Regional Medical Center of San Jose

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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

1. (a) Pregnant patients with a pregnancy beyond 20 weeks of gestation were continuously monitored [continuously monitored means continuous electronic fetal monitoring] per nationally recognized standards of practice.

(b) Pregnant patients with a pregnancy less than 20 weeks receive a fetal heart rate measurement to check on the fetal condition at the time of the Emergency Department (ED) visit.

This practice increased the risk of substandard care for all pregnant ED patients;

2. Expired supplies were removed and/or necessary supplies were stocked from the trauma room and OB (Obstetrics) room (Room 21) as required by hospital policy. The deficient practices had the potential to allow supplies with unknown sterility and delay necessary care to pregnant patients by not being ready for patient use;

3. Preventive maintenance on 1 of 4 sampled medical devices was performed as required by manufacturer instructions. The deficient practices had the potential to allow medical devices in unknown mechanical condition to be used on patients;

4. Timely triage and medical screening examinations (MSE) for two of 38 sampled patients (Patients 2 and 6) were conducted. This failure had the potential to cause untimely recognition of emergency medical conditions; and,

5. Pain management for Patient 16 was provided. This failure caused the patient having pain while receiving treatment in the ED.

Findings:

1. Review of the Guidelines for Perinatal Care 8th edition dated 2017, showed in part, ...Chapter 4. Maternal & Neonatal Inter-hospital transfer ...If the patient to be transported is pregnant, pretreatment evaluation needs to include the following: 1) Maternal vital signs 2) Fetal assessment by electronic fetal monitoring or Doppler, depending on the gestational age ...Maternal Patients. Uterine activity of maternal patients and fetal heart rates need to be monitored before and after transport ...Chapter 9. Medical & Obstetric complications ...Trauma during pregnancy ...most cases of trauma during pregnancy result from motor vehicle crashes. Other frequent causes of trauma during pregnancy are falls and direct assaults on the abdomen ...Fetal assessment. The use of electronic fetal cardiac and uterine activity monitoring in pregnant trauma patients at the time of fetal viability ( > 23-24 weeks gestation) may reveal a diagnosis of abruptio placentae (the placenta separates from the womb and may compromise the well-being of the fetus). Because abruption usually becomes apparent shortly after injury, monitoring should be initiated as soon as the woman is stabilized. The duration of fetal monitoring in the viable pregnancy ( > 23-24 weeks gestation) has been debated, with most experts recommending a minimum of 2-4 hours.

Review of the ACOG educational bulletin Obstetric aspects of trauma management dated September 1998, showed in part, ...Several series of fetal losses resulting from trauma indicate that more than 50% of fetal losses occur in association with seemingly minor or insignificant maternal trauma ...Fetal assessment. The use of electronic fetal cardiac and uterine activity monitoring in pregnant trauma victims beyond 20 weeks of gestation may be predictive of abruption placentae ...Because abruption usually becomes apparent shortly after injury, monitoring should be initiated as soon as the woman is stabilized. Recommended minimum time of post-trauma monitoring includes 4 hours and 2-6 hours ...monitoring should be continued (continuous fetal monitoring) and further evaluation carried out if uterine contractions, a non-reassuring fetal heart rate pattern, vaginal bleeding, significant uterine tenderness or irritability, serious maternal injury, or rupture of the amniotic membranes is present. If these findings are not present, the patient may be discharged or transferred ...Electronic fetal and uterine monitoring is an important component of management beyond mid-trimester trauma.

Review of the American College of Emergency Physicians article titled Trauma in the Obstetric patient: A bedside tool dated 2021, showed in part, ...A viable fetus should be promptly placed on continuous monitoring until under the care of an obstetrician. Institute monitoring for a viable fetus as soon as the mother's status allows, preferably in the emergency department ...continuous monitoring can be discontinued after 4 hours if there are no fetal heart rate abnormalities, uterine contractions, bleeding or uterine tenderness ...Fetal morbidity or mortality can occur in mothers without significant injury ...but should abruption placentae occur, it will do so generally by 24 hours. This can be effectively screened for by 4 hours of monitoring of the potentially viable fetus ...The viable fetus should be promptly placed on continuous monitoring until under the care of an obstetrician ...

Review of the medical record for Patient 23 was initiated on 8/24/21. The medical record showed Patient 23 came to the acute care hospital ED on 11/13/20 at 0213 hours.

The H&P for Patient 23 dated 11/13/20, showed Patient 23 stated she was five months pregnant and she stated she fell on e week prior to her arrival at the ED. She reported having abdominal cramping since she fell on e week ago. The OB ultrasound dated 11/13/20 at 0500 hours, showed Patient 23 was actually 11 weeks and one day pregnant. There was no documented evidence of the fetal heart rate measurement on the ultrasound report. The ED record showed no documented evidence of measurement of the fetal heart rate. Patient 23 was discharged on [DATE] at 0519 hours.

Review of the medical record for Patient 24 was initiated on 8/24/21. The medical record showed Patient 24 came to the acute care hospital ED on 11/24/20 at 1910 hours. The H&P for Patient 24 dated 11/24/20, showed Patient 24 was 15 weeks pregnant and she stated she fell at 1645 that day. She reported abdominal pain since the fall. The ED record showed no documented evidence of the fetal heart rate. Patient 24 was discharged on [DATE] at 2144 hours.

Review of the medical record for Patient 32 was initiated on 8/24/21. The medical record showed Patient 32 came to the acute care hospital ED on 1/11/21 at 0022 hours. The H&P for Patient 32 dated 1/11/21, showed Patient 32 was 36 weeks pregnant. She reported having intermittent pelvic pressure for three to four weeks and heart palpitations starting that evening which she believed were due to high blood pressure. The ED record showed no documented evidence of the fetal heart rate. Patient 32 was discharged on [DATE] at 0454 hours.

During an interview with the Vice President of Quality (VPQ) on 8/25/21 at 0950 hours, she stated, We don't do fetal monitoring, so there is no policy for fetal heart monitoring. She also stated, We don't have fetal heart rate monitors, so no policy.

2. During a tour of the designated room for pregnant patients, on 8/23/21 at 12:30 p.m., the following supplies were expired:

a. one suture (3-0) Ethicon perma-hand silk, expired 1/31/2002;

b. four vicryl suture;

c. 18 chromic gut suture;

d. three dozen Ethicon 3-0 vicryl;

e. one pediatric central line central venous catheter set triple lumen 5.0 French, expired 6/15/21;

f. one fetal spiral electrode attachment pad (large), expired 3/31/21;

g. one Kendall 1052 NPSM neonatal electrode, expired 2/28/19;

h. one sterile Aquasonic 100 ultrasound transmission gel, expired 1/2021;

i. one Argyle phototherapy eye protector, expired 3/6/21;

j. three 501- care safety blood collection needle 23 gauge + inches X 12 inches, expired 2/8/21; and,

k. one Kiwi palm pump for vacuum assisted delivery. Contents: One Kiwi cup with palm pump, expired 5/29/21.

During a concurrent interview with the emergency department supervisor (EDS), on 8/23/21 at 12:30 p.m., she acknowledged the findings.

During observation and concurrent interview on 8/23/21 at 12:28 p.m., the EDS confirmed the following items in the Neonatal Resuscitation Cart were expired:

a. Neo-StatCO2 below Kg End Tidal CO2 Detector, expired 2/17/2021;

b. two sodium chloride vials, expired 9/1/2020;

c. central Venous Catheter set, expired 6/15/2021;

d. benzoin tincture swabstick, expired 1/20/20;

e. aterial blood gas (ABG) kit, expired 1/31/21;

f. ABG kit, expired 3/21/21; and

g. two stopcocks, expired 3/31/21.

During observation and concurrent interview on 8/23/21 at 12:28 p.m., the EDS confirmed the following items were missing from the Neonatal Resuscitation Cart:

a. laryngoscope handle

b. two umbilical vessel catheter (UVC) cath 5 French (Fr)

c. stopcock

d. two butterfly needles

e. intravenous support board

f. eleven (11) Maxplus minibore extensions sets

g. five heel warmers.

During observation and concurrent interview on 8/23/21at 1:10 p.m., the EDS confirmed the following items in the Massive Transfusion Cart were expired:

a. 0.9% sodium chloride 100 milliliters (ml), expired 6/2021;

b. 0.9% sodium chloride 100 ml expired 7/2021;

c. two bags of lactated ringers 1000 ml, expired 1/2021;

d. two lab tubes with pink top, expired 8/7/21;

e. Bakari postpartum balloon, expired 6/29/21;

f. multi lumen central venous catheterization kit, expired 5/31/21; and

g. level 1 normothermic IV fluid administration set expired 8/22/21.

During observation and concurrent interview on 8/23/21 at 1:10 p.m., the EDS confirmed the following items were missing from the Massive Transfusion Cart:

a. Consents

b. 10 blunt needles

c. small Richardson retractor

d. Deaver retractor

e. two Allis clamps (single)

f. two Allis clamps (double)

g. two bivalve speculums

h. Army Navy retractor

i. Kelly Clamps (two pack)

j. Metzbaum scissors

k. needleholder (seven inches)

l. blood warming tubing

m. five-in-one connector

n. foley catheter 16 French

o. arterial /CVP line supplies

p. radial Artery Cath set

q. TruWave 3cc/60in (150cm) Pressure Monitor set

r. Bair Hugger blanket

s. blood Component Recipient set with standard blood filter and luer adapter 170-260 micron filter 1.4m (55').

During an ED observation with the ED manager (EDM) on 8/23/21 at 1:20 p.m., the following trauma emergency supplies were expired:

a. perivac kit expired 06/19/21;

b. sodium chloride 100 milliliters expired 05/21;

c. arterial line catheter expired 8/15/20;

d. cesarean section (CS) cut down tray expired on [DATE];

e. introducer sheath expired on [DATE];

f. 20 centimeter distal flexibility with softened tip expired on [DATE];

g. starter guide wire expired on [DATE];

h. arterial line catheter expired 3/15/20;

i. one box of pneumothorax kit expired on [DATE]; and,

j. peritoneal lavage kit expired on [DATE].

During a concurrent interview with the EDM he confirmed the trauma emergency supplies were expired and the supplies should have been removed from the cabinet.

In an observation and interview on 8/23/21 at 12:34 p.m. in Trauma Room 1, the supply cabinet contained a tracheostomy tray (a tray of supplies used to create an opening in the neck for patients to breathe through in an emergency) labeled with an expiration date of 3/31/21. The EDM acknowledged the expiration date had passed. The suture rack (rack containing needles and threads used to stitch wounds closed) contained a 2-0 (size) Perma-Hand (brand name) silk suture with a manufacturer's label indicating the suture had expired on [DATE]. The EDM acknowledged the suture was past the manufacturer's expiration date.

Review of hospital policy FAC-1658: Managing Products with Expiration Dates (revised 5/3/19) indicated, All expired merchandise (including intravenous solutions, kits with pharmaceuticals, other various medical devices, etc.) that is no longer saleable must be identified and expeditiously removed physically (to quarantine) and systematically from the warehouse/storeroom/pharmacy/POU [point of use] area...

3. In an observation on 8/23/21 at 12:34 p.m. in Trauma Room 1, the Glidescope (brand of video laryngoscope, a device used to insert breathing tubes in patients) did not have decals affixed indicating the device had received preventive maintenance.

In a concurrent interview and record review on 8/23/21 at 1:46 p.m., the Vice President of Quality (VPQ) stated the Glidescope was in a category of medical device which the hospital inventoried and repaired as needed, but which did not receive routine preventive maintenance. The VPQ presented the surveyor a service report dated 8/23/21 which indicated the Glidescope had failed on 11/23/20 due to a flickering screen. On 12/1/20, the problem was found to be a chipped camera lens, which was repaired by replacing the video baton (a fiberoptic tube with a camera). No documentation was presented indicating the Glidescope had received routine preventive maintenance.

Review of the undated GlideScope Cobalt AVL System [make and model of video laryngoscope] User's Manual indicated, Periodic inspections should be performed to ensure safe and effective operation. It is recommended that a qualified technician perform a full visual inspection of all components at least every three months. The technician should check for the following items: - External damage - Damage to the power supply - Connectors and cable insulation integrity To ensure patient safety, users should perform a routine inspection of the GlideScope Cobalt AVL video baton before every use to ensure that all endoscopic components are free of unintended rough surfaces, sharp edges, protrusions or cracks.

4. Review of Patient 2's medical record indicated she arrived in the hospital ED on 1/1/21 at 2:52 p.m. Patient 2's MSE began at 3:06 p.m., 14 minutes after her arrival. Patient 2 was seen by the triage nurse at 3:10 p.m.

During an interview on 8/24/21 at 1:40 p.m., the Emergency Department Manager (EDM) stated Patient 2's triage and MSE happened 14 minutes after the arrival time.

Review of Patient 6's medical record indicated he arrived in the hospital's emergency department (ED) on 4/1/21 at 10:14 a.m. Patient 6's MSE began at 10:28 a.m., 14 minutes after his arrival. Patient 6 was seen by a triage nurse at 10:30 a.m.

During an interview on 8/24/21 at 1:29 p.m., EDM confirmed Patient 6's MSE and triage was delayed. The EDM stated under the current policy, triage should be done within 10 minutes.

Review of the hospital's policy, TRIAGE IN THE EMERGENCY DEPARTMENT, reviewed 6/20/12, indicated rapid assessment, the dynamic process of sorting, prioritizing and assessing the patient will be done within 10 minutes of arrival.

5. Review of Patient 16's Emergency Provider Report, dated 7/1/21, indicated Patient 16 presented to the ED for constant, moderate left hand swelling and pain. Patient 16 felt dizzy and had a headache, causing him to fall. Patient 16 hit his head on the floor and had a laceration and bruising on his left hand.

Review of Patient 16's Rapid Initial Assessment on 7/1/21 at 5:15 p.m., Patient 16 rated his pain as 5, using the numeric pain scale (0 means no pain and 10 means worst pain).

Review of Patient 16's Pain Assessment/Reassessment on 7/1/21 at 8:40 p.m., Patient 16 rated his head pain as 6.

Review of Patient 16's left hand X-ray results, on 7/1/21 at 8:28 p.m. indicated, Fracture at the base of the left first metacarpal [long bone of the hand]. Suspect fracture at the base of the second metacarpal.

Review of Patient 16's Disposition Decision indicated Patient 16 would be admitted to the hospital.

Review of Patient 16's Departure Information indicated Patient 16 departure date/time was 7/1/21 at 9:39 p.m.

During an interview on 8/24/21 at 1:30 p.m., the emergency department manager (EDM) stated patients should get pain medication in the ED if the physician orders pain medication.

During an interview on 8/24/21 at 1:45 p.m., the EDM stated pain medications were not ordered for Patient 16 until the time of admission to the hospital.

There was no documentation in Patient 16's Emergency Patient Record that indicated he was given or offered pain medication in the ED. During an interview on 8/24/21 at 3:20 p.m., the EDM confirmed there were no nursing notes that indicated Patient 16 was offered pain medication.

Review of the hospital's policy, PAIN MANAGEMENT, ASSESSMENT AND REASSESSMENT, indicated patients have the right to effective pain management, a treatment plan will be developed for any patient experiencing pain, and providers will order pain management interventions to address parameters for mild, moderate, and severe levels of pain.

Based on observation, interview, and record review, the hospital failed to comply with the Emergency Medical Treatment and Active Labor Act (EMTALA) requirements as evidenced by:

1. Failure to triage patients in a timely manner (refer to A2406).

2. Failure to provide necessary stabilizing treatment for emergency medical conditions (refer to A2407).

3. Failure to document a physician certification enumerating and weighing expected medical benefits and risks of the transfer (refer to A2409).

Based on observation and interview, the hospital failed to post signs regarding patient rights under EMTALA (the Emergency Medical Treatment and Labor Act) in four of nine sampled emergency department (ED) treatment rooms (rooms 13, 14, 24, and 25). In one of three sampled ED patient areas other than treatment rooms (the vertical treatment area or VTA, an area where patients sit in recliners instead of lying on gurneys), the posted sign failed to specify whether the hospital participates in Medicaid. The deficient practices had the potential to cause patients to be unaware of their rights under EMTALA.

Findings:

In observations and interviews during the ED tour on 7/19/21 from 12:47 p.m. to 1:58 p.m., the sign posted in the VTA regarding patient rights under EMTALA did not disclose whether the hospital participates in Medicaid. The Director of Emergency Services (DES) stated there was no EMTALA sign in the VTA, and the posting viewed by the surveyor was an insurance sign. ED treatment rooms 13 and 14 did not contain signs regarding the rights of patients under EMTALA. The DES stated not all ED treatment rooms have the EMTALA sign. ED treatment rooms 24 and 25 did not contain signs regarding the rights of patients under EMTALA. Both rooms had a blank frame mounted on the wall with remnants of tape at each corner of the frame. The DES acknowledged there was no EMTALA sign in room 24 and commented that one could see the stickers where the sign was. The DES stated room 25 was the same.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to consistently provide on-call coverage for the emergency department (ED) commensurate with services available at the hospital. The hospital had ten members (Providers 1 through 10) of its medical staff in obstetrics and gynecology (OB/GYN), nine of which (Providers 1 through 8, and 10) provided routine services at the hospital. Yet the on call schedule for the ED offered OB/GYN coverage only for trauma patients, and a reference sheet regarding the scope of the hospital's services for emergency transfers indicated OB/GYN was not provided. Two of 20 sampled patients (Patients 2 and 7) did receive non-trauma OB/GYN on-call coverage in the ED and one of 20 sampled patients (Patient 1) did not.

Findings:

Review of Patient 1's medical record indicated she was seen at the ED on 7/5/21 complaining of a fever, bleeding, and pain following a hysterectomy (removal of the uterus) at Hospital C on 6/19/21. The EMERGENCY PROVIDER REPORT dated 7/5/21 indicated, I discussed the case with the patient's surgeon [Physician B] who felt that the patient should be treated here at Regional Medical Center however we do not have gyn service on-call. I discussed with our CMO [chief medical officer]... who states that the patient should be transferred ER [emergency room ] to ER to [Hospital C] where the patient had the initial surgery for this post op [post-operative] complication. This would be for higher level of care for Gyn services.

Review of the physician on-call schedules provided by the hospital indicated the schedules for the OB/GYN service for January 2021 through July 2021 were labeled OB/GYN - TRAUMA ONLY. No on-call schedule for non-trauma OB/GYN was provided.

Review of the Regional Medical Center Reference List (revised 4/14/21) indicated the document delineated dispositions for various types of patients being considered for transfer in to the hospital. The document indicated OB/GYN was not offered on an on-call basis and that such patients could be declined without escalating to the administrator on call since the service was not offered.

Review of the hospital's undated medical staff roster indicated there were ten members of the medical staff specializing in OB/GYN (Providers 1 through 10), and that Physician B was not a member of the medical staff at the hospital.

In an interview on 7/20/21 at 12:04 p.m., the Director of Medical Staff (DMS) stated the OB service had been closed in April, 2020 and the case volumes of the OB/GYN medical staff had been nil since then. The DMS stated the call schedule for the emergency room was maintained because of trauma. The DMS stated Provider 9 had ambulatory status on the medical staff, which was a status pertaining to clinic physicians who do not come to the hospital.

In an interview on 7/20/21 at 12:26 p.m., the Quality Director of Clinical Excellence (QDCE) stated the OB service at the hospital was closed on March 30, 2020 because it was not financially viable due to too few patients. She stated the perinatal unit was taken off the hospital's license on 6/11/21.

Review of a letter from the California Department of Public Health to the QDCE dated 6/8/20 indicated the Neonatal Intensive Care Unit and the perinatal unit were removed from the hospital license effective 5/30/20.

Review of Provider 1's credentials file indicated she was an active member of the medical staff, specialty OB/GYN, last reappointed on 7/1/21 for a two-year term. Provider 1's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies (removal of the uterus through the vagina or the abdominal wall), laparascopically assisted vaginal hysterectomy (LAVH, using a fiber-optic tube for part of the surgery), and total laparascopic hysterectomy (TLH, using fiber-optic tubes rather than traditional incisions for the surgery). Provider 1's case log for dates of service June 2020 to June 2021 indicated she had performed 5 surgeries and admitted 8 inpatients at the hospital during the time period covered by the report.

Review of Provider 2's credentials file indicated he was an active member of the medical staff, specialty OB/GYN, last reappointed on 7/28/20 for a term expiring on 6/30/22. Provider 2's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies, LAVH, and TLH. Provider 2's case log for dates of service June 2020 to June 2021 indicated he had performed 29 surgeries and admitted 4 inpatients at the hospital during the time period covered by the report.

Review of Provider 3's credentials file indicated he was an active member of the medical staff, specialty OB/GYN, last reappointed on 1/26/21 for a term expiring on 12/31/22. Provider 3's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies. Provider 3's case log for dates of service June 2020 to June 2021 indicated he had performed 11 surgeries and admitted 1 inpatient at the hospital during the time period covered by the report.

Review of Provider 4's credentials file indicated she was an active member of the medical staff, specialty OB/GYN, last reappointed on 6/23/20 for a term expiring on 5/31/22. Provider 3's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies. Provider 4's case log for dates of service June 2020 to June 2021 indicated she had performed 11 surgeries at the hospital during the time period covered by the report.

Review of Provider 5's credentials file indicated he was an active member of the medical staff, specialty OB/GYN, last reappointed on 11/7/19 for a term expiring on 10/31/21. Provider 5's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies, and LAVH. Provider 5's case log for dates of service June 2020 to June 2021 indicated he had performed 2 surgeries and admitted 15 inpatients at the hospital during the time period covered by the report.

Review of Provider 6's credentials file indicated she was an active member of the medical staff, specialty OB/GYN, last reappointed on 4/1/21 for a two year term. Provider 6's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies. Provider 6's case log for dates of service June 2020 to June 2021 indicated she had not performed any surgeries or admitted any inpatients at the hospital during the time period covered by the report.

Review of Provider 7's credentials file indicated she was an active member of the medical staff, specialty OB/GYN, last reappointed on 5/1/21 for a two year term. Provider 7's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies, LAVH, and TLH. Provider 7's case log for dates of service June 2020 to June 2021 indicated he had performed 11 surgeries and admitted 6 inpatients at the hospital during the time period covered by the report.

Review of Provider 8's credentials file indicated he was an active member of the medical staff, specialty OB/GYN, last reappointed on 2/25/20 for a term expiring on 1/31/22. Provider 8's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies. Provider 8's case log for dates of service June 2020 to June 2021 indicated he had performed 6 surgeries at the hospital during the time period covered by the report.

Review of Provider 9's credentials file indicated she was a member of the medical staff in the ambulatory (outpatient) category, specialty OB/GYN, last reappointed on 1/16/20 for a term expiring on 11/30/21. Provider 9's credentials file indicated she did not have privileges at the hospital.

Review of Provider 10's credentials file indicated he was a courtesy member of the medical staff, specialty OB/GYN, last reappointed on 6/1/21 for a two year term. Provider 10's privileges included (among others) inpatient admitting and attending, core procedural privileges, vaginal and abdominal hysterectomies. Provider 10's case log for dates of service June 2020 to June 2021 indicated he had performed 7 surgeries and admitted 2 inpatients at the hospital during the time period covered by the report.

In an interview on 7/20/21 at 12:42 p.m., the DMS stated OBs were called in to the ED, not only for trauma patients. He stated the OB/GYNs on the medical staff were still doing hysterectomies at the hospital.

Review of Patient 2's medical record indicated she was seen at the ED on 1/26/21. The EMERGENCY PROVIDER REPORT dated 1/26/21 indicated, SHE WAS SENT HERE BY HER OB/GYN TO RULE OUT MISCARRIAGE VERSUS [DIAGNOSES REDACTED]. (In an [DIAGNOSES REDACTED], the embryo attaches outside the uterus. The fetus usually cannot survive, and [DIAGNOSES REDACTED] can cause severe bleeding in the mother.) The provider note did not indicate Patient 2 had any traumatic injuries. The provider note indicated the ED provider consulted Provider 3, an OB/GYN on the hospital's medical staff.

Review of Patient 7's medical record indicated she was seen at the ED on 6/9/21. The EMERGENCY PROVIDER REPORT dated 6/9/21 indicated ...Ob was consulted. Advised to initiate therapy for potential pre term labor... The provider report did not indicate Patient 7 had any traumatic injuries. The provider note indicated the ED provider consulted Provider 1, an OB/GYN on the hospital's medical staff.

In an interview on 7/21/21 at 10:57 a.m., the surveyor asked the QDCE to explain the inconsistent interviews and record reviews regarding OB/GYN on call coverage. The QDCE replied that to her knowledge, OB/GYN on call coverage was only for trauma, but she would have the chief medical officer (CMO) address the question.

In an interview on 7/21/21 at 11:23 a.m., the CMO stated OB provided trauma call for any pregnant trauma patient. She stated the labor & delivery unit at the hospital was closed on 5/3/20. Initially, the OB service supported any pregnant patient, but now on-call OB is only for OB trauma. The CMO stated the hospital has OB/GYNs on its medical staff, who bring patients to the hospital to have surgical procedures, and those patients may be admitted , but the OB/GYNs do not take calls. Regarding Patient 1, the CMO stated anyone who operates cares for their own patients for the first 30 days after surgery. The CMO acknowledged Patient 1's surgeon, Physician B, was not on the medical staff at the hospital, and stated Physician B would not have seen the patient, so the hospital would triage and transfer such a patient. The CMO stated the physicians who had covered the labor and delivery unit had resigned, and the remaining members of the medical staff did not provide consultations on inpatients. When the surveyor asked why Patients 2 and 7, who were not trauma patients, had OB consults while they were in the ED, the CMO replied that OB helps the ED out of courtesy, but they are not on call.

Based on interview and record review, the hospital failed to perform timely triage and medical screening examinations (MSE) for one of 20 sampled patients (Patients 11). This failure had the potential to cause untimely recognition of emergency medical conditions.

Findings:

Review of Patient 11's medical record indicated he arrived in the hospital's emergency department (ED) on 5/29/21 at 1:45 p.m. Patient 11 was seen by a triage nurse 20 minutes later at 2:05 p.m. Patient 11's MSE began at 2:08 p.m., 23 minutes after his arrival.

During an interview on 7/21/21 at 3:19 p.m., the emergency department manager (EDM) confirmed Patient 11's triage and MSE were delayed.

Review of the hospital's policy, TRIAGE IN THE EMERGENCY DEPARTMENT, reviewed 6/20/12 indicated rapid assessment, the dynamic process of sorting, prioritizing and assessing the patient will be done within 10 minutes of arrival.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview record review, the hospital failed to provide necessary stabilizing treatment for emergency medical conditions, for two of 20 patients (Patients 6 and 9), before they were transferred to other hospitals due to their insurance reasons. This failure had the potential to delay necessary treatment of patients with emergency medical conditions.

Findings:

1. Review of Patient 6's Emergency Provider Report, dated 5/31/21 at 11:22 a.m., indicated the patient was a [AGE]-year-old female, with history of hypertension (HTN, high blood pressure) and diabetes (a metabolic disease that causes high blood sugar), and transferred from another hospital (Hospital A) for high level of care for stroke (a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off resulting in injury to the brain due to absence of blood flow and oxygen). It indicated the patient woke up at 8:20 a.m. on that day when she felt sudden onset of sharp headache with associated right arm and right leg weakness. At Hospital A, the computerized tomography (CT, a medical imaging technique used in radiology to get detailed images of the body noninvasively for diagnostic purposes) reading showed left superior (situated upper) cerebellar (relating to the part of the brain at the back of the skull in vertebrates, which coordinates and regulates muscular activity) hemorrhage (an escape of blood from a ruptured blood vessel) and the computed tomography angiography (CTA, a type of medical test that combines a CT scan with an injection of a special dye to produce pictures of blood vessels and tissues in a part of the body) result showed questionable occlusion in right posterior (back in position) inferior (lower) cerebral (of or relating to the brain) artery (blood vessels that deliver oxygen-rich blood from the heart to the tissues of the body).

On the same report, Review of Systems (ROS) indicated the patient showed right arm weakness and the physical exam indicated the patient had mild weakness to right upper extremity. Review of the CT result, dated 5/31/21 at 11:46 a.m., indicated the impression was mild chronic changes without acute intracranial (within the skull) hemorrhage. ED course indicated the patient received medications including Aspirin 325 mg (blood thinner) by mouth and Levetiracetam (anticonvulsant) IV (intravenously), and laboratory tests and electrocardiogram (ECG,a test for electrical activity of the heart) check were performed.

Review of Free Text MDM (Medical Decision Making) Notes indicated the patient presented with symptoms concerning for acute CVA [stroke] versus TIA [transient ischemic attack or also called mini stroke, a temporary disruption in the blood supply to part of the brain]. It indicated the ED (emergency department) provider discussed the patient care with a neurointerventional radiologist and the patient was deemed to not be an interventional candidate. It indicated the patient's insurance as with [Hospital B] and case was discussed with [Hospital B] transferring facility who will accept the patient at this time. It further indicated the primary impression was CVA and the secondary impressions were left leg weakness, numbness and tingling of right arm, and right arm weakness. It indicated Transfer Reason was insurance.

Review of Patient 6's EMTALA MEMORANDUM OF TRANSFER, dated 5/31/21 at 6:31 p.m., indicated the diagnosis for the transfer was TIA, the reason for transfer was Medically Indicated, and the question if the Patient Requested was unmarked. Under the section of RISKS AND BENEFITS FOR TRANSFER, for medical benefits, the physician marked as the transfer was to Obtain level of care/service unavailable at this facility and the service was Neurology.

During an interview on 7/21/21 on 11:25 a.m., the chief medical officer (CMO) stated Patient 6 was transferred when the patient was stable. She stated when the patient has Hospital B's insurance, Hospital B requests to transfer the patient to its hospital. She reviewed Patient 6's Emergency Provider Report and stated there was no document Hospital B or the patient requested the transfer. CMS stated if the patient did not have Hospital B's insurance, there was no reason to transfer the patient to Hospital B because the hospital could provide high level of neurology services.

Review of the UpToDate (an online medical reference) article, Initial evaluation and management of transient ischemic attack and minor ischemic stroke, updated 4/30/21, indicated TIA is a neurologic emergency because patients with a time-based TIA (i.e., symptoms lasting less than 24 hours) or minor, nondisabling ischemic stroke are at increased risk of recurrent and potentially disabling ischemic stroke, especially in the days following the index event. Accumulating evidence suggests that immediate intervention after a TIA or minor, nondisabling ischemic stroke can reduce the risk of recurrent stroke compared with delayed intervention. For patients who present with TIA or minor ischemic stroke, implementation of appropriate diagnostic evaluation and stroke prevention treatment should proceed without delay, preferably within one day of the ischemic event. Urgent evaluation of suspected TIA and minor, nondisabling ischemic stroke is necessary for confirming the diagnosis of TIA or ischemic stroke, excluding stroke mimics, and determining the ischemic mechanism, which has important implications for directing targeted treatment for secondary stroke prevention. The evaluation includes urgent brain imaging, vascular imaging, a cardiac evaluation, and laboratory testing (algorithm 2). The evaluation proceeds in tandem with initiation of antiplatelet therapy; both should be implemented without delay, preferably within one day of the ischemic event.

2. Review of Patient 9's Emergency Provider Report, dated 7/10/21 indicated Patient 9 was a [AGE] year old female with a history of HTN, diabetes, and congestive heart failure (CHF, condition when the heart cannot pump blood efficiently). Patient 9 presented with shortness of breath (SOB) after running out of lasix [medication to treat extra fluid in body] 5 days ago. The CT reading showed interval development of small right pleural effusion [buildup of fluid between lungs and chest wall] since 6/27/21 and interval development of small ascites [buildup of fluid in the abdomen] and body wall edema [swelling caused by excess fluid] since the prior exam of 6/27/21. Patient 9's clinical impression (problem) was CHF exacerbation.

Review of the Free Text MDM Notes indicated Patient 9's symptoms improved after lasix. Patient 9 was discharged in stable condition and given a prescription of lasix.

Review of Patient 9's Emergency Provider Report, dated 7/12/21 indicated Patient 9 presented with constant, moderate SOB, vomiting and intermittent cough with phlegm. Patient 9 has not been able to take lasix for her CHF because she is having trouble filling her prescription. An X-ray reading showed mild vascular congestion, possibly positional in etiology.

Review of Patient 9's Free Text MDM Notes indicated, She [Patient 9] has been out of her Lasix for a couple weeks. Patient was given Lasix... We did ambulate the patient without oxygen. It was noted that her oxygen level did stay above 95% however her heart rate quickly became tachycardic [fast heart rate]. She reported subjective shortness of breath at this time. Given her continued symptoms and her vital sign abnormalities I do believe that she requires admission for further IV [intravenous] Lasix and evaluation. Patient ... will be transferred to [Hospital D]. There was no documentation that indicated the reason Patient 9 was not admitted to this hospital.

Review of Patient 9's EMTALA MEMORANDUM OF TRANSFER, dated 7/12/21 indicated the diagnosis for the transfer was CHF exacerbation, the reason for tranfer was Medically Indicated. Under the section RISKS AND BENEFITS FOR TRANSFER, for medical benefits, the physician marked the transfer was to obtain level of care/service unavailable at this facility. The area to indicate which service was unavailable was left blank.

During an interview on 7/21/21 at 11:35 a.m., the CMO stated the hospital was able to treat a patient with congestive heart failure.

During an interview on 7/21/21 at 3:25 p.m., the Director of Emergency Services (DES) stated if a provider determines a patient needs to be admitted , they look at the patient's insurance and let the unit clerk know. Then they notify the hospital under the patient's insurance and initiate transfer.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure one of 20 patients' (Patient 1) medical records contained a physician certification (a documentation indicating that a physician certifies the expected medical benefits of the transfer outweigh the increased risks that results from being transferred) or document specifying the expected benefits of the transfer and risks associated with the transfer. This failure had a potential to deprive patients of information necessary to make informed decisions about their treatment and transfer and could cause an unnecessary transfer with unspecified reasons of the transfer.

Findings:

Review of Patient 1's Emergency Provider Report, dated 7/5/21, indicated the patient was a [AGE]-year-old female, with past history of hysterectomy (surgery to remove a woman's uterus [the place where a baby grows when a woman is pregnant]) on 6/19/2 in Hospital C, and presented to the ED (emergency department) complaining of bleeding from the post-op (postoperative) site on the abdomen and associated abdominal pain.

On the same report, Review of Free Text MDM (Medical Decision Making) Notes indicated at 2:58 p.m., Physician A re-evaluated Patient 1 and some pus was also expressed from the wound. Physician A discussed Patient 1's care with Patient 1's surgeon in Hospital C, who felt that the patient should be treated here at [the hospital name] however we do not have gyn [gynecology, the branch of physiology and medicine which deals with the functions and diseases specific to women and girls, especially those affecting the reproductive system] service on-call. It indicated Physician A discussed with the chief medical officer (CMO) and the CMO stated the patient should be transferred to Hospital C where the patient had the initial surgery for the post-op complication and this would be for higher level of care for Gyn services. At 5:30 p.m. Physician A discussed the case with a doctor who accepted the patient in transfer to Hospital C for higher level of care for gynecology services. There was no documentation regarding the expected medical benefits and risks associated with transfer and/or whether the benefits outweighed the risks.

Review of Patient 1's Emergency Patient Record, dated 7/5/21, indicated at 7:10 p.m. Patient 1 was transferred to Hospital C. There was no physician certification indicating the physician certified that the expected benefits of the transfer outweighed the risks.

Review of the hospital's Memorandum of Transfer, a transfer form utilized in the hospital, indicated the form certified the risk and benefits of the transfer, verification of health records being sent, accepting physician, and certification whether the patient was in stable condition.

During an interview on 7/19/21 at 2:10 p.m., Quality Director of Clinical Excellence (QDCE) stated when a patient is transferred to another hospital, the physician has to fill the form, Memorandum of Transfer. She reviewed Patient 1's medical records and stated Patient 1's record did not contain Memorandum of Transfer form.

Review of the hospital's policy, EMTALA-CALIFORNIA TRANSFER POLICY, dated 11/2016, indicated any transfer of an individual with an emergency medical condition must be initiated either by a written request for transfer from the individual or the legally responsible person acting on the individual's behalf, or by a physician order with the appropriate physician certification as required under EMTALA. It indicated a physician must sign an express written certification that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual. The certification should meet the following requirements: 1) The certification must state the reason for transfer. The narrative rationale need not be a lengthy discussion of the individual's medical condition as this can be found in the medical record but should be specific to the condition of the patient upon transfer. 2) The certification must contain a complete picture of the benefits to be expected from appropriate care at the receiving facility and the risks associated with the transfer, including the time away from an acute care setting necessary to effect the transfer. 3) The date and time of the physician certification should closely match the date and time of the transfer. 4) Certifications may not be backdated. It further indicated a Memorandum of Transfer must be completed for every patient who is transferred to anther separately licensed hospital. A copy of the Memorandum of Transfer shall be retained by the transferring hospital and incorporated into the patient's medical record.

Review of the hospital's policy,EMERGENCY DEPARTMENT PATIENT TRANSFER PROCESS, dated 4/9/31, indicated the physician completes the Physician Section of the Memorandum of Transfer (MOT) form after reviewing all ordered tests and treatments and stabilizing the patient and certifies the patient status for transfer by signing the certification. The primary care nurse completes the nursing section of the MOT form.

Based on interview and record review, the hospital failed to ensure an ongoing quality improvement (QI) program with measurable outcomes were implemented to identify and reduce a recurrence of the delay of administration of STAT (to be administered immediately) medications. This failure could lead to unmonitored incidents of delayed STAT medication administration.

Findings:

During an interview with the Director of Clinical Outcomes (DCO) on 6/8/17 at 8:25 a.m., she stated the immediate change implemented by the hospital was the revision of the computerized method of ordering bolus and drip medications. The DCO stated there are now screen locks that ask for dosage of the medication prior to the processing of the order. When asked if there were any QI monitoring or tracking for the administration of STAT medications in the emergency department or intensive care units since this adverse event occurred, she replied there were none.

Review of the hospital's Medication Administration policy dated 6/28/16 indicated a new entry which read, Medication ordered as STAT NOW shall be administered to the patient within 30 minutes of the order entry and prior to transfer to receiving unit. This entry, according to the DCO, is set to go for approval by the Medical Executive Committee by the end of this month, June 2017, prior to its full implementation.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record and document review, the hospital failed to administer medications as ordered when two STAT (a directive to medical personnel during an emergency, which means immediately or instantly) medications for Patient 1 were not administered immediately or within 30 minutes as stipulated per hospital policy and procedure. Patient 1's heparin (an anticoagulant; a blood thinner to prevent blood clots) was given 4 hours 7 minutes after ordered, and his valproate sodium (a medication to prevent seizure) was given 2 hours 25 minutes after ordered. This failure may have contributed to a rapid decline in Patient 1's health status and may have resulted in significant physical impairment.

Findings:

Patient 1 was a [AGE] year old male brought in by ambulance with a cervical collar (neck brace, a medical device used to support a person's neck) to the hospital's emergency department (ED) on 3/22/17 at 7:03 a.m. with neck pain after sustaining a fall at home. According to the physical examination record documented by Physician 1 on 3/22/17, Patient 1 arrived at the ED awake, alert, and oriented with no motor or sensory deficits.

The consultation report by Physician 2 on 3/22/17 indicated Patient 1 had a history of [DIAGNOSES REDACTED] (tumor that develops in the cells of the membrane that surrounds the brain and spinal cord) and the tumor was surgically removed in 2003. He was placed on Dilantin (medication to control seizure) for more than 9 years, and was discontinued for the last 5 to 6 years.

Patient 1's medical record, dated 3/22/17, revealed shortly after his arrival at the ED, he was taken to the radiology department for an initial computed tomography (CT) scan (a series of X-ray images taken from different angles using computer processing to create cross-sectional images of the bones, blood vessels, and soft tissues inside one's body) of the head and cervical spine to determine the extent of the injury and to determine whether surgery was needed.

Physician 2's Consultation Report, dated 3/22/17, indicated the CT scan showed evidence of the fracture of the 7th cervical vertebrae (C7; a spinal segment located near the base of the neck), and the CT angiogram (a CT imaging test that looks at the arteries and tissues in various parts of the body) showed an injury to the vertebral artery [a major blood vessel of the neck] with potential clot in the vertebral artery as well.

The physical examination in Physician 2's Consultation Report showed Patient 1 was alert and oriented x 3 [a person's awareness of three dimensions: person, time, and place]. Speech is fluent, and [N]eurologically, [Patient 1] has no focal deficit. His fracture is generally considered stable. I will keep him in a cervical collar for now; however, I am more concerned about his vertebral artery injury. If this truly has a clot, he may need to be anticoagulated. I recommend we get IR involved. [Patient name] needs to have better imaging study like an MRI scan of his head just to make sure there is no sort of contusions or injury to his brain that would preclude him from having anticoagulation therapy...

The CT angiogram results on the diagnostic imaging report, dated 3/22/17 at 9:45 a.m., revealed evidence of left vertebral artery dissection (a tear of the inner wall or lining of the vertebral artery) in addition to the C7 fracture.

During an interview on 6/6/17 at 12:50 p.m., Physician 1 said he was the physician who examined Patient 1 when he first arrived to the ED. He said Patient 1 came in as trauma activation due to the injury sustained at home. He said he did not recall any neurological findings; the patient was alert and oriented. The CT scans showed fracture of the neck and a report of vascular injury, so Neuro Interventional Radiology (IR - department specializing in minimally invasive image-based technologies and procedures used in diagnosis and treatment of diseases of the head, neck, and spine) was consulted.

During an interview on 6/6/17 starting at 10:25 a.m., physician's assistant (PA) 1 said she was working in the Neuro IR when she was contacted to consult on Patient 1 in the ED around noon on 3/22/17. Patient 1 had a fall at home after a seizure and was identified to have a fracture of the cervical vertebrae. She said Patient 1 had a history of a brain lesion removed in the past, therefore a brain MRI (a non-invasive imaging technology that produces three dimensional detailed anatomical images without the use of damaging radiation) was ordered. After the MRI results showed no evidence of bleeding, and after consulting with the Neuro IR attending physician and the neurosurgeon, the decision was to put Patient 1 on heparin. PA 1 said she placed the orders for a STAT heparin bolus dose and the heparin infusion (a maintenance dose to be given over time) per protocol (a set of orders for adjusting doses based on patient response and laboratory results), to be administered immediately. PA 1 said the CT angiogram showed a vertebral artery dissection so she was concerned about a clot; therefore, she wanted the heparin to be given immediately. PA 1 stated she expected the heparin to be given STAT.

During the above interview, PA 1 said she approached the ED nurse (RN 1) regarding the heparin orders and RN 1 told her he wanted to see the coagulation lab results before giving heparin. Coagulation lab refers to the PTT (partial thromboplastin time - blood test that measures the time it takes your blood to clot). PA 1 said she did not know the heparin protocol required PTT before the administration of heparin. PA 1 said she even went to the inpatient pharmacy and informed one of the pharmacists about her new heparin orders.

The Adult General Consultation report by PA1, dated 3/22/17, indicated PA 1 discussed the findings with Physician 3 (neurologist) who agreed with the heparin treatment. The report also indicated PA 1 communicated the treatment plan with Physician 1 (ED physician), Physician 2 (neurosurgeon) and Physician 4 (ED Trauma physician).

According to Patient 1's medical record, PA 1 entered the STAT heparin bolus and heparin drip orders, to be given intravenously (IV-directly through the vein), at 1:53 p.m. on 3/22/17. However, neither of the heparin orders was administered by nursing staff to Patient 1 until 6:00 p.m., or 4 hours 7 minutes after the medication had been first ordered.

The prescribing information for heparin indicates it is an anticoagulant to prevent blood clot formation and thus can help prevent a stroke. It's onset of action (time for a medication to take effect) is immediate if given intravenously.

A concurrent interview and review of Patient 1's medical record was conducted on 6/5/17 at 3:20 p.m. with the director of pharmacy (DOP), pharmacist (Pharm) 1, and the quality project manager (QPM). They said PA 1, on 3/22/17 at 1:53 p.m., entered the heparin bolus and infusion orders in Meditech (an electronic health record system) for Patient 1, but PA 1 did not include a dosage for the bolus. The computer system allowed this order to go through even without the bolus dose. They said Pharm 2 was on duty on that day and was responsible for verifying the heparin orders. Pharm 2 had to clarify the bolus dose since none was indicated. Pharm 2 had difficulty locating PA 1 on that day and finally found her after calling different departments in the hospital. Pharm 2 did not look up PA 1's contact information in the physician's directory (available online). Once PA 1 clarified the bolus dose, Meditech did not allow Pharm 2 to input the bolus order for PA 1 because PA 1 had locked the patient's Meditech order entry screen (the system was set up such that only one user can access the order entry screen at a time). After several attempts, Pharm 2 was able to get into the Meditech order screen and verified the bolus dose.

During an interview on 6/7/17 at 10:10 a.m., Pharm 2 stated she saw PA 1's heparin orders for Patient 1 a minute after they were ordered, but she needed to clarify the heparin bolus because it lacked a dosage. She called the ED first, then ICU, and finally was told to call Interventional Radiology (IR) to reach PA 1. She said she did not look up PA 1's contact information in the physician directory. She stated, looking back, it would have saved her a few minutes had she used the directory. She continued to explain that, after she finally reached PA 1 and clarified the bolus dosage, she could not get into the Meditech order screen to clarify the bolus order, as it was locked by PA 1. Pharm 2 said she tried at least three times between other tasks and activities, and was finally able to get into Meditech.

The medical record showed the heparin bolus order was clarified and completed at 2:51 p.m. on 3/22/17, 58 minutes after the initial order entry by PA 1. At this time, Patient 1 was still in the ED and was about to be transferred to the intensive care unit (ICU).

According to Patient 1's medical record, a baseline PTT was obtained on 3/22/17 at 7:15 a.m. shortly after the patient arrived in the ED. This PTT result would have been available in the computer by the time the heparin orders were made at 1:53 p.m. The medical record showed another PTT test was ordered on [DATE] at 2:09 p.m. as part of the heparin infusion protocol; this result was available at 2:40 p.m. At this time, Patient 1 was still in the ED.

During an interview on 6/6/17 at 11:25 a.m., Administrative Staff 1 (Admin 1) said RN 1 did not know of the existing PTT in the medical record at the time PA 1 was telling him of her heparin orders.

During an interview on 6/7/17 at 1:50 p.m., the ED director said interview with RN 1 revealed RN 1 had to verify the coagulation labs before he could give the heparin, and there was also a problem with the heparin bolus order that the pharmacy needed to clarify.

RN 1 was no longer employed by the hospital and not available for interview during the survey.

While still in the ED on 3/22/17 at 2:20 p.m., Patient 1's medical record showed Physician 3 was called and notified of the patient's complaint of nausea. Physician 3 ordered to hold the patient in the ED until he assessed the patient.

Patient 1 was transferred to the ICU on 3/22/17 at 3 p.m. and that was about the time for the next shift change in the ICU.

During an interview on 6/6/17 starting at 1:20 p.m., RN 2 said she received Patient 3 from the ED around 3 p.m. on 3/22/17. The patient was alert and oriented x 4 (patient's awareness of person, time, place, and circumstances) and was conversant. She said she conducted the neuro hand-off (checked the patient's neurological status, asked a series of questions, checked pupil size, strength of extremities, etc.) with RN 1 and Patient 1 had no neurological deficit. RN 2 said she was told by RN 1 there was a heparin order but it was not finalized. At this time, RN 2 was about to go off her shift, and she was to transfer Patient 1's care to the on-coming ICU nurse (RN 3). RN 2 said, during the hand-off with RN 3, she told RN 3 there was heparin to be administered. RN 2 said she did not recall whether RN 1 told her the heparin was a STAT order.

The medical record showed the second PTT result was available at 2:40 p.m. and the heparin bolus order was clarified and completed at 2:51 p.m. (before patient transfer).

RN 2's nurses note, dated 3/22/17 at 3 p.m., indicated, Received pt [patient] from ED. Neuro handoff completed at bedside with [QNUR mnemonic for RN 1]. However, the notes did not document what information was exchanged between the two nurses, whether communication regarding the heparin was relayed, what the patient's neurological status was at the time, and whether medication orders were discussed and reviewed.

Review of Patient 1's medical record did not find any hand-off documentation between RN 2 and RN 3 during the shift change at around 3:00 p.m. on 3/22/17.

During an interview on 6/8/17 at 8:20 a.m., the ICU director said she expected the ICU nursing staff to document the following hand-off information in the patient's medical record: the patient's Glascow Coma Scale (common scoring system used to describe the level of consciousness in a person following a traumatic brain injury), the NIHSS (NIH Stroke Scale, stroke assessment tool to evaluate and document neurological status in acute stroke patients), and how the patient was at the time.

The hospital Intensive Care Unit Standards of Care, revision date 4/2015, indicated, When admitting or transferring a patient with neurological deficits/injury, the ICU nurse will do a brief, bedside neurologic assessment with the nurse handing off or receiving the patient. The ICU nurse will document this hand off assessment in the nursing narrative notes... Change of shift hand-off will include on-coming and off-going RN doing a bedside double-check of patient status to include: review of all IV infusions/rates, assessment of skin, verification of relevant assessment findings (IE: neurological status, IABP settings, etc.)

During an interview on 6/7/17 at 2:10 p.m., RN 3 said he remembered Patient 1 got sick and had a large vomit in bed shortly after arriving in the ICU on 3/22/17. The patient was given a dose of Zofran for the vomiting. The patient began to get sick again after he was cleaned up. After two episodes of vomiting, which were about 20 to 30 minutes apart, the patient experienced an episode of seizure. The trauma physician (Physician 4) from the ED was called to the ICU for emergent treatment. Patient 1 stopped seizing after a second dose of Ativan (IV medication for seizure). The medical record showed Ativan was given at 4:43 p.m. and 4:44 p.m. The patient was intubated (placement of flexible plastic tube into the windpipe to maintain an open airway) and was sedated with propofol (medication for induction and maintenance of anesthesia or sedation). RN 3 said he did not remember if he and RN 2 completed the hand-off before the patient got sick. He did not recall being told about the heparin order by RN 2.

During this interview, RN 3 said right after the patient was intubated, Physician 3 (neurologist) asked him about the heparin order, and that was the first time he was informed about it. The medical record indicated the patient was intubated at 4:50 p.m. on 3/22/17. When asked why he did not give the STAT heparin after he was informed by the physician, RN 3 said he could not remember what happened after that. He was busy cleaning up the patient (after the second vomiting episode).

Patient 1's medication administration record (MAR) indicated the heparin STAT order was not administered until 6:00 p.m. on 3/22/17, 4 hours 7 minutes after ordered.

Review of the hospital policy, dated 6/28/16, entitled, Medication Administration, on page 4 under procedure, it read, 2. b. Medication ordered as STAT NOW shall be administered to the patient within 30 minutes of the order entry.

During an interview on 6/7/17 at 10:32 a.m., Physician 4 (ED trauma physician) said he was in communication with PA 1 regarding the course of treatment for Patient 1, and PA 1 told him she felt she could write the orders for heparin. Physician 4 said, because of the vertebral artery dissection, Patient 1 was at high risk for an occlusion (blockage or closing of a blood vessel), so the proactive approach was to place the patient on heparin to prevent an occlusion. When he was called to the ICU after the patient started seizing, he asked the ICU nurse if heparin was given and was told no. (Physician 4 was the one who told RN 3 about the heparin order, not Physician 3 as per interview with RN 3 above.) Physician 4 said he told the ICU nurse to give the heparin right away, but the ICU nurse said, I'm too busy and that he did not have time.

Review of Patient 1's clinical notes, dated 3/22/17, by Physician 4 indicated, Called at 1630 for pt seizing, had recently vomited and maintained in Cspine precautions. Seizure continuing and gave Ativan 2 mg times 2 doses without resolution of seizure ... Pat [patient] post ictal [after a seizure] and not responsive... Anesth called and intubated at 1650 with glidescope and maintained in C collar. [Physician 3] called and recommended Propofol and EEG [electroencephalogram; a test that measures and records the electrical activity of the brain].

An interview was conducted with Physician 3 (neurologist) on 6/7/17 starting at 8:55 a.m. He recalled assessing Patient 1 in the ED and found the patient to be alert and oriented and neurologically intact. Through communication with PA 1 and other physicians, the decision was to put Patient 1 on heparin infusion because there was a clot in vertebral artery. He said the idea was to prevent a new clot from forming and the existing clot to get larger. Physician 3 stated the goal was to prevent further clotting, to prevent a stroke; and that before Patient 1 was transferred to the ICU, he was called about the patient complaining of nausea and vomiting, so he told the nurse to hold the patient until he could assess the patient again. He said his examination found Patient 1 to be neurologically intact and allowed for patient transfer to the ICU.

During this interview, Physician 3 said he was called to the ICU after Patient 1 had an episode of seizure and Physician 4 had already been there. He ordered the valproate sodium STAT to prevent further seizure. He said he expected the medication to be given STAT. Physician 3 said he was later told that he incorrectly input the valproate sodium order in Meditech but he was unsure what happened.

Patient 1's medical record indicated Physician 3 had ordered valproate sodium 1,500 mg IV STAT at 4:44 p.m. on 3/22/17. However, review of the record indicated the valproate sodium order was not verified by pharmacy until 6:23 p.m. or about one and one half hour after it was first ordered by Physician 3. The medication administration record (MAR) showed the valproate sodium was administered at 7:09 p.m., or 2 hours 25 minutes after ordered.

During an interview on 6/7/17 at 1:05 p.m., Pharm 1 explained the valproate sodium ordered by Physician 3 did not include a carrier (the base solution). The medication order required mixing valproate sodium concentrated solution with a base solution (sodium chloride 0.9%), to be infused intravenously over time. Since the order was written without the carrier, it had to be re-entered to add the carrier while discontinuing the old one. When a medication order was made, the pharmacy sig (sig means directions on a prescription) automatically included ASDIR (as directed) as a default sig. When Pharm 4 re-entered the valproate sodium order, she did not change the default sig to STAT. Pharm 1 further explained that, the way the computer was set up, when no sig change happened, the pharmacy label would not come out unless the user input a 1 in another field for the label to print. Because this did not happen, no pharmacy label was printed, and no valproate sodium solution was prepared. This resulted in the delay in the verification of order, preparation, and delivery of the medication to the ICU. Pharm 1 said the hospital policy stipulated verification and processing for STAT medication orders to be done within 15 minutes.

During an interview on 6/7/17 at 4:05 p.m., Pharm 4 said when she re-entered the valproate sodium order for Patient 1, she did not change the sig to STAT and did not know the pharmacy label did not come out. She said a physician and the ICU nurse called later that day inquiring about the status of Patient 1's STAT valproate sodium, and that was when she realized what had happened.

Review of the hospital policy, dated 2/23/16, entitled, Prescribing, Verification and Clarification of Medication Orders, indicated the turn-around time for processing of STAT medication orders was 15 minutes.

Patient 1's medical record indicated PA 1 entered the STAT heparin orders on 3/22/17 at 1:53 p.m. The orders were not acknowledged by a nursing staff until 5:56 p.m., more than 4 hours later.

Patient 1's medical record also indicated an order for an NIHSS to be done every 8 hours, ordered by PA 1 on 3/22/17 at 11:40 a.m. This order was not acknowledged by a nursing staff until 9:02 p.m. (more than 9 hours later).

During an interview on 6/7/17 at 8:30 a.m., Admin 1 said she was not sure if there was a policy and procedure addressing a timeframe by which the nurse had to acknowledge the orders.

During an interview on 6/7/17 at 2:25 p.m., the ICU director said the STAT medication orders had to be acknowledged by nursing within 15 minutes, and the routine orders by the end of the shift.

The medical record showed, while in the ED on 3/22/17 at 9:30 a.m., Patient 1 had a NIHSS score of 0 (no neurologic deficit). At midnight on 3/22/17, RN 4 conducted the neurological assessment and documented the NIHSS score of 29 (based on scale from 0 to 42; score of 21 to 42 = severe stroke). However, there was no documented evidence RN 4 called and reported the changed NIHSS score of 29 to the physician or the PA of this change.

RN 4 was no longer employed by the hospital and was not available for interview during the survey.

During an interview on 6/6/17 at 2:15 p.m., the ICU manager verified RN 4 did not call and report the NIHSS of 29 to a physician or a PA. She said according to nursing procedures, a physician should be called when the patient had a change in the NIHSS score of 4 or greater. The patient's previous NIHSS documented on 3/22/17 at 9:30 a.m. was zero (0), and at midnight the patient had a score of 29, so there was a significant change in the patient's neurological condition.

During an interview on 6/6/17 starting at 10:25 a.m., PA 1 said she examined Patient 1 the next morning (3/23/17) and found significant neurological change as compared to the day before. She said Patient 1 was only blinking without facial expression, not following any commands, and had no response to stimuli. She immediately notified Physician 3 and a STAT magnetic resonance angiogram-provides pictures of blood vessels using a magnetic field and pulses of radio wave energy (MRA) of the head was ordered.

Review of the neurological assessment, dated 3/23/17, indicated Neuro exam is very limited today, despite propofol off since 8:15 a.m. Pt. opens eyes spontaneously, but does not track. Gaze in midline.

The MRA findings, dated 3/23/17, revealed large pons (area of the brain that serves as a message station between several areas of the brain; helps relay messages from the cortex and the cerebellum) infarct (a localized area of dead tissue resulting from failure of blood supply) and progression of left vertebral artery dissection with complete occlusion from the origin.

Subsequent consultation, dated 3/23/17, concluded the patient had [DIAGNOSES REDACTED] (a condition in which a patient is aware but cannot move or communicate verbally due to complete paralysis of nearly all voluntary muscles in the body except for vertical eye movements and blinking) with poor prognosis for functional recovery.

The Trauma Progress Notes, dated 3/24/17, indicated, He [Patient 1] was intubated and placed on a heparin drip in an effort to keep the L [left] dissected vertebral artery open. His mental status also declined overnight, and he underwent MRA brain this morning, which showed complete occlusion of the L vertebral artery and a large ischemic pontine [related to the pons] stroke. [Physician 3] diagnosed him with [DIAGNOSES REDACTED]... He may improve over the next few months to years, but will likely not be fully independent and will never reach his former functional status.

During this interview on 6/7/17 at 9:25 a.m., Physician 3 said he was informed of the delay of heparin the next day. He said the patient's seizure (while in the ICU) may have caused the stroke; or it could have happened during the intubation. Physician 3 was asked if heparin was given immediately after ordered, would it have prevented the stroke from happening. He said he was not 100 percent sure as his research did not yield a lot of data, but it [heparin] would have decreased the chance of further clotting. He stated if heparin was given as expected, it would more likely than not have prevented the stroke from happening. When asked what percentage of assurance he could give for this likelihood, he said 51 percent.

During an interview on 6/7/17 at 10:48 a.m., Physician 4 said the goal for the heparin treatment was to prevent occlusion in the blood vessel as the CT angiogram showed narrowing of the vertebral artery due to the injury. When asked could a stroke have happened if heparin was given immediately after ordered, Physician 4 said, Not giving it made it more likely to occlude [close up or block].

Based on observation, interview, and document review, the hospital failed to ensure safe dispensing of compounded (mixed) sterile preparations (CSPs) when:

1. Compounded intravenous (IV, given directly through the vein) antibiotic medications (to treat or prevent infections) were used as stock solutions for multiple pediatric patients and given a beyond-use-date (BUD, date after which a compounded preparation should not be used) longer than specified by hospital policy and procedure and current professional standards; and

2. Seven out of seven new pharmacy staff members did not have gloved fingertip sampling (GFS) conducted three times before initially being allowed to compound CSPs for human use, as in accordance with the hospital policy and procedure.

These failures had the potential to expose patients to preventable infections.

Findings:

1. During a visit to the pharmacy on 6/5/17 at 10:35 a.m., the director of pharmacy said the hospital followed the standards in United States Pharmacopoeia (USP) <797> for CSPs.

USP 797 refers to chapter 797 Pharmaceutical Compounding - Sterile Preparations in the USP National Formulary. USP <797> establishes best practices and regulations for the production of CSPs.

On 6/5/17 at 11:20 a.m. in the presence of Pharmacist (Pharm) 3, an inspection of the pass-through medication refrigerator between the ante-room (a staging area where hand-hygiene and garbing procedures take place) and the clean room (where compounding of CSPs occurs) identified two syringes of compounded IV antibiotic (to treat infections) solutions. One was clindamycin 18 milligrams (mg) per milliliter (ml); the other was ceftriaxone 40 mg/ml. The label on the syringes indicated each was assigned a 9-day beyond-use-date (BUD). For example, one was prepared on 6/2/17 and had the expiration date of 6/11/17 (9 days). Upon interview, Pharm 3 said they were compounded antibiotics (antibiotic medication mixed with a diluent) as stock solution for pediatric patients. He explained the stock solution syringes were prepared by the pharmacy so individual doses for pediatric patients could be drawn from the syringe at a later time within the 9-day period. Each syringe was attached with a dispensing pin (an access device for withdrawal of solution from the syringe).

The compounding formula indicated clindamycin 300 mg/2ml and sodium chloride 0.9% solution (as a diluent) were used to make the clindamycin 18 mg/ml solution; and ceftriaxone 1 gram vial and sodium chloride 0.9% solution were used to make ceftriaxone 40 mg/ml solution.

During this visit, Pharm 3 was requested to provide the individual components that make up the above stock solutions. A vial each of clindamycin 300 mg/2ml, ceftriaxone 1 gm, and a vial containing 25 ml of sodium chloride 0.9% injection solution were presented. The manufacturer's label on each vial indicated single use vial or single dose container.

A review of the manufacturer's prescribing information for the above two antibiotics and sodium chloride 0.9% indicated that all these products did not contain any bacteriostatic or antimicrobial agents for the inhibition of microbial replication. Each final product (after mixed together) contained no bacteriostatic or antimicrobial agent to prevent bacterial growth.

The Centers for Disease Control and Prevention (CDC) indicated vials labeled by the manufacturer as single dose or single use should only be used for a single patient. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately. The CDC further guided that, in time of critical need, contents from unopened single-dose/single-use vials can be repackaged for multiple patients. However, this should be performed by qualified healthcare personnel in accordance with the standards in USP <797>. It further indicated that following the USP standards is imperative, as medication contamination and patient harm can occur when repackaging (e.g. splitting doses) is not done properly. (www.cdc.gov; accessed 6/12/17)

According to the current USP <797>, opened or needle-punctured single-dose containers... shall be used within 1 hour if opened in worse than ISO Class 5 air quality (ISO Class 5 air quality is that provided inside an IV hood), and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.

During an interview on 6/5/17 at 11:30 a.m., Pharm 3 acknowledged that multiple entries (multiple withdrawals at various times over a 9-day period) to the stock solution without antimicrobial agent increased the risk of accidental microbial contamination of the product. He agreed the IV antibiotic stock solution for pediatric patients should be treated as single-use/single-dose containers, and when prepared in accordance with the standards in USP <797>, should not be used beyond 6 hours if prepared, and the stock solution remained in an ISO Class 5 environment.

The hospital policy and procedure entitled Compounded Sterile Preparations (CSPs): Environmental Control, revision date 2/2016, indicated the following for single-dose containers:

1) 6 hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry

2) 1 hour for closure sealed single-dose containers after being opened or entered in worse than ISO Class 5 air.

2. Gloved fingertip sampling (GFS) is a procedure that measures the ability of compounding personnel to perform hand hygiene and garbing without contaminating gloved hands.

The hospital's policy and procedure entitled Compounded Sterile Preparations (CSPs): Quality Assurance, reviewed and revised 7/2016, indicated, All pharmacy staff must successfully complete 3 (three) Gloved fingertip sampling occurrences prior to compounding CSPs for human use. For new pharmacy employees, each of these three occurrences will occur prior to beginning of three days of Media-Fill verification. (Media-fill verification is a procedure to test whether aseptic procedures are adequate to prevent contamination during the production of a CSP.)

On 6/8/17, the initial training and competency evaluation for seven new pharmacy staff members (four pharmacists and three pharmacy technicians) were requested for review.

On 6/8/17 at 12:18 p.m., Pharm 1 said all pharmacy staff members were required to be evaluated for competency initially after hire and annually; part of the competency evaluation was the GFS, whether or not the staff was assigned compounding responsibilities.

On 6/8/17 at 12:40 p.m., a review of seven new pharmacy staff members' personnel records with Pharm 1 and Pharm 3 revealed each member had completed the initial GFS only once, with two different reported results - one for before and one after the media-fill test. In other words, each staff member had only one occurrence of GFS during one media-fill verification. Pharm 1 and Pharm 3 verified the new pharmacy staff members did not have GFS conducted three times as stipulated by the hospital policy and procedure. Pharm 1 stated all but one (one technician) had been involved in the compounding of CSPs.

Based on observation, interview, and document review, the hospital failed to ensure expired medications were removed and not available for patient use. The failure had the potential for patients to be given expired or ineffective medications.

Findings:

A visit to the Medical/Surgical Oncology Unit was conducted on 6/6/17 at 9:15 a.m. with several hospital staff members including Pharmacist (Pharm) 3. A random inspection of medications in the Pyxis (an automated dispensing cabinet) identified Rapid Sequence Intubation kit (a kit containing medications for endotracheal intubation that is used where the patient is at a high risk of pulmonary aspiration or impending airway compromise, to maintain the airway) in the medication refrigerator. One of one vial of succinylcholine (drug to induce skeletal muscle relaxation to facilitate tracheal intubation) inside the kit had an expiration date of 5/1/17. The label outside the kit indicated the kit would expire on 5/1/18 (wrong year). Pharm 3 confirmed the succinylcholine vial had expired, and that the kit was mislabeled with the wrong expiration date.

During this visit, a bag containing 1-liter of normal saline with 20 milliEquivalent potassium (a solution for fluid and potassium replenishment) was identified in the Pyxis. It had an expiration date of 3/1/17. Pharm 3 verified it had expired and should be removed from the Pyxis.

The hospital's Medication Storage and Inspections policy and procedure, reviewed 2/2016, indicated, All expired... medications are segregated until they are removed from the hospital.