1- no Accept/Reject result;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time or initials for "out of incubator",
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date, or initials for "out of incubator."

5/25/17
Sterilizer 1:
Load 1 - no Accept/Reject result,
Load 3 - no Fluorescent/Visual Controls;
Sterilizer 2:
Load 1 - no Accept/Reject result,
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no time, no date, or initials for "out of incubator",
Load 4 - no Fluorescent/Visual Controls;
Sterilizer 3:
Load 1- no Accept/Reject result,
Load 2 - no Fluorescent/Visual Controls, no Biological indicator time or +/-;
Sterilizer 4:
Load 1- no pressure result or Accept/Reject result;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/- ,
Load 4 - no Fluorescent/Visual Controls,
Load 5 - no Fluorescent/Visual Controls,
Load 6 - no Fluorescent/Visual Controls, no Biological indicator time or +/-, no time, date, or initials for "out of incubator";
Sterilizer 4:
Load 8 - no Fluorescent/Visual Controls or Biological indicator time or +/- result.

5/26/17
Sterilizer ID absent with no date, no Bowie-Dick Test,
Load 1 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, no Accept/Reject result,
Load 4 - no Fluorescent/Visual Controls, no Biological indicator time or +/- result, and no time, date, or initials for "out of incubator."

5/28/17
Sterilizer 2:
Load 1- no Accept/Reject result;
Load 2 - no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls or Biological indicator time or +/-, no Accept/Reject result;
Sterilizer 4 - no Accept/Reject result, no Fluorescent/Visual Controls, or Biological indicator time or +/-.

5/30/17
Sterilizer 3:
Load 1 - no Accept/Reject result or initials;
Load 2 - no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls, no Biological indicator time or +/-;
Sterilizer 2:
Load 1 - no Accept/reject result or initials;
Load 2 - no Biological indicator time or +/-; no Fluorescent/Visual Controls;
Load 3 - no Fluorescent/Visual Controls or Biological indicator time or +/- ;
Load 4 - no Fluorescent/Visual Controls.

5/31/17
Sterilizer 1:
Load 3 - no Accept/Reject result;
Sterilizer 3:
Load 8- no Fluorescent/Visual Controls or Biological indicator time or +/-;
Sterilizer 4:
Load 2- no Fluorescent/Visual Controls or Biological indicator time and +/-;
Sterilizer 3:
Load 1 - no initials,
Load 2 - no Biological indicator time or +/-;
Load 4 - no Biological indicator time or +/-;
Load 5 - no Biological indicator time or +/-.

6/8/17
Sterilizer 3:
Load 2- no Biological indicator time or +/-;
Load 3- no Biological indicator time or +/-, no time, date, or initials "out of incubator"

6/9/17
Sterilizer 3: Load 3- no Biological indicator time or +/-;
Load 4 - no Fluorescent/Visual Controls or Biological indicator time and +/-.

6/12/17
Sterilizer 2: Load 1- no Accept/Reject result;
Load 2 - no Biological indicator time or +/-;
Load 3- no Biological indicator time or +/-;
Load 5- no Biological indicator time or +/-;
Load 6 - no Biological indicator time or +/-;
Sterilizer 3: Load 1- no Accept/Reject result;
Load 2 - no Time/Temp/pressure results under "Exposure";
Load 5 - no time, date, or initials for "out of incubator."

6/13/17
Sterilizer 3: Load 6- no time, date, or initials for "in incubator", no time,date, or initials for "out of incubator", no Time/Temp/Pressure under "exposure", no Accept/Reject result, no Fluorescent/Visual Controls or Biological indicator time or +/-, no Mfg, Lot No, no Initials, or date.

On 6/14/17
Sterilizer 2: Load 1- no initials;
Load 4- no Fluorescent/Visual Controls and no Biological indicator time or +/-;
Sterilizer 3: Load 1- no initials; Load 4 - no Fluorescent/Visual Controls or Biological indicator time or +/-.

On 6/16/17:
Sterilizer 4: Load 3 had no time, date, or initials for "out of incubator", no Mfg, no Lot No, no Initials, or date;
Load 6: no time, date and initials for "out of incubator";
Load 8: no time, date and initials for "in incubator", no time, no date or initials for "out of incubator", no Time/Temp/Pressure under "exposure", no Accept/Reject result, no Fluorescent/Visual Controls or Biological indicator time and +/-, no Mfg, Lot No, no Initials, or date.

On 6/21/17:
Sterilizer 2: Load 2 had no Biological indicator time or +/- indicator.

On 6/22/17 at 6:30 p.m., the findings were verified with SPS 2 who reviewed the information with the surveyor.
On 6/23/17 at 12:45 p.m., Manager 2 revealed, "Everything on these logs should be completed. The OR(Operating Room) staff marks the pass/reject results and places a patient sticker on here. The sterile processing staff is responsible for the remainder of the data."

On 6/23/17 at 12:25 p.m., Manager 2 in the Operating Room revealed, "The Director of Sterile Processing left in May 20017, and there really hasn't been any one managing or monitoring central processing since she left. "

On 6/23/2017 at 1:00 pm, the Chief Medical Officer reported that there had been 4 interim directors in the operating room since December 2016.

Hospital policy, titled, "Perioperative Services Guideline for Equipment and Instrument Sterilization PGR", reads "....4.3 Air removal testing (Bowie Dick) performed on the first cycle daily and documented....4.11 Load print out is monitored and reviewed and signed at the end of each cycle to ensure all parameters of temperature, time, and pressure were effectively met....5. Immediate Use Steam Sterilization (Operating Rooms/ORs): 5.6 Load print out is monitored and reviewed and signed at the end of each cycle to ensure all parameters of temperature, time, and pressure were effectively met....5.7 Documentation of each cycle includes date and time of cycle, operator, items sterilized, cycle parameters, chemical indicator verified, patient identification, and reason for sterilization....5.9 All sterilizer documentation is reviewed for process verification..."

Manufacturer guidelines for VERIFY Integrating Indicator- Instructions for Use: reads, "....3. Examine the Verify Integrating Indicator to determine that the dark bar has passed the red FAIL area and reached the green PASS area. This is your assurance that sterilizing conditions have been met. 4. If the dark bar did not reach the green PASS area, it is the indication that sterilizing conditions have not been met. the entire pack must be reprocessed according to standard hospital procedures for reprocessing packs..."

Review of AAMI guidelines: 10.3.2 Sterilizer records, reads, "....For each sterilization cycle, the following information should be recorded and maintained: a) the lot number; b) the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towel packs, type/name of instrument sets); c) the exposure time and temperature, if not provided on the sterilizer recording chart; d) the name or the initials of the operator; e) the results of the biological testing, if applicable; f) the results of the Bowie-Dick testing, if applicable; g) the response of the CI placed in the PCD (BI challenge test pack, BI challenge test tray, or CI challenge test pack), if applicable; and h) any reports of inconclusive or nonresponsive CIs found later in the load..."

AORN Sterilization and Disinfection guidelines, reads, "...VII.g..Documentation of cycle information and monitoring results should be maintained in a log....VII.g.1. Immediate use steam sterilization records should include information on each load, including the items processed, the patient on whom the items were used, the type of cycle...., the cycle parameters used (e.g., temperature, duration of cycle), monitoring results, the date and time the cycle was run, the operator information (ie., person who initiated the cycle, person who retrieved the item from the sterilizer), and the reason for IUSS..."

Based on observations, record reviews, interviews, and review of the hospital's policies and procedures, the hospital's governance failed to ensure that the Emergency Department operated in a responsible manner to ensure the safety of those patients.

The findings are:

Cross reference to A 1103: The hospital's governance failed to ensure that the Emergency Department operated in a responsible manner to ensure the safety of those patients.

Cross Reference to A 0063: The governing body in accordance with hospital policy failed to ensure that specific patient care requirements for patients in the emergency department were met.

Cross Reference to A 0144: The hospital failed to ensure patients in its emergency department receive care and services in a safe setting.

Cross Reference to A 0386: The hospital failed to ensure a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care for patients assessed as high risk for suicidal intervention in the emergency department.

Cross Reference to A 0392: The hospital patients failed to receive care and services in accordance with the hospital's policies and procedures and Standards of Practice for its emergency department for 1 of 31 patient charts reviewed for care and services. (Patient 18)

Cross Reference to A 0395: The emergency department staff failed to ensure the safety and well-being of patients admitted to the department expressing suicidal/homicidal ideas or behaviors in failing to supervise contractual security staff in the performance of their duties resulting in potential harm to this patient and other patients admitted with suicidal/homicidal ideas.

Based on observations, record reviews, interviews, and review of the hospital's policies and procedures, the hospital's governance failed to ensure that the Emergency Department operated in a responsible manner to ensure the safety of those patients.

The findings are:

On 06/21/2017 at 11:00 a.m., review of Patient 20's emergency department chart revealed a 38-year-old patient presented to the hospital's emergency department on Saturday, 06/17/2017 at 07:28 am and was triaged on 06/17/2017 at 07:43 am. Review of the registered nurse triage notes revealed the patient's chief complaint was documented as "Mental Health Complaint". The triage nurse documented "pt(patient) friend bropught[sic] pt in stats[sic] the pt wants to harm himself. Patient sates[sic] wanting to take pills, ambu to room from triage patient took pills our of pooket[sic] and took approx (approximately) 2 - 4 pills from seroquel bottle." Review of the patient's triage notes revealed the nurse documented the patient's vital signs as: 98.2 degrees Fahrenheit, pulse 115 bpm (beats per minute(high), blood pressure 125/85, and pulse Oxygen saturation level 100 % (percent). The triage nurse documented the short version of the Columbia-Suicide Severity Rating Scale (CSSRS) which showed the patient had exhibited suicidal thoughts, a wish to be dead, idea with(w) - Method No intent, Idea w- intent No Plan, Suicide Intent w- plan, suicide behavior within the past month. Review of the triage level acuity revealed a level one (1) using the ESI Scale for Acuity. Review of nursing documentation in the patient's chart dated 06/17/2017 at 07:50 am revealed, "Calm Environment. MD (Medical Doctor)
Notified, Security notified, Security Watch Initiated, 1:1 With Staff . Pt verbalizes SI (Suicidal Ideation) with plan. Pt. States, "I just want end it." Pt states he took 5 of his seroquel pills." Review of a clinical note, titled, "Assessment &
(and) Referral Clinical Note", dated 6/17/2017 at 11:52 am revealed, "Pt. Presents as sedated and PET is unable to complete an assessment at this time. Nursing staff reported that after pt. was triaged and being escorted to a Gold Zone room that he ingested an unknown amount Seroquel 300mg (Milligrams) tablets but what he may have actually taken is unknown as he was walking he took the pills..." Review of the nursing documentation in the patient's chart revealed a nurse note dated 06/18/2017 at 3:32 am that revealed RN 38 (emergency department Charge Nurse per review of the emergency department's staff assignment sheet dated 6/17/2017) gave RN 39 a report on Patient 20. Review of the patient's emergency department chart in the section labeled "Activity" revealed the nurse documented on 6/18/2017 at 04:14 am that physician was made aware of of recent incident with patient. The nurse recorded, "He gave verbal order for cardiac monitor to be removed. He was in to eval (evaluate) post incident. No further orders obtained at this time."
Review of a nurse note labeled"Emergency department Note:" dated 6/18/2017 at 03:46 am was electronically entered on 6/18/2017 at 04:43 am. revealed RN 39 documented, "pt 1;1 with security. nurse instructed guard door needed to
be opened more to better visualize the patient, as guard was sitting in the doorway." Review of the patient's chart revealed a note dated 06/18/2017 at 04:14 am documented by RN 38 that reads, "This Charge Nurse was called
into room by nurse tech as well as monitor tech who saw patient was no longer on the monitor at this time. Upon my arrival I entered the room and immediately removed the cardiac cable that had previously been plugged into the spacelab and was monitoring patient. Once cord was removed it was also detached from patient chest. I assessed patient neck, and chest and no evidence of ligature marks or bruising was noticed. Pt was able to speak in full sentences
and was cursing at me. I explained to patient that he was going to be moved to room 5 where there was no cardiac monitor. I explained to him that he would no longer be able to have the lights off nor would he be able to the door cracked shut. I explained to security at this time the same. Patient became angry and began cursing at me. Dr. informed of above incident and gave verbal order to d/c (discontinue) the cardiac monitor, and to evaluate patient at this time. Will cont(continue) to closely monitor at this time." Review of a record of the incident dated 6/18/2017 at 4:14 am revealed, "Pt was in room 7 and was on monitor as he had overdosed on Seroquel as he was being wheeled into the ED
(emergency department). Pt has been a 1/1/watch since his arrival to the ED. Approx 0414, ...RN who was watching monitors notified ...RN that the patient in 7 was off the monitor. She went directly to the room and I was subsequently
I was called immediately to the room as the patient had unplugged the cord from the monitor and wrapped it around his neck in an attempt to harm himself. The monitor cord was immediately removed and then he was immediately removed
from that room and placed in room 5 where there was no monitor. I have notified security that this patient is not
allowed to have his room lights turned off and that his door must remain open at all times..." On 6/23/2017 from 12:00 to 12:54 pm, review of the observations documented on the contracted security company's observation form for Patient
20 for 06/17/207 - 06/18/2017 revealed the contracted security personnel (Security Officer 1) was assigned for suicide watch at the 1:1 level. Review of the documentation revealed Security Officer 1 was relieved for break on 6/18/2017
from 0330 am - 0407 am by Security Officer 2. There was no documentation of observations of Patient 20 by Security Officer 2 during this period. Review of Security Officer 1's documentation from 0330 - 0404 which was the period that Security Officer 1's was absent, "Patient got up out bed had something tied around his neck nurse came in and Officer.... and removed objects out of his room." Review of Security Officer 1's witness statement dated authenticated and dated 06/18/2017 at 04:31 am revealed "Upon returning from break around 0400, I heard patience[sic] moving around
in Room. I got up to check on him, and then I found him standing up next to sink with a cord wrapped around his neck. Another Officer and I along with nurses went/came inside to remove cord and take other objects out of the room...."
In an interview on 6/23/2017 at 11:45 am with Security Officer 1, Security Officer 1 verified that she was assigned for suicide watch 1:1 from 10 pm to 6:00 am on 6/17 -18, 2017. Security Officer 1 reported that he/she went on break for
about 20 minutes and was relieved by security Officer 2 during that shift. Security Officer 1 stated that during the shift, she sat outside the the patient's room with the door open and he/she could see the patient from the door. Security
Officer 1 stated that she documented on the sheet every 10 minutes while she was son duty. Security Officer 1 reported that when he/she returned from break, Security Officer 2 stated she heard something moving around . I opened the
door and saw him (patient) standing by the sink. Security Officer 1 stated a nursing technician was sitting outside the room at the computer behind her. Security Officer 1 stated that they snatched everything from the room and moved the patient to room 5 because he was getting wild and another security guard was watching him. Security Guard 1 stated that she usually worked at another health care facility in main lobby greeting people, and had received no training in
observations for patients on suicide precautions." Review of Security Officer 1's training record with the security company verified Security Officer 1 had not completed any training for working with suicidal/ homicidal patients since her hire on 1/12/2017. Security Officer 1 reported that he/she had not received a report from the nursing staff relative to the patient's care. On 6/23/2017 at 1:00 p.m., review of Security Officer 2's witness statement revealed, "...relieved S/O (security officer)(1) in Gold Zone 7 at 0340 a nurse was present when I was there and s/o was on break. The nurse stated that the door would not stay open so I propped open the door with a stool so I could see in room. The nurse had cut the lights out in gold 7 when the s/o returned it was 0405 and I left gold zone. Patient was laying in bed when I was there between 0340 to 0405 Nurse was doing vitals on patient. When nurse left room she stated to S/O (Security
Officer 1) that the door would not stay open so Security Officer (1) propped door open with a sitting stool. Nurse had turned out the lights in patient room goldzone 7 and patient was lying quietly in bed." The witness statement was
signed and dated 6/18/2017 at 0445 am. On 6/26/2017 at 1:15 p.m. revealed Security Officer 2 had no documentation of training for working with suicidal/homicidal patients in the file.

On 6/23/2017 at 1:10 p.m., review of Security Officer 40's witness statement relevant for the incident that occurred on 6/18/2017 revealed, "I conducted checks on the officers assigned to patient watch during the shift and found all were
positioned in the doorway of the patients room with the door open and patient in view." On 06/23/2017 from 10:30 a.m. until approximately 11: 15 a.m., Registered Nurse(RN) 26 was interviewed. RN 26 verified that he/she was the triage nurse on duty on 06/17/2017 on the 07:00 a.m. shift when the patient presented to the emergency department with a friend. RN 26 reported that he/she obtained the patient's vital signs and was escorting the patient and friend to
emergency department room 4. RN 26 stated that he/she was in front of the patient and the patient's friend was behind the patient as they walked to the room. RN 26 reported that when she arrived at the door to the room and turned,
he/she saw the patient remove a bottle from the pocket of he/s her pants, uncapped the lid, and removed pills from the bottle and swallowed them. RN 26 stated that she thought it was 2 to 4 pills and the bottle was labeled Seroquel. RN 26
stated the physician of the patient's actions and the patient was placed on a cardiac monitor and one- (1)-to-one (1) security watch. RN 26 explained that 1 to 1 security watch required a sitter be within arms reach of the patient at all
times. RN 26 explained that the patient was not placed in the hospital emergency department's blue zone dedicated for patients presenting to the emergency department with psychiatric and/or behavioral problems because that area of the
emergency department was closed and since the patient was placed on the monitor related to the ingestion of the pills in the bottle, the patient was placed in room 4 which is also used for patients admitted with coronary symptoms. On 6/23/2017 at approximately 11:20 am to 11:30 am, observations were made in the Gold Zone of Patient Room 4, Room 7, and Room 5. Patient Room 4 had multiple equipment and items to meet the emergent needs of patients presenting
with coronary or other critical issues. Patient Room 7 was equipped to handle the less critical issues. Patient Room 5 had no equipment and was designed for the safety of patients expressing suicidal/homicidal ideas.

Review of the hospital's policy effective 10/21/2015, titled, "Suicide and Homicide Observation PGR", reads, " Suicide and Homicide Observation Policy"
1. Nursing Assessment [Evaluation of Suicide Risk (Reference Text)]
1.1 The RN will assess each patient for potential risk of self-harm and/or harm towards others upon admission and as a part of the nursing assessment and system review by direct observation.
1.2 Information gathered through the Suicide Risk section of the Risk Precautions section within the Nursing Admission History form helps to determine the need for suicide/homicide observations.
2. Physician Orders
2.1 If the patient exhibits suicidal/ homicidal behavior and/or has a positive risk assessment for suicide/homicide, the nurse should notify the attending physician for further direction.
2.1.1 Suicide or homicide observation must be ordered by the physician. In emergent situations, registered nurses may place the order to be signed by the physician at a later time
2.1.2 A physician's order is required to discontinue suicide and homicide precautions.
2.2 If the patient is placed on suicide/homicide observations, then a psychiatric consult should be obtained.
3. Observation Levels
3.1 There are two suicide/homicide observation levels that are used on behavioral care units.
3.1.1.1 Suicide/Homicide 1:1 Observations - Staff must remain within an arm's length of the patient at all times. Observation are made on the patient's location and activity. Documentation is made every 10 minutes on the observation
record, including times when the patient is sleeping and using the bathroom. This type of observation is used when a patient admits to having suicidal/homicidal thoughts, has an active plan or has recently attempted suicide prior to
admission.

The Emergency Severity Index (ESI) is a five-level tool for use in emergency department (ED) triage. Experienced ED nurses use the ESI to rate patient acuity, from level 1 (most urgent) to level 5 (least resource intensive). The ESI is
unique among triage tools, by including both acuity and resource needs in the system of categorizing ED patients.