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Tag No.: A1100
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 one week prior to her arrival at the ED. She reported having abdominal cramping since she fell one 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 to home on 11/13/20 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 to home on 11/24/20 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 to home on 1/11/21 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 ¾ 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.
34383
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 8/13/20;
e. introducer sheath expired on 1/31/20;
f. 20 centimeter distal flexibility with softened tip expired on 4/6/16;
g. starter guide wire expired on 9/30/20;
h. arterial line catheter expired 3/15/20;
i. one box of pneumothorax kit expired on 6/30/21; and,
j. peritoneal lavage kit expired on 9/30/21.
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.
26674
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 9/30/20. 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."
36623
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.