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Based on interview and record review, the hospital's Governing Body failed to be responsible for the quality and safety of services provided because:
The contracted alarm installation company had not been subjected to quality review (see A-0083).
The fire alarm system was not functioning correctly to minimize the risk of fire hazard (see A-0700).
The risk of infection had not been minimized through the implementation of an effective infection control program (see A-0747).
The hospital's plan of correction for the survey completed on 12/22/15 showed that significant events would be referred to leadership within 24 hours. However, problems with critical processes such as fire alarm safety and instrument sterilization were not ensured because the Governing Body did not have adequate surveillance mechanisms to identify the problems promptly. During interviews with hospital leadership including the CEO, Sr VP of Hospital Operations and others on 4/4/16 at 1530 and on 4/7/16 at 1510, they were not aware of the recurrent problems with the fire alarm and sterile processing systems, and were not aware of the actions of hospital staff.
The cumulative effect of these failings meant the hospital did not ensure high quality healthcare was provided in a safe environment.

Based on observation, interview and record review, the contracted fire alarm installer had not been the subject of performance review, creating the risk of substandard alarm services.
Findings:
The Rules and Regulations of the Governing Board (undated) showed that the functions of the Governing Board included, "Assure that all services furnished on a contract basis at or by the Hospital meet the standards set forth by the Governing Board, Hospital Administration and the Medical Staff, and further that such services are being furnished in compliance with all applicable federal, state and accreditation agency requirements."
Review of hospital documents showed that there was a fire in the hospital during January, 2015. and that subsequently there were failures of the audible fire alarm system in September, 2015, December, 2015, and during vendor testing on January 22, 2016. Failures in the audible fire alarm system was also noted during this survey (see A-700).
In an interview with the Dir of Facilities on 4/7/16 at 1410, he stated that there were problems with the audible alarms during the week. In an interview with the Dir of Facilities on 4/7/16 at 1415, he stated that they were not doing audible alarm testing quarterly, but that an annual review was done in January.
During an interview with the Dir QA on 4/7/16 at 1400, she stated that the QAPI program obtained information about the fire alarm system from the EOC minutes. She stated that the minutes should include information about the January alarm system testing results.
The EOC minutes were reviewed, and read that the fire marshall had signed off on the fire alarm system. There was no information about the failure of fire alarms in January, 2016.
Documentation from the fire marshall showed that the fire alarm system had not been approved due to unresolved problems.
During an interview with the Dir QA on 4/8/16 at 0920, she stated that the QA Department provided annual evaluation of contracted service providers using a standard form. During a second interview with the Dir QA, on 4/8/16 at 1120, she stated that the contracted fire alarm contractor had started in January, 2015, and the contractor's work had not been evaluated. She stated that the evaluation should have been done in January, 2016.

Based on interview and record review, the hospital failed to ensure that one grievance (for Patient M604) was investigated, creating the risk of a failed grievance process and persistent poor practices.
Findings:
The grievance of Patient M604 was reviewed on 4/7/16, and showed that the patient reported being discharged prematurely, being provided with conflicting information about the discharge, and had complaints about behavior of one nurse, who he described but did not name. He did not present a complaint about his assigned nurse, but that another nurse, who he described as a hispanic woman, was unpleasant and insisted that he leave the hospital.
During a review of the medical record, the discharge order written at approximately 1800 hours on 3/16/16 was contingent upon a consultants approval. The consultant arrived to see the patient at 2100 hours, but indicated in his note that he approved the discharge earlier in the day. The patient was discharged from the hospital an hour prior to midnight on 3/16/16, but returned the following day to complain.
In an interview with AS2, she was able to confirm the descriptions of his nurse and the nurse about whom he complained matched the description of his assigned nurse and the charge nurse on duty the night he was discharged.
The grievance investigation by the manager restated the complaint incorrectly, confusing the description of the nurse about whom he was complaining. The manager then noted that the patient did not have such a nurse caring for him. The manager also noted that the patient had a signed discharge order, but failed to investigate why a discharge ordered at six in the evening resulted in a discharge at 11pm, and did not show that staff were interviewed about providing conflicting information regarding the discharge or mistreatment of the patient. There was no evidence that any witnesses to the events were interviewed.
A response letter that was sent to the complainant 3/31/16 did not address the allegation of mistreatment by the nurse.
In an interview with the Dir QA, she concurred that there appeared to be incomplete follow-up of the grievance.

Based on observation, interview and facility policy review, the facility failed to ensure that all patients admitted to the facilities behavioral health unit maintained the right to wear their own clothing. This failure denied patient's rights without due cause.

Findings:

A review of the facility policy titled, "Patient's Rights" dated 09/15, indicated in part, "3. Policy and Procedure, A. All patients admitted to the Behavioral Health Unit have the right: 1: To wear their own clothing."

A review of facility policy titled, "Care of Patient Belongings and Valuables," effective date 02/16, indicated in part, "C: Admission Process. 8. On the Behavioral Health Unit (BHU), two (2) changes of clothing may be in patient's possession, to be stored in the patient's personal closet."

A review of facility policy titled, "Patient's Rights, Denial of," effective date 09/15, indicated in part, "3. Policy/ Procedure. A. Psychiatric facilities must uphold the following specific legal rights of patients, which may only be denied when "Good Cause" exists: 1 The right to wear own clothing..........."

During an observation and tour of the Behavioral Health Unit (BHU) on 4/6/16, starting at 8:45 a.m., accompanied with Adm1, Adm 2, Adm 3, RN 4, and MD 2 patients on all units (open, C and D), were noted to be in the halls and or in bed. All observed patients were noted to be dressed in forest green colored hospital gowns. The activities schedule indicated groups for these units started at 8:30 a.m.. During the tour, the patient rooms had patient personal closets, random openings of these closets did not reveal any patient personal clothing.
During a concurrent observation and interview with ADM 1 on 4/6/16, beginning at 8:45 a.m., when asked where the patient's personal clothing was, ADM 1 stated, "We store them, because some patient's wander in and out of rooms and take things."
During an interview with Patient N100 on 4/6/16, at 9:15 a.m., accompanied with MD 2 and ADM 2, Patient N100 was observed sitting in her room in a wheelchair, dressed in a hospital issued gown, listening to music playing from a radio on a side table. When asked where her clothes were, Patient N100 stated, "They took them, I came in with a green robe, and pants and they won't give them back to me." When Patient N100 was asked if she would like to wear her own clothing , Patient N100 stated, "Yes." MD 2 was questioned as to whether it was routine to take a patients clothing, MD 2 stated, "No." ADM 2 added, "We can get everyone's clothing back to them today."
During an interview with RN 4 on 4/7/16, at 10:05 a.m., when questioned about the process for patient belongings, RN 4 stated, most of the BHU patients come through the ER (emergency room), where their clothes are bagged and the patients are put into a gowns, when they come up to the unit (BHU) their clothes go into storage. RN 4 shared there was no denial of rights form filled out.

Based on interview and record review, the hospital failed to provide documentation of follow-up for Patient N300 who requested further information regarding Advance Directives at the time of admission.

Findings:

The hospital policy and procedure titled "Advance Directives" dated 3/2016. indicated that the hospital "shall provide to each adult individual, at the time of his or her admission as an inpatient, written information describing: i. An individual's right under California statutes and court decisions to...formulate Advance Directives...E. If the patient does not have an Advance Directive and is able to decide for self, the Admitting Clerk will ask the patient if information is desired...ii. If the patient would like further information: a. The admitting staff will give the patient a packet explaining how to obtain an Advance Directive. The patient's name will be placed on a list entitled "Referral to Social Services for Follow-up on Advance Directives."This list is kept in the admitting office and is picked up by the Case Manager and/or LCSW who will follow-up with the patient in-house and provide counseling, if needed..."

During a concurrent review of Patient N300's electronic record (e-record) and interviews with administrative staff (AS)1 and social worker (SW) 1 on 4/5/16 at 2 p.m., a form titled "Conditions of Admission" dated 3/29/16 indicated that Patient N300 wanted more information regarding Advance Directives. SW 1 said that there is a "Referral to Social Services for Follow-up on Advance Directives" binder in admissions which was obtained.SW 1 said that admitting has to put the patient's name in the the referral book for someone to get back to the patient with further information on Advance Directives. The dates for follow-up went from 3/25/16 through 4/5/16. After review, both AS1 and SW 1 agreed that Patient N300's name was not included on the list for follow-up.

Based on observation, interview and record review, the facility failed to write a plan of care for Patients N501 and N503 who were placed in wrist restraints for non-violent behavior. This failure to write patient specific plans of care for wrist restraints placed the patients at risk for complications.

Findings:

Review of the facility's policy and procedure titled "Restraints and Seclusion" dated 2/2016, indicated "Care Plan, the restrained or secluded patient's written plan of care shall be modified to address the appropriate interventions implemented to assure the patient's safety and encourage the least restrictive means of protecting the patient."

Review of the facility's policy and procedure titled "Interdisciplinary Plan of Care" dated 2/2016 indicated "An individualized Plan of Care is developed for each patient; each patient's careplan identifies goals that:
i. Reflect the patient's unique needs
ii. Are realistic and measurable
iii. include a time frame for achievement, when appropriate."

During an observation and consecutive interview with an RN (RN 1) on 4/4/16 at 2:45 p.m., Patient N501's private room door to the hallway was shut. RN 1 stated the door was shut for the patient's privacy. Patient N501 was overheard yelling "Help me." and "I want to take it off." over and over. Patient N501 was observed lying in bed on her back with both wrists tied to the sides of the bed, the call light was not within reach.

Review of Patient N501's clinical record did not reveal a plan of care for the use of wrist restraints.

During an interview with RN 2 on 4/4/16 at 4:30 p.m., RN 2 confirmed there was no plan of care for restraints completed for Patient N501.

During an observation and concurrent interview of Patient N503 on 4/4/16 between 3:05 and 4:30 p.m., Patient N503 was lying in bed on her back with both wrists tied to the sides of the bed. RN 7 stated the restraints were to keep the patient from scratching herself.

Review of Patient N503's clinical record did not reveal a plan of care for wrist restraints.

During an interview with RN 2 on 4/8/16 at 10:45 a.m., RN 2 confirmed there was no plan of care for restraints completed for Patient N503.

Based on observation, interview and record review, the facility failed to assess, monitor and document on Patients N501 and N503 who were placed in wrist restraints for non-violent behavior. Failure to monitor and assess for restraints places these patients at risk for negative complications during the use of restraints.

Findings:

Review of the facility's policy and procedure titled "Restraints and Seclusion" dated 2/2016 indicated "Restraints not used for the management of violent behavior shall be subject to ongoing monitoring and assessment as specified in the patient's plan of care. Monitoring and assessments shall occur at least every 2 hours."

During a fifth floor facility tour on 4/4/16 between 11:05 a.m. and 4:30 p.m., Patients N501 and N503 were observed with wrist restraints.

During an observation and consecutive interview with an RN (RN 1) on 4/4/16 at 2:45 p.m., Patient N501's private room door to the hallway was shut. RN 1 stated the door was shut for the patient's privacy. Patient N501 was overheard yelling "Help me." and "I want to take it off." over and over. Patient N501 was observed lying in bed on her back with both wrists tied to the sides of the bed, the call light was not within reach.

Review of Patient N501's "Protective (Safety) Restraint Doctor's Order and Daily Record" form dated from 3/38/16 to 4/5/16 indicated a check off list for assessment and temporary restraint release during care, however, Patient N501's documentation was inconsistent and assessments were not checked as completed on 3/29, 3/31, 4/1, 4/2, 4/3, and 4/4/16. The Patient's restraints were not temporarily released to provide care on all shifts, the patient was not assessed to require ongoing restraint for protection, and the patient was not assessed to tolerate the restraint without physical or psychological incident on all shifts per the facility policy and procedure.

During an observation of Patient N503 and concurrent interview on 4/4/16 between 3:05 and 4:30 p.m., Patient N503 was lying in bed on her back with both wrists tied to the sides of the bed. RN 7 stated the restraints were to keep the patient from scratching herself.

Review of Patient N50 's "Protective (Safety) Restraint Doctor's Order and Daily Record" forms dated 3/29 and 4/2/16 were not complete and indicated the patient was not assessed to tolerate the restraint without physical or psychological incident consistently.




35399

Based on interview and record review, the hospital did not ensure the efficacy of the discharge process because there was an incomplete analysis of the discharge planning issues and inaccurate data, creating the risk of persistent poor practices, and did not ensure the quality program provided oversight of fire safety in the hospital, creating the increased risk of unsafe discharges and an unsafe hospital environment.
Findings:
1 The hospital's plan of correction from a survey dated 12/22/15 showed that "Quality indicators for the Behavioral Health Unit now address discharge processes and follow-up on obtaining information on efficacy of the patient's discharge."
The hospital policy, Discharge Planning (reviewed 11/2012) read, "Discharge planning identifies the patient's needs after he leaves the hospital, delineates plans to meet those needs and teaches the patient and family how to implement the plan."
During review of three randomly selected records at the Van Nuys campus, all three showed rapid readmission to the hospital after recent discharges, with the following admission dates: patient M601 admitted 2/18/16 and 4/4/16, patient M602 admitted 2/11/16 and 3/31/16, patient M605 admitted 3/17/16 and 3/23/16.
The open medical record of Patient M601 was reviewed.
During an interview with SS Staff 1 on 4/6/16 at 0900, she stated that the patient had been admitted previously in December, 2015 and February, 2016. She stated that it was up to the patient to follow up with referrals at discharge, and that there was no documentation of why the patient did not follow up with the resources provided. She stated that the telephone number of an outpatient clinic was provided to the patient during her discharges.
The open medical record of Patient M602 was also randomly selected for review at the VN campus, and showed that the patient was homeless, suicidal, and had a previous admission in February, 2016. The list of discharges within the past year indicated the patient had 11 admissions to the hospital within the past 12 months.
In an interview with the Dir SS VN on 4/6/18 at 0930, he stated that referrals offered to the patients included a county program referred to as the FSP program. He stated that the program provided assistance to patients after discharge, and that a program representative visited the hospital to meet with patients. He stated that he was unable to find documentation that Patient M602 had been referred to the county FSP program, but that the patient might have refused such a referral.
In an interview with Patient M602 on 4/6/16 at 0945, he stated that he had been wanting to enter the county's FSP program and needed assistance to do so.
The hospital's QAPI follow-up of discharge planning was reviewed with VN QAPI Staff 1 on 4/6/16, and showed that the hospital attempted to call 31 patients regarding post-discharge follow-up, but that only six had been reached. Three of the six contacted had followed up with the planned post-discharge services.
During an interview with the Dir SS VN on 4/6/16 at 1010, he stated that there was often trouble identifying a single fixed point of responsibility (SFPR) person who could assist with discharge planning. He estimated that 50-60% of discharges did not have such a contact person. He stated this issue had not yet been discussed in the psychiatry committee.
During a review of the QAPI evaluation of the efficacy of discharge planning with Coord QAPI VN on 4/6/16, he stated that it was difficult to follow up on the efficacy of discharge planning due to problems with contact information for the patients. He stated that the problem of patients not obtaining post-discharge services could be related to transportation problems because of the distance from the patients' homes to the outpatient clinics. He stated that they had not contacted the outpatient clinics to see if transportation was available. He stated that he had also been collecting data regarding the readmission rate for the facility since 2014, but had not used the data yet.
The QAPI data presentation for the discharge plan efficacy data was reviewed, and the graph depicted 100% efficacy of the discharge plan.
In an interview with the Dir QA on 4/7/16 at 0925, she concurred that the goal of the indicator was to validate the efficacy of the discharge plan. She stated that the hospital had been able to contact six of 31 discharged patients, and that three patients followed up with suggested services at discharge. She agreed that the depiction of 100% efficacy did not accurately reflect the data gathered.
2 The Quality Assessment and Performance Improvement Plan (2016) read, "The Quality Council shall provide a systematic and coordinated approach to the maintenance and improvement of patient safety through the establishment of mechanisms that support effective responses to actual occurrences; ongoing proactive reduction in medical/health care errors; and integration of patient safety priorities into the new design and redesign of all relevant organizational processes, functions and services as identified in the Quality Indicator s and Health Care Outcomes".
A Review of hospital documents showed that there was a fire in the hospital during January, 2015. and that subsequently there were failures of the audible fire alarm system in September, 2015, December, 2015, and during vendor testing on January 22, 2016. Failures in the audible fire alarm system was also noted during this survey.
The Quality Assessment and Performance Improvement Indicators for 2016 included, "Four total fire system PM" (preventive maintenance). The EOC minutes presented to the Quality Council 2/2016 showed that "All audible issues were remediated the same day as survey. This will be monitored on a quarterly and annual basis by the fire alarm vendor."
In an interview with the Dir Facilities on 4/7/16 at 1410, he stated that there were problems with the audible alarms during the week. He stated that they were not doing audible alarm testing quarterly, but that an annual review was done in January.
B On 4/4/15, at approximately 1030 am, an overhead page announced a "code red". However, no representatives from the fire department appeared at the hospital.
Review of hospital documents showed that the fire alarm was not being transmitted to the fire department because the system was being placed in "test" mode daily.
In an interview with the Dir Facilities on 4/7/16 at 1425, he stated that the system should never have been put in "test" mode routinely, and that he had just found out about the practice the prior day. He stated that he was currently training the staff not to put the system in "test" mode unless it was required and approved.
In an interview with the Alarm Project Mgr on 4/7/16 at 1520, he stated that the contractor had not requested that the system be put in "test" mode, and that the system should not be put in "test" mode without permission.
In an interview with the Dir QA on 4/7/16 at 1340, she stated that she thought there would be an occurrence system report of recurrent or persistent physical plant problems, but that she had not seen ongoing reports on those issues. She stated that the issues would be communicated to leadership if in the occurrence reporting system.
In an interview with the Sr VP Hospital Operations on 4/7/14 at 1520, he stated that the EOC provided information regarding the safety of the environment, and that the EOC Committee reported to the quality department quarterly, and the information was then reported to the Governing Body.
During a review of the EOC Minutes provided to the QAPI Committee, there was no indication that the fire alarm system was being placed in "test" mode, or that there was an intention to refrain from notifying the fire department about fire alarms.
C The hospital policy, Risk Management Confidential Report (reviewed 11/12), read, "An occurrence is not consistent with the routine operation of the hospital or routine care of a patient. An occurrence is actual or potential injury and/or property damage."
In an interview with the Dir QA on 4/8/16 at 0940, she stated that the EOC critiqued code reds, and that she would expect a summary in the EOC committee report. She stated that code reds were not incidents reported through the occurrence reporting system. She stated the code red observed on 4/4/16 was not documented in the incident system.

Based on interview and document review, the hospital failed to ensure a complete investigation and follow-up actions were performed and documented for three incidents reviewed, creating the risk of persistent poor practices and substandard health-care.
Findings:
From the incident log, incidents recorded on 3/23, 3/24 and 3/28/16 were randomly selected for review.
The documentation for the three incidents appeared incomplete because not all of the recipients had noted that they reviewed the event, because there was no or incomplete investigation documented, and because there was no follow-up action documented.
The incident dated 3/23/16 involved a near miss medication error which was caught by the pharmacy. Review of the incident documentation did not show that an investigation occurred. There was no documentation of interviews of involved staff to determine the source of the error. The department manager had not reviewed the incident, and the section of the form for Manager's Proposed Action was left blank. Three of eight people on the list of reviewers had not reviewed the incident.
The incident dated 3/28/16 involved a physician who refused to follow-up on missing documentation. Four of 11 people on the list of reviewers had not reviewed the incident. The department manager checked that the review was completed on 3/30/16, and recommended that the physician be sent to peer review. The Dir Medical Staff Services documented reviewing the incident on 4/1/16, but did not provide information about whether the medical staff concurred with the recommendation for peer review, or whether peer review was scheduled. Another staff member documented on 4/7/16 that the incident was to be sent to peer review, but there was no clear mechanism for documenting whether this had occurred.
In an interview with the Dir QA on 4/7/16 at 1015, she stated that the department manager was to initiate follow-up within 24 hours of the incident. She reviewed the documentation of the 3/23 incident and stated that the review and investigation by the manager was not documented. She reviewed the documentation of the 3/24/16 incident reported by the wound care nurse, and stated that the director was to do an investigation, but it was not documented. She stated that incident reviews were being analyzed and tracked by the QAPI department, with the goal of 90% of incidents being correctly managed.

Based on interview and record review, the hospital failed to ensure that one patient, Patient M603, was adequately assessed, creating the risk of a substandard health outcome.
Findings:
1 The hospital policy, Triage Classification System (reviewed 3/2016) showed that "Level 1 RESUSITATION: Patients who present with a life-threatening complaint and require immediate intervention. This may include patients that are dying, intubated, apneic, pulseless, in severe respiratory distress, with acute mental changes or unresponsive. These patients are placed immediately in bed. Initial nursing assessment is initiated and the physician is immediately notified."
In an interview with the ER RN Mgr at 1110 on 4/4/16, she stated that the initial blood pressure of 149/98 at 0428 indicated the patient was stable, so the blood pressure was not reassessed for an hour. She stated that the paramedics report off the patient's condition to the nurse.
The triage nursing assessment was reviewed, but no or minimal handoff from the paramedics was documented. The paramedic documentation was requested for review.
During a second interview with the ER RN Mgr, at 1130 on 4/4/16, she stated that the paramedics were to fax their documentation over when it was completed, but she did not see it. She was subsequently able to obtain the document, the Prehospital Care Report Summary. The patient's blood pressure had been 79/49 when first assessed by the paramedics at 0413 hours, but rose to 174/126 during the eight minute transport. The report showed that the patient was speaking in full sentences, and upon arrival at the hospital at 0428 had a Glascow Coma Scale score of 15 (full neurologic functioning).
The bedside nurse's assessment, documented at 0458, showed that the patient was nonverbal, and had no response to voice or pain.
Despite the patient's unstable vital signs in transit and acute change in mental status, there was no blood pressure recorded for the patient in the ER from 0432 (when it was 145/98) until 0530, when it was 49/27. In an interview with the CNO on 4/6/16 at 1310, she stated that the blood pressure was not documented for some time after the admission, and that it was unclear if the change in the patient's condition during transport had been explained as this was not documented.
2 The hospital policy, Titration of Drugs in the Critical Care Area (reviewed 1/2016) showed that "All patients requiring titratable medications will be monitored, including EKG, blood pressure and SPO2."
The Medical Orders showed a medication order for Levophed (a medication to raise blood pressure) was recorded at 0600, with the direction to titrate the medication to maintain a blood pressure of 110/60. The nurse noted that at 0721, "levophed hung to infuse at 18mcg/min ".
The ER documentation of the patient's vital signs from 0715 until 1000 were missing from the Vitals page of the record. The Clinical-Interdisciplinary Notes showed free text record of the blood pressure at 0721 (92/47), at 0759 ("systolic blood pressure remains in 90's), but not again until 0950 ("BP is in the 50's systolic").
In a continuing interview with the CNO, she stated that she believed the vital signs for the time period from 0715 until 1000 must be recorded somewhere.
In an interview with AS1 on 4/6/16 at 1315, she stated that she was unable to find the missing vital signs for the patient.



33720

Based on observation, interview and facility policy review, the facility failed to asses and care plan for suicidal ideation for Patient N102, who was admitted to the BHU on an involuntary hold for suicidal ideation. There was no nursing assement and care plan for suicidal ideation for six days post admission. This failure has the potential to impact patient safety.

Findings:

The facility policy and procedure titled, "Suicide Risk Assessment," effective date of 01/2016, indicated in part, "A. During the admission process, an individual may be identified as having a need that requires monitoring based on assessments of patient's behavior and needs...." "On the behavioral health unit, precautions are initiated by physician order/ and or nursing staff assessment." The policy included "ii. When a patient is identified as being at risk for self harm, the admitting RN shall initiate a Treatment Plan for destructive behavior directed at self."

The facility policy and procedure titled, "Interdisciplinary Plan of Care." effective date of 02/2016, indicated in part, "B. The Interdisciplinary Plan of Care shall be based upon assessments performed by all disciplines, which describes the intentions, rationale, and interventions associated with identified issues..." "C. The admission data collection shall be completed within 24 hours of admission..."

During a review of the clinical record for Patient N102 the record revealed that Patient N102 was admitted to the BHU unit on 3/29/16, at 5:29 p.m., on an involuntary hold for suicidal ideation. Admitting physician indicated in part "She (Patient N102) has suicidal ideation with intention to overdose on her medication or cut her wrists." The physician note(s) dated 3/31/16, 4/01/16, 4/02/16, 4/3/16, all indicated Patient N102 had thought content that was "positive for suicidal ideation with intention to overdose or cut her wrist."
A review of nursing assessment dated 3/29/16 at 7 p.m., indicated "Assess for auditory hallucinations and paranoid behavior, give medications, re-orient patient to reality, encourage to participate in group interactions, therapy." There were no other updates to the care plan until 4/4/16, where the care plan indicated short term goals, "Patient will not try to hurt herself for two days." A review of the nursing narrative notes from 3/29/16 through 4/4/16 did not indicate patient suicidal ideation or precautions.
During an interview with ADM 2 on 4/6/16, at 4 p.m., while concurrently reviewing patient N102's clinical record, Adm 2 acknowledged that nursing clinical records between the time of admission on 3/29/16 through 4/4/16 lacked an assessment and care plan for suicidal ideation. Adm 2 stated, "I need to keep working with the staff, I have told them that safety and suicidal assessment is always first."





26881

Based on observation, interview, and document review, the hospital failed to ensure:

1. No significant amount of reconstituted injectable medications for administration via patient's vein was left remaining in the vial potentially under-dosing the patient; and,

2. The rubber top of the injectable vials was wiped with alcohol as per infection control standards consistent with the hospital audit.

3. Based on record review and interviews, the facility failed to ensure nursing services provided by the facility met professional standards related to duplicate therapy without clarification of physicians' orders for two of three patients:
A. Patient 400 had pain medication orders for two different potent narcotics (drugs that in moderated doses dulls the senses, relievespain and induces profound sleep) without any instructions when they should be given. The form indicated to order only one pain medication. The nurse caring for Patient 400 noted the orders without clarification of which medication should be given..
B. Patient 402 had orders for two different medications for high blood pressure (HTN) without any instructions which should be given first. The nurse caring for Patient 402 noted the orders without clarification of which medication should be given.
These failures placed patients at risk for over medication that could lead to 1. over sedation or stupor and 2. low blood pressure which ultimately could lead to death.


Findings:

1. During a medication pass observation on 4/9/16 at 2:05 P.M., RN 70 prepared for infusion to Patient 600, a Pharmacy-assembled generic injectable antibiotic for Zosyn (antibiotic) 3.375 gram (gm) connected to the 50-ml bag containing 5% Dextrose in Water by a device called addEASE Binary Connector, BC2000, made by B. Braun.

The Binary Connector allows for the fluid for infusion to remain separated, until activated, from the additives such as the injectable vial containing Zosyn powder. This assembly adds convenience and longer usable dating compared to the Pharmacy-compounded drug when prepared under sterile conditions.

After RN 70 activated the injectable Zosyn and reconstituted the powder inside the Zosyn vial by transferring the fluid from the IVPB (IV piggyback) bag to the vial and back to the bag, she proceeded to programmed the IV pump and administered the medication.

On closer inspection of the fluid that remained in the vial, approximately a quarter of the vial was filled with the reconstituted fluid.

In an interview on 4/5/16, at 2:15 P.M., RN 70 stated about 5 to 10 cc (cubic centimeter; same as milliliter) of reconstituted fluid remained in the antibiotic vial.

RN 70 then was observed to be able to transfer completely the remaining fluid from the vial to the IVPB bag.

In an interview on 4/5/16 at 3:30 P.M., the DOP stated each Medication Room in the Nursing Stations had the poster on activation and reconstitution of the connected antibiotic system for infusion via the Binary Connector and nurses were periodically educated on the proper techniques.

The document posted on the wall of the Medication Room titled, "addEASE - How to activate?" showed,

"Step 6: With vial positioned above (referring to the picture of a person holding the connected bag upside down) container (as shown) squeeze or flex and release container to transfer solution from vial to container (repeat twice or until no residual drug is visible)."

2. During a medication pass observation on 4/5/16 at 9:10 A.M., RN 72 was observed not to disinfect with alcohol the rubber top of the vial of the injectable Protonix (a medication used to reduce acid in the stomach) IV 40 mg before the needle penetration.

In an interview on 4/5/16 at 3 P.M., the VPPO stated the top of the vials should have been cleaned with the alcohol wipes.

In a concurrent interview, the DOP stated the medication pass audit conducted by the Pharmacy would ensure the top of the vials were wiped with alcohol.

Review of the hospital document used as a tool for medication pass audits, titled, "Medication Pass Audit Form" showed the following to be asked and checked during a medication pass audit:

"Was the administration technique correct as per the drug? Vial swabbed?"

According to "WHO (World Health Organization) Best Practices for Injections and Related Procedures Toolkit,"

"This chapter assimilates the best practices for delivering injections in health-care and related facilities. It is based on a range of evidence and expands the scope of the WHO publication, Best infection control practices for intradermal, subcutaneous, and intramuscular needle injection. The chapter outlines recommended practices, skin preparation, preparation and administration of injections, and related health procedures.

Best injection practices described are aimed at protecting patients, health workers and the community...

Wipe the access diaphragm (septum) with 70% alcohol (isopropyl alcohol or ethanol) on a swab or cotton-wool ball before piercing the vial, and allow to air dry before inserting a device into the bottle..."




33720

3. According to "Fundamentals of Nursing-8th edition," (Potter & Perry; Mosby, 2013), page 305 "The health care provider (physician or advanced practice nurse) is responsible for directing medical treatment. Nurses follow health care providers' orders unless they believe the orders are in error or harm patients."
A. During a review of the clinical record for Patient 400, the Post Anesthesia Care (PACU) Orders, dated 4/6/16 at 12:30 p.m. indicated: "Fentanyl (a powerful synthetic narcotic medication) 50 micrograms (mcg) intravenous (IV) (injection of medication directly into the vein) every (q) 10 minutes (min) for 10 doses. Hydromorphone (a narcotic pain reliever similar to morphine) 200 mcg IV q 10 min for 10 doses."
B. During a review of the clinical record for Patient 402, the Post Anesthesia Care Orders, dated 4/7/16 at 9:32 a.m. indicated: "Labetalol (medication used to treat high blood pressure) 10 milligrams (mg) intravenous push (IVP) (injection of medication directly into the vein) q 10 min prn (as needed) SBP (systolic blood pressure) > (greater than) 180 may repeat x (times) 3 prn. Hydralazine (medication used to treat high blood pressure by relaxing smooth muscle) 5 mg IVP q 10 min prn SBP >180 may repeat x 3 prn."
During an interview and concurrent record review of PACU orders for Patients 400 and 401, on 4/7/16 at 10:10 a.m., the Director of Infection Control (ICP 1) and the Interim Director of Surgical Services (RN 3) acknowledged the PACU nurses had no protocols on these medications. The ICP 1 and RN 3 confirmed, physician orders for 2 medications without specific indications of when they should be given is not an acceptable practice. RN 3 reported it is beyond the nurse's scope of practice to decide which medicine should be given and the orders should have been clarified with the physician.
During an interview and concurrent review of the PACU orders for Patient 402 on 4/7/16 at 10:10 a.m., the certified registered nurse anesthetist (CRNA 1) explained he was unaware ordering two medications for the same condition was beyond the scope of nursing practice.
During an interview and concurrent review of the PACU orders for Patient 400 and 402 on 4/7/16 at 1:35 p.m., the director of nurses (DON) acknowledged orders for 2 medications without specific indications of when they should be administered is an unacceptable practice.

Based on interview and record review, the hospital failed to ensure that one medication was correctly administered to Patient M603, creating the risk of substandard health outcome.
Findings:
The hospital policy, Titration of Drugs in the Critical Care Area (reviewed 1/1016) showed that Norepinephrine (levophed) should be started at an initial rate of 4 mcg/min, with a titration rate of 1 mcg/min at 5 minute intervals for a target goal of a systolic blood pressure greatern than 90.
Patient M603 arrived in the ER on 4/4/16 and was found to have a low blood pressure of 49/27 at 0530. The Medical Orders showed a medication order for Levophed (a medication to raise blood pressure) was recorded at 0600, with the direction to titrate the medication to maintain a blood pressure of 110/60. The nurse noted that at 0721, "levophed hung to infuse at 18mcg/min".
The nursing note from 0750 showed, "Levophed at 18.8 ml/hour to maintain BP" and "systolic blood pressure remains in 90's " .
There were no additional notes regarding Levophed administration until 0950, when the nurse noted, "Pt's levophed increased to 9 mcg/min". The blood pressure at 0950 was,"in the 50's systolic".
Starting at 10:00, upward titration of the Levophed each five minutes, by 1mcg, per protocol, was seen.
During an interview with the CNO on 4/6/16 at 1310, she concurred that the documentation of Levophed administration was unclear.

Based on interview, record review, and facility policy and procedure review, the facility failed to ensure telephone orders for Patients N-301 and N-303 were authenticated within 48 hours, per facility policy.

Findings:

The facility policy and procedure titled "Telephone and Verbal Orders" dated 3/2016, indicated that the policy and procedure is organization- wide and applies to all staff that are employed by the hospital. "A. Telephone Orders i. Telephone Orders are to be written and read back to the physician to clarify; medication orders must be signed within 48 hours."

Review of the electronic record (e-record) of Patient N-301 on 4/5/16 at 2:35 p.m., reflected the patient was admitted on 3/28/16 and discharged on 4/1/16. Further review indicated computerized physician order entries (CPOE) of a total of 25 different medication orders, both routine and as needed (PRN) for Patient N-301's stay. The e-record indicated that the medications orders were all electronically signed on 4/4/16, 72 hours after the patient was discharged.

During a concurrent e-record review and interview with administrative staff (AS) 1 on 4/5/16 at 3:35 p.m., agreed that the orders were not signed within the 48 hours per facility policy.

During a concurrent review and interview of the e-record for Patient N-303 on 4/8/16 at 10:40 a.m. with AS 1, the e-record reflected medication orders through CPOE dated 3/30/16 and 4/4/16. AS 1 acknowledged that the medication orders had not been signed within 48 hours, per facility policy.


33720

Based on observation, interview, and record review, the facility failed to ensure accounting procedures for controlled substances in the Culver City Pharmacy were performed in accordance with the facility policy to document consistently that accounted for the overfill in the injectable vials used to compound PCA (Patient Controlled Analgesia) infusion bags containing hydromorphone (a potent Scheduled II narcotic pain medication) resulting in the creation of discrepancies. This failed practice resulted in narcotic medications to be potentially diverted.

Findings:

During an inspection of the Pharmacy Drug Storage Room at Culver City on 4/5/16 at 10:30 A.M., it was noted there were two Narcotic Towers for storage of controlled substances. It was also noted that during the inventory count for hydromorphone (a federally Scheduled II narcotic pain medication) 40 mg/ 20 ml vials, the logged quantity in the computer inventory log did not match the actual quantity on hand.

In a concurrent interview, the DOP stated the hydromorphone vials were used to compound PCA bags according to the master formula that called for 27.5 ml and explained the count was off because of the overfill from the vials that accumulated over time.

The DOP stated the overfill in the vials was not taken into account each time the medication was accessed and allowed the discrepancy to continue until there was enough difference in volume existed between the inventory count and the visual count of the actual amount remained in stock. The resulting overfill would be added to the inventory count by creating and resolving the discrepancy with another pharmacist.

The DOP also stated the amount in volume of hydromorphone used to compound the PCA bags was automatically calculated and deducted each time from the inventory and did not accurately reflected the actual amount that remained in stock.

In a concurrent interview, the DOP and the VPPO acknowledged the potential diversion due to the unknown amount of accumulated overfill which was not taken into account and resolved each time the medication was accessed from the Narcotic Tower.

On 4/7/16, a review of the hospital document titled, "All NarcStation Events" from 3/11/16 to 4/7/16 showed daily audit of the inventory count for hydromorphone 20 mg/ml conducted to be accurate on 4/2/16 and 4/4/16.

There was a discrepancy resolution made on 4/5/16 due to the plus 6-ml difference between actual and the documented amount.

According to the hospital P&P titled, "Controlled Substance System" last revised, "10/2012,"

"Controlled substances include all drugs listed in Schedules II, III IV, and V...of the Federal Uniform Controlled Substance Act, as amended, or the California Controlled Substances Act, as amended...

The pharmacy shall conduct random audits of all C-II drugs periodically. The physical count shall be verified and confirmed by 2 registered pharmacists..."



33720




34709

Based on interview and document review, the hospital failed to ensure medication orders were prescribed only by licensed health professionals within their scope of practice authorized by law and per approved hospital protocol.

Findings:

Review of the hospital P&P titled, "Preparation and Administration of Medications" showed,

"...All chronic medication orders must be renewed every thirty days unless the physician specifically orders otherwise. Pharmacy shall evaluate and contact the physician for clarification. Exceptions...The MEC (Medical Executive Committee) has authorized the Clinical Pharmacist to renew certain "Critical Medications", if the prescriber fails to renew the medications..."

In an interview on 4/5/16, at 3:30 P.M., the DOP was not able to provide MEC approved protocol, list of critical medications and the definition of what were considered critical medications.

In a concurrent interview, the VPPO stated the pharmacists were not allowed to renew medications without a physician order to do so.






34709

Based on interview and document review, the hospital failed to ensure:

1. Pharmacy compounded medications achieved the final concentrations that met the potency and strength as intended;

2. Pharmacy and nursing were aware after activating the compounded medications they should be immediately used and not stored in the medication refrigerator for later use.

3. Pharmacy and nursing was aware of the compounded medications for immediate use should not be stored longer than 1 hour from the time the medications were compounded and not be given an expiration date of 24 hours consistent with the hospital P&P and the standards of practice.

Findings:

1. Review of the Hospital's "Compounding Record" for hydromorphone PCA (Patient Controlled Analgesia) 5.5 mg/55 ml (0.1 mg/ml) showed the following direction:

"Draw up 27.5 mL of Hydromorphone 2 mg/ml #20 mL vial. Dilute in 500 mL bag of NS (with 35 mL overfill approximate). Mix solution...Ingredient...Hydromorphone 20 mg/mL...Base Solution...0.9% NaCl (sodium chloride; salt) (option to choose brands from) Baxter, B. Braun, or Hospira..."

The resulting concentration of the final compounded product would not be 0.1 mg/ml (55/562.5ml)

In an interview on 4/5/16 at 10:30 A.M., the DOP was not able to ensure accuracy and consistency of the overfill amount, 35 ml, in each 500 ml bag of NS (Normal Saline).

In an interview on 4/5/16 at 11 A.M., RPH 7 stated last time the 500 ml bag was measured was about a year ago and acknowledged that there could be variability in the overfill volume in different batches, different lot, different manufacturers.

Review of the Hospital P&P titled, "Pharmacy Compounding" dated, "03/2016," showed,

"The pharmacist performing or supervising the compounding has the responsibility for the integrity, potency, quality, and strength of the compounded product until it is dispensed..."

2. During an inspection of the ICU Mediation Room on 4/6/16 at 12:50 P.M. it was noted there was a Pharmacy-assembled injectable Vancomycin (antibiotic) 750 mg vial connected to the infusion fluid bag containing Dextrose 5% in Water by a Binary Connector that provided the physical separation between the powder in the vial and the IV fluid in the bag until activation. The vial was observed to be filled with fluid indicating the Vancomycin powder in the vial was mixed with the fluid from the infusion bag for reconstitution and administration.

In an interview on 4/6/16 at 12:55 P.M., RN 71, a nurse manager, stated the antibiotic was placed in the refrigerator because of the change in the administration time from 9 A.M this morning to 2 P.M.

In a concurrent interview, VPPO stated the antibiotic should have been disposed because it was not administered to the patient.

The American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacy organization, develops official professional policies, in the form of policy positions and guidance documents and according to "ASHP Guidelines on Compounding Sterile Preparations,"

"...Activation of the devices should be completed at the point of care just prior to administration."

3. During a tour of the ICU (Intensive Care Unit) at Hollywood on 4/6/16 at 12:45 P.M., it was noted there was in an amber plastic bag one 250-ml injectable Dextrose 5% in Water (D5W) bag and two vials of norepinephrine 4 mg placed in one of the plastic bins in the Medication Room. It was also noted there was no expiration date/beyond use dating on the label.

During an interview on 4/6/16 at 1 P.M., RN 73 stated the compounded norepinephrine infusion bag would be good for 24 hours and the BUD of 24 hours would be written on the Pharmacy Printed label attached to the D5W bag.

During a concurrent interview, the VPPO stated the compounded norepinephrine infusion bag would have an expiration date of 24 hours.

Review of the hospital P&P titled, "Pharmacy Compounding" dated "3/2016" showed,

"Beyond-use dates (BUDs) are assigned according to the risk of contamination and storage conditions consistent with the definitions and standards of USP<797>...When there are no literature references, refer to the standards of USP<797>. See Table 1..."

The Table 1 of the P&P showed for "Immediate-Use" risk category, the BUD was 1 hour.

United States Pharmacopeia (USP) Chapter <797> sets the minimum practice and quality standards for CSPs to prevent harm to patient and according to USP Chapter <797>,

"Beyond-Use Date...the date or time after which a CSP (Compounded Sterile Preparations) shall not be stored or transported. The date is determined from the date or time the preparation is compounded."

The American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacy organization, develops official professional policies, in the form of policy positions and guidance documents and according to "ASHP Guidelines on Compounding Sterile Preparations,"

"The immediate-use category should be reserved for emergent use or situations in which adhering to low-risk compounding procedures would add additional risk due to delays in patient care. Examples of such situations may include cardiopulmonary resuscitation, diagnostic procedures, or short-stability
Medications that must be prepared immediately before administration outside health care facilities (e.g., in home infusion or emergency care at the accident site or in an ambulance). Immediate-use CSPs do not need to be compounded in an ISO Class 5 environment and garbing and gowning are not required, as long as all of the following criteria are met...The preparation is labeled with patient identification, names and amounts of all ingredients, name or initials of preparer, and exact 1-hour BUD and time.

If CSPs prepared for immediate use are not administered within 1 hour, they must be properly discarded. All medications must be labeled to meet regulatory and accreditation standards and in accordance with facility policy..."




34709

Based on observation, interview and record review, the facility failed to collect and process urine specimen as per policy and procedure. Failure to follow specimen collection procedure puts patient at risk for delay in medical treatment or not being treated accurately.

Findings:

During a tour of the laboratory on 4/6/16 at 8:58 a.m., and cocurrent interview with the laboratory director (LD), patient N 205's urine specimen was observed in refrigerator # 2. The specimen was dated 4/3/16 at 9:45 p.m., according to LD urine specimens are discarded after 24 hours of time of collection.

During the interview with the LD, he explained the urine order was acknowledged (this step communicates to the lab that there is an order) and processed (this step prints out a label in the laboratory with name, date and time the specimen was collected) by the nurse on 4/3/16 at 9:45 p.m. The specimen was collected on 4/4/16 at 4:40 a.m., received in the laboratory on 4/4/16 at 6:14 a.m. When the urine specimen arrived in the laboratory, the lab technician attached the print out label (dated 4/3/16 at 9:45 p.m.) to the specimen. The laboratory has no means or method of printing out another label to attach to specimens when they actually arrive in the lab.

During an interview on 4/6/16 at 10:30 a.m., with RN 15 she explained once the urine specimen is processed... its logged on the "Laboratory Specimen Tracking Log" in order for the specimen to be transported to the lab.

Concurrently, the "Laboratory Specimen Tracking Log" was reviewed to locate patient N 205's urine specimen log in, but the specimen was not found on the log. This patient's specimen collection process was unclear.

A review of policy and procedure titled: Retention of Records and Specimens, dated 04/2016, indicated urine specimens are retained for 24 hours.

A review of policy and procedure titled: Laboratory Specimen Transport, dated 7/4/12, in part 4.1.4. indicated "All transported specimens are tracked by the specimen tracking log located on all Nursing Units and in the Main Laboratory."

Based on observation, record review, and interview, the facility failed to maintain their fire and life safety systems to ensure a safe environment in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition and NFPA 72 National Fire Alarm Code 1999 Edition.

This was evidenced by the failure to:
1. Ensure that the fire department was dispatched by the approved central station during an actual Code Red event. (See LSC K51)
2. Ensure that the fire alarm system was continuously monitored by the approved central station. (See LSC K51)
3. Maintain the audible fire alarm signals in the Tower. (See LSC K51)
4. Ensure that the fire alarm system at the acute psychiatric facility transmitted fire alarm signals to the approved central station. (See LSC K51)
5. Ensure that smoke detectors were correctly addressed in the fire alarm system. (See LSC K51)

The cumulative effect of these systemic problems, identified during the Life Safety Code (LSC) Survey, resulted in the failure to demonstrate the ability to ensure the provision of quality health care in a safe environment. This affected all patients at the Pavilion, the Tower, and the Van Nuys Acute Psychiatric Hospital and could result in injury due to the delay in notifying occupants of a fire, a delay in evacuation in the event of a fire, and a delay in response from emergency forces. (Refer to the LSC Survey dated 4/8/16)

Findings:

During tour of facility with staff from 4/4/16 to 4/8/16, the fire alarm systems were tested and observed. The Pavilion and the Tower building, located across the street from the Pavilion, shared the same fire alarm system.

Van Nuys:

1. From 12:00 p.m., to 12:30 p.m., on 4/6/16, fire alarm testing was conducted and this included initiating devices such as pull stations, smoke detectors, and waterflow switches. At 4:17 p.m., the monitoring report from the testing was provided. The monitoring report showed that the remote monitoring station only received Zone 2 fire trouble signals for all types of initiation devices tested.

During a telephone interview at 4:18 p.m., a representative from the monitoring company stated that they would not dispatch the fire department upon receipt of a Zone 2 trouble signal.

During a telephone interview at 4:47 p.m., another representative from the monitoring company stated that the last Zone 1 fire alarm signal received from the facility was on 12/30/15. He stated that the only fire trouble signals were received on 1/23/16. The annual testing of the fire alarm system was conducted on 1/23/16 and documents showed that all initiation devices were tested on that day.

During an interview at 5:00 p.m., the Director of Facilities Services (DFS2) stated that a fire watch would be implemented immediately until the fire alarm panel was fixed.

Records showed that a fire alarm vendor fixed the panel on 4/7/16. The vendor reported that there was a loose wire for Zone 1 in the panel that caused all the signals to be reported as Zone 2.

Pavilion:

2. At 10:28 a.m., on 4/4/16, the fire alarms sounded and a Code Red was paged overhead. PBX paged "Code Red Sixth Floor" three times. At 10:33 a.m., the Head of Security (HS1) reset the fire alarm system at the notification panel in the lobby.

During an interview at 10:33 a.m., HS1 stated that security staff had investigated and saw no signs of fire. He stated that the panel indicated that the smoke detector was activated in the hallway outside the EVS (environmental services) closet on the sixth floor.

At 10:35 a.m., there were two security staff holding fire extinguishers in Wing A of the sixth floor. They stated that the smoke detector inside Room 605, which was adjacent to an EVS closet, was blinking red. They gave an "all clear" after inspecting that room.

At 10:50 a.m., Plant Operations Lead Staff (PO1) removed the detector in Room 605 and an addressable trouble signal on the panel read "Pav 6th Smoke Patient Room 605."

During an interview at 10:51 a.m., PO1 and HS1 were unsure if Room 605 was the origin of the fire alarm activation/Code Red and if security staff responded to the wrong location.

At 2:37 p.m., a print out from the panel indicated that, "Pav 6th Smoke Patient Room 605" caused a "Common Trbl Act" (a local trouble signal) at 10:24 a.m. and that, "Pav 6th Smoke Hall Outside EVS" caused an "Alarm Active" at 10:28 a.m.

During an interview at 2:38 p.m., the Fire Alarm Technician (F.A. Tech2) stated that the source of the fire alarm activation was not Room 605. He said that he and the other technicians were still trying to locate the smoke detector that was addressed incorrectly as "outside EVS."

During an interview at 4:05 p.m., F.A. Tech 2 stated that the smoke detector that caused the Code Red was actually in a linen closet in Wing C, not in the Wing A corridor outside the EVS closet.

Facility staff responded to the wrong location during the Code Red incident due to a smoke detector that was not addressed correctly on the panel.

Culver City Campus:

3. Per record review and interviews, it was observed that the fire alarm system was frequently placed on test during the past month. When the system is on test, fire alarm signals received by the remote monitoring station would not result in dispatch of the fire department. During the Code Red on 4/4/16 (Finding 2 above), the fire department was not dispatched.

During an interview at 10:33 a.m., on 4/4/16, HS1 stated that the system was on test and PBX would call the fire department upon investigation by the facility and security staff.

At 4:05 p.m., on 4/6/16, this surveyor was unable to conduct an interview with the PBX operator. There was only one PBX operator at the time and he was busy with phone calls. The fire alarm annunciator in PBX was across the room from the operator. PBX did not meet the NFPA 72 requirements of a listed central station or proprietary supervising station.

During an interview at 1:57 p.m., on 4/5/16, the Los Angeles Fire Prevention Specialist (LAFPS) from Culver City Fire stated that the Fire Department should have been dispatched during the Code Red incident yesterday (Finding 2 above) and the Code Red incident in December (See K48 from the December 2015 Life Safety Code Survey). He stated the last time the fire department was notified of a fire alarm at the facility was on 3/11/16. He stated that the fire department was not notified of the alarms in the building yesterday. He requested to review a month of the monitoring reports from the offsite monitoring stations.

During an interview at 5:01 p.m., on 4/6/16, Plant Operations Lead Staff (PO1) stated that the facility placed the fire alarm system in test mode daily, for both the Tower and Pavilion, although construction was only conducted in the Pavilion Penthouse.

During an interview at 8:49 a.m., on 4/7/16, the LAFPS stated the facility cannot place the fire alarm system on test daily without informing the local AHJ that the system is out of service. He stated he was unaware of any construction work that would require that the entire fire alarm system be put on test daily for both Tower and Pavilion Buildings.

During an interview at 8:50 a.m., on 4/7/16, the Los Angeles Fire Inspector (LAFI) from the local Fire Department stated the facility cannot be on test so often without notifying the local AHJ. He stated that the facility must notify the AHJ when the fire alarm system is on test for construction work.

During an interview at 11:44 a.m., on 4/7/16, the Office of Statewide Health Planning and Development (OSHPD) Fire Life Safety Officer (FLSO) stated the facility should get approval from the FLSO for putting the system on test during any construction.

During an interview at 12:30 p.m., on 4/7/16, the Director of Facilities Services (DFS1) stated that PBX was carrying out instructions from the previous Facilities Director to put the system on test from 5 a.m. to 5 p.m. daily whether the fire alarm system was being worked on or not.

During an interview at 2:48 p.m., on 4/7/16, F.A. Tech1 stated the fire alarm system has the capability to place only certain zones on test, such as specific construction areas or while working on a portion of the fire alarm system.

During an interview at 9:50 a.m., on 4/8/16, F.A. Tech1 stated he was unaware that the facility had placed the fire alarm system on test when he and his staff were not working on the system. F.A. Tech1 provided his staff's work schedule for the month of March 2016. He confirmed that they were not in the building during the Code Red incident on 4/4/16.

At 10 a.m., on 4/13/16, comparison of the facility's fire alarm monitoring reports and the fire alarm vendor's work schedule showed days that the fire system was placed on test while no work was conducted on the system. The monitoring report indicated that the facility placed the entire fire alarm system on test from 5:00 a.m., to 5:00 p.m. for most days, including Saturdays and Sundays, without notifying the local AHJ. The fire alarm system was placed on test late into the evening on other days: on 3/14/16, the system was placed on test from 7:28 p.m., until 11:30 p.m. and on 3/22/16, from 6:16 p.m., until 11:59 p.m.

The monitoring report indicated the system was placed on test on 3/11/16 from 5:00 a.m., to 5:00 p.m., for selective zones only. A fire alarm was activated in an area that was not on test and the fire department was dispatched. Interview with LAFPS above confirmed that this was the last time they received fire alarm signal from the facility.

Per the monitoring report and the fire alarm vendor's schedule for March 2016, the facility had their entire fire alarm system on test from 5:00 a.m., to 5:00 p.m. for 14 days (including Saturdays and Sundays) while there was no fire alarm vendor in the building. The system was on test on 3/9/16 while there was no fire alarm vendor working on the fire alarm panel. The report indicated the panel exhibited a supervisory signal. The signal was not sent to the local fire department.

Tower
First Floor:

4. At 3:53 p.m., on 4/6/16, the pull station on the first floor in the Emergency Department was tested. The fire alarm chimes failed to activate an audible alarm and no fire alarms could be heard throughout the building.

At 3:54 p.m., on 4/6/16, the pull station by the exit door of the Emergency Department was tested. The fire alarm chimes failed to activate an audible alarm and no fire alarms could be heard throughout the building.

During an interview at 3:55 p.m., F.A. Tech1 stated he would go and investigate the problem.

At 5:52 p.m., the notification devices at the Tower were still not repaired.

During an interview at 9:01 a.m., on 4/7/16, F.A. Tech1 stated he finished working on the fire alarm system yesterday at approximately 8:30 p.m., and all the chimes on all the floors of the Tower should be working now.

Tower
Basement:

At 10:29 a.m., a pull station was tested and the fire alarm chime box failed. No alarms could be heard in the basement.

This deficiency was cited during the September 2015 and December 2015 Life Safety Code surveys under K52. During the survey on 9/22/15, the fire alarm chimes on the first floor and fourth floor of the Tower failed during testing of the fire alarm system. During the survey on 12/16/15, the fire alarm chimes failed on the seventh floor of the Tower while fire alarm testing. Documentation from the Inspector of Record (IOR) showed that, during testing on 1/22/16, the audible fire alarms failed on the first floor, third floor, basement, and fifth floor of the Tower. The items were documented as having been corrected on 1/27/16. The recurring failure of the fire alarm chimes had not been corrected.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases for patients. The infection control program failed to meet the needs of all patients and staff as evidenced by failure to:
1. The hospital failed to provide a functional and sanitary environment for the provision of patients who received surgical services. The hospital failed to ensure that surgical instruments were properly cleaned and disinfected in a manner that protected the lives and safety of patients who required these services (refer to (A0749).
2. The hospital failed to provide a functional and sanitary environment for the provision of patient services. The hospital failed to ensure that patient rooms were cleaned and disinfected according to manufacturer's instructions for use or EPA regulations, and risked the lives and safety of patients who required these services (refer to A0749).
3. The hospital failed to provide a functional and sanitary environment for the provision of patient services that required finger stick glucose monitoring. The hospital failed to ensure that glucometers were properly cleaned and disinfected according to manufacturer's instructions for use or EPA regulations that protected the lives and safety of patients who required these services (refer to A0749).
4. The hospital failed to provide a functional and sanitary environment for the provision of patient services who received services which required the use of a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity). The hospital failed to properly clean and disinfect vaginal probes according to the manufacturer's guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services (refer to A0749).
5. The hospital failed to provide a functional and sanitary environment for the provision of patient services who received services which required the use of Transesophageal echocardiogram probes (TEE - A specialized probe containing an ultrasound transducer which contains a tip which is passed into the patient's esophagus. This allows images and Doppler evaluation of the heart, which can be recorded). The hospital failed to properly clean and disinfect TEE probes according to the manufacturer's guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services (refer to A0749).
The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.



29643

Based on record review, observation, and interview, the facility failed to implement its Transmission-Based Isolation Precautions and Hand Hygiene policies relating to contact plus isolation for Patient N502 and N504.

1. Staff did not follow contact plus isolation precautions for Patient N502.
2. Staff did not place Patient N504 on contact isolation per policy.

The failure to implement these policies placed other patients at risk for contracting communicable diseases.

Findings:

1. Review of the facility policy and procedure titled "Transmission-Based Isolation Precautions" dated 3/2016 indicated Contact Plus Isolation Precautions is designated for patients who have Clostridium Difficile (C Diff. a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon.) The policy indicated staff must wear gowns and gloves prior to entering when contact with the patient or environment is anticipated and hand hygiene should be done before leaving the room.

Review of the facility policy and procedure titled "Hand Hygiene" dated 3/2016 indicated hands should be washed with soap and water if contact with C Diff is anticipated.

During an observation on 4/4/16 at 11:15 a.m., Patient N502 was in bed in the room which was labeled "Contact Plus." A licensed vocational nurse (LVN 1) was sitting in the room at the computer on wheels without wearing gloves. LVN 1 was then observed donning gloves without washing hands.

During a review of Patient N502's plan of care dated 3/29/16 indicated the patient had a C Diff infection.

During an interview and consecutive observation on 4/4/16 at 2:40 p.m., LVN 1 said she cleans patient equipment with a "PDI Sani Cloth with Bleach." She demonstrated how she uses the bleach wipes while she wiped the faucet handles located at Patient N502's bedside. LVN 1 stated the area must remain wet for two minutes to be effective. LVN 1 was then observed to remove her isolation gown and gloves just inside of the patient's door, placing them in the trash receptacle, then used alcohol hand sanitizer located in a container on the wall inside of the patient's room to wash her hands before exiting Patient N502's contact plus isolation room.

During an interview with the infection control director (ICP 1) on 4/5/16 at 11:25 a.m., ICP 1 stated staff must use soap and water to wash their hands and alcohol hand sanitizer is "Never" appropriate in a contact plus isolation room when the patient has C Diff. ICP 1 said when cleaning with the bleach wipes the area must remain wet for four minutes. ICP 1 said the use of bleach wipes for two minutes is "ineffective."

2. Review of the facility policy and procedure titled "Transmission-Based Isolation Precautions" dated 3/2016 indicated "Contact Precautions should be applied empirically if the patient being admitted has a history of infection or colonization with an MDRO (Multidrug resistant organisms are defined as bacteria that have become resistant to more than one class of antimicrobial agents and usually are resistant to all but one or two commercially available antimicrobial agents, complicating treatment of illnesses they cause.)."

During a facility tour on 4/4/16 between 3:05 and 4:30 p.m., Patient N504's was observed and was not in an isolation room.

Review of Patient N504's clinical record on 4/6/16 indicated the patient had been a patient on the same floor of the facility for almost two months and had been on contact isolation for more than one MDRO. Patient N504 was transferred to a skilled nursing facility on 4/1/16 and was re-admitted to this facility 4/3/16, two days later.

During an interview with RN 7 on 4/6/16 at 4:30 p.m., RN 7 confirmed Patient N504 was well known on this floor of the facility because of the previous admission and had been on contact isolation. RN 7 said the patient was not placed on contact isolation upon return from the skilled nursing facility.

During an interview with Patient N504's physician (MD 3) on 4/7/16 at 9:05 a.m., MD 3 said Patient N504 should have been placed on contact isolation upon return from the skilled nursing facility due to colonized MDROs.

Based on observation, interview and record review, the hospital failed to develop and implement a system for the identification, prevention and control of infections and communicable diseases, when:
1. Sterilized surgical Instruments were visibly contaminated and could not be verified
as sterile.
2. During environmental cleaning, products were not used according to manufacturer's
guidelines or EPA regulations.
3. Glucometers (instrument to measure blood sugar) were not cleaned and disinfected in
accordance with manufacturer's guidelines or EPA guidelines.
4. The hospital failed to provide a functional and sanitary environment for the provision of patient services, which required the use of a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity). The hospital failed to properly clean and disinfect vaginal probes according to the manufacturer ' s guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services.
5. The hospital failed to provide a functional and sanitary environment for the provision of patient services who received services which required the use of Transesophageal Echocardiogram probes (TEE - A specialized probe containing an ultrasound transducer which contains a tip which is passed into the patient's esophagus. This allows images and Doppler evaluation of the heart, which can be recorded). The hospital failed to properly clean and disinfect TEE probes according to the manufacturer ' s guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services.
Findings:

1. On April 4, 2016 at 11:30 am, during an interview, ICP 1 stated that the facility adopted the Centers for Disease Prevention and Control (CDC), Association of peri-Operative Registered Nurses (AORN),
Association for the Advancement of Medical Instrumentation (AAMI), Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) as their nationally accepted infection control guidelines.

On a tour of the sterile supply department on April 4, 2016 at 12:00 pm, the CS obtained a random sterilized major instrument tray (tools are made from surgical stainless steel used by professionals for major surgery). Upon inspection of the instruments, eight instruments had small areas of dark brown residue on the distal ends. This material could be scraped off with a fingertip. This was confirmed by CS. A random sterilized minor instrument tray (used for a minor surgery) was presented and opened by CS. Upon inspection ten instruments were inspected and contained dark brown residue in small amounts on the distal end of the instruments. This was verified with the CS and RN 3.

On April 4, 2015 at 1:45 pm, ADM 5 stated that all operating room cases would be cancelled for the remainder of the day [April 4, 2016] and for April 5, 2016. He stated that the automatic instrument washer, which had water issues previously, would immediately be taken out of service and mechanical cleaning by the decontamination staff would remain as the only cleaning process prior to steam sterilization. All of the surgical trays and instruments would be re-cleaned and re-sterilized prior to any scheduled surgery.

On April 5, 2016 at 2:55 pm on a tour of the sterile supply department, the CS obtained a random sterilized major instrument tray for inspection. The instruments were examined, there was no brown residue visible but the instruments had some minor clear water staining on the instruments.

On April 6, 2016 at 12:15 pm ADM 5 stated that the facility was in contact with the service representative for the chemical cleaning products and had requested water chemistry tests in the decontamination and sterilizing locations. Documentation was provided to support this action.

According to the Association for the Advancement of Medical Instrumentation (AAMI TIR30, Section 5.4.):
Medical device manufacturers should be familiar with cleaning, disinfection, and sterilization technologies used in health care facilities and with the kinds of soil and microbial contamination encountered as a result of patient use.
Organic soil such as blood, serum, lipids, tissue fragments, and inorganic salts can impede the disinfection or
sterilization process if it is not removed during cleaning. Most of these soil components are substrates for the
sterilants used for disinfection or sterilization; that is, they are competitors for sterilant action. If these soil
components are insufficiently removed, they can also protect microorganisms from inactivation by limiting the
diffusion of the sterilant to the microorganisms ' location on the medical device.

Users must establish an appropriate cleaning protocol for the reusable medical devices used at their sites. The
procedures should be based on the recommendations of the device manufacturer and the cleaner manufacturer,
published data on cleaner efficacy for the medical devices (if available), and published, validated, recommended
practices or guidelines. Cleaning efficacy tests that are performed following reprocessing are used to verify the
ability of a cleaning process to remove or reduce to an acceptable level the organic soil and microbial
contamination that occurs during the use of reusable devices. A number of methods can be used to evaluate the
results of the cleaning process. The most common method is a visual inspection, sometimes involving the use of
a lighted magnifying glass. Health care personnel inspect every device for visible organic soil and contamination
in a simple functionality check, usually as part of the inspection, preparation, and packaging procedure. However,
residual organic soil and microbial contamination might be present on an accessible surface even though the
device " looks clean. " Furthermore, visual inspection is not possible for the inner components of medical devices
that have lumens or that are of nonsealed tubular construction (e.g., flexible endoscope channels, laparoscopic
accessory devices, biopsy forceps). Ideally, cleaning verification by users should include (a) visual inspection
combined with other verification methods that allow the assessment of both external surfaces and inner housing
and channels of medical devices, (b) testing the cleaning efficacy of equipment, and (c) monitoring key cleaning
parameters (e.g., temperature). Manufacturers should strive to provide users with such tests so that medical
devices can be tested directly after cleaning in a way that will not damage the device or require recleaning.

According to ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) 10.2 Monitoring of mechanical cleaning equipment: The first step in processing a medical device is decontamination. To ensure that mechanical cleaning equipment is working properly and according to the manufacturer ' s specifications, health care personnel may perform verification tests as part of the overall quality assurance program. Methods of verification include the use of devices that directly test individual instruments for residual soils, challenge cleaning effectiveness with
standardized test methods, or measure specific key parameters to evaluate the functionality of the cleaning
equipment ...

Mechanical cleaning equipment should be tested upon installation, weekly (preferably daily) during routine use,
and after major repairs. When evaluating or changing to a new type of cleaning chemistry and after all major
repairs, all cycles used should be tested to ensure the cleaning chemistry and cleaning action are effective. A
major repair is a repair that is outside the scope of routine preventive maintenance and that significantly affects
the performance of the equipment. Examples include replacement of the water pump(s), detergent delivery
system, heating system, water delivery system, water treatment system, or computer control or an upgrade to
software.

2. On April 4, 2016 at 11:30 am, during an interview, ICP 1 stated that the facility adopted the Centers
for Disease Prevention and Control (CDC), Association of peri-Operative Registered Nurses (AORN),
Association for the Advancement of Medical Instrumentation (AAMI), Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) as their nationally accepted infection control guidelines.

On April 5, 2016 at 10:40 am during an observation in the housekeeping closet, EVS 1 demonstrated how the floor disinfectant (Clorox® Pro Quaternary) was prepared for use. When asked how long the product must remain wet on the floor to be effective (to kill pathogens), EVS 1 replied five to ten minutes. This was validated by ICP 1.

On April 6, 2016 at 10:50 am during an observation in the housekeeping closet, EVS 2 demonstrated how the floor disinfectant (Clorox® Pro Quaternary All-Purpose Disinfectant Cleaner) was prepared for use. When asked how long the product must remain wet on the floor to be effective, EVS 2 replied she did not know. This was validated by ICP 2.

According the manufacturer ' s (The Clorox® Company) directions for use of Clorox® Pro Quaternary
All-Purpose Disinfectant Cleaner: To disinfect hard, nonporous surfaces, add 1 ounce per gallon of water. Apply solution with a mop, cloth, sponge, hand pump trigger sprayer or low-pressure coarse sprayer in order to wet all surfaces thoroughly. Allow to remain wet for 10 minutes.

According to the Centers for Disease Prevention and Control (CDC) / Healthcare Infection Control Practices Advisory Committee (HICPAC), Guideline for Disinfection and Sterilization in Healthcare Facilities (2008):

Antimicrobials are regulated by the EPA and FDA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food, Drug and Cosmetic Act. Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms) must be registered and users must explicitly follow the labeling directions on each product, i.e., " It is a violation of federal law to use this product in a manner inconsistent with its labeling. " Thus, health-care workers must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action.

According to the CDC / HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas:

Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants ...and use them in accordance with the manufacturer's instructions.

3. On April 4, 2016 at 11:30 am, during an interview, ICP 1 stated that the facility adopted the Centers for Disease Prevention and Control (CDC), Association of peri-Operative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) as their nationally accepted infection control guidelines.

On April 5, 2016 at 10:40 am, in the ICU, RN 16 was asked to demonstrate the disinfection of a glucometer (instrument used to measure blood sugar) in between patient use. RN 16 did not know the product ' s (Clorox Healthcare Bleach Germicidal Wipes) required wet time. She did not know that the glucometer had to be cleaned of any blood residue prior to disinfection. This was validated by ICP 2.

On April 6, 2016 at 11:00 am on unit two, LVN 1 was asked to demonstrate how to disinfect a glucometer in between patients. LVN 1 did not know the required wet time [time the product needed to remain wet on the surface to kill pathogens (bacteria, fungi and viruses)] of the product (Clorox Healthcare® Bleach Germicidal Wipes). This was validated by ICP 2.

According to the manufacturer (The Clorox Company) Clorox Healthcare® Bleach Germicidal Wipes
[should be] used as directed on precleaned hard, nonporous surfaces [and] must remain wet for three minutes.

According to the Centers for Disease Prevention and Control (CDC) / Healthcare Infection Control Practices Advisory Committee (HICPAC), Guideline for Disinfection and Sterilization in Healthcare Facilities (2008):

Antimicrobials are regulated by the EPA and FDA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food, Drug and Cosmetic Act. Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms) must be registered and users must explicitly follow the labeling directions on each product, i.e., " It is a violation of federal law to use this product in a manner inconsistent with its labeling. " Thus, health-care workers must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action.

According to the CDC / HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas:

Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants ...and use them in accordance with the manufacturer's instructions.




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4. An observation was conducted on April 6, 2016 at 8:35 am of the hospital ' s Ultrasound Department, with the Director of Infection Control & Prevention (ICP 1) present. An Ultrasound Technician (US 1) was asked to demonstrate and explain how the hospital provided high level disinfecting (a method used to kill vegetative bacteria, tubercle bacillus, fungi, lipid and nonlipid virus) of the vaginal probes, a semi-critical instrument (items that contact mucous membranes).
During the same observation, a concurrent interview was conducted with US 1. She demonstrated the hospital's practice for cleaning, disinfecting and rinsing the vaginal probes and stated that they used "Cidex OPA" solution (a high level disinfectant {HLD} an observation of the Cidex bottle confirmed her interview). US 1 stated that after they soaked the probe in the Cidex OPA solution, they immersed it in water and rinsed it for 1 minute and then the probe gets rinsed a second time under running water in a sink located in the department. According to US 1, they followed the operator's manual for the soak station system (GUS) that they used to disinfect the probes.
5. On March 6, 2016 at 9 am, a second observation in the same area and a concurrent interview with a Vascular Technician (VT 1) were conducted. VT 1 was asked if she performed HLD of semi - critical instruments, she stated that she performed HLD of the Transesophageal echocardiogram probes (TEE - A specialized probe containing an ultrasound transducer which contains a tip which is passed into the patient's esophagus. This allows images and Doppler evaluation of the heart, which can be recorded). VT 1 stated that they used Cidex OPA to perform HLD on the TEE probes.
VT 1 stated that after they soaked the scopes in the Cidex OPA solution, they immersed the scopes in water and rinsed them three (3) different times, allowing them to soak for 30 seconds each time, in 2 gallons of water. She also stated that she used the operator's manual instructions for their soak system (GUS), for disinfecting the probes.
On March 6, 2016 at 9:20 am, the hospital's Infection Control and Preventionist (ICP 1) was asked which Nationally recognized Infection Control Guidelines the hospital followed. She stated that they followed Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control (CDC), American Journal of Infection Control (APIC), and manufacturer's guidelines.
US 1 and VT 1 were asked to produce the hospital policies for the HLD of vaginal probes and the TEE probes and to also produce a copy of the manufacturer's guidelines they used for the HLD disinfecting of the probes.
During a record review of both policies, on March 6, 2016 at approximately 9:25 am, it was identified that the policies did not reference the manufacturer's guidelines for the use of the Cidex OPA HLD solution, the policies referenced "Society of Diagnostic Medical Sonography", "American Institute of Ultrasound Medicine", "American College of Radiology", and "Department of Public Health - Radiation Health Bureau". The policies also referenced the use of the hospital's HLD soak system (GUS).
On March 6, 2016 at approximately 9:30 am, US 1 was asked to produce a copy of the manufacturer's guidelines for the Cidex OPA solution. A copy was produced and reviewed:
According to the manufacturer, Cidex OPA is a high-level disinfectant (HLD) used in reprocessing heat sensitive medical devices such as vaginal probes and TEEs.
According to the manufacturer:
DIRECTIONS FOR USE CIDEX OPA SOLUTION USAGE- Rinsing Procedure
1. Manual Processing:
* Following removal from CIDEX OPA Solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g., two gallons) of water. Use sterile water unless potable water is acceptable. See item 2 or 3 below.
* Keep the device totally immersed for a minimum of one minute in duration, unless a longer time is specified by the reusable device manufacturer.
* Manually flush all lumens with large volumes (not less than 100 mL) of rinse water unless otherwise noted by the device manufacturer.
* Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Do not reuse the water for rinsing or any other purpose.
* Repeat the procedure TWO (2) additional times, for a total of THREE 3) RINSES, with large volumes of fresh water to remove CIDEX OPA Solution residues. Residues may cause serious side effects. SEE WARNINGS. THREE (3) SEPARATE, LARGE-VOLUME WATER IMMERSION RINSES ARE REQUIRED ..."
Further review of the CIDEX OPA guidelines revealed the following: "Special Instruction for Transesophageal Echocardiography (TEE) probe reprocessing ...not rinsing three times with a fresh quantity of water each time many result in residual CIDEX OPA Solution remaining on the device, the use of which may cause staining, irritation or chemical burns of the mouth, throat, esophagus and stomach ..."

Based on observation, interview and record review, the hospital's leadership was not responsible for the implementation of a successful corrective action plan for the sterile processing department, because unresolved or recurrent problems with incomplete sterilization of surgical instruments were noted, creating the increased risk of the spread of infection to surgical patients.
Findings:
The plan of correction for the survey dated 12/22/15 showed that in response to findings that included sterile instruments that had discolored spots and built up material adherent to them, education, monitoring, and reprocessing of surgical instruments was to occur. However, during observations of trays of sterile instruments on 4/4/16, brown spots and adherent material was again seen on sterilized surgical instruments.
In an interview with the Sr VP Hospital Operations on 4/4/16 at 1510, he stated that there was a drain that they had a problem with which was backing up into the washer, and this could be the source of the problem with the surgical instruments. He stated that staff had resumed using the washer without his knowledge.