The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ASCENSION ST JOHN MEDICAL CENTER 1923 SOUTH UTICA AVENUE TULSA, OK 74104 Oct. 26, 2018
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on record review, observation, and interview, the hospital failed to:


I. provide a safe environment for 14 (Patient #4, 25, 26, 29, 30, 32, 33, 34, 35, 37, 39, 40, 41, and 42) of 14 suicidal patients due to sitters not being between the door and the patient, clothes and equipment with cords present in the patients' rooms, and/or personal belongings not being inventoried at the time of admission for contraband/ prohibited items such as weapons, chemicals and medications that could be used to self-harm or harm others.


II. ensure the safety of 14 (Patient #6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19) of 21 patients who were being monitored by virtual monitor technicians (VMTs) that resulted in patient falls, dislodgment of hemodialysis catheter with blood loss, removal of tubes and intravenous catheters, and missing patients.


These failed practices:


I. had the likelihood to result in compromised patient safety by allowing 14 (Patient #4, 25, 26, 29, 30, 32, 33, 34, 35, 37, 39, 40, 41, and 42) patients who were on suicide precautions to have access to multiple ligature and safety hazards such as cell phone charges, equipment cords, and other prohibited items, potentially causing self-inflicted injury or injury to others.


II. resulted in injury to one (Patient #16) patient secondary to blood loss, and the likelihood for increased risk for injury and adverse health outcomes for 13 (Patient #6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, and 19) patients who virtual sitter monitoring.


Findings:


I. Suicidal Patients

Review of hospital policy titled "Suicidal Patient, revised 10/18" showed patients who presented to the hospital with "suicidal tendencies" were to be placed in a unit where they received "continuous visual monitoring and direct line of sight of an associate monitoring them." Suicide precautions included but were not limited to the following interventions:

*Search personal belongings for items that could be used potentially to harm self or others and remove.

*Remove/restrict access to personal clothing. Patient should be placed in a hospital gown.

*Hospital linens, including sheets, pillow cases and blankets should be kept to a minimum.

*Objects with cords should be removed including but not limited cell phone cords, belts, and shoe laces that may be used for a ligature device. "Cord-like objects that cannot be removed must be identified by caregiver and remain under observation ..."

*Only items that were needed for specific procedures should be taken into the room, remain in the control of the staff member during the procedure and removed after the completion of the procedure.

*All potentially harmful items should be removed from the patient's room including but limited to plastic trash liners, soda cans, jewelry, street clothes, and electrical devices with cords, medications, weapons, and chemicals (perfumes, deodorants, mouthwash with alcohol, cleaning supplies).


Review of untitled hospital document identified by Staff N (sitter) as the "Sitter Guidelines, dated 09/17" showed "sitters must be within 1-2 arm's length of patient ...on the side of the patient with the door" ... "NO electronic devices ...no personal belongings ...no plastic trash liners, no telephone cords, or other electrical charge cords ...no street clothes ...no excessive linens, no balloons - strings".


Review of hospital document titled "Patient Sitter Assignment, dated 09/17" showed "each sitter will be provided a unit phone to alert staff of needs for SI and aggressive patients".


Review of untitled hospital document identified by Staff U as "Live (physically present with patient 1:1) Sitters Census, dated 10/25/18" showed evidence of the following:

*Patient #26, 33, and 37 were EOD (emergency order of detention) patients on suicidal precautions and were assigned a 1:1 sitter.

*Patient #4, 25, 31, 32, 34, 35, and 39 were on suicidal precautions and assigned 1:1 sitter.

*Patient #36 was an EOD patient and assigned a live sitter.


Patient #4 admitted due to suicide attempt by overdose was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:43 am, surveyors observed the following items in the patient's room: helium balloons with long strings/cords attached, no evidence of a unit phone present with sitter.


Patient # 25 admitted due to suicide attempt by overdose was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:33 am, surveyors observed the sitter seated next to window not on side of patient with the door.


Patient #26 admitted due to suicide attempt by was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:26 am, surveyors observed the following items in the patient's room: patient in hospital gown and sweat-pants, blood pressure machine with cords attached not currently being used for procedure, and a hooded zippered sweat-jacket lying on the window seal.


Patient #32 admitted due to suicide attempt was placed on suicide precautions with a 1:1 sitter. On10/25/18 at 9:06 am, surveyors observed the following items in the patient's room: personal cell phone, extra linens were stacked in room, blood pressure machine with cords attached not currently being used for procedure.


Patient #33 admitted due to suicide attempt was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:11 am, surveyors observed the following items in the patient's room: blood pressure machine with cords attached not currently being used for procedure, no evidence of a unit phone present with sitter.


Patient #34 admitted secondary to suicide attempt was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:15 am, surveyors observed the sitter seated next to window not on side of patient with the door, no evidence of a unit phone present with the sitter.


Patient #35 admitted secondary to suicide attempt was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:25 am, surveyors observed the a plastic liner in the trash can.


Patient #37 admitted secondary to suicide attempt was placed on suicide precautions with a 1:1 sitter. On 10/25/18 at 9:45 am, surveyors observed the following items in the patient's room: blood pressure machine with cords attached not currently being used for procedure, patient's personal cell phone and charger.


Review of six (Patient#29, 30, 39, 40, 41, and 42) of six variance reports involving patients with suicidal tendencies showed hospital policy and procedure were not followed to ensure patient safety as evidenced by:

*Screwdriver and medications found in personal belongings, corded phone and plastic trash liners found in room after admission to the floor from the ED (Patient #40).

*Sitter left patient on suicide precautions unattended with guard during lunch break (Patient #30).

*Sitter not within arm's length of patient or facing patient while in bathroom, found walking hallway outside room without sitter (Patient #29).

*Pocket knife and lighter found in clothing after admission to the floor from the ED (Patient #39).

*Attempted suicide with pulse ox cord (Patient #41).

*On suicide precautions, only intervention implemented was sitter. Patient had all belongings including clothing, phone chargers, and bag. Telephone, cords and other potential items that could be used as self-harm were not removed from room (Patient #42).


On 10/25/18 at 9:00 am, Staff FF stated blood pressure machines are kept in the patient rooms for "staff convenience" when blood pressure needed to be taken. Staff FF stated patients are not usually on frequent vital signs.


On 10/25/18 at 9:38 am, Staff Q stated he/she did not have a Spectra (unit) phone today. Staff Q stated, he/she usually did not receive a phone because they were short of phones.


On 10/25/18 at 9:43 am, Staff DD, stated, he/she did not receive a Spectra phone today, usually all of the nurses and techs receive the phones. Staff DD stated, if he/she needed assistance he/she would use the call light to get help. Staff DD stated, if there was an emergency he/she did have a "duress button" on his/her badge that produced a sound and everyone would come running. Staff DD stated that this was a new call light system but all units did not have it yet.


On 10/25/18 at 10:05 am, Staff T (ED RN) stated, when a patient comes in with suicidal ideations or suicide attempt the nurse would notify security and assess the patient to determine stability of the patient. Staff T stated, staff would get the patient undressed, go through the patient's belongings with security for any items that could be used for weapons to harm self or others and bring those to the nurses' station and label them. Staff T stated, staff would get blood, put up suicide precautions so everyone was aware of concerns, and request a sitter for 1:1 observation. Staff T stated, if a psych safe room was not available staff would assess the room and remove items that could be used to harm self or others and turn the bed to face the door.


On 10/26/18 at 9:20 am, Staff M (RN) stated, suicidal or self-harm patients that were admitted to the floor, staff would "proof the room" prior to the patient's arrival. Staff M stated, this would include taking all things out of the room that the patient could harm themselves or others with such as cords, phone, chair alarm system, shower curtain, plastic trash liner, and SCD (sequential compression device) machine. Staff M stated, the patient would be placed in a hospital gown and all personal clothing removed. Staff M stated, nursing staff would make sure the patient had a sitter and performed a suicidal screening on admission to the floor.



II. Virtual Monitor Technicians (VMTs also known as "Virtual Sitters")


Review of hospital policy titled "Virtual Sitter Monitoring Process, revised 01/18" showed, the use of virtual sitters were utilized "to assist with patient safety" ...patients who met criteria for a virtual sitter were those patients that "warranted a closer level of observation and/or were identified to be at risk for injury or fall". The decision for initiation and discontinuation of a virtual sitter was based on the "clinical judgment" of the Registered Nurse (RN) ...The virtual sitter and nursing staff should maintain active communication for patients being monitored. First line of intervention should be audio redirection by the virtual sitter to the patient. Virtual sitter would notify nursing staff when a non-emergent patient issue arose that needed staff response. For emergent situations or when patients were not following redirection a STAT alarm should be initiated by the VMT.


Review of 14 (Patient #6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19) of 14 variance investigative files for patients assigned a virtual sitter showed hospital policy and procedure were not followed to ensure patient safety and quality care as evidenced by:

*Patient #16 pulled out newly placed hemodialysis catheter, no notification by virtual sitter. Patient found by nursing staff bleeding and rapid response team (RRT) was called, blood loss estimated at 500 cc. Investigation showed "patient chose to pull out (hemodialysis catheter), VMT not able to see". Recommendations included place posey mittens (finger control mittens) and utilize lights.

*Patient #7 repeatedly pulling off BiPaP oxygen mask, no redirection by virtual sitter, response from VMT was "I don't have time to sit and watch all of these (patients) at once". Investigation showed "VMT unable to monitor patient to prevent from removing mask. Recommendations were "none". There was no evidence of investigation regarding VMT's report of having difficulty watching "all these patients at once".

*Patient #8 out of bed twice no alarm sounded by virtual sitter to notify staff. Investigation showed "VMT failed to follow communication escalation work instructions". Recommendations included "education VMT".

*Patient #9 found "hanging off bed with BiPaP mask around neck and urinated everywhere", no notification to staff by VMT, VMT stated "not watching patient for BiPaP, only for high risk for falls". Investigation showed "failure to report what to monitor and follow-up when patient took off Bipap". Recommendation was VMT would notify nursing.

*Patient #6 left room and was found at the elevators by staff, VMT did not sound alarm when patient left room, and VMT stated "dealing with multiple issues, phone call, three busy patients requiring verbal instructions and this patient leaving the room." Investigation showed "VMT dealing with multiple issues". Recommendations were to "education patient and family" and "VMT hypervigilance ..." There was no evidence of investigation regarding VMT's inability to maintain observation of Patient #6 due to "dealing with multiple issues ...".

*Patient #10 being monitored for impulsivity and high risk for falls, was able to get out of bed and completely undress and make it to the bathroom before staff were notified by the VMT. Investigation showed "failure of the patient to cooperate ...reset bed alarm and clear process for VMTs to take turns exchanging report." Recommendations were to "use distraction techniques, mask lines, posey mittens and fall prevention measures."

* Patient #11 pulled their PICC (peripherally inserted central catheter) out of his/her arm and VMT did not notify staff. It was noted the VMT sitter had several patients requiring interventions at the same time. Investigation showed "patient did not listen to redirection, VMTs had several patients requiring interventions at the same times". Recommendations were to "use distraction techniques, mask lines, posey mittens and fall prevention measures." There was no evidence of investigation VMT's not able to respond to Patient #11 due to having several other patient interventions at the same time.

*Patient #12 was standing in area VMT "could barely see" and then patient was no longer visible. VMT notified staff by phone instead of using the alarm, and before staff could make it too room, patient had left room and was found on another floor. Investigation showed "VMT delay in calling by VMT". Recommendations were "none".

*Patient #13 had removed "foley secure device three times, oxygen multiple times, found naked and half out of bed at least three times, and finally pulled out intravenous (IV) line without VMT ever alerting anyone or sounding alarm". Investigation showed "patient failed to cooperate with fall prevention ...increase visual sitter observation, poor communication between nursing unit and VMTs." Recommendations were "to leave STAT alarm on, document communication and educate patient on fall prevention." There was no evidence there was follow-up to determine these measures were implemented.

*Patient #14 found headed towards elevators by staff, virtual alarm did not sound until after "three to five minutes after patient exited room" VMT stated they did not have staff phone numbers prior to the event occurring. Investigation showed "VMTs had multiple EOD patients, failure to communicate EOD status and follow policy". Recommendations were to "use STAT alarm, put active patients near each other on the screen, EOD patients wear a gown and RN call report to VMT." There was no evidence there was follow-up to determine these measures were implemented.

*Staff heard virtual sitter alarm and responded and found patient (Patient #15) had lost his/her footing and fell on to his/her bottom. Upon examination of the virtual sitter system there was no evidence of patient redirections or STAT alarms from the VMT prior to the fall. Investigation showed patient was "confused, impulsive, able to rise but unsteady." Recommendations were for "bed cords to be attached in a more reliable manner" ... "hard to find where alarm coming from when ringing in room". No evidence there was investigation why there was no alarm that could be heard outside of the patient's room.

*Patient #17 stood up and fell against the wall and table, no notification from the VMT. Investigation showed "patient inability to comply with safety measures." Recommendations were "reminders to staff, patients and family".

*Patient #18 pulled out his/her nasogastric (NG) tube and there was no notification from the VMT. Patient was receiving tube feedings from the NG tube. The investigation was not completed during the review by surveyors on 10/25/18. The due date for the investigation was 10/22/18. Staff B stated an email had been sent out to the Department Manager.

*Patient #19 got up from bed and VMT activated the alarm, nurse went in room and put patient in chair. Approximately 10 minutes later patient was found wondering in the halls with no notification or alarm from the VMT. VMT stated "sorry, was not watching him/her after the nurse went into the room". Investigation showed "associate watching distracted, not paying attention or had technical issues and did not follow proper procedures." Recommendations were "educate staff". There was no evidence there was follow up by Risk Management or Quality to determine the event occurred as a result of the VMT "being distracted" and what caused the distraction, or what "technical issues" occurred that resulted in this occurrence.


There was no evidence these variances were investigated to determine the number of patients the VMTs were assigned, types of patients being monitored, and how many interventions the VMT were responding too at the time of each incident.


On 10/23/18 at 10:45 am, Staff D stated, VMTs could monitor a maximum of 12 to 16 patients at a time on one large screen. Staff D stated, the maximum he/she has had was 13 at one time during a shift. Staff D stated, he/she could talk to the patient in order to redirect them. Staff D stated, he/she could "zoom in and see what was hanging and infusing on the IV pump, and watch to see if they were trying to pull at their lines and tubes so they could verbally redirect".


On 09/25/18 at 12:30 pm, Staff B stated, initially when a variance comes in all risk managers review the report. Staff B stated, the department leader could also see the variance. Staff B stated, the variance would then be sent out for information to be gathered for the "event cause", contributing factors and recommendations. Staff B stated, the department manager would send the completed variance back to risk management and it was reviewed by one of the risk managers. Staff B stated, he/she does not review all variance reports to ensure the investigation had been completed.
VIOLATION: QAPI Tag No: A0263
Based on record review and interview, the hospital failed to ensure the Quality Improvement Program was on-going and included executive and leadership roles and responsibilities for identifying safety expectations using measurable indicators which identified and reduced patient safety issues, medical errors and adverse outcomes through measuring, analyzing causes, implementing preventive actions and communicating lessons learned as evidenced by the lack of discussion in nine of nine Quality Management Committee (QMC) meetings from 01/25/18 to 09/27/18, nine of nine Medical Staff Quality Committee meetings from 01/23/18 to 09/25/18, and three of three Board of Directors (Governing Body) meetings from 01/29/18 to 07/23/18 for:


I. Eight (Patient #29, 30, 39, 40, 41, 42, and two unknown) of eight suicidal patient variances reviewed for 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, that resulted in staff's failure to search patients' personal belongings for safety hazards (weapons and medications), removal of ligatures, suffocation and other harmful objects from patient rooms, and maintaining 1:1 supervision to ensure patients remained within line of sight of assigned sitter. Including one (Patient #40) patient who obtained an equipment cord and attempted to hang him/herself.


II. 17 (Patient #6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and three unknown) of 21 patient VMT variances reviewed from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, for the VMT's failure to re-direct patients, notify nursing and/or activate the STAT alarm that resulted in blood loss to one (Patient #16) patient, three (Patient #15, 17, and one unknown) patient falls, four (Patient #8, 10, 13, and one unknown) patients found out of bed, four (Patient #6, 12, 14, and 19) patients located outside of their rooms, three (Patient #7, 9, and 13) patients who had removed oxygen devices and three (Patient #11, 13, and 18) patients who had pulled out their IV lines or tubes. VMTs reported in four (Patient #7, 6, 11, and 14) of 21 variance having difficulty maintaining direct observation of individual patients due to workload.


III. Six (Patient #28, 43, 44, 45, 46, and 47) of six variances from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, related to possession of contraband or prohibited items that resulted in respiratory distress and RRT for one (Patient #46) patient due to "cheeking and snorting" pain medication; one patient (Patient #47) was found unconscious with residue in a spoon and tourniquet at bedside, an RRT was called; diversion of narcotic medication vials from a sharps container (Patient #28); one (Patient #45) patient found down with an empty syringe with powder residue in IV tubing; and one (Patient #43) patient in possession of a loaded handgun on arrival to the unit from the ED.


IV. Ten (Patient #48, 49, 50, 51, 52, 53, 54, 55, 56, and 57) of 14 variances involving skin integrity issues from the ED from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, resulted in blanchable redness to the back, sacrum, coccyx and bilateral posterior thighs for one (Patient #50) patient due to lying on a "hard fabric" EMS sheet for hours, five (Patient #51, 53, 54, 55 and 56) patients covered in urine, feces and/or vomit without being provided hygiene care, two (Patient #48 and 57) patients left on bedpan with noticeable redness, and one (Patient #52) with continued nausea and distended abdomen due to NG tube not placed as ordered while in the ED.


These failed practices:


I. had the likelihood for increased risk for injury to self or others, and adverse health outcomes related to the lack of Risk Management and Quality Management's failure to investigate, review, discuss, and analyze variance reports, identify action plans and opportunities for improvement, and report findings to QMC, Medical Quality Committee and Board of Directors.


II. resulted in deficient variance reporting by Risk Management to QMC, Medical Staff Quality and the Board of Directors for eight (Patient #29, 30, 39, 40, 41, 42, and two unknown) of eight suicidal patient variances, 17 (Patient #6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and three unknown) of 21 patient VMT variances, six (Patient #28, 43, 44, 45, 46, and 47) of six variances related to possession of contraband or prohibited items, and ten (Patient #48, 49, 50, 51, 52, 53, 54, 55, 56, and 57) of 14 variances involving skin integrity issues from the ED. Therefore, executive committees lacked sufficient information to make informed decisions related to the provisions of quality patient care.


Findings:


Review of hospital policy titled "Variance Reporting, revised 06/16" showed the hospital would maintain a "non-punitive system" for the identification of events that involved patients, staff, and/or others not employed by the hospital in an effort to "identify potential opportunities to improve patient safety by reducing morbidity and mortality." The policy failed to provide evidence of the following:

*Investigative process including information required,

*Who would be responsible for the investigation of the variance?

*Time parameters for the investigation and depending on severity of reported event would time parameters be the same,

*Who would the results of the investigation be reported back too; and

*Follow-up requirements.


Review of hospital document titled "Director Risk Mgmt-In Market Region, dated 10/23/17" showed, the Director of Risk Management was responsible for the "collection, evaluation and maintenance of data concerning patient injuries, claims and other risk-related data" ..."advises in the design and implementation of risk reduction" ..."investigates, analyzes and reports root causes, patterns and trends that could result in ...serious adverse events and near misses ...assists with identification and implementation of corrective actions".


Review of hospital document titled "Risk Manager, dated 11/20/17" showed, the Risk Manager was responsible for "collection and assessment of data to identify potential or actual sources of risk to patients and employees" ..."collaborates with staff and quality committee members with respect to risk-related incidents" ..."responsible for event and claim investigations ...facilitates reporting and classification of safety data/events ...participates in root cause analysis related to near miss and medical errors".


Review of hospital document titled "Dir-Quality Mgmt, dated 07/15/18" showed, the Director of Quality Management was responsible for "the analysis of patient care information to identify real or potential concerns and oversees development of recommendations to correct or prevent concerns".


I. Suicidal Patients

Review of hospital policy titled "Suicidal Patient, revised 10/18" showed, patients who presented to the hospital with "suicidal tendencies" were to be placed in a unit where they received "continuous visual monitoring and direct line of sight of an associate monitoring them." Suicide precautions included but were not limited to the following interventions:

*Search personal belongings for items that could be used potentially to harm self or others and remove.

*Remove/restrict access to personal clothing. Patient should be placed in a hospital gown.

*Hospital linens, including sheets, pillow cases and blankets should be kept to a minimum.

*Objects with cords should be removed including but not limited cell phone cords, belts, and shoe laces that may be used as a ligature device. "Cord-like objects that cannot be removed must be identified by caregiver and remain under observation ..."

*Only items that are needed for specific procedures should be taken into the room, remain in the control of the staff member during the procedure and removed after the completion of the procedure.

*All potentially harmful items should be removed from the patient's room including but limited to plastic trash liners, soda cans, jewelry, street clothes, and electrical devices with cords, medications, weapons, and chemicals (perfumes, deodorants, mouthwash with alcohol, cleaning supplies).


Review of hospital document titled "Quality Management Committee (QMC)" meeting minutes from 01/25/18 to 09/27/18, showed, no evidence of discussion of variances regarding suicidal patients who had access to dangerous items, staff who failed to maintain 1:1 supervision of suicidal patients per hospital policy and procedure, and an attempted suicide due to staff's failure to maintain a safe environment per hospital policy.


Review of eight (Patient #29, 30, 39, 40, 41, 42, and two unknown) of eight suicidal patient variances from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, showed the following:

*Four (Patient #39, 40, 42, and one unknown) patients were admitted to the floor from the ED with their personal belongings still in their possession. One (Patient #40) patient variance showed, the patient had a screwdriver and medications in his/her possession. On arrival a corded phone and plastic trash liners were noted to be in patient's room after admit. Patient #39 variance showed, after arrival to the floor a pocket knife and lighter were found in patient's clothing.

*Two (Patient #42 and one unknown) patients were allowed to have personal cell phones and chargers in their room while on suicide precautions and 1:1 supervision. The outcome of the investigation for these variances included education and coaching/counseling for staff members involved.

*One (Patient #41) patient attempted to hang themselves with cord from a piece of medical equipment secondary to the room not being searched and determined safe prior to placing a suicidal patient in the room. Investigation showed "RN chose not to follow protocol because felt not needed" ..."coaching provided". Recommendation from the investigations were to increase the number of psych rooms in the ED.

*One (Patient #30) variance showed, a sitter for a patient on suicide precautions left the patient unattended with a guard while he/she took their dinner break. The patient was not monitored by hospital staff during this time period. The outcome of this investigation was to educate staff.

*One (Patient #29) patient on suicide precautions was found wandering the halls attempting to gain access to the linen closet while the sitter was turned away not maintaining line of sight of the patient. Investigation showed "sitter had been up multiple times with patient ...this time sat down and did not realize that patient stepped out into hall ...sitter became complaisant and bored forgetting it only takes one time ...to be distracted and patient to harm themselves." Recommendations were for "regular education and testing".

*One (Patient name unknown) suicidal pediatric patient awaiting transfer to a psychiatric facility was able to escape from the locked pediatric unit and elope from the hospital. Variance was filed on 09/25/18 and at the time of surveyor's review on 10/24/18 the Director of Risk Management was unaware of the outcome for this variance and if there had been any changes to hospital processes as a result of this occurrence.

* There was no evidence Risk Manager, Director of Risk Management or Director of Quality reviewed incident reports to determine investigation was completed, analyzed for causes, identified trends or process issues that could impact patient safety, assisted in implementation of preventive actions to decrease the risk of re-occurrence and communicated lessons learned to QMC, Medical Staff Quality Committee and Board of Directors.


II. VMT Program

Review of hospital policy titled "Virtual Sitter Monitoring Process, revised 01/18" showed the use of VMTs were utilized "to assist with patient safety" ...patients who met criteria for a VMT were those patients that "warranted a closer level of observation and/or were identified to be at risk for injury or fall". The decision for initiation and discontinuation of a VMT was based on the "clinical judgment" of the Registered Nurse (RN) ...The VMT and nursing staff should maintain active communication for patients being monitored. First line of intervention should be audio redirection by the VMT to the patient. The VMT would notify nursing staff when a non-emergent patient issue arouse that needed staff response. For emergent situations or when patients were not following redirection a STAT alarm should be initiated by the VMT.


Review of 17 (Patient #6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and three unknown) of 21 patient VMT variances reviewed from 06/01/18 to 09/23/18 and 09/04/18 to 10/22/18 showed the following:

*One (Patient #16) variance report showed, a patient was able to remove a newly placed hemodialysis catheter with 500 cc blood loss and no notification or alarm by the VMT. The outcome of the investigation was to utilize posey mittens, utilize lighting to visualize IV lines and minimize bedding and pillows.

*Three (Patient #15, 17, and one unknown) variance reports showed falls with no prior notification or alarm from the VMT. The outcome of the investigations included reminders to staff of fall risk and making sure "bed cords were attached to beds in a more reliable manner".

*Three variance reports revealed a PICC line was pulled out the patient's (Patient #11) arm, an IV line removed (Patient #13) and an NG tube pulled out (Patient #18). There was no notification or alarm sounded by the VMT in regards to any of these incidents. The outcome of the investigations included utilization of distraction techniques, use of posey mittens, and education of patients and staff.

*Eight variances reports showed four (Patient #8, 10, 13, and one unknown) patients were found out of their beds, and four (Patient #6, 12, 14, and 19) were located outside of their rooms. There was no notification or alarm sounded by the VMT prior to the patients getting out of bed or leaving their rooms. One (Patient #12) patient was able to wander from his/her room and staff were not noticed by the VMT until after he/she had wander to another floor/unit of the hospital. The investigation showed there was "a delay in the VMT calling the nursing aide". There were no recommendations identified from the investigation to ensure this event did not occur again.

*Three (Patient #7, 9, and 13) variances reports showed patients had removed oxygen devices (two BiPaP masks, one oxygen mask). The outcome of the investigations included the VMTs were "unable to monitor patient to prevent removal of mask", education of VMTs to notify staff when patient's removal BiPaP masks, and education of patients.

*Four (Patient #6, 7, 11, and 14) variances reports showed VMTs reported having difficulty maintaining direct observation of patients due to workload. There was no evidence workload of the VMTs were investigated and/or analyzed to determine if it was a contributing factor to these four events or any of the other 13 related events.

*There was no evidence Risk Manager, Director of Risk Management or Director of Quality reviewed variance reports to determine investigation was completed, analyzed for causes, identified trends or process issues that could impact patient safety, assisted in implementation of preventive actions to decrease the risk of re-occurrence and communicated lessons learned to QMC, Medical Staff Quality Committee and Board of Directors.


III. Possession of Contraband and/or Prohibited Items

Review of hospital policy titled "Inspection of Packages, Purses, or Belongings, revised 01/17" showed, the hospital and security officers "has the right to inspect packages, purses or other belongings of patients ...to identify harmful or dangerous items ..." Suicidal patients should have their belongings inspected and removed from patient access.


Review of hospital policy titled "Weapons, Explosives and Other Unlawful Items, revised 03/16" showed, suicidal or mentally ill patients should be searched to ensure a "safe and secure environment and reduce the risk of harm to patients, staff and visitors" ...


Review of hospital policy titled "Pharmaceutical Waste Management, revised 02/18" showed, nursing staff were responsible for the disposal of pharmaceutical waste into the "black Flammable/Toxic RCRA waste container" ...all medications including but not limited to vials, pills, capsules, tables ... must be disposed of in the container.


Review of eight of eight variances from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, showed the following:

*One variance report showed a patient was found in respiratory distress and an RRT was called due to "cheeking and snorting" one-half of their oxycodone. Patient had been seen "taking unsupervised visits to the bathroom, verbalizing anxiety over pain medication regimen and keeping backpack with him/her" by nursing staff. Event occurred on 10/08/18 and investigation had not been completed at time of surveyor review on 10/24/18.

*One variance report showed, a patient was found down in the bathroom with an empty syringe attached to the IV tubing and a white powder residue inside the syringe. Request was made by risk management to "include when patient was last physically seen by the nurse rounding, medications given, etc." Review of the completed investigation showed no evidence of when the patient was last seen by nursing, when medications were given or the reason for patient admission.

*One variance report showed, a sharps container in patient's room was damaged and during the search of the patient's room 8 pills of Robaxin 750mg (muscle relaxer), 21 vials of Dilaudid (narcotic pain medication), and 34 vials of Benadryl (antihistamine) were found. The vials were determined to be empty photographed and disposed of in the medication room sharps container by security. There was no investigation on how or why this event occurred, Pyxis (medication dispensing system) records were not pulled to analyze the number of vials pulled from the machine equaled the number of vials inventoried from the patient's room, and pharmacy was not involved in the investigation. The event occurred on 10/11/18 and there was no evidence the investigation had been completed at the time surveyor reviewed variance on 10/24/18. An investigation was provided by security to surveyors on 10/25/18 which included the "Case Report" completed by security with no submitted or reviewed date and photographs of the medication vials confiscated from the patient's room.

*One variance report showed, a patient was found unresponsive and an RRT was called, a spoon with residue and tourniquet was found at the bedside. Investigation noted actions were "related to human factors out of hospital control" and "recommendations were unable to be given at the time".

*Two variance reports showed, one patient was in possession of a handgun found in bed with the patient and another patient had "drugs and paraphernalia that fell from bed" upon rising. The investigation showed no recommendations were made to ensure these occurrences did not re-occur.


There was no evidence Risk Manager, Director of Risk Management or Director of Quality reviewed variance reports to determine investigation was completed, analyzed for causes, identified trends or process issues that could impact patient safety, assisted in implementation of preventive actions to decrease the risk of re-occurrence and communicated lessons learned to QMC, Medical Staff Quality Committee and Board of Directors.


IV. Emergency Department Issues

Review of hospital document titled "Patient Information and Education Handbook, revised 12/16" showed, patients "have the right to expect the hospital would make a reasonable effort to provide appropriate medical care" ..." the "right to care that is considerate and respectful" ... "practicing cleanliness is needed to prevent infections and illnesses" ... "hospital staff are available to assist with these practices as needed during your hospital stay."


Review of hospital policy titled "Pressure Ulcer Prevention Work Instruction Manual, revised 01/16" showed, skin integrity preservation was considered an important part of nursing care. "All levels of nursing staff are responsible for skin care ..." When patient was incontinent patient should be cleaned quickly and if linens soiled they should be changed.


Review of hospital policy titled "Nursing Documentation, revised 06/17" showed, all patient care activity including but not limited to hygiene, personal care, and patient activity should be documented in the appropriate sections of that patients electronic medical record.


Review of ten (Patient #48, 49, 50, 51, 52, 53, 54, 55, 56, and 57) of 14 variances involving skin integrity issues from the ED from 06/01/18 to 09/23/18, and 09/04/18 to 10/22/18, showed the following:

*Patient #48 arrived to unit on bedpan, transport unaware of patient on bedpan, bottom red from imprint from bedpan, repositioned to determine further skin damage. Investigation showed "spoke with staff regarding not to leave patient on bedpan for extended periods." No evidence to determine extent of any skin damage caused by event.

*Patient #49 "patient had strong smell of urine, found diaper very full of urine and stool ...bed linens were wet. Rectal area was red." Investigation included education of staff to "assess fundamentals and basics of care when possible ...try to assess skin and hygiene ASAP." Recommendations from investigation were "none".

*Patient #50 was left on a "hard fabric" EMS transfer sheet, "blanchable redness on back, sacrum, coccyx and bilateral posterior thighs" Stage I pressure ulcer were noted. Investigation included "staff did not remove mega slider upon arrival". Recommendations from investigation were "none".

*Five (Patient #51, 53, 54, 55 and 56) patients covered in urine, feces and/or vomit without being provided hygiene care by ED staff prior to transfer to other units. Investigations included "spoke with staff ...", "lack of assessment by staff ..." Recommendations from investigations included "assess patients prior to transport", "additional educational", and "none".

*Patient #52 diagnosed with small bowel obstruction with an order for NG tube placement at 3:07 pm. Patient arrived on the floor at 5:00 pm, reporting continued nausea and distended stomach due to NG tube not being placed in ED, patient stated the nurse said "the NG tube could be done by the nurse on the floor". Investigation included "spoke with staff ...order accidentally overlooked by staff". Recommendations from investigation was "none".

*Patient #57 arrived to unit and bedpan underneath patient. Patient stated he/she had been on it for a "few hours". Patient had been unable to void, bladder was scanned, told by ED nurse bladder was full with 400mL of urine and placed on bedpan. Bladder scan on floor showed 959mL, patient was in-and-out (straight) cathed with a return of 1200mL of urine. Investigation included "spoke with staff ...education of staff". Recommendations from investigation showed "RCA (root cause analysis) complete. There was no evidence of the findings from the RCA in the investigative file.

* There was no evidence Risk Manager, Director of Risk Management or Director of Quality reviewed variance reports to determine investigation was completed, analyzed for causes, identified trends or process issues that could impact patient safety, assisted in implementation of preventive actions to decrease the risk of re-occurrence and communicated lessons learned to QMC, Medical Staff Quality Committee and Board of Directors.


On 09/25/18 at 12:30 pm, Staff B stated, initially when a variance comes in all risk managers review the report. Staff B stated, the department leader could also see the variance. Staff B stated, the variance would then be sent out for information to be gathered for the "event cause", contributing factors and recommendations. Staff B stated, the department manager would send the completed variance back to risk management and it was reviewed by one of the risk managers. Staff B stated, risk management "strives for completion of the investigation within 14 days". Staff B stated, if they had not received the report back from the department manager within 14 days an email would be sent to their director and the Director of Nursing. Staff B stated, all variances regardless of severity are treated the same. Staff B stated risk managements "goal was for the department managers to be responsible for trending their own data and not relying on risk management to do this."


On 10/24/18 at 9:16 am, Staff B stated, Staff C (Director of Quality) gets a list of daily variances but does not know what he/she does with them. Staff B stated, he/she reports variances quarterly to QMC. Staff B stated, he/she provides the number of events for the hospital, the ED and an overall number of events. Staff B stated, he/she graphs the top five or six types of events and overall how the hospital was doing in regards to these events. Staff B stated, he/she does not discuss individual variances.


On 10/25/18 at 8:07 am, Staff C stated, risk management data was reported to QMC on a quarterly basis. Staff C stated, individual events were not usually discussed in QMC. Staff C stated, he/she received a "daily variance report" and either he/she or Staff U would "look at it a couple of times a week". Staff C stated, he/she would look at it "from a perspective for anything that caused harm." Staff C stated, "if there was no harm then generally Quality would not get involved." Staff C stated, "I agree that there is a big trend for the suicidal patients and virtual sitters". Staff C stated, he/she knew about the variance involving the diversion of the narcotic vials because it was discussed in a staff meeting (safety huddle). Staff C stated, "the way the current process is set up Quality does not get involved in the root cause and if there is not an issue Quality does not get involved. Staff C stated, for new programs (Virtual Sitter Program) the Quality Program did not require quality indicators. Staff C stated "nursing probably would set up quality indicators".
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on record review, observation, and interview, the Governing Body failed to ensure the Quality Improvement Program used data to monitor and improve program effectiveness, patient safety and quality outcomes for high volume, high risk, and problem prone issues through tracking and analysis for events, such as a new Virtual Sitter (VS) process that began in 07/2017.


These failed practices resulted in the following critical incident events reported between 07/10/18 and 10/20/18, and had the likelihood of the events' rates to re-occur or increase due to the lack of implementation of quality improvement measures.


Findings:


A Virtual Sitter (VS) monitoring process was started in 07/2017. The policy (Virtual Sitter Monitoring Process dated 01/2018) states that patients were remotely monitored in a centralized area ...monitoring can be initiated based on nurse assessment. Active communication will be maintained between monitoring staff and nursing staff.


Documents titled "Safety Event Entry" showed the following:

1. Patient pulling at his IVs and popped of the breathing limb to hi BiPap several times. No notification from the VS. The VS stated "I don't have time to sit and watch all these at once." (07/01/18)

2. Patient out of bed twice with no alarm sounding or notification from the VS. (07/09/18)

3. Patient had legs hanging off bed with BiPap mask around neck, urinated on self. VS stated she was not watching the patient for BiPap; was only considered high risk for falls so did not call about other issues. (07/11/18)

4. Aggressive patient left floor unattended. VS did not notify nurse/aide. (07/13/18)

5. Patient had removed clothes and was walking down the hallway. VS did not notify nurse/aide. (07/14/18)

6. Patient pulled PICC line. VS did not sound alarm or notify nurse/aide. (07/20/18)

7. Patient fell hitting head. VS did not redirect or sound stat alarms prior to fall. (09/05/18)

8. Confused patient found headed toward elevated. VS did not notify nurse/aide. (08/28/18)

9. Patient pulled her Foley secure device, pulled off oxygen and was found naked and out of bed. VS stated she was monitoring, but had not contacted nurse/aide. (08/16/18)

10. Patient pulled newly placed HD catheter, nurse not contacted by VS and patient found bleeding with loss of 500 ml blood. (09/17/18)

11. Patient pulled NG tube. VS had not seen patient pulling tube. (10/14/18)

12. Patient was found wondering outside of room and no alarm sounding. VS was not watching.(10/20/18)


Documents titled "Nursing Quality Practice Council: (dated 01/10/18 through 10/10/18) and "Quality Management Committee" (dated 01/25/18 through 09/27/18) contained no discussion, monitoring, tracking or analysis of events of this new process.


Observed the monitoring centralized area: one tech would monitor up to 13 patients at five facilities located in five different cities. Staff A (10/23/18 at 10:45 am) stated, he collected data on response time, how often the VS process was used and how many "saves" (based on the number of stat alarms that were sounded). Staff A did not report the data into the quality program, there were no goals for improvement developed, and no tracking or analysis of this new, high-risk process through the quality program. Staff C (10/25/18 at 8:05am) stated, the VS process was established by Nursing and Quality had not advised or developed quality indicators.