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

SAINT VINCENT MEDICAL CENTER 2131 W 3RD ST LOS ANGELES, CA 90057 July 11, 2019
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, interview, and record review, the facility failed to ensure that expired medications were not available for patient administration.

This facility failure had the potential for unsafe medication delivery and potential adverse effects.

During an observation and concurrent interview with licensed nurse (LN 14) and director of perioperative services (DPOS) on 7/8/19 at 2:24 p.m., in the post anesthesia care unit (PACU), eight syringes (A medical device that is used to inject fluid into, or withdraw fluid from, the body) containing Ancef (a medication used to prevent bacterial infection) had an expiration date of 7/6/19. LN 14 stated "I will throw them out." DPOS acknowledged the eight syringes of Ancef were expired.

The facility policy and procedure titled "Drug Storage and Preparation Area" dated 8/17, indicated "The pharmacy department conducts monthly inspections of all medication storage areas. Rotation of stock with removal of expired medication is performed."
VIOLATION: SECURE STORAGE Tag No: A0502
Based on observation, interview, and record review, the facility failed to keep medications secured in a locked anesthesia cart in operating room (OR) # 7 on the main floor.

This failure had the potential for medication tampering, removal by unauthorized individuals, and unavailability of the medication for the surgical case.

Findings:

During an observation and concurrent interview on 7/8/19 at 12:30 p.m., in OR #7 on the main floor, the manager of surgery (MSUR) acknowledged the anesthesia cart was unlocked and contained 4 vials of injectable Lidocaine HCL(local anesthetic [for pain control]) 160 mg (milligrams) /4 ml (milliliters) in the medication drawer. MSUR indicated the anesthesia cart should be locked.

The facility policy and procedure titled: "Drug storage and Preparation Area" dated 8/2017, indicated ..." Storage areas must be secure; fixtures and equipment used to store drugs should be constructed so that drug is accessible only to designated and authorized personnel" ..." such personnel must be carefully selected and supervised."
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on interview and record review the facility failed to ensure informed consent was properly executed.

This facility failure has the potential for the patient not receiving accurate information regarding the treatment he is consenting.

Findings:

The facility policy and procedure titled "Informed Consent" dated 12/2018 indicated in part a properly executed informed consent will include the name of the practitioner who conducted the informed consent discussion with the patient or the patient's representative. Date, time, and signature of the person witnessing the patient or patient's legal representative signing the consent form.

During an interview with the telemetry charge nurse (LN 12) and concurrent record review on 7/9/19 at 11:30 AM, Patient 500's Blood Transfusion Consent Form does not have a witness signature and the physician's name is not on the consent form. LN 12 acknowledged the consent form was not executed properly.

During an interview with the director of telemetry (DON 3) on 7/10/19 at 2:20 PM, indicated the blood transfusion consent form of Patient 500 is missing a witness signature and physician's name. The DON 3 indicated this is an improperly executed consent form.
VIOLATION: CONSULTATION WITH MEDICAL STAFF Tag No: A0053
Based on interview with facility staff and review of records the governing body failed to document direct consultations with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff, or his or her designee.

Findings:

In an interview on 07/09/2019 at 2 p.m. the CEO stated there was no documentation available of direct consultations between the chief of the medical staff and the governing body. There were no documents available for review.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interview, observation, and review of administrative records, policies and procedures, infection control, and quality assurance documentation, the facility's governing body failed to assume full responsibility for determining, implementing, and monitoring policies governing the facility's total operation. The governing body failed to ensure that the facility:
1. Implemented and maintained an ongoing, data-driven quality assessment and performance improvement program that was a proactive, comprehensive, and ongoing program to improve both quality and safety (refer to A0263).
2. Implemented an infection control program and guidelines for infection prevention and control (refer to A0747).
3. Provided a functional and sanitary environment for the provision of surgical services and acceptable standards of practice (refer to A0940).
4. Documented direct consultations between the governing body and the chief of the medical staff (refer to A0053).
5. Documented review of the services performed under contract (refer to A0084).
6. Maintained a list of all services provided under contract (refer to A0085).
VIOLATION: CARE OF PATIENTS Tag No: A0063
Based on observation, interview, and record review, the hospital failed to ensure policy and procedure (P&P) was implemented when Intravenous (IV) tubing and IV site were not labeled to determine the date it needs to be changed and IV site rotated for one of 34 patients. (Patient N300).

This failure had the potential to affect the patient's care and health condition.

Findings:


The hospital policy "Vascular Access Device Insertion and Maintenance" revised 09/2011 indicated procedure including " ...PIV (peripheral IV) dressings are changed with site rotation every 96 hours and as needed. PIV catheters are replaced at least every 96 hours. Replace tubing used to administer Propofol infusions every 12 hours. In patients not receiving blood, blood products or TPN, replace administration sets that are continuously used, including secondary sets and add-on devices, no more frequently than at 96 hour intervals. Extension tubing, which is attached at the time of device insertion, will be considered a part of the device. If the extension tubing must be attached after insertion, it will be changed every 96 hours ..."

During initial tour of the critical care unit on 7/8/19 at 12:34 PM, inside Patient N300's room, the following was observed:

>Patient N300 had an intravenous (IV) catheter in her right antecubital. There was no label on the IV dressing.
>The Propofol (used to sedate a patient who is under breathing machine) IV tubing was not labeled.

The Registered nurse 1 (LN1) concurrently confirmed the above findings.

During an interview on 7/10/19 at 11:17 AM with Registered nurse 3 (LN3) indicated the IV dressing must be labeled with insertion date, nurse's initials, and gauge size. The Propofol tubing must be changed every 12 hours.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview with facility staff and review of records the governing body failed to ensure that the services performed under a contract were provided in a safe and effective manner.

Findings:

In an interview on 07/10/2019 at 2:30 p.m. the QSED stated that not all services provided through outside resources had been reviewed by the governing body. There were no documents available for review.
VIOLATION: CONTRACTED SERVICES Tag No: A0085
Based on interview with facility staff and review of records the governing body failed to ensure that a list of all contracted services, including the scope and nature of the services provided, was maintained.

Findings:

In an interview on 07/10/2019 at 2:30 p.m. the QSED agreed that the list of contracted services provided at the time of the entrance was incomplete and that it did not contain all contracted services. A more complete list was not provided for review.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the hospital failed to ensure one sampled Patient (Patient 201) received care in a safe setting when Fall precautions were not fully implemented while receiving care in the Intensive Care Unit (ICU).

This facility failure created an unsafe hospital environment and had the potential to cause additional loss, injury or adverse consequences to Patient 201.

Findings:

During an observation on 7/8/19 at 2:10 p.m. in the Intensive Care Unit (ICU), Patient 201 was lying in bed with intravenous (through a vein) nitroglycerin (a medication that relaxes the blood vessels, increasing the supply of blood and oxygen to the heart while reducing its work load) medication infusing, oxygen through a nasal cannula tubing (tube that delivers supplemental oxygen through the nose), and sequential compression devices (pump that squeezes the lower part of the legs alternately, to keep blood from pooling and forming a blood clot) to both lower legs. Blue non-skid socks were lying on the floor between the wall and Patient 201's bed. The call light was looped around the call light box attached to the wall opposite Patient 201's bed and out of reach of Patient 201.

During an interview on 7/8/19 at 2:20 p.m., licensed nurse (LN 2) confirmed Patient 201 was identified as a fall risk by the yellow band on the wrist and a yellow falling star placed outside Patient 201's room. LN 2 confirmed not knowing the socks were on the floor and that Patient 201 removed the socks. LN 2 confirmed Patient 201 could not have called for help because the call light was not within Patient 201's reach. LN 2 stated, "The call light cord is a tripping hazard for the RN or anyone coming in the room as well as the patient, so we leave on the wall."

The facility policy and procedure titled "Fall Prevention and Management, Adult Patient" dated 11/2012, indicated in part ... "Purpose ...1. To prevent falls among patients presenting to (facility name) ...2. To identify, minimize and help manage patient's fall risk factors, thereby contributing to a reduction in patient falls at (facility name) ...Place call light where easily accessible to patient ..."
VIOLATION: QAPI Tag No: A0263
Based on interview with facility staff and review of administrative records, policies and procedures, and quality assurance and performance improvement (QAPI) documentation the facility failed to implement and maintain an ongoing, data-driven quality assessment and performance improvement program that was a proactive, comprehensive, and ongoing program to improve both quality and safety. The facility failed to ensure that:
1. The quality of services provided by clinical contracted services in the facility was reported to the governing body (refer to A0309).
2. Review of the services performed under contract was documented (refer to A0084).
3. A list of all services provided under contract was maintained (refer to A0085).
4. Implemented an infection control program and guidelines for infection prevention and control (refer to A0747).
5. Provided a functional and sanitary environment for the provision of surgical services and acceptable standards of practice (refer to A0940).
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on interview and record review, the facility failed to have oversight of clinical contracted services by integrating the evaluation of these services into the hospital's Quality Assessment and Performance Improvement (QAPI)program.

The facility's failure to evaluate the safety and effectiveness of contracted services has the potential to expose patients to ongoing substandard care and for the governing body to lack information relative to the quality of care being provided to patients in the facility.

Findings:

The facility document titled "Verity Health System-Saint Vincent Medical Center Quality Assessment and Performance Improvement Program (QAPI) FY 2018, dated 6/20/2017, indicates under "Scope and Applicability: This is an organization-side plan. It applies to all departments, care, treatment, and service settings including those services furnished under contract agreement".

During review of minutes of the Quality of Care Committee (QCC) from 2018 through May 2019, there is no indication of reporting of the quality of services provided by clinical contracted services in the facility.

During an interview on 7/10/19 at 2:35 p.m., the quality services executive director (QSED) acknowledged that currently a system is not in place to integrate clinical contracted services into the QAPI program.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on observation, interview, and record review, the facility failed to:

1. Follow its policy and procedure for "Critical Tests and Diagnostic Procedures Results- Reporting" by failing to ensure one sampled patient's (Patient 200) critical lab value was reported to the patient's physician within 60 minutes of notification.

2. Reassess one of two sampled patients (Patient 401) at least hourly.

These facility failures had the potential to:
1. Result in a delay in treatment and place Patient 200 in jeopardy for a potential life threatening situation.
2. For Patient 401, result in an unrecognized change in condition.

Findings:

1. Record review of Patient 200's electronic medical record (EMR) the Critical Results Readback dated 7/8/19 at 3:50 a.m. indicated that the lab notified the licensed nurse at 6:08 a.m. of the critical lab "Troponin I" result of 2.64 ng/mL. (a lab test done to check for damage to the heart - the heart releases troponin into the bloodstream following an injury, such as a heart attack. Troponin levels in the blood are normally very low, heart damage can cause Troponin levels to increase significantly) There was no documentation to support that the licensed nurse had notified the physician of Patient 200's critical lab value (normal range for Troponin is between 0 - 0.4 ng/mL).

During an observation and concurrent interview with Patient 200 on 7/8/19 at 12:07 p.m. in the Intensive Care Unit, Patient 200 confirmed being admitted to the facility from the emergency room last night because of chest pain. Sign on the wall read "NPO" (nothing by mouth). Patient 200 confirmed he was not to eat or drink due to an upcoming test to check the heart.

During an interview on 7/8/19 at 12:15 p.m, a licensed nurse (LN 21) confirmed the physician ordered an angiogram (thin tube inserted through an artery in the groin and up to the heart. Dye is injected through catheter so arteries show up on X-rays taken during procedure) to be completed on 7/8/19 for Patient 200.

During an interview with the Chief Nurse Executive (CNE) and concurrent record review of Patient 200's electronic medical record (EMR) on 7/9/19 at 11:00 a.m., the CNE confirmed that the licensed nurse did not notify the physician regarding Patient 200's critical lab value and the expectation and facility policy is for the licensed nurse to notify the physician within one hour of receipt of notification of critical lab results and document such notification in the Patient's EMR.

The facility policy and procedure titled "Critical Tests and Diagnostic Procedures Results- Reporting" dated revised 08/2011 indicated in part... "All documented critical test...results will be reported to the patient's physician within 60 minutes of notification...Procedure 1. Reporting of critical test...results...i. Critical Test results are reported immediately by the technician. The technician calls the nursing unit and speaks to the RN who is in charge of the patient...The technician documents the name of the RN and the time that the critical result was reported...The RN receiving the report writes down and then reads back the critical result to the technician to verify accuracy and documents the technician's name on the Critical Test and Diagnostic Reporting record...(Note: in the electronic medical record, documentation is made in the "Critical Results Readback" section under Unscheduled Documentation on the Patient level. The RN immediately places a call to the ordering physician...ii. When the physician is contacted, the RN relays the result and request the physician repeat the information to verify accuracy. All communication with the physician is documented on the "Critical Test and Diagnostic Procedure Results Reporting Record." (Note: in the electronic medical record, documentation is made in the "Critical Results Readback" section under Unscheduled Documentation on the Patient level...2. Critical Laboratory Values are:...Troponin >0.05 ng/mL...




2. The facility policy and procedure titled "Emergency Department Triage" dated 09/2015, indicated " ...will reassess patients at appropriate intervals ...at least hourly ...."

During a review of the clinical record for Patient 401, the Events dated 07/08/19, at 14:03 (2:03 P.M.) indicated time of triage, at 16:33 (4:33 P.M.) indicated time to treatment room (two hours 30 minutes after triage), and at 20:08 (8:08 P.M.) indicated removed from Emergency.

During a review of the clinical record for Patient 401, the Emergency Flow Sheet dated 07/08/19, at 14:04 (2:04 P.M.) and 19:54 (7:54 P.M.) indicated an assessment of vital signs five hours 50 minutes apart.

During an interview on 07/09/19, at 2:15 PM, the Emergency Department Director (DON1) stated the vital signs, "Should have been taken more often."
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and record review the hospital failed to individualize a care plan for four of four patients. (Patients N300, N302, N301 and N350).

These failures resulted in staff not having guidelines on meeting the patient's needs, lack of care and potential increase in patient's pain.


Findings:

The facility policy titled "Interdisciplinary Plan of Care" dated 11/1993 indicated procedure including "...All patient plan of care is individualized. Assessment, planning, intervention and evaluation are based on: a) Actual or potential nursing diagnosis, f) Physician's treatment orders. The Interdisciplinary Plan of Care will be reviewed every shift and updated as patient condition status changes..."

1.During a review of Patient N 300's clinical record and concurrent interview with the Critical Care Charge Nurse (CCCN) on 7/09/19, at 12:11 PM, the CCCN reviewed and confirmed Patient N 300's clinical record included:

>admission date of [DATE] with diagnoses including [DIAGNOSES REDACTED] and Altered Mental Status.
>The physician order of Zoloft 25 mg via tube daily dated 7/7/19 time stamped 5:12 AM.
>The Medication Administration record indicated Patient N 300 received Zoloft for depression since 7/7/19.
>The psychosocial care plan did not indicate the problem related to depression and did not include the Zoloft medication in its intervention.

In an interview with Registered Nurse 3 (LN3) on 7/10/19 at 10:59 AM, the LN3 indicated the initial care plan is initiated upon admission and each shift the nurse reviews the care plan to determine if it needs to be updated, discontinue if resolved and create a new one tailored or based on patient needs, diagnosis, and problem.

2. During an observation of Patient N 302 and concurrent interview with the Critical Care Registered Registry nurse (CCRRN) on 7/08/19 at 2:34 PM, the CCRRN indicated Patient N 302 was placed on contact isolation precaution due to [DIAGNOSES REDACTED], ESBL and positive bacteria in the blood.

In a review of Patient N 302's clinical record on 7/10/19 at 4:03 PM and concurrent interview with LN3 confirmed Patient N 302's care plan for infection did not address the current infection and the contact isolation precaution in its intervention.

3. During an observation of Patient N 301 inside room 411 and concurrent interview with the Critical Care Registered Registry nurse (CCRRN) on 7/08/19 at 2:41 PM, the CCRRN indicated Patient N 301 was placed on contact and enteric isolation precautions due to positive[DIAGNOSES REDACTED] stool, ESBL in sputum, and VRE in urine.

Review of Patient N 301's clinical record on 7/10/19, at 3:53 PM indicated N301's care plan related to infection did not indicate the actual infection problems and the isolation precaution in the intervention. Concurrent interview with LN3 confirmed the care plan was not updated and should have been.




4. During a review of Patient 350's clinical record and concurrent interview with licensed nurse (LN7) on 7/09/19, at 3:03 p.m., LN7 indicated Patient 350 admitted on [DATE] with diagnoses including Peripheral T-cell [DIAGNOSES REDACTED] (a form cancer that affects white blood cells), Intractable Pain, and Chest Wall Mass. The clinical record document titled "Interdisciplinary Plan of Care" dated 7/3/19 at 12:00 a.m., indicated Patient 350's care plan entry related to pain did not specify the location of pain, documented the pain was related to the PCA (patient controlled analgesia) instead of documenting the PCA as an intervention and did not include an expected outcome "demonstrate ability to use PCA pump." LN7 confirmed the care plan was not correctly completed and did not reflect individualization for Patient 350.

The facility policy and procedure titled "Interdisciplinary Plan of Care" dated 9/2018 indicated in part "Purpose: 1. To identify individualized patient care goals and interventions...Procedure: 1. All Patient Plan of Care is individualized...4. The Interdisciplinary Plan of Care will be reviewed every shift and updated as patient condition status changes..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review the facility failed to:

1. Administer STAT (give immediately) medications within 30 minutes for two of two sampled patients (Patient 400 and Patient 401) in the Emergency Department.

2. Reassess pain according to policy and procedure after pain medication administration.

Findings:

1. The facility policy and procedure titled "Medication Administration" dated 03/2019, indicated "STAT orders must be administered to the patient within 30 minutes."

During an interview on 07/09/19, at 10:45 A.M., the Emergency Department Director (DON1) stated, "All orders are considered STAT orders in the ED."

During a review of the clinical record for Patient 401, the Medication Service dated 07/08/19 indicated:
a. Lidocaine Viscous (used to relieve pain and discomfort), ordered 2:04 P.M., given 4:17 P.M. (two hours three minutes after ordered in the ED).
b. Maalox Advanced Maximum Strength (used to help neutralize stomach acid), ordered 2:04 P.M., given 4:18 P.M. (two hours 14 minutes after ordered in the ED).
c. Sodium Chloride 0.9% (used to replace lost body fluids and salt), ordered 2:04 P.M., given 5:06 P.M. (three hours two minutes after ordered in the ED).
d. Toradol (used to relieve pain and discomfort), ordered 2:04 P.M., given 4:22 P.M. (two hours 18 minutes after ordered in the ED).

During a review of the clinical record for Patient 400, the Medication Service dated 07/09/19 indicated:
a. Morphine Sulfate (used to relieve severe pain), ordered 9:26 A.M., given 10:33 A.M. (one hour seven minutes after ordered in the ED).
b. Sodium Chloride 0.9%, ordered 9:26 A.M., given 10:33 A.M. (one hour seven minutes after ordered in the ED).
c. Zofran (used for nausea and vomiting), ordered 9:26 A.M., given 10:34 A.M. (one hour eight minutes after ordered in the ED).





2. Lippincott Nursing Procedure LWW; Seventh Edition ([DATE]) indicate to reassess patient's pain level and quality approximately 15 to 30 minutes after parenteral pain medication or approximately 60 minutes after oral pain medication. If the patient is still in pain notify the practitioner and alter the treatment plan as appropriate.

The facility policy and procedure titled "Pain Management" dated 11/2012 indicated pain must be reassessed within one hour after intervention. Interventions can either be pharmacologic or non-pharmacologic.

During an interview with the resource nurse (LN 9) and a concurrent record review on 7/9/19 at 1030 AM, the electronic health records indicates the Patient 500 was given Tylenol 325mg (pain medication), 2 tablets by mouth on 7/4/19 at 7:57 AM, post pain reassessment was done 38 minutes after medication administration. On 7/4/19 at 8:14 AM, Patient 500 was given Norco (narcotic pain medication) 325/5 mg, 1 tablet by mouth, reassessment was done at 8:39 AM 25 minutes after medication administration. And on 7/7/19 at 5:11 PM, Patient 500 was given Norco 325/5 mg, 1 tablet by mouth, post pain reassessment was done at 5:45 PM, 34 minutes after medication administration. LN 9 indicated post pain medication reassessment given by mouth should be done one hour after medication administration.
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and interview, the hospital failed to ensure the telephone order for Levophed (functions as a peripheral vasoconstrictor) was signed by an authorized practitioner within 48 hours.

This failure had a potential to pose an increased risk of miscommunication that could contribute to a medication error and could result in a patient adverse event.

Findings:

The clinical record for Patient N302 was reviewed with Registered Nurse 3 (LN3) on 7/9/19 at 3:25 PM indicated Patient N302 was admitted on [DATE] with severe sepsis.

Concurrent review of the electronic physician order revealed a telephone order which was not signed by the practitioner within 48 hours included:

A telephone order from a physician on 7/5/19 time stamped 01:08 to start a Levophed drip at 4 mg/250 ml IV at 5 mcg/min and titrate to systolic blood pressure greater than 90.

Concurrent interview with LN3 confirmed the above telephone order was not signed by the ordering physician. LN3 was unable to find documentation of physician signature of the levophed order in the electronic medical record. LN3 stated the order should be signed by the physician within 48 hours.

The Hospital's Medical Staff General Rules and Regulations amended 5/2018 indicated on page 6 H. Diagnostic and Therapeutic Orders " ...A physician may dictate an order via telephone to registered nurse. The orders are to be transcribed on the Doctor's Order Sheet and signed as a telephone order by the nurse. The telephone orders are to be timed, dated and signed by the physician within 48 hours ..."
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
Based on interview and record review, the facility failed to ensure documentation for Patient-Controlled Analgesia (PCA- patient self-administers intravenous [IV-into the vein] pain medication by pushing a button) for pain was accurately completed for one sampled patient (Patient 350).

This facility failure had the potential for Patient 350 to receive the wrong dose of pain medication.

Findings:

The facility policy and procedure titled "Patient Controlled Analgesia (PCA)" indicated in part "Procedure: 1...Two RN's (or RN and pharmacist) must verify and document orders, including medication and concentration and PCA pump setting, by documenting ...when...Hand-off reporting...4. Documentation: All patient assessment parameters/VS/Pain intensity/side effects/O2 saturation every 4 hours...Number of bolus attempts, total amount of medication administered (in mg [milligrams]) (including loading dose, patient bolus doses, continuous infusion and clinician bolus doses) every 4 hours..."

During a review of the clinical record for Patient 350 on 7/09/19, at 3:03 p.m., the "Physician order" dated 7/5/19 at 10:22 a.m., for the PCA medication indicated Morphine 1mg (milligram)/mL (milliliter) at a continuous dose of 1 mg per hour and demand doses (amount administered each time the patient activates the pump by pushing the button) at 0.5 mg per dose with the lockout interval of every 30 minutes (the time period in which a patient cannot initiate doses).

During an observation and concurrent interview with a licensed nurse (LN7) on 7/9/19 at 3:35 p.m. in room 503, LN7 confirmed the PCA pump setting were correctly set to follow the physician orders.

During an interview with the director of nursing telemetry/DOU (DON3) on 7/9/19 at 3:15 p.m., DON3 reviewed the clinical record and was unable to find documentation of the required PCA documentation for 7/9/19 at 8:00 a.m. or documentation of between shift hand-off reporting for 7/9/19.

During an interview with a licensed nurse (LN10) on 7/9/19 at 3:15 p.m., LN10 confirmed the documentation for 8:00 a.m. had not been completed. LN10 acknowledged "I forgot to document."
VIOLATION: CONTENT OF RECORD Tag No: A0449
Based on observation, interview, and record review, the facility failed to ensure the accuracy of the medical record for one sampled Patient (Patient 201).

This facility failure had the potential to affect continuity of care for Patient 201.

Findings:

Record review of Patient 201's medical record face sheet indicated Patient 201 came to the hospital emergency room department with complaints of chest pain, congestive heart failure exacerbation and pulmonary edema on 7/7/19 and was admitted to the hospital at 16:45 p.m. (4:45 p.m.).

During an observation on 7/8/19 at 4:32 p.m., Patient 201 was lying in bed awake in a private room on the 4th floor Intensive Care Unit (ICU).

During an observation and concurrent interview with the interim ICU Nurse Manager nurse (NM 1) on 7/9/19 at 3:00 p.m., Patient 201 was asleep in a patient bed in a private room. NM 1 indicated Patient 201 was transferred to the 6th floor ICU from the 4th floor ICU.

During an interview with the Chief Nursing Executive (CNE), the Director of Nursing (DON 1) and the interim ICU Nurse Manager nurse (NM 1) and concurrent medical record review of Patient 201's electronic medical record (EMR) on 7/9/19 at 3:05 p.m. on the 6th floor Intensive Care Unit (ICU), the EMR identified the following "Order Entry Checklist" admission steps as being "Incomplete" for Patient 201:
* Admit Order
* Admit Patient Status
* Code Status/POLST
* Family Health History
* Allergies
* Medication Reconciliation
The CNE, DON 1, and LN 1 could not explain the reason for a box with the admission steps showing as "Incomplete" in red, in the lower right hand corner of Patient 201's EMR. The EMR also indicated "allergies" with a red exclamation point in the top bar by Patient 201's name. LN 1 selected the exclamation point and a small box opened that read "viewed." LN 1 selected "viewed" and a white checkmark replaced the red exclamation point over "allergies." Under the Order Entry Checklist, the Allergies Incomplete was no longer listed in the box.

During an interview with the Director of Nursing (DON 1) and the Nurse Manager (LN 1) and concurrent medical record review of Patient 201's electronic medical record (EMR) on 7/10/19 at 11:45 a.m., the Order Entry Checklist Incomplete box items were identified as completed.

Record review of facility Health Information Management report for review and changes made to Patient 201's EMR since surveyor noted incomplete orders, indicated the physician and licensed nurse wrote, received, and signed orders for Patient 201 to admit to the 4th Floor ICU, transfer to 6th floor ICU, and transfer to Telemetry I, all on 7/9/19 between 3 p.m. and 7 p.m., two days after Patient was admitted to the 4th floor ICU from the emergency room .

Record review of the facility policy and procedure titled "Admission of Patients" dated 11/2012, indicated in part ... "4. Nursing Department ...c. A licensed nurse is responsible for notifying the attending MD of the patients' admission and obtaining necessary orders, if not already done by Patient Access. A licensed nurse is also responsible for obtaining the medication reconciliation information ...5. Physician Responsibility ...a. Provides specific orders for the care of the patients ...b. Assess the patient within a reasonable length of time, as defined by Medical Staff Bylaws ..."

The facility document titled "Medical Staff General Rules and Regulations" amended May 2018, indicated in part..."Rule 1 Admission and Discharge of patients...1.1..The official admitting policy of the hospital shall govern all practitioners...Rule 2 Medical Records...The attending physician shall be held responsible for the preparation of a complete medical record...2.1 In and Outpatient Records...L. Late entries in the medical record must be defined as a "late entry", must be dated the date the entry was made, and authenticated by the author...Rule 3 General Conduct of Care...3.2 Following the admission of any patient to (facility), the Nursing staff will immediately notify the attending physician of such admission, will inform the attending of the status of the patient, and will request of the attending physician any orders or procedures that may be deemed necessary for the best care of the patient...If the record is delinquent, the Director of Health Information Management or designee will notify the practitioner that his/her privileges to...perform elective operations have been suspended...The practitioner shall remain suspended until the records have been completed. All appropriate hospital departments, including Admitting, Nursing and Administration shall be notified of this action...It shall be the responsibility of the Hospital President of the Medical Center and the President of the Medical Staff to report to the Medical Board of California any responsible medical practitioner whose privileges are restricted for a medical disciplinary cause, (eg, that aspect of a licentiate's professional conduct which is likely to be detrimental to patient safety or to the delivery of patient care..."
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation and interview, the hospital failed to safely maintain the physical plant:

1. Electrically powered indicator lights did not have safety covers in eighteen of sixty-four patient rooms (patient rooms 601, 602, 603, 604, 605, 606, 607, 609, 628, 629, 630, 631, 632, 633, 634, 635, 636, and 638)

2. A bathroom shower light bulb housing fixture was loose and hanging from the ceiling in one of sixty-four patient rooms (room 629) bathroom

3. A twelve inch diameter wall clock laying on the counter top in the patient room for one of sixty four patient rooms (room 623)

These hospital failures had the potential to cause electrocution and physical injury to patients.

Findings:

Review of Potter and Perry, 6th Edition, "Mosby's Fundamentals of Nursing", page 966 indicated "A checklist should be used to assess potential electrical hazards to reduce the risk of electrical fires, electrocution, or injury from faulty equipment. In health care setting, clinical engineering staff makes regular safety checks of equipment."

1. During an observation on 7/10/19 at 3:17 p.m. accompanied by the Director of Environmental Services (EVSD) and the Operations Manager Environmental Services (EVSOM) electrically powered indicator lights on the walls of rooms 601, 602, 603, 604, 605, 606, 607, 609, 628, 629, 630, 631, 632, 633, 634, 635, 636, and 638 had no safety covers, the light bulbs were exposed, and lit up when pushed with a finger indicating electrically active. The EVSD and the EVSOM observed the light bulbs actively lighting when pushed with finger and indicated the safety covers are missing. The EVSD and the EVSOM also indicated the uncovered indicator lights are a safety risk for electrocution, electric shock, and need to be fixed.

2. During an observation on 7/10/19 at 3:45 p.m. accompanied by the EVSD and the EVSOM, in the bathroom of room 629, the shower light bulb housing fixture was loose and hanging from the ceiling. The EVSD and the EVSOM observed, confirmed, and indicated the shower light bulb housing fixture was loose and hanging from the ceiling, a risk for harm to patients, and needs to be fixed.

3. During an observation on 7/8/19 at 2:19 p.m. accompanied by the Director of Medical Surgical Services (DOMS), a twelve-inch diameter wall clock was laying on the counter in room 623. The DOMS observed and confirmed the 12-inch diameter clock laying on the counter. The DOMS indicated the clock should not be laying on the counter and should be attached to the wall of the room.

The hospital policy titled "EC-Electrical Safety Testing" revised 3/2014 indicated Clinical Engineering will ensure that all electrically powered medical equipment is electrically safe for patients, visitors, and associates. The hospital policy titled "Facilities, Scope of Service" revised 9/2017 indicated "the hospital building and grounds are maintained in a safe and sanitary condition."
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, interview, and record review, the facility failed to ensure their supplies and equipment were maintained when:

1. Preventative maintenance was not performed timely on the automated endoscope reprocessor (AER) (a device widely used in the health care setting to reprocess endoscopes by disinfecting between uses)

2. Preventative maintenance was not performed timely on the light source for the gastrointestinal (GI) lab endoscope equipment

3. Sterile culture swabs were expired

4. Sterile "FemoStop" (a compression device used on a femoral artery or vein) packages were expired

5. Preventative maintenance was not performed timely on cardiac cath lab equipment

6. Supplies were stored close to the ceiling in the soiled utility room

7. Oxygen cannister was not stored safely

These facility failures had the potential to effect the safe delivery of patient care

Findings:

1. During an observation in the GI lab reprocessing room and concurrent interview with the biomedical technician (BT1) on 7/8/19, at 12:00 p.m., BT1 confirmed the 0.45 micron filters for the AER were last changed 8/18 and should have been changed quarterly. Additionally, the 0.2 micron filter for the AER was last changed 8/18 and should have been changed in 2/18. BT1 indicated there was a change of staff in the biomedical department and the GI lab filters were missed.

During a review of Endoscope Reprocessor User Manual dated 2006, page 3 indicates " The high performance 0.2 micron water filter included with the reprocessor is a bacterial-retentive filter. The filter removes all microorgansims and particles greater than 0.2 micron. The routine maintenance schedule recommends replacing the 0.2 micron water filter every 6 months or sooner..."

During a review of the policy and procedure titled "Flexible Endoscopes-Cleaning and High Level Disinfection" dated 2/19, indicated "Daily, prior to using the AER: check the filter logs to ensure all filters are within use life..."

According to AORN "Guideline for Processing Flexible Endoscopes" 2/1/16, "Although mechanical processors provide many advantages compared with manual processing, there are some disadvantages. Mechanical processors require preventative maintenance to ensure safe and effective operation.. mechanical processers that are not maintained or functioning correctly, may cause processing failures of flexible endoscopes and increase the risk for infection..."

2. During an observation in the GI lab and concurrent interview with BT1 on 7/8/19 at 12:25 p.m., BT1 acknowledged the light source for the Olympus Evis Exera III was last performed on 2/18 and was past due for annual prevenative maintenance.

The facility policy and procedure titled " Scheduled Maintenance of Medical Equipment" dated 5/18, indicated " Purpose...The scheduled maintenance program is a component of the Medical Equipment Management Plan and is designed to ensure the performance and clinical operational functionality of the medical equipment..."




3. During an observation, and concurrent interview, with Director of Perioperative Services (DPOS) on 7/9/19 at 9:45 a.m., in the Doheny operating room corridor, ten culture tubes (used to collect bacteria from surgical sites for laboratory identification) had an expiration date of 5/19. DPOS acknowledged the culture tubes were expired.

The facility policy and procedure titled "Sterile Supplies - Storage, Shelf Life, and Stock Rotation" dated 2/19, indicated "Outdated supplies are removed from stock and discarded as necessary."




4. During an observation in the Cardiac Catheterization Lab on 7/9/19, at 10:30 a.m., two packages of Sterile "FemoStop" compression device were noted to have an expiration date of 5/16/19. The packages were stored in one of the supply storage cabinets inside Procedure Room # 2.

During an interview on 7/9/19, at 10:45 a.m., the Catherization Lab Manager (CLM) and the Director of Risk Management (DRM) acknowledged the two packages had expired and were available for staff to utilize.

The facility policy and procedure titled "Sterile Supplies - Storage, Shelf Life, and Stock Rotation" dated 2/19, indicated "Outdated supplies are removed from stock and discarded as necessary."

5. During an observation in the Cardiac Catheterization Lab and concurrent interview with CLM on 7/9/19, at 11:30 a.m., the CLM acknowledged the Cool Flow Pump (infusion pump) preventative maintenance was due to be performed on 4/2019 and was currently past due.

During an interview and concurrent record review with BT 1 on 7/10/19, at 2:20 p.m., BT 1 acknowledged that this medical equipment was past due for service and maintenance records confirmed the equipment was due for preventtive maintenance 4/1/2019.

The facility policy and procedure titled " Scheduled Maintenance of Medical Equipment" dated 5/18, indicated " Purpose...The scheduled maintenance program is a component of the Medical Equipment Management Plan and is designed to ensure the performance and clinical operational functionality of the medical equipment..."





6. During an initial tour of the Critical Care Unit and concurrent interview with the Director of Nursing (DON1) on 7/8/19 at 2:05 PM, inside the soiled utility room there was a metal shelving and on top of it were multiple trash cans stored close to the ceiling despite the written instruction posted to not put anything on top of the shelf near the ceiling. DON1 confirmed the above findings and indicated for safety there should not be any items stored above the rack close to ceiling.





7. Review of The National Fire Protection Association's "Medical Gas Cylinder Storage" dated 1/2018, at https://www.nfpa.org/~/media/4B6B 1E04E 4672EBB319C4F.pdf indicated "...appropriate restraints and storage of gas cylinders to protect cylinder regulators and valves should be maintained because damage can allow escaping gas to propel the cylinder violently in a dangerous manner."

During an observation on 7/8/19 at 2:39 p.m. in the Six West 1 Hall Dirty Utility "Biohazard" Room accompanied by the Director of Medical Surgical Services (DOMS), an unsecured oxygen cylinder containing 1300 pounds of pressurized oxygen gas was stored on a moveable intravenous pole (IV pole-used to hold equipment in the administration of medications into patient's veins).The DOMS confirmed the oygen cylinder should be stored in the used oxygen cylinder rack in the Dirty Utility "Biohazard" Room. The DOMS indicated oxygen cylinders that contain pressurized oxygen gas and not stored in designated racks are a safety hazard.

The hospital policy and procedure titled "Oxygen Safety Guidelines" revised 9/2015 indicated "provisions shall be made for racks or fastening to protect cylinders from accidental damage or dislocation". The policy also indicated "freestanding cylinders shall be properly chained or supported in a proper cylinder stand and shall not be chained to portable or moveable apparatus, and oxygen cylinder(s) shall be protected from abnormal mechanical shock, which is liable to damage the cylinder, valve, or safety device."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observations, interviews, and record reviews, the hospital failed to implement the infection control program and guidelines for infection prevention and control when:

1. Gastrointestinal (GI) endoscopes were stored with the distal tip touching the drying cabinet walls (Cross reference A0749)

2. Terminal cleaning in the sterile processing department (SPD) was not performed according to policy and procedure(Cross reference A0749)

3. Temperature and humidity was not monitored daily in the operating rooms (ORs) and OR sterile supply rooms(Cross reference A0749)

4. Operating Rooms were not cleaned between cases according to Association of Operating Room Nurses (AORN) guidelines (Cross reference A0749)

5. Temperature and humidity was not monitored daily in the Cardiac Cath Lab (CCL) (Cross reference A0749)

6. A wire rack lacked a solid surface on the bottom shelf where sterile instrument sets were stored (Cross reference A0749)

7. Environmental services (EVS) personnel did not gown when entering a contact isolation room and wore the gloves from the isolation room into the hallway (Cross reference A0749)

8. Two intensive care unit (ICU) staff did not perform hand hygiene according to policy and procedure (Cross reference A0749)

9. Expired sterile supplies were contained in a crash cart on one unit (Cross reference A0749)

10. A rehabilitation unit chair with torn upholstery available for patient use (Cross reference A0749)

11. Policy and procedure was not followed when obtaining blood cultures (Cross reference A0749)

12. EVS equipment was stored in a medication room (Cross reference A0749)

13. Isolation personal protective equipment (PPE) was not removed prior to exiting the room (Cross reference A0749)

14. Work station on wheels (WOWs) and vital sign machines were not cleaned according to policy and procedure (Cross reference A0749)

15. Dirty patient care equipment was stored in clean patient rooms (Cross reference A0749)

16. Patient shower floors were unsanitary (Cross reference A0749)

17. Suction tubing was not properly stored in clean patient rooms (Cross reference A0749)

18. Bottles of enteral feedings were stored improperly (Cross reference A0749)

19. Soiled linen hampers contained linens which were overflowing (Cross reference A0749)

20. Intravenous (IV) tubing and IV insertion sites were not labled with change dates (Cross reference A0749)

21. A sterilized surgical tray exceeded 25 pounds in weight (Cross reference A0749)

The cumulative effect of these systemic problems resulted in failure to ensure implementation of a safe and effective infection control program.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview and record review, the hospital failed to ensure a safe and sanitary environment and implement policy and procedures to minimize the transmission of healthcare acquired infections (HAIs) when:


1. Gastrointestinal (GI) endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were stored with the distal tip touching the drying cabinet walls

2. Terminal cleaning in the sterile processing department (SPD) was not performed according to policy and procedure

3. Temperature and humidity was not monitored daily in the operating rooms (ORs) and OR sterile supply rooms

4. Operating Rooms were not cleaned between cases according to Association of Operating Room Nurses (AORN) guidelines

5. Temperature and humidity was not monitored daily in the Cardiac Cath Lab (CCL)

6. A wire rack lacked a solid surface on the bottom shelf where sterile instrument sets were stored

7. Environmental services (EVS) personnel did not gown when entering a contact isolation room and wore the gloves from the isolation room into the hallway

8. Two intensive care unit (ICU) staff did not perform hand hygiene according to policy and procedure

9. Expired sterile supplies were contained in a crash cart on one unit

10. A rehabilitation unit chair with torn upholstery available for patient use

11. Policy and procedure was not followed when obtaining blood cultures

12. EVS equipment was stored in a medication room

13. Isolation personal protective equipment (PPE) was not removed prior to exiting the room

14. Work station on wheels (WOWs) and vital sign machines were not cleaned according to policy and procedure

15. Dirty patient care equipment was stored in clean patient rooms

16. Patient shower floors were unsanitary

17. Suction tubing was not properly stored in clean patient rooms

18. Bottles of enteral feedings were stored improperly

19. Soiled linen hampers contained linens which were overflowing

20. Intravenous (IV) tubing and IV insertion sites were not labled with change dates

21. A sterilized surgical tray exceeded 25 pounds in weight


These failures had the potential to result in contamination and or cross contamination of infectious microorganisms to patients, staff, and visitors.

Findings:

1.During an observation in the GI lab and concurrent interview with the director of perioperative services (DPOS) on 7/8/19, at 11:50 a.m., the DPOS acknowledged there were four endoscopes stored in the drying cabinet with the distal tips of the scope touching against the front of the cabinet wall. The DPOS confirmed the scopes should hang freely and not touch other surfaces after high level disinfection.

The facility policy and procedure titled "Flexible Endoscopes-Cleaning and High Level Disinfection" dated 2/19, indicated "Storage of the endoscope after high-level disinfection (HLD): Hang the endoscope vertically with the distal tip hanging freely ..."

2. During a record review of the terminal cleaning logs for SPD and concurrent interview with executive director of quality services (QSED) on 7/8/19, at 2:30 p.m., QSED confirmed the terminal cleaning log dated 7/19 indicated the terminal cleaning on 7/1/19, 7/2/19, 7/3/19 and 7/5/19 was initiated prior to the end of the day.

During a telephone interview with the director of infection prevention (IP1), on 7/10/19, at 4:00 p.m., IP1 confirmed terminal cleaning in SPD should be performed at the end of the day.

The facility policy and procedure titled "Terminal Cleaning in Surgical, Invasive Procedural Areas and SPD" revised 2/19, indicated "Policy ...terminal cleaning of sterile processing department, decontamination and reprocessing areas will be performed at the end of each day ..."




3. According to AORN (Association of Peri-Operative Nurses) Standards of Peri-Operative Nursing Practice, Guidelines for a Safe Environment of Care, Part 2 (2017): indicated in part... "The health care organization should create and implement a systematic process for monitoring HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance parameters and a mechanism for resolving variances... personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures.... rapid communication between affected and responsible personnel can help facilitate resolution of the variance... the temperature range for sterile storage is maximum 75 F and humidity maximum of 60 % ...the operating/procedure room temperature is 68 to 75 F and the humidity range is 20% to 60%."

During a review of the facility "Temperature and Humidity Logs" dated May thru July 2019, indicated several days that the temperatures and humidity were not recorded on the Main Surgical Floor Operating Rooms 1-12, Main Surgical Sterile Supply Storage, the Doheny Surgical Floor Operating Rooms 1-5, and Doheny Surgical Sterile Supply Storage.

During a review of the temperature and humidity logs and concurrent interview with the director of perioperative services (DPOS) and the manager of surgery (MSUR) on 7/8/19, at 2:45 p.m., the DPOS acknowledged several missing dates on the logs and indicated the facility is not monitoring the temperature and humidity on non-surgical days. MSUR indicated the facility follows AORN guidelines. MSUR indicated ... "we are not monitoring temperature and humidity when we are not here." MSUR further indicated she could not ensure the integrity of the sterile supplies and equipment were not compromised.

The facility policy and procedure titled: "Temperature and Humidity Control" dated 2/2019, indicated in part ..."The purpose of the policy is to assure that temperature and humidity is maintained in necessary areas within recommended ranges in order to ensure sterile integrity for infection control purposes ...monitored in the following areas: ...operating rooms and sterile storage ...temperature and humidity ranges to be maintained: operating room temperature 68-75F and humidity 30-60%...sterile storage area temperature max 75F and humidity max 60% ...monitor and log the temperature and humidity on the Temperature and Humidity log daily ... notify facilities services if either humidity or temperature is out of range."

According to AORN 2012-2019, Guideline for Perioperative Practice: Design and Maintenance of the Surgical Suite XII: indicated in part..."Heating, ventilation, and air conditioning systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas ... the HVAC system reduces the amount of environmental contaminants (eg, microbial-laden skin squames, dust, lint) in the surgical suite by carrying airborne contaminants away from the sterile field and removing them through the return duct vents located at the periphery of the room... the restricted areas are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent."

4. According to AORN (Association of Peri-Operative Nurses) Standards of Peri-Operative Nursing Practice, Guideline for Environmental Cleaning (2012-2019): indicated in part... "All personnel should take precautionary measures to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ...cleaning and disinfection activities should be performed in a methodical pattern that limits transmission of microorganisms ...cleaning should progress from clean to dirty areas ...cleaning should progress from top to bottom areas ...clockwise or counter-clockwise cleaning may be performed when used in conjunction with clean-to-dirty and top-to-bottom methods."

During an observation in operating room (OR) #2 on the Doheny floor on 7/9/19 at 11:45 a.m., environmental services staff (EVS 1) was cleaning the operating room between patients. EVS 1 first cleaned the operating table down to the floor. EVS 1 then cleaned the OR lights, anesthesia machine, outer counter tops and mayo stands with the same cleaning rag. The sequence of cleaning was center of room to periphery. EVS 1 then left the OR, touching the OR door knob without changing gloves. EVS 1 brought in a new cleaning rag with the same dirty gloves and continued to clean.

During an interview with EVS 1 on 7/9/19 at 12:00 p.m., indicated he cleans the OR table first then cleans outward.

During an interview with the infection preventionist (IP 2) on 7/9/19 at 12:10 p.m., indicated she observed the room cleaning by EVS 1 and confirmed the cleaning sequence was incorrect. IP 2 acknowledged AORN guidelines and indicated the cleaning of the OR should be periphery to the center. The OR table should be last. IP 2 acknowledged EVS 1 should have changed gloves before exiting the room. IP 2 further indicated EVS 1 should have performed hand hygiene and don new gloves upon reentry into the OR with the clean rag.




5. During a review of the facility Temperature and Humidity Logs for Catherization Lab and a concurrent interview with the catherization lab manager (CLM) on 7/9/19, at 11:30 a.m., the log for procedure rooms 2 and 3 indicate the temperture and humidity was not monitored for July 4th, 6th, and 7th. Procedure Rooms 4 and 5 are missing temperature and humidity monitoring for July 4th and 6th. The CLM confirmed the logs were current as presented.

The facility policy and procedure titled: "Temperature and Humidity Control" dated 2/2019, indicated in part ..."The purpose of the policy is to assure that temperature and humidity is maintained in necessary areas within recommended ranges in order to ensure sterile integrity for infection control purposes ...monitored in the following area: cardiac catherization lab........monitor and log the temperature and humidity on the Temperature and Humidity log daily ... notify facilities services if either humidity or temperature is out of range."




6. During an observation and concurrent interview with interim manager doheny (IMD) on 7/9/19, at 4:52 p.m., in operating room four, a wire rack lacked a solid surface on the bottom shelf where sterile instrument trays were stored. IMD acknowledged the bottom shelf should have a solid surface.

The facility policy and procedure titled "Sterile Supplies - Storage, Shelf Life, and Stock Rotation" dated 2/19, indicated "Sterile items stored on wire racks will be protected by a solid bottom or placed within plastic bins to protect from moisture during floor cleaning activities."





7. During an observation on 7/8/19 at 2:18 PM, in the Telemetry Unit an Environment Services Staff (EVS 3) entered a contact isolation room without wearing a gown. When exiting EVS 3 did not take off the gloves and was about to go on the next room when EVS 3 was stopped by the Chief Nurse Executive (CNE). EVS 3 took off the gloves and sanitized her hand and then proceeded to go to the next room.

During an interview with EVS 3 on 7/8/19 at 2:20 PM, EVS indicated she has been working in the hospital for 1 year and 8 months. EVS 3 indicated that they get classes for infection control every year. EVS 3 indicated she saw the contact isolation sign in front of the patient's room but did not wear a gown because she was just going to take out the trash.

The facility policy and procedure titled "Infection Control Policy and Procedure Manual" dated 12/2018 indicated in part on contact precautions procedures ... in addition to wearing gloves and gown as outlined under Standard Precautions, wear clean nonsterile gloves and gown when entering the room... remove the gown and gloves before leaving the patient's room. Perform hand hygiene after removing gloves.

During an interview with the CNE on 7/8/19 at 2:30 PM, the CNE indicated all hospital employees including contracted staff were trained about hospital policies and have refresher course every year via online or actual in-service. The CNE acknowledged EVS 3 did not follow infection control practice when she entered an isolation room and wearing the same gloves used in the isolation room in the hallway.







8. During an observation on 7/8/19 at 12:34 PM, a Registered Nurse 1 (LN1) was observed entering the contact isolation room 401 and exiting the room touching the door latch with a gloved hand. LN1 then removed her gown, gloves and mask outside the isolation room. LN1 indicated the gown, gloves, and mask should have been removed inside the isolation room and hands should have been sanitized before exiting the room.

On 7/8/19 at 2:53 PM, the Critical Care Registered Registry Nurse (CCRRN) was observed inside the enteric and contact isolation room 411. CCRRN removed her gown, gloves and mask inside the room and exited the room without washing hands. CCRRN confirmed not washing hands in the sink inside room 411.

The hospital policy titled "Hand Hygiene" dated 8/2018 indicated " ...B. Wash hands with soap and water at least 20 seconds 4.When caring for patients who have diarrhea associated with c-difficile. C. Hand sanitation with an alcohol-based hand sanitizing product may be performed 2. Before and after direct patient care. 7. after contact with body fluids. 12. Before putting on gloves. 13. after removing gloves. N. Wear gloves when contact with blood or other potentially infectious materials. O. Remove gloves after caring for a patient ..."




9. During an observation of the crash cart in the Acute Rehab Unit, and concurrent interview with the pharmacist (PHARM1) on 7/9/19 at 10:00 a.m., the following expired supplies were found in the crash cart at the Acute Rehab Unit:
a. Sterile masks and bonnets in a sterile package was opened on one end, leaving the masks and bonnets open to the air.
b. Two IV start kits with expired date of 5/31/19.
c. Sterile scissors with expired date of May, 2019.
d. Sterile gloves with expired date of 6/20/19.
e. Sterile scissors in a sealed, sterile intubation tray with expired date of 10/2018.
f. Central Venous Catheterization kit with expired date of 6/30/19.
PHARM1 confirmed the supplies had expired, and should have been removed from the cart.

Review of the facility Policy & Procedure titled, "Crash Carts and Defibrillator Checks", dated 7/2017, stated "2. a. All crash carts are inspected twice yearly in June and December for outdated supplies. b. CPD will be responsible for maintaining and removing expired supplies."

10. During an observation of the Rehab Gym, and concurrent interview with the Program Director, Rehab Unit (PDRU) on 7/8/19 at 12:20 p.m., the seat portion of a plastic/leather chair in the Rehab gym was noted to have three long rips, each approximately 6" in length. PDRU confirmed the chair could not be cleaned and should have been discarded.

Review of the facility Policy & Procedure titled, "7 Step Cleaning Procedure", dated 01/2019, states, "Step 7 - Inspect the Work According to SVMC Standards ...b. Being sure that the room is free of sharp hazards, wall penetrations, and that the plumbing and furnishings are all operating properly."




11. The facility policy and procedure titled "Blood Culture Collection Guidelines and Procedure dated 12/14/18, indicated "Acute febrile (fever) episode ...Draw 1 set of blood ...Draw another set ...after 10-15 minutes apart ..." and "Order of Draw/collection ...Collect blood cultures ...from the first site...Draw all other blood work ...collect blood cultures from second site ..."

The facility policy and procedure titled "Registered Nurse" emergency room /Department Job Description dated 04/30/19, indicated " ...Adheres to policies and procedures directing ...phlebotomy (blood draw) ...."

During an observation and concurrent interview on 07/08/19, starting at 2:35 P.M., in the ED triage/blood draw area, a licensed nurse (LN5) was observed drawing two sets of blood cultures without changing the blood draw site or waiting 15 minutes between blood culture draws. An administrative house supervisor licensed nurse (ANHS) verified the observation. LN5 stated she drew the first set of blood cultures, the labs (non-blood culture tubes of blood), then immediately drew the second set of blood cultures without waiting or changing the blood collection site. LN5 stated she was aware of the policy requiring 15 minutes between blood culture draws if using the same site.

12. The facility policy and procedure titled "Infection Prevention & Control for Environmental Services" dated 11/2016, indicated "Equipment Maintenance and Storage ...stored in a designated storage area ..."

During an observation and concurrent interview on 07/08/19, at 12:12 P.M., in the ED medication room, ANHS stated, "Yes ma'am," a vacuum cleaner with black and grey particles on it appeared dirty and should not be stored in the medication room.




13 Review of Potter and Perry, 6th Edition, "Mosby's Fundamentals of Nursing", pages 796 and 798 indicated protective disposable gowns, gloves, and masks used in the care of a patient in isolation (separated from other patients to prevent the spread of infectious organisms) should be removed and hands washed before exiting the patient room to prevent the spread of infection. The reference also indicated any article brought into an isolation room and not disinfected before removing the article from the room increases the risk of spreading infection to other patients or personnel.

During an observation of a Rapid Response (RR-medical emergency personnel team called to revive a patient) on 7/9/19 at 12:12 p.m. and 12:23 with the Director of Medical Surgical Services (DOMS), a Respiratory Therapist 2 (RT2) were providing emergency care to a patient (patient 602) on isolation precautions. RT2 was with protective gloves, gown, and hair covering (PPE) on while providing the emergency care. RT2 exited the room with PPE on, did not wash hands and proceeded to remove a cell phone ( #5732-hospital issued CP) from a pocket with gloved hands and place the CP on top of a crash cart (CC- cart with drawers of emergency supplies and medications) at the hallway. RT2 opened the bottom drawer of the CC, retrieve emergency supplies and re-entered patient's 602's room . RT2 left the CP on top of the CC.

During another observation on 7/9/19 from 12:12 p.m., to 12:23 p.m., RT1 was outside patient's of 602's room observing the emergency care. The CP on top of the CC rung. RT1 picked up the CP with ungloved hands and answered the call. After the call, RT1 returned the CP back on top the CC. RT1 did not wash or sanitized both hands or sanitized the CP prior to opening a nearby cart containning PPEs .

During an observation on 7/9/19 at 12:25 p.m. with the DOMS, the DOMS called out three times for the RR team to remove isolation garments (PPE) before exiting patient 602's room after the emergency care was provided. Licensed Nurse 19 (LN19) exited patient 602's room without removing PPE's and failed to wash hands.

During an interview on 7/9/19 at 12:36 p.m. with the DOMS, the DOMS confirmed LN19 and RT2 did not remove isolation garments (PPEs) not washed hands before exiting room .The DOMS further confirmed RT2 placed the CP on top of a CC with gloves on used during the emergency care and RT1 picked up the CP with ungloved hands and failed to wash hands or sanitized the CP. The DOMS indicated the hospitals protocol on infection control was not followed and all surfaces and articles touched by LN19, RT1, and RT2 must be disinfected to prevent the spread of infection.

During an observation and interview on 7/10/19 at 10:20 a.m. with Laboratory Phlebotomist 1 (Lab 1), Lab1 exited isolation room of Patient 601 without removing PPEs on and washing/sanitizing hands .Lab 1 carried out unused emergency supplies and a handheld device (PDA) from Patient 601's room and laid the items onto the surface of the phlebotomy cart. Lab 1 indicated and confirmed the PPEs should have been removed prior to exiting the Patient 601's room.

During an interview on 7/10/19 at 12:22 p.m. with the DOMS, the DOMS indicated and confirmed staff should remove protective isolation garments and gloves, wash/sanitize hands before exiting an isolation room to comply with infection control and prevent spread of infection.

On 7/8/19 at 12:34 PM, the Registered Nurse 1 (LN1) was observed entering a contact isolation room (R401) with PPEs on. LN1 exited R401 with PPEs on and touched the door latch with gloves on. LN1 indicated failing to removed PPEs inside R401 and washing/ sanitizing hands before exiting.

The hospital policy and procedure titled "Isolation-Standard and Transmission-based Precautions" revised 12/2018 indicated ..."protective gowns and gloves shall be removed before exiting isolation rooms and hand hygiene performed after gloves are removed" The policy also indicated "...reusable patient-care equipment should be cleaned and disinfected before removing from isolation rooms."

14 Review of Potter and Perry, 6th Edition, "Mosby's Fundamentals of Nursing", pages 776 and 777 indicated infectious organisms can be spread through contaminated items and "Because so many factors can promote the spread of infection to a client, all health care workers must be conscientious in using infection-control practices, such as proper hand washing and ensuring that equipment has been adequately disinfected or sterilized."

During an observation and interview on 7/8/19 at 12:22 p.m. with the Director of Medical Surgical Services (DOMS) on Six West at the end of Hall 2, four workstations on wheels (WOWs) numbered SVRSPT09, SV6W2T05, SV6W1T05, SV6W2T07 had gray and black stains and marks on the writing surfaces, handles, keyboard, trays, and base. WOWs numbered SVRSPT09, SV6W2T05, SV6W1T05 were not supplied with disinfecting wipes. The DOMS confirmed and indicated , the WOWs were not clean/ready to use in patient care, should be cleaned, and stocked with disinfecting wipes.

During an observation and interview on 7/8/19 at 12:26 p.m. outside of R621 with the DOMS, a blood pressure (V ) and body temperature machines (V ,V ,V ) had black and gray particles and spots on the trays and handles.The DOMS confirmed and indicated the blood pressure and body temperature machines were not clean,disinfected, and ready to use in patient care, and should be cleaned.

During an observation and interview on 7/9/19 at 9:47 a.m. with the DOMS on Six West Hall 1, four WOWs) numbered SV6S1T01, SV6W1T06, SV6W1T01, and 6W2 had gray and black stains and marks on the writing surfaces and base. WOWs numbered SV6S1T01 and 6W2 were not supplied with disinfecting wipes.The DOMS indicated the WOWs were not clean, disinfected, and ready to use in patient care, and should be cleaned, and stocked with disinfecting wipes.

The hospital policy and procedure titled "Cleaning and Disinfection of Computers" revised 4/2014 and "Cleaning and Disinfection of Non-Critical Patient Care Equipment" revised 4/2013 indicated WOWs, blood pressure machines, and temperature machines are to be stocked with a supply of disinfecting wipes, cleaned, and disinfected when visibly soiled or contaminated.

15 Review of Potter and Perry, 6th Edition, "Mosby's Fundamentals of Nursing", pages 776 and 777 indicated infectious organisms can be spread through contaminated items and "Because so many factors can promote the spread of infection to a client, all health care workers must be conscientious in using infection-control practices, such as proper hand washing and ensuring that equipment has been adequately disinfected or sterilized."

During an observation and interview on 7/8/19 at 11:28 to 11:40 a.m. with the DOMs inside clean patient room R608 an intravenous pump machine (IVPM Pump-machine that pumps liquid medication through tubing into patient's vein) was found. The IVPM was with raised dried brown spots and drippings on the back .The DOMS confirmed and indicated the IV Pump was not clean, disinfected, and ready for patient use.

During an observation and interview on 7/8/19 at 12 p.m. with the DOMS inside clean patient R614 an IVPM with black and gray stains on the top and back of the unit was found. The DOMS confirmed and indicated the IV Pump was not clean, disinfected, and ready for patient use.

The facility policy titled "Cleaning and Disinfection of Non-Critical Patient Care Equipment" revised 4/2013 indicated after a patient is discharged , IV Pumps shall be cleaned and disinfected before using on another patient.

16 Review of Potter and Perry, 6th Edition, "Mosby's Fundamentals of Nursing", page 1028, skill 38-1, step B(2) indicated before patients use a shower for bathing purposes "Check tub or shower for cleanliness" and "Cleaning prevents transmission of microorganisms."

During an interview and observation of clean empty patient rooms 623, 626, 628, 629, 630, and 631, on the Medical Surgical Unit on 7/8/19 from 12:28 p.m. to 3:30 p.m. accompanied by the DOMS the stall floors in the bathroom shower were with black and gray stains covering the floors.The DOMS indicated the bathrooms and shower stall floors had been cleaned by the Environmental Services Department (ESD)and were ready for patient use.The DOMS confirmed the presence of stains indicated the shower stall floors are not clean and hygienic for patient use and should be cleaned again.

During an interview and observation at the Medical Surgical Unit on 7/9/19 from 10:10 a.m. to 11:47 a.m. accompanied by the DOMS the bathroom shower stall floors of clean empty patient rooms 601, 602, 603, 605, 606, 633, 634, 635, 636, 637, and 638 were with black and gray stains. The DOMS indicated the bathrooms and shower stall floors had been cleaned bythe ESD and were ready for patient use. The DOMS indicated the shower stall floors are not clean and not hygienic for patient use and should be cleaned.

During an observation and concurrent intertviews on 7/10/19 from 3:17 p.m. to 3:45 p.m., with the Director of Environmental Services (EVSD) and the Operations Manager Environmental Services (EVSOM), the bathrooms of clean empty patient rooms 601,602, 603, 604, 605, 606, 628, 629, 630, 631, 632, 633, 634, 635, 636, and 637 at the Medical Surgical Unit were with black and gray stains covering the shower stall floors. The EVSD and the EVSOM indicated the bathrooms and shower stall floors had been cleaned by the ESD and ready for patient use. The EVSD and the EVSOM confirmed and indicated the shower stall floors are not clean and not hygienic for patient use and should be cleaned.

The facility policy and procedure titled "Environmental Services Department 7 Step Cleaning Procedure" revised 1/2019 and the "Infection Prevention and Control for Environmental Services" revised 11/2016 indicated to thoroughly clean the restroom and disinfect the shower stall floor.

17. The facility policy and procedure titled "Cleaning and Disinfection of Non-Critical Patient Care Equipment" revised 4/2013 indicated nursing staff is responsible for cleaning, disinfecting and removing patient care equipment that is not "native to the room after patient discharge."

During an observation and interview on 7/8/19 at 2:25 p.m. and 2:51 with the DOMS inside the empty clean patient rooms 625 and 630 ,exposed ends of uncoiled single use suction tubing were hanging loose and draped over other wall mounted appliances and attached at the other end of a wall mounted suction canister containing a disposable single use plastic liner.The DOMS indicated the suction tubing and canister linings are single use and disposable, should not be in clean patient rooms.

During an interview on 7/10/19 at 2:20 p.m. with the Executive Director of Quality Services (QSED), the QSED indicated "equipment native to room" means the bed and mattress only and other equipment should be removed from patients' room at discharge. The QSED also indicated equipment used in patient care should be brought in according to patient needs after admission.

18. Review of https://www.ncbi.nlm.nih.gov/books/NBK 9/ "Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2.11.3.3. Store feeds safely" dated 2012 section 11.3.3, indicated ready to use formula used for enteral feeds should be stored in a clean environment and when not for immediate use should be refrigerated and discarded after 24 hours.

During an observation at the 6 West 1 Hall Pantry and interview on 7/8/19 at 2:49 p.m. with the DOMS, two 1000 milliliter containers of Jevity 1.2 calorie enteral tube feeding (feeding formula via tube /opening in the stomach) were on the counter next to the handwashing sink, under the paper towel dispenser, and within splashing distance of water from the faucet.The DOMS indicated the containers were in an area where potential contamination could occur and should be moved.

During an observation in the pantry of the definitive observation unit (DOU) and concurrent interview with the director of nursing telemetry/DOU (DON3) on 7/8/19 at 11:49 a.m., three bottles of enteral feedings were stored on the side of a countertop ice machine next to open vents. DON3 acknowledged the bottles should not be kept next to the ice machine vents, "it is probably too warm."

During an observation in the pantry on the definitive observation unit (DOU) and concurrent interviews with DON3 and a licensed nurse (LN 9) on 7/10/19 at 10:45 a.m., two bottles of enteral feedings were stored directly to the left side of a sink and two bottles sat on top of a coffee maker. LN9 indicated after delivery from kitchen, nursing stores the bottles next to sink for use. DON3 indicated the feeding formula bottles should not be kept on top of coffee maker and stated "tube feedings should not be stored near heat and should probably not be stored near sink as it might not be sanitary."

During an observation in the pantry on the 7th floor and concurrent interview with the director of nursing 7th floor (DON2) on 7/8/19 at 2:47 p.m. 4 bottles of tube feeding were stored directly to the left of a sink. DON2 agrees that these are nutrition for patients today. DON2 indicated is not sanitary conditions to store tube feeding productsby the sink and stated, "People wash hands or things in that sink that could splash on bottles. We used to keep them in a cabinet and that is where they should be."

According to the National Clinical Guideline Center, Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care dated 3/2012, section 11.3.3 titled "Store Feeds Safely" indicated, "Expert opinion and manufactures advise that ready-to-use, prepackaged feeds should be stored in a clean environment, protected from extremes of temperature."

According to the Food and Drug Administration (FDA) Food Code 2017, section 3-305.11 titled "Food Storage" indicated in part, (A) ... food shall be protected from contamination by storing the food: (1) In a clean, dry location; (2) Where it is not exposed to splash, dust, or other contamination ..."





19. During an observation in the soiled utility room on the definitive observation unit (DOU) and concurrent interview with the director of nursing telemetry/DOU (DON3) on 7/8/19 at 11:55 a.m., two soiled linen hampers noted with overflowing linen, not allowing for closure of the lids and two soiled linen hampers noted to have soiled linen hanging outside of closed lid. DON3 acknowledged the hampers were overflowing and confirmed all soiled linen should be inside a closed soiled linen hamper with enough space to tie linen bag. DON3 indicated hampers changed out "at least twice daily by housekeeping and nursing staff should call for pickup if hampers are overflowing."

During an observation in the soiled utility room on the definitive observation unit (DOU) and concurrent interview with a licensed nurse (LN9) on 7/8/19 at 2:35 p.m., there were eight soiled linen hampers in utility room with one hamper overflowing so that lid not closed and three hampers noted to have soiled linen hanging outside of closed lid. LN9 confirmed linen hampers were not properly closed, "we need to contact housekeeping to pick up."

During an observation in the soiled utility room on the definitive observation unit (DOU) and concurrent interview with the director of nursing telemetry/DOU (DON3) on 7/10/19 at 10:50 a.m., there were two soile
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview, and record review, the hospital failed to provide a functional and sanitary environment for the provision of surgical services and acceptable standards of practice when:

1. Temperature and humidity was not monitored daily in the operating rooms (ORs) and OR sterile supply rooms (Cross reference A0749 & A0951)

2. Operating Rooms were not cleaned between cases according to Association of Operating Room Nurses (AORN) guidelines (Cross reference A0749 & A0951)

3. A wire rack lacked a solid surface on the bottom shelf where sterile instrument sets were stored
(Cross reference A0749 & A0951)

4. Sterile culture swabs were expired (Cross reference A0724 & A0951)

The cumulative effect of these systemic problems resulted in failure to ensure provision of quality health care in a safe environment.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview and record review, the hospital failed to ensure a safe, sanitary environment and implement policy and procedures in accordance with acceptable standards of practice when:

1. Temperature and humidity was not monitored daily in the operating rooms (ORs) and OR sterile supply rooms

2. Operating Rooms were not cleaned between cases according to Association of Operating Room Nurses (AORN) guidelines

3. A wire rack lacked a solid surface on the bottom shelf where sterile instrument sets were stored

4. Sterile culture swabs were expired

These failures resulted in improperly stored sterile supplies and had potential to spread microorganisms which could result in surgical site infections .

Findings:

1. According to AORN (Association of Peri-Operative Nurses) Standards of Peri-Operative Nursing Practice, Guidelines for a Safe Environment of Care, Part 2 (2017): indicated in part... "The health care organization should create and implement a systematic process for monitoring HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance parameters and a mechanism for resolving variances. Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures. Rapid communication between affected and responsible personnel can help facilitate resolution of the variance... the temperature range for sterile storage is maximum 75 F and humidity maximum of 60 % ... the operating/procedure room temperature is 68 to 75 F and the humidity range is 20% to 60%."

During a review of the facility "Temperature and Humidity Logs" dated May thru July 2019, indicated several days that the temperatures and humidity were not recorded on the Main Surgical Floor Operating Rooms 1-12, Main Surgical Sterile Supply Storage, the Doheny Surgical Floor Operating Rooms 1-5, and Doheny Surgical Sterile Supply Storage.

During a review of the temperature and humidity logs and concurrent interview with the director of perioperative services (DPOS) and the manager of surgery (MSUR) on 7/8/19, at 2:45 p.m., the DPOS acknowledged several missing dates on the logs and indicated the facility is not monitoring the temperature and humidity on non-surgical days. MSUR indicated the facility follows AORN guidelines. MSUR indicated ... "we are not monitoring temperature and humidity when we are not here." MSUR further indicated she could not ensure the integrity of the sterile supplies and equipment were not compromised.

The facility policy and procedure titled: "Temperature and Humidity Control" dated 2/2019, indicated in part ..."The purpose of the policy is to assure that temperature and humidity is maintained in necessary areas within recommended ranges in order to ensure sterile integrity for infection control purposes ...monitored in the following areas: ...operating rooms and sterile storage ...temperature and humidity ranges to be maintained: operating room temperature 68-75F and humidity 30-60%...sterile storage area temperature max 75F and humidity max 60% ...monitor and log the temperature and humidity on the Temperature and Humidity log daily ...notify facilities services if either humidity or temperature is out of range."

According to the association of operating room nurses (AORN) 2012-2019, Guideline for Perioperative Practice: Design and Maintenance of the Surgical Suite XII: indicated in part... "Heating, ventilation, and air conditioning systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas... the HVAC system reduces the amount of environmental contaminants (eg, microbial-laden skin squames, dust, lint) in the surgical suite by carrying airborne contaminants away from the sterile field and removing them through the return duct vents located at the periphery of the room... the restricted areas are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent."

2. According to AORN (Association of Peri-Operative Nurses) Standards of Peri-Operative Nursing Practice, Guideline for Environmental Cleaning (2012-2019): indicated in part... "All personnel should take precautionary measures to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ...cleaning and disinfection activities should be performed in a methodical pattern that limits transmission of microorganisms ...cleaning should progress from clean to dirty areas ...cleaning should progress from top to bottom areas ...clockwise or counter-clockwise cleaning may be performed when used in conjunction with clean-to-dirty and top-to-bottom methods."

During an observation in operating room (OR) #2 on the Doheny floor on 7/9/19 at 11:45 a.m., environmental services staff (EVS 1) was cleaning the operating room between patients. EVS 1 first cleaned the operating table down to the floor. EVS 1 then cleaned the OR lights, anesthesia machine, outer counter tops and mayo stands with the same cleaning rag. The sequence of cleaning was center of room to periphery. EVS 1 then left the OR, touching the OR door knob without changing gloves. EVS 1 brought in a new cleaning rag with the same dirty gloves and continued to clean.

During an interview with EVS 1 on 7/9/19 at 12:00 p.m., indicated he cleans the OR table first then cleans outward.
During an interview with the infection preventionist (IP 2) on 7/9/19 at 12:10 p.m., indicated she observed the room cleaning by EVS 1 and confirmed the cleaning sequence was incorrect. IP 2 acknowledged AORN guidelines and indicated the cleaning of the OR should be periphery to the center. The OR table should be last. IP 2 acknowledged EVS 1 should have changed gloves before exiting the room. IP 2 further indicated EVS 1 should have performed hand hygiene and don new gloves upon reentry into the OR with the clean rag.

3. During an observation and concurrent interview with interim manager doheny (IMD) on 7/9/19, at 4:52 p.m., in operating room four, a wire rack lacked a solid surface on the bottom shelf where sterile instrument trays were stored. IMD acknowledged the bottom shelf should have a solid surface.

The facility policy and procedure titled "Sterile Supplies - Storage, Shelf Life, and Stock Rotation" dated 2/19, indicated "Sterile items stored on wire racks will be protected by a solid bottom or placed within plastic bins to protect from moisture during floor cleaning activities."

4. During an observation, and concurrent interview, with Director of Perioperative Services (DPOS) on 7/9/19 at 9:45 a.m., in the Doheny operating room corridor, ten culture tubes (used to collect bacteria from surgical sites for laboratory identification) had an expiration date of 5/19. DPOS acknowledged that the culture tubes were expired.

The facility policy and procedure titled "Sterile Supplies - Storage, Shelf Life, and Stock Rotation" dated 2/19, indicated "Outdated supplies are removed from stock and discarded as necessary."
VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to ensure an operative report was prepared immediately after surgery for one patient (Patient 203) who underwent neurosurgery (specialty surgical treatment that can affect any portion of the nervous system including the brain, spinal cord, peripheral nerves, and extra-cranial cerebrovascular system).

This failure had the potential to obscure clinical information relevant to the patient's immediate post-operative and future health care.

Findings:

During an observation of the 6th floor Neurosurgical Intensive Care Unit (patients brought directly from operating room for post-anesthesia recovery (PACU) by PACU nurse and once recovered a licensed nurse working on the unit takes over care of the patient) and concurrent interview with licensed nurse (LN 4) on 7/10/19 at 10:10 a.m., LN 4 confirmed being assigned to care for Patient 203 who was post-operative day 3 for a craniotomy (specialty surgical procedure where the neurosurgeon opens the skull to enable full access) performed on 7/8/19 to remove a [DIAGNOSES REDACTED] ([DIAGNOSES REDACTED] with fibers attaching it to the 3 outer layers covering the brain and bone).

During an interview with the Director of Nursing (DON 1) of the Intensive Care Unit and a concurrent record review of Patient 203's medical record on 7/10/19 at 11:10 a.m., DON 1 confirmed there was no operative report for neurosurgery performed on Patient 203 on 7/8/19 that concluded at 6:35 p.m. DON 1 further confirmed the same surgeon was scheduled to perform a surgery the afternoon of 7/10/19.

Record review of Patient 203's "Operative Report" (description of the surgery) dated 7/8/19, indicated that it was dictated by the surgeon and completed on 7/10/19 at 11:39 a.m.

The facility document titled "Medical Staff General Rules and Regulations" amended May 2018, indicated in part..."Rule 2 Medical Records...2.1 In and Outpatient Records...E. Operative or Interventional Procedure Report...2. An operative report must be dictated or written in the medical record immediately following the surgery...2.8 Deficient and Delinquent Medical Records:...An incomplete medical record will be considered delinquent under the following circumstances...B. Operative Report not dictated immediately following the procedure...If the record is delinquent, the Director of Health Information Management or designee will notify the practitioner that his/her privileges to...perform elective operations have been suspended...The practitioner shall remain suspended until the records have been completed. All appropriate hospital departments, including Admitting, Nursing and Administration shall be notified of this action...It shall be the responsibility of the Hospital President of the Medical Center and the President of the Medical Staff to report to the Medical Board of California any responsible medical practitioner whose privileges are restricted for a medical disciplinary cause, (eg, that aspect of a licentiate's professional conduct which is likely to be detrimental to patient safety or to the delivery of patient care..."
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
Based on interview and record review, the hospital failed to educate staff to manage a neonatal (newborn) resuscitation (the process of correcting a lack of breathing or heartbeat).

This failure had the potential to result in the death of a compromised newborn.

Findings:

According to the American Academy of Pediatrics (AAP) website: https://pediatrics.aappublications.org/content/124/4/1233, accessed on 07/18/19, "The majority of ill and injured children are brought to community hospital emergency departments (EDs) by virtue of their geography within communities ... It is imperative, therefore, that all hospital EDs have the appropriate resources (medications, equipment, policies, and education) and staff to provide effective emergency care ... resources necessary to ensure that hospital EDs stand ready to care for children of all ages, from neonates to adolescents."

Review of the employee file for licensed nurse (LN5) and concurrent interview on 07/10/19, starting at 9:45 A.M., the vice president of human resources (VPHR) was not able to find documentation of a neonatal resuscitation certificate for LN5 . The VPHR stated,"It is not required," on the unit competency or training. The vice president of patient care (CNE), indicated a neonate (newborn infant) could arrive in the ED and stated,"Then we would transfer."

During an interview on 07/10/19, at 1:45 P.M., an emergency room physician (MD1) stated he would, "Call RT (respiratory therapist)," if there was a neonatal resuscitation situation.

During an interview with emergency room physician assistant (PA1) on 07/10/19, at 1:55 P.M., PA1 indicated not trained in neonatal resuscitation.

During an interview with an emergency room physician (MD2) on 07/10/19, at 1:58 P.M., MD2 indicated not been trained in neonatal resuscitation.

During an observation and concurrent interview on 07/10/19, at 2 P.M., in the emergency department, a baby warmer (medical equipment used to maintain the temperature of newborn infants) contained supplies including a neonatal EKG (heart monitoring) lead. An emergency department director (DON1) indicated the neonatal EKG lead is not compatible (will not work) with the heart monitors available for use in the ED.

During an interview on 07/10/19, at 2:30 P.M., the DON1 stated, "No," when asked if the ED was prepared for a neonatal resuscitation.

During a phone interview on 07/10/19, at 2:33 P.M., a respiratory therapist (RT1) stated none of the RTs are certified in neonatal resuscitation.

The facility job description titled "Registered Nurse" emergency room /Department dated 04/30/19 indicated "Direct Patient Care ...Responds to emergency situations ...Age Specific Competencies ...Newborn (0-1 yr.) ..."

The facility job description titled "Charge Nurse" emergency room /Department, undated, indicated " ...Age Specific Competencies ...Newborn (0-1 yr.) ..."