HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to protect and promote patent's rights to received care in a safe setting for two of seven sampled patients (Patient 1 and Patient 3) when:

1. Patient 1 had numbness and weakness to her right leg and was discharged from the hospital without an assessment to determine the cause of the numbness and weakness to her right leg and provide medications to prevent Deep Vein Thrombosis (DVT- a medical condition that occurs when a blood clot forms in one or more of the deep veins in the body, usually in the legs).

This failure resulted for Patient 1 to discharged on 12/1/22 and expired on 12/7/22 with pulmonary embolism (PE- a sudden blockage of an artery (blood vessel) in the lungs, usually occurs when a blood clot in a deep vein in the leg breaks loose and travels through the blood to the lungs) as the final diagnoses. (Refer to A144 finding 1)

2. Patient 3 was in the operating room (OR- a room in the hospital specially equipped for surgical operations) on 12/19/22 for a gall bladder (a small pear-shaped organ that stores bile located in the right upper abdomen) removal, and the surgical staff failed ensure the stability and integrity of the Intravenous (IV) pole (a device that holds bags of intravenous fluids [a formula administered into the vein] in place as it is being administered to a patient through a tube) during Pt 3's transfer from bed to the OR table.

This failure resulted for the IV pole to fell and struck Patient 3's right eye which ruptured her right eyeball and caused vision impairment, pain and required immediate surgical intervention. (Refer to A144 finding 2)

The cumulative effect of these problems resulted in failure of the hospital to ensure patients received and provided care in a safe setting.







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Based on observation, interview, and record review, the hospital failed to protect and promote patent's rights to received care in a safe setting for two of seven sampled patients (Patient 1 and Patient 3) when:

1. Patient (Pt) 1 had numbness and weakness to her right leg and was discharged from the hospital without an assessment to determine the cause of the numbness and weakness to her right leg and provide medications to prevent Deep Vein Thrombosis (DVT- a medical condition that occurs when a blood clot forms in one or more of the deep veins in the body, usually in the legs).

This failure resulted for Pt 1 to discharged on 12/1/22 and expired on 12/7/22 with pulmonary embolism (PE- a sudden blockage of an artery (blood vessel) in the lungs, usually occurs when a blood clot in a deep vein in the leg breaks loose and travels through the blood to the lungs) as the final diagnoses.

2. Pt 3 was in the operating room (OR- a room in the hospital specially equipped for surgical operations) on 12/19/22 for a gall bladder (a small pear-shaped organ that stores bile located in the right upper abdomen) removal, and the surgical staff failed to ensure the stability and integrity of the Intravenous (IV) pole (a device that holds bags of intravenous fluids [a formula administered into the vein] in place as it is being administered to a patient through a tube) during Pt 3's transfer from bed to the OR table.

This failure resulted for the IV pole to fell and struck Pt 3's right eye which ruptured her right eyeball and caused vision impairment, pain and required immediate surgical intervention.

Findings:

1. During a review of Pt 1's "History and Physical" (H&P), dated 11/22/22, the H&P indicated Patient 1's admission diagnosis was labor check (a labor and delivery (L&D) nurse will ask the patient questions about contractions (the periodic tightening and relaxing of the uterine muscle), check the patient's vital signs (measurement of the body's basic function), assess the patient's contractions, and see how baby was doing). The H&P indicated, Patient 1 presented to the hospital with hypertension (high blood pressure) and had an induction of labor (IOL-the use of medications or other methods to bring on labor) for gestational hypertension (a form of high blood pressure in pregnancy). The H&P indicated, Patient 1 had a problem list which included: metabolic syndrome (a collection of conditions that often occur together and increase the risk of diabetes (a disease that occurs when your blood sugar is too high), stroke (occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts), and heart disease), morbid obesity (the individuals weight was more than 80 to 100 pounds above their ideal body weight), low serum high density lipoproteins (HDL -sometimes called the "good" cholesterol could indicate an individual's risk of developing conditions such as heart disease), elevated alanine transaminase (ALT -an enzyme found in the liver and could be a sign of liver damage), cholelithiasis (gallstones are hardened deposits of digestive fluid that could form in your gallbladder), and fatty liver (fat inside the liver that could, over time, affect liver function and cause liver injury).

During a concurrent interview and record review, on 3/22/23, at 9:48 a.m., with Medical Doctor (MD) 14, Pt 1's "Certificate of Death (COD)," dated 1/31/23 was reviewed. The COD indicated, on 12/7/22, Patient 1's cause of death was Pulmonary Thromboemboli (a sudden blockage of a blood vessel in the lung) caused by DVT with other significant conditions contributing to death but not resulting in the underlying cause of death were obesity, recent pregnancy, and epidural anesthesia (procedures that deliver medicines that numb parts of your body to block pain). MD 14 stated, the postpartum state (begins soon after the delivery of the baby) could be considered contributory due to a higher risk for clotting.

During a concurrent interview and record review on 3/22/23, at 10:56 a.m., with the Postpartum Manager (PPM), Pt 1's "Electronic Health Record (EHR)," dated 11/24/22 was reviewed. The PPM stated, the EHR indicated the D-dimer (determines if patient may have a blood clotting condition) and fibrinogen (a protein involved in forming blood clots in the body) were elevated. The PPM stated there was no indication of physician notification of the D-dimer and fibrinogen.

The PPM stated, the Disseminated Intravascular Coagulation (DIC-a rare but serious condition that causes abnormal blood clotting throughout the body's blood vessels) Coagulation Panel (test checks how quickly small blood vessels close and stop bleeding) was check because Pt 1 was bleeding. The PPM stated, the DIC coagulation panel was not recheck because Pt 1 stopped bleeding. The PPM stated, "It is common for the D-dimer and fibrinogen to be elevated in pregnancy."

During an interview on 3/22/23, at 1:30 p.m., with MD 1, MD 1 stated, he was the physician who discharged Pt 1 home. MD 1 stated it was never determined the cause of Pt 1's numbness and weakness to her right leg upon discharge.

During an interview on 3/23/23, at 9:25 a.m., with MD 2, MD 2 stated, she was one of the physicians who provided care to Pt 1. MD 2 stated, every pregnant woman was at risk for DVT and Pt 1's weight placed her at higher risk for DVT. MD 2 stated she should have administered Enoxaparin (an anticoagulant that helps prevent the formation of blood clots) to Pt 1 and ordered an Ultrasound (a procedure that uses high energy sound waves to look at tissues and organs inside of the body) to Pt 1's legs to check for DVT.

During an interview on 3/23/23, at 10:09 a.m., with RN 23, RN 23 stated, Pt 1 was pregnant and delivered therefore the Fibrinogen and D-dimer would be elevated after delivery. RN 23 stated, the Fibrinogen and D-dimer labs could indicate bleeding and increased clotting. RN 23 stated a pregnant mom was more likely to clot.

During a concurrent interview and record review on 3/23/23, at 10:15 a.m., with RN 23, Patient 1's "Plan of Care (POC)," dated 11/25/22 was reviewed. The POC indicated, " ...1930[7:30 p.m.]: started pushing ...1944[7:44 p.m.]: Spontaneous vaginal delivery ..." RN 23 stated, the delivery was fast, it lasted less than 15 minutes and based on the delivery summary, Patient 1 did not have hyperextension of her legs during delivery.

During an interview on 3/23/23, at 10:41 a.m., with the PPM, the PPM stated, Patient 1 was totally dependent on nursing staff to get around her room.

During an interview on 3/24/23, at 9:25 a.m., with Family Member (FM) 1, FM 1 stated, when Pt 1 was discharged from the hospital she had numbness on her right lower extremities (RLE), right hip and lower back. FM 1 stated, Pt 1 required a lot of assistance when using the four wheeled walker (FWW-helps with walking when you can stand on both legs) and was mostly using the wheelchair to get around the house. FM 1 stated, Pt 1 had swelling on both legs, and the right leg was a little more swollen than the left leg.

During a concurrent interview and record review on 3/24/22, at 10:55 a.m., with the PPM, Pt 1's LDA flowsheet, dated 11/23/22 to 11/24/22 was reviewed. The LDA flowsheet indicated, there was no documented epidural "Safety Check" assessment completed when the labor epidural was initiated and while the epidural was infusing. The PPM stated, the Safety Check assessment consisted of epidural catheter status, site assessment, dressing type, patient sensory testing, and side effects, should have been completed. The PPM stated the Safety Check assessment should have been completed.

During an interview on 3/24/23, at 1:30 p.m., with MD 10, MD 10 stated, it was possible to have a DVT without S&S of pain in the calves, warmth to calves, redness, and increased swelling. MD 10 stated, Pt 1 had an elevated body mass index (BMI-a measure that uses your height and weight to work out if your weight is health). MD 10 stated, on 11/29/22, Pt 1 complained of weakness and numbness to her right leg. MD 10 stated, the neurology consult and was not able to determine the reason for Pt 1's leg numbness.

During a concurrent interview and record review on 3/24/23, at 1:45 p.m., with MD 10, Pt 1's "Laboratory Result (LR)", dated 12/1/22 was reviewed. The LR indicated Pt 1's uric acid was 7.1 [3.5 to 7.2 milligrams per deciliter (mg/dl- unit of measurement) MD 10 stated uric acid elevation could have been caused by dehydration.

During an interview on 3/27/23, at 12 p.m., with MD 15, MD 15 stated, she provided care to Pt 1 during delivery and immediately following delivery. MD 15 stated Pt 1 had fever and pre-eclampsia (a serious blood pressure condition that develops during pregnancy), and increased bleeding. MD 15 stated, she ordered a medication to stop the bleeding and ordered a coagulation panel. MD 15 stated, the D-dimer and fibrinogen were a part of the DIC coagulation panel . MD 15 stated, an elevated D-dimer could indicate infection, pregnancy, and bleeding which could mean increased risk for clotting.

During a review of Pt 1's "Lab Results" (LR), dated 11/25/22, the "LR" indicated, Pt 1's Fibrinogen was 654 [normal range below 500 mg/dl] and D-dimer was 2,180 [third trimester normal range 130 - 1700]. The "LR" indicated, " ... If the patient's clinical risk for acute [sudden] DVT/PE is medium or high, further work up may be indicated ..."

During an interview on 3/27/23, at 12:10 p.m., with MD 15, MD 15 stated, she was aware Pt 1 had weakness and numbness to her right lower leg and Physical Therapy (PT) and Occupational Therapy (OT) were consulted. MD 15 stated, Pt 1 had limited mobility, pregnancy, and was a high risk for DVT due to her comorbidities. MD 15 stated, interventions to prevent DVT were anticoagulant stockings, SCDs, and anticoagulant medications like Enoxaparin. MD 15 stated she would recommend Enoxaparin for cesarean (the surgical delivery of a baby through a cut made in the mother's abdomen) delivered mothers who were mostly bedbound (confined in bed) which could place them at a higher risk for DVT. MD 15 stated, Pt 1 did not get up in bed to move around and was at risk to develop DVT. MD 15 stated, when she learned of Pt 1's death, she thought more about her obese and immobile patient who are at risk to develop DVT. MD 15 stated, she would immediately start anticoagulant medications for patients who are at risk for DVT.

During a concurrent interview and record review on 3/27/22, at 1:54 p.m., with the Clinical Coordinator Registered Nurse (CCR), Resident 1's "Home Health Visit (HHV)" note, dated 12/5/22 was reviewed. The HHV indicated, " ...Level of assistance entering/leaving residence: moderate assist ...other homebound reasons; confined to bed/chair, dependent for ADLs [Activities of Daily Living], unable to ambulate ...pain score 3 ...pain goal 0 ...frequency of pain interfering with patient's activity or movement: 3-Daily, but not constantly ...pain quality ...dull, achy ...mobility: walk 10 feet ...Not attempted due to medical condition or safety concerns ...pt has Rt[right] LE [lower extremity] partially paralyzed ..." The CCR stated once PT completed their first home health visit with Patient 1, PT would write a case communication and the message would be routed to the primary care physician (PCP). The CCR stated the HHV indicated, " ...on 12/5/22 ...Patient is post partum. Experiencing RLE numbness and paralysis. Unable to ambulate and difficulty with transfers. P.T. for strengthening/ROM [range of motion]/transfers/gait as tolerated ..."

During a record review on 3/27/23, at 2:45 p.m., with Physical Therapist (PT) 1, Pt 1's "Acute Care Physical Therapy Treatment Note (PTT)," dated 11/27/22 was reviewed. The PTT indicated, " ...New PT consult acknowledge, pt [Pt 1] evaluated on 11/25. RN states MD requesting reassessment by PT, per chart review and discussion with RN [name], pt has not been mobilized by nursing staff since cleared to do so by PT on 11/25. PT cleared pt to dangle [an intermediary stage of assisting people into the sitting position with their legs hanging over the side of the bed] at EOB [edge of bed] with moderate assistance per Plan of Care ...Pt continues to have numbness in RLE (pt stating numbness increases proximally) and experiencing more "burning" in the R [right] hip ...Pt unable to progress to ambulation at this time ...Equipment needs: bariatric equipment [a heavy-duty bed, wider than standard hospital bed to safely accommodate larger individuals], front wheel walker, 3 in 1 commode [a piece of furniture that looks like a chair but has a container use as a toilet], wheelchair ...Patient had not been dangled at EOB for two days ..." PT1 stated, Pt 1 did not state she had pain, just the "burning" and she did not remember when Patient 1 had this "burning" sensation or how often.

During a record review of Pt 1's "Acute Care Occupational Therapy Initial Assessment and Discharge Summary (OT)" note, dated 11/30/22, the OT note indicated, " ...Reason for Consult: ADLS [Activities of Daily Living] ...received bariatric w/c [wheelchair], Four Wheeled Walker (FWW), drop arm commode [drop arm mechanism allows arm rest to be removed for better transferring], leg lifter [aid patients in getting in and out of bed, by offering additional support in lifting one or both of their legs], and sliding board [transfer board] ...Prior Level of Function Level of Independence: Independent with ADLs and functional transfers, Independently ambulates without assistive devices, Drives ...Transfers & Mobility: ...transfers: sit <> stand [sit to stand] from the EOB with min/mod A [minimum/moderate assistance] x1 [one person] using a FWW; EOB <> w/c transfers using a sliding board with SBA [stand by assistance] ...Ambulation: NA [not applicable] ...Pt [patient] was referred to OT due to a decline in activities of daily living function and functional mobility after she developed RLE [Right Lower Extremity] weakness post-delivery. During session, pt noted to RLE weakness and impaired sensation..."

During a record review of Pt 1's "OT" note, dated 11/30/22, the OT noted indicated, " ...Ambulation: Distance Ambulated (ft): 0 ft ...Gait Description: unable ...Activity Aid: FWW ...Balance: Sit Balance: Good at EOB ...Stand Balance: Fair+/Poor: Pt unable to increase WB [weight bearing] on RLE, poor stability and buckling [collapse] of RLE with weight shifting [when a person shifts weight from one leg to another] ..."

During a review of Pt 1's "Labor Epidural Procedure (LEP)," dated 11/23/22, the LEP indicated, the labor epidural [provides anesthesia during labor] was performed by MD 12 on 11/23/22 at 3:41 p.m. and ended at 4:15 p.m.

During a professional reference review from NYULangone.org, titled "Preventing Deep Vein Thrombosis," undated was reviewed. The reference indicated, " ...Dehydration contributes to the development of sluggish blood flow and blood clots ...advise drinking 8 to 10, 8-ounce glasses of water each day for optimal blood flow. It's especially important to do this when your mobility is limited for long periods ..."

During a record review of Pt 1's "Discharge Summaries (DS)," dated 12/1/22, the DS indicated, " ...Discharge Diagnosis: Term Pregnancy [a pregnancy that last between 39 weeks], Gestational HTN, Induction of Labor, Postpartum preeclampsia [a condition when you have high blood pressure soon afterbirth], Right lower extremity weakness and numbness ..."

During a review of Pt 1's "ED Provider Notes (EDP)," dated 12/7/22, the EDP indicated, " ...Patient presented in asystole [when there is no movement in the heart] with prolonged downtime and unwitnessed arrest [no one was present when at the time the patient collapsed]. No history initially available aside from recent postpartum state and notes suggesting preeclampsia. No physical findings suggestive of DVT ...she had been complaining of R leg pain since discharge from the hospital. Was in her normal state of health today though was continuing to complain of calf pain and upper leg pain. Subsequently lost consciousness and became cyanotic [bluish or purplish discoloration due to lack of oxygen in the blood] prior to CPR [cardiopulmonary resuscitation-a life-saving procedure done when someone's breathing or heartbeat has stopped] being initiated ...Right lower leg: no edema [swelling] ...Left lower leg: no edema ...Given preceding symptoms since discharge from the hospital, suspected massive pulmonary embolism as cause death ..."

During a review of Patient 1's "Record of Death (ROD)," dated 12/7/22, the ROD indicated, " ...Date of Death: 12/7/22 ...Time of Death: 1815 [6:15 p.m.] ..."

During a review of the hospital's P&P, titled, "Patient's Rights and Responsibilities," dated 2/10/22, the P&P indicated, " ...To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting ...To receive reasonable continuity of care ...To received effective treatment of pain through a pain assessment and management process ..."

During a review of the reference from Merck Manual- Professional edition titled,
"Thromboembolic Disorders [a circulating blood clot that gets stuck and causes obstruction] in Pregnancy," dated 9/2022, the reference indicated, "...In the US, thromboembolic disorders- deep venous thrombosis (DVT) or pulmonary embolism (PE)-are leading cause of maternal mortality. Thromboembolic disorders can occur without symptoms, with only minimal symptoms, or with significant symptoms...During pregnancy, risk of thromboembolic disorders is increased, but most thromboemboli develop postpartum and result from vascular trauma during delivery ...Diagnose deep vein thrombosis using Doppler ultrasonography..."

During a review of the reference titled "Deep vein thrombosis (DVT): Overview; NCBI Bookshelf, National Institutes of Health," dated March 23, 2017, the reference indicated, "...Typical symptoms of DVT include pain in a leg or hip, tenderness, tightness, and red skin. The affected area may also swell and feel warm. But sometimes deep vein thrombosis doesn't cause any symptoms...Blood clots may form if the blood flow in a vein is too slow, if there is a blood clotting disorder, or if the wall of a blood vessel is damaged. This can happen in the following cases: ...After longer periods of bed rest...Staying in bed for a longtime and not moving much can lead to poor blood circulation in your legs. There are also various other factors that can increase someone's risk of developing DVT: ...Being severely overweight (obese)... Pregnancy...A rarer but more serious complication of deep vein thrombosis is known as pulmonary embolism. This happens if the blood clot breaks away from its original site and is carried in the blood to the lungs. If pulmonary embolism develops, then it usually does so within two weeks of the DVT. The risk of pulmonary embolism is greater if the thrombosis is in the upper part of your leg or in your pelvis..."




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2. During a review of Pt 3's "Electronic Medical Record" (EHR- an electronic version of a patient's demographics, medical history and treatments), dated 12/16/22, the "EHR" indicated, Pt 3 was a 44 year old female with no significant (serious) medical history. Patient 3 was admitted to the Emergency Department (ED- a department in the hospital that provides immediate treatment for acute illness and trauma) on 12/16/22 with a chief complaint (reason for encounter) of abdominal (part of the body containing the digestive organs) pain. Patient 3 was diagnosed (identified the nature of an illness or other problem by examination of the symptoms) with Acute Pancreatitis (inflammation of the pancreas) on 12/19/22 and was scheduled for Laparoscopic Cholecystectomy (a surgical procedure performed through 4 small incisions with use of a camera to visualize the inside of the abdomen with long tools to remove the gallbladder).

During an interview on 1/12/23, at 2 p.m., with Pt 3, Pt 3 stated, on 12/19/22, she was scheduled for a surgical procedure to have her gall bladder removed. Patient 3 stated, "They took me to the OR, there were lots of people in there. One guy was pulling on the IV pole. A girl said lay down on the OR table (a table a patient lies on while having an operation). I laid down and my right eye felt like it exploded. Everyone was just standing there. Water was coming from my eye. Then a lady put a cloth on my eye. My eye was bleeding. Everyone was apologizing. My eye and head was pounding so much ... I was screaming, asking for the phone to call my daughter and dad ... Then I was taken to a room and they put a cup on my eye and they called the eye doctor ... The eye doctor came and asked what happened ... Then I was taken to [name of hospital] and had eye surgery." Pt 3 stated she still had stitches and no vision in her right eye. Patient 3 stated, "I see only black out of the right eye." Pt 3 stated, she was on pain medications to relieve her headache and pain in her right eye, with a pain scale of 7/10 (scale used to measure pain with 0 indicating no pain and 10 indicting worse pain imaginable).

During a record review of Pt 3's "Operative Report" (OP- a report written in a patient's medical record to document the details of a surgery), dated 12/20/22, the "OP" indicated, "DATE OF OPERATION: 12/19/22. PREOPERATIVE DIAGNOSIS: Ruptured globe [eyeball], right eye. POSTOPERATIVE DIAGNOSIS: Ruptured globe, right eye. OPERATIVE PROCEDURE: Exploration and repair of ruptured globe and repositioning of uveal (the middle part of the eye, lying beneath the sclera and cornea, comprising the iris, choroid, and ciliary body) contents, right eye."

During an interview on 1/6/23, at 12:40 p.m., with Surgery Procedural Assist (SPA) 1, SPA 1 stated, he was one of the SPA assigned to Pt 3 on 12/19/22. SPA 1 stated, his duties and responsibilities in the OR was to assist patient transfer from the hospital bed to the OR table and provide equipment and supplies as needed for the OR staff. SPA 1 stated, on 12/19/22 Pt 3 arrived to the OR on a hospital bed, and inside the OR room including him were Registered Nurse (RN) 16, RN 17, Surgical Technologist (ST) 1 and SPA 2. SPA 1 stated, the Surgeon (a physician that performs surgery) and the Anesthesiologist (a physician that administers anesthesia) were not in the OR at the time. SPA 1 stated, when the bed and OR table (a table in which the patient lies on during a surgical procedure) were positioned right next to one another, Pt 3 was instructed to move herself from the bed to the OR table. SPA 1 stated, Pt 3 was lying on the OR table in a supine position (lying on the back with face upward). SPA 1 stated, he was positioned at the head of the OR table, on Pt 3's left side, and SPA 2 was positioned at the head of the OR table, on Pt 3's right side. SPA 1 stated, RN 16 was at the desk documenting on the computer; RN 17 was at the foot of the OR table on Pt 3's left side putting a sequential compression device (SCD- a medical device use to improve blood flow to the leg) to Pt 3's leg, and ST 1 was at the foot of the OR table on Pt 3's right side. SPA 1 stated, SPA 2 transferred Pt 3's IV bag (a bag filled with solution used for intravenous infusion [into the vein]) from the IV pole that was attached to the hospital bed to the OR IV pole. SPA 1 stated, the OR IV pole was standing at the head of the OR table between him and SPA 2. SPA 1 stated, SPA 2 pushed the hospital bed away from the OR table, while Pt 3 turned his back from Pt 3 to set up the arm rest (a board used to rest patient's arm while on the OR table). SPA 1 stated, he heard a loud bang, and Pt 3 was yelling and crying. SPA 1 stated, he turned to look at Pt 3 and saw the IV pole had fallen onto Pt 3's face. SPA 1 stated, he immediately lifted the IV pole from Pt 3's face. SPA 1 stated, the IV pole was "very heavy." SPA 1 stated, attached to the IV pole was an IV Pump (a medical device used to deliver fluids into the patient's body in a controlled manner), an irrigation pump (a device used to deliver solution to wash an area of the body), and one IV bag. SPA 1 stated, when he lifted the IV pole off Pt 3, the base of the IV pole was "wobbly and unstable." SPA 1 stated, Pt 3's eye was bleeding and swollen. SPA 1 stated, everyone in the OR was responsible to ensure patient safety.

During an interview on 1/10/23, at 3:09 p.m., with SPA 2, SPA 2 stated, he was one of the SPA assigned to Pt 3 on 12/19/22. SPA 2 stated, his duties and responsibilities in the OR was to prepare the OR for surgical procedures, connect patients to the monitors, and transfer patients from the hospital bed to the OR table. SPA 2 stated, on 12/19/22 Pt 3 arrived at the OR on a hospital bed. SPA 2 stated, when the hospital bed and the OR table were positioned right next to each other, Pt 3 was transferred from the hospital bed to the OR table. SPA 2 stated, he then transferred the IV bag from the hospital bed IV pole to the OR IV pole. SPA 2 stated, he moved the hospital bed away from the OR table, and the IV pole fell on Pt 3's face. SPA 2 stated, he did not know how the IV pole fell on Pt 3. SPA 2 stated, "[IV pole] may have been top heavy." SPA 2 stated, it was important to ensure patient safety in the OR.

RN 16 and RN 17 were unavailable for interview.

During an interview on 3/23/23, 2:29 p.m., with RM 4, RM 4 stated, RM 4 was assigned to review the 12/19/22 incident in which the IV pole fell and injured Pt 3's right eye. RM 4 stated, all the OR staff in the OR during the time of the incident were interviewed. RM 4 stated, it was verified (confirmed) that Patient 3 was transferred to the OR table, SPA 2 hung one bag of IV fluid on to the IV pole, moved the bed on the right side of Pt 3 while SPA 1 on left side of Pt 3 was handling the arm board. SPA 2 stated, then they heard a loud crash, one of the top of the IV hook fell on Patient 3's right eye.

During an interview on 3/23/23, at 2:45 p.m., with the Director of Surgery (DOS), the DOS stated, the Surgeon, Anesthesiologist, RN, Surgical Technologist, and Surgery Procedural Assist could transfer an IV bag from one IV pole to another IV pole. The DOS stated, the end user (the person who uses a particular equipment or product) was the RN assigned to patient care and was responsible for the IV management. The DOS stated, it was the OR team's responsibility to ensure patient safety in the OR. The DOS stated, after the incident which the IV pole fell on Patient 3's face and injured her right eye, the OR department removed all IV poles with a four wheel base and was replaced with a 5 wheel base to ensure stability.

During a concurrent interview and record on 3/23/23, at 2:50 p.m., with the Director of Clinical Engineering (DCE), the "IV Pole Stability Testing," dated 1/30/23, was reviewed. The test used the IV pole which fell and struck Patient 3 in the right eye. The "IV Pole Stability Testing" indicated ..."Fully loaded. IV pole placed on 5-10 degree grade (platform raised at an angle) and casters (wheels) locked: IV pole does not move. IV bag swung on knob: IV pole does not move. IV bag tugged on: IV pole tips. IV tubing pulled on: IV pole tips." The DCE stated, the IV pole passed multiple test and inspection. The DCE stated, the IV pole tipped when the IV bag tubing was tugged on. The DCE stated, the hospital removed all IV poles with 4 wheelbase and replaced the IV poles with [brand name] IV pole to standardize use with clearer manufacturer instructions for use (MIFU). The DCE stated, the hospital was unable to obtain the MIFU for the IV pole which injured Patient 3's right eye.

During an interview on 3/24/23, at 9:55 a.m., with RN 18, RN 18 stated, the primary responsibility of the OR RN was patient safety; make sure the patient was safe throughout the surgical procedure from arrival in the OR to discharge from the OR. RN 18 stated, the priority is the patient. RN 18 stated, OR RNs would transport patient from the Preop (an area where patient's are prepared for surgery) to the OR. RN 18 stated, once the patient arrived in the OR, the OR staff will introduce themselves to the patient. RN 18 stated, the Surgeon and Anesthesiologist were not always in the OR during the arrival of the patient to the OR, but the OR RN should be with the patient. RN 18 stated, the patient would be transferred to OR table and the Anesthesiologist would be at head the of the OR table and the OR nurse at the side of the patient. RN 18 stated, the OR nurse and the Anesthesiologist were responsible to safely transfer the patient to the OR table, and ensure IV lines was secured and free from kinks, knots and entanglement to avoid getting caught and pulled unintentionally.

During an interview on 3/24/23, at 11:36 a.m., with RN 19, RN 19 stated, the responsibility of the OR RN was to provide safe patient care throughout the surgical process. RN 19 stated, the OR RN was responsible to ensure all lines and drains were free from getting pulled unintentionally. RN 19 stated, the OR RN should have been handling the IV bag during patient transfer from the hospital bed to the OR table. RN 19 stated, the IV pole should be stable, have a wide base, and the weight of the IV pump, and IV bag attached to the IV pole should be evenly distributed to prevent the IV pole from tipping over and hitting and injuring the patient. RN 19 stated, the previous IV poles which caused the injury to Pt 3 were replaced because it did not have a wide base in comparison to the new IV poles.

During an interview on 3/27/23, at 2:37 p.m., with the Chair of Surgical Services and Pathology (CSSP), the CSSP stated, the priority in the surgical services department was patient safety. The CSSP stated, the OR staff consisted of the Surgeon and/or Physician Assistant, Circulating (OR) RN, Surgical Technologist, and the Anesthesiologist. The CSSP stated, SPA were assistants that retrieve supplies and equipment and assist the OR staff as needed. The CSSP stated, the transfer of patient from the bed to the OR table was a collective effort of all OR staff involved. The CSSP stated, he was made aware of the IV pole which fell and injured Patient 3's right eye on 12/19/22. The CSSP stated, the incident was avoidable. The CSSP stated, OR staff needed to be vigilant (alert) with lines and drains connected to the patient to make sure they were secure. The CSSP stated, an investigation was conducted of the incident and the data was analyze and concluded the OR staff was not vigilant during the transfer of Patient 3 from the bed to the OR table.

During an interveiw on 3/27/23, at 10:15 a.m., with Risk Manager (RM) 4, RM 4 stated, the stainless-steel IV pole which fell and struck Patient 3's right eye on 12/19/22 measured 78.5 inches (unit of measurement) in height. RM 4 stated, the bottom of the IV pole had 5 wheels which measured 20 inches wide in diameter (side to side measurement in a circular format). RM 4 stated, the top of the pole had 6 hooks for hanging IV bags. RM 4 stated, the IV pump mounted to the IV pole was measured at 54 inches from the floor and had two channels on each side. RM 4 stated, the Irrigation pump mounted to the IV pole on top of the IV pump was measured at 63.5 inches from floor. RM 4 stated, the weight of the IV bag was 2.3 lbs. (pounds unit of measure). RM 4 stated, the weight of the Irrigation pump was 4.4 lbs. RM 5 stated, the weight of the IV pump with two channels was 13.2 lbs. RM 4 stated, the entire set up without the IV bag was 44.6 lbs.

During an interview on 3/28/23, at 1:26 p.m., with the Director of Risk Management and Patient Safety (DRM), the DRM stated, the adverse event (an event that should not have happened) that occurred on 12/19/22 in which the IV pole in the OR fell and injured Patient 3's right eye was avoidable. The DRM stated, "it was the lack of situational awareness." The DRM stated, the OR staff did not take into account the environment surrounding Patient 3, the IV tubing, and equipment surrounding the bed and OR table. The DRM stated, "there was no formalized process in clinical policy for assessment and awareness of the OR environment during the transfer of Patient 3 in order to ensure Patient 3's safety."

During a review of the hospital's policy and procedure (P&P) titled, "Patient's Rights and Responsibilities," dated 2/10/22, the P&P indicated, " ...IV. Patient Rights ... the hospital shall provide processes to support the following patient rights: ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, fr

Based on interviews, and record reviews, the facility failed to meet the Condition of Participation for Nursing Services, when:

1. Eight of ten sampled patients (Patient 1, 24, 26, 27, 34, 35, 36, and 37) received labor epidurals (a procedure used to control pain during childbirth) during labor and the labor epidural assessments were not documented according to the hospital's policy while the epidural was infusing.

This failure had the potential for complications from the labor epidural not assessed which includes dislodgement (to remove from a fixed position), inadequate pain control, permanent nerve damage and persistent numbness and tingling.

2. Two of ten sampled patients (Patient 1 and Patient 35) did not have puncture (a small hole in the skin) wound site assessments from the epidural catheter site after the removal of the labor epidural catheter.

This failure had the potential for complications from the epidural site not assessed which includes infection, hematoma (blood clot), and pain.

3. One of ten sampled patients (Patient 9's) urine analysis (a test used to check the appearance, concentration, and content of urine) and urine tox screen (a test used to determine traces of drugs in the urine) STAT (immediately) physician order was not obtained and processed.

This failure had the potential for PT 9, a known polysubstance user (the use of more than one drug) with altered mental status (AMS- a change in mental function) to undergo sedation (the use of drugs to induced calmness and sleep) without knowing the drugs PT 9 took prior to coming to the emergency department which placed PT 9 at risk for adverse drug interaction (unintended harmful reactions attributed to the use of medications).

The cumulative effect of these systemic problems resulted in the nursing department's inability to ensure the provision of quality health care in a safe environment and in compliance with the Condition of Participation for Nursing Services.


45929

Based on interview and record review, the hospital failed to ensure registered nurses were following the hospital's policies and procedures when:

1. Eight of 10 patients (Patient 1, 24, 26, 27, 34, 35, 36, and 37) when Patient 1, 24, 26, 27, 34, 35, 36, and 37 received labor epidurals (a procedure used to control pain during childbirth) during labor and the labor epidural assessments were not documented according to the hospital's policy while the epidural was infusing.

This failure had the potential for complications from the labor epidural not assessed which includes dislodgement (to remove from a fixed position), inadequate pain control, permanent nerve damage and persistent numbness and tingling.

2. Two of 10 patients (Patient 1 and 35) when Patient 1 and Patient 35 did not have puncture (a small hole in the skin) wound site assessments from the epidural catheter site after the removal of the labor epidural catheter.

This failure had the potential for complications from the epidural site not assessed which includes infection, hematoma (blood clot), and pain.

3. One of 10 sampled patients, when Patient (PT) 9's urine analysis (a test used to check the appearance, concentration, and content of urine) and urine tox screen (a test used to determine traces of drugs in the urine) STAT (immediately) physician order was not obtained and processed.

This failure had the potential for PT 9, a known polysubstance user (the use of more than one drug) with altered mental status (AMS- a change in mental function) to undergo sedation (the use of drugs to induced calmness and sleep) without knowing the drugs PT 9 took prior to coming to the emergency department which placed PT 9 at risk for adverse drug interaction (unintended harmful reactions attributed to the use of medications).

Findings:

1. During a concurrent interview and record review on 3/23/23, at 10:30 a.m., with the Perinatal Educator (PE), Patient (Pt) 24's electronic health record (EHR), dated 3/17/23 was reviewed. The anesthesia (the use of drugs to prevent pain during surgery and other procedures) record indicated, on 3/17/23 at 4:17 p.m., a labor epidural containing fentanyl (an opiate pain medication) and bupivacaine (a numbing medication) was administered by the anesthesiologist (Medical Doctor [MD 17]-a doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures). The anesthesia record indicated, Pt 24's labor did not progress and on 3/18/23 at 8:48 a.m. the baby was born by cesarean section (the surgical delivery of a baby through a cut made in the mother's abdomen), utilizing the epidural for anesthesia during surgery. The anesthesia record indicated, on 3/18/23 at 12 p.m., Pt 24's epidural catheter was removed. During a review of Pt 24's "Lines, Drains, and Airways (LDA)" flowsheet, dated 3/17/23- 3/18/23, the LDA flowsheet indicated, there was no documented epidural "Safety Check" assessment completed and was verified by the PE.
The PE stated the Safety Check assessment consisted of epidural catheter status, site assessment, dressing type, patient sensory testing, and side effects, should have been completed.

During a concurrent interview and record review on 3/23/23, at 10:40 a.m., with the PE, Pt 26's EHR, dated 10/28/22, was reviewed. The anesthesia record indicated, on 10/28/22 at 8:15 p.m., a labor epidural containing fentanyl and bupivacaine was administered by the anesthesiologist (MD 18). The record indicated, the baby was born on 10/29/22 at 12:30 a.m., and at 2:10 a.m. Pt 26's epidural catheter was removed. During a review of Pt 26's LDA flowsheet, dated 10/28/22- 10/29/22, the PE stated the epidural "Safety Check" assessment was not completed and should have been completed.

During a concurrent interview and record review on 3/23/23, at 10:45 a.m., with the PE, Pt 27's EHR, dated 10/25/22, was reviewed. The anesthesia record indicated, on 10/25/22 at 8:30 a.m., a labor epidural containing fentanyl and bupivacaine was initiated by the anesthesiologist (MD 11). The record indicated, Pt 27 delivered a baby on 10/25/22 at 2:28 p.m., and at 5:15 p.m. Pt 27's epidural catheter was removed. During a review of Pt 27's LDA flowsheet dated 10/25/22, the PE stated the epidural "Safety Check" assessment was not completed and should have been completed.

During a record review on 3/24/23, at 10:55 a.m., with the Post-Partum Manager (PPM), Pt 1's EHR, was reviewed. The anesthesia record indicated, on 11/23/22 at 4:11 p.m., a labor epidural was initiated by the anesthesiologist (MD 12). The record indicated, Pt 1 delivered the baby on 11/24/22 at 7:44 p.m., and at 10 p.m. Pt 1's epidural catheter was removed.

During a concurrent interview and record review on 3/24/22, at 10:57 a.m., with the PPM, Pt 1's LDA flowsheet, dated 11/23/22 to 11/24/22 was reviewed. The LDA flowsheet indicated, there was no documented epidural "Safety Check" assessment completed when the labor epidural was initiated and while the epidural was infusing. The LDA flowsheet indicated there was no initial pain assessment when the labor epidural was initiated. The PPM stated the first pain assessment documented after the labor epidural was placed, was on 11/23/22 at 8:29 p.m. The PPM stated, Pt 1 had a pain assessment on 11/24/22 at 8:15 a.m. and the reassessment of Pt 1's pain was not reassessed until 10 a.m. The PPM stated intravenous (IV-into a vein) pain medications should be assessed sooner but within an hour and oral (by mouth) medications should be reassessed within an hour. The PPM stated, Pt 1's pain reassessment was not documented within an hour. The PPM stated the importance of reassessing pain was because pain was the fifth vital sign and could indicate tissue damage and continuous pain. The PPM stated, when pain medications were administered, the pain reassessment would determine if the medication was adequate for pain relief.

During a concurrent interview and record review on 3/24/23, at 11:44 a.m., with Clinical Nurse Supervisor (CNS) 1, Pt 1's EHR, dated 11/24/22 was reviewed. CNS 1 stated once the labor epidural was placed, vital signs monitoring included the patient's heart rate, blood pressure, and oxygen saturation (a measure of how much oxygen was in your blood) every 15 minutes for an hour then every 30 minutes thereafter. CNS 1 stated, the patient's pain was assessed after the epidural was initially placed and then every hour. CNS 1 stated, the epidural assessment should be done at shift change (the time during the workday when one group of health care providers arrives for work and another group prepares to leave) and hand off (transfer of patient care) to another nurse.

During an interview on 3/24/23, at 12 p.m., with CNS 1, CNS 1 stated, pain reassessment should be assessed within an hour of pain medications administered whether the medication was administered orally or IV. CNS 1 stated, the importance of assessing and reassessing pain was to make sure the patient was comfortable and had less pain. CNS 1 stated, if the patient's pain was not reassessed within an hour, the patient could become more stressed, causing a decrease in oxygen (a gas essential for humans to survive) to the fetus (an unborn offspring), which could cause decelerations (temporary decreases (to become less) in the fetal (fetus) heart rate during labor).

During an interview on 3/24/23, at 12:08 p.m., with CNS 1, CNS 1 stated, the importance of assessing the labor epidural site was to make sure the epidural was still in place, not leaking, bleeding or dislodged. CNS 1 stated, if the epidural "Safety Check" assessment was not assessed, there was a possibility the tape was not holding the epidural catheter in place, and this could cause the patient to start complaining of pain due to not receiving medications to relieve their pain.

During a concurrent interview and record review on 3/27/23, at 2:17 p.m., with the Assistant Chief Nursing Officer (ACNO), the hospital's P&P titled, "Epidural Injections & Continuous Infusions," dated 10/13/22 was reviewed. The P&P indicated: " ...The RN [registered nurse] will document the following in the EHR: 1. "Epidural" infusion on the MAR [medication administration record] and also under Lines, Drains, and Airway (LDA) section of the EHR...4. Every shift and at times of patient Hand-Off: a. Patency and integrity of catheter. b. Patient assessment and effect of infusion. c. Drug dose (if continuous infusion) and total amount infused in the MAR d. Number of bolus (a single dose of a drug given over a short period of time) or patient demand doses in the MAR. e. Rate of infusion and total infused for shift ...vitals and sedation level ...adequacy of pain control on a pain scale ...any epidural infusion side effects and patient response to interventions ..." The ACNO stated, the epidural assessments should be documented per policy and reflect accurately what was being done for the patient.

During an interview on 3/27/23, at 2:30 p.m., with the ACNO, the ACNO stated, it was important to document the vital signs (measurements of the body's most basic functions) to get a baseline, monitor the patient's response to the procedure and reporting abnormal findings to the provider. The ACNO stated, the Registered Nurses should have been monitoring and documenting vital signs per physician orders to respond to abnormal findings and was not.

During a record review of Pt 35's "LDA flowsheet", dated 3/20/23, the LDA flowsheet indicated, on 3/20/23 at 9:08 a.m., a labor epidural was initiated by (MD 19). The LDA flowsheet indicated, the labor epidural was removed on 3/20/23 at 12:22 p.m. The LDA flowsheet indicated there were no documented epidural "Safety Check" assessments from the time the labor epidural was initiated until the removal of the labor epidural. The LDA flowsheet indicated, the pain assessments were not documented at initiation of the labor epidural and the documented pain assessments were not documented according to the hospital's policy.

During an interview on 3/27/23, at 4:28 p.m., with Registered Nurse (RN) 26, RN 26 stated, there was an area in flowsheets where she documented the labor epidural assessments. RN 26 stated, the labor epidural was assessed initially and every four hours while the epidural was infusing. RN 26 stated, once the labor epidural was inserted, the vital signs frequency should be documented every three minutes for 15 minutes, every 15 minutes for an hour and then every 30 minutes for the duration of the epidural.

During an interview on 3/27/23, at 5:11 p.m., with RN 25, RN 25 stated, when her patient had a continuous epidural, she documented the epidural "Safety Check" assessment every shift to check for leaking, bruising, swelling or if the epidural was dislodged when the patient repositioned. RN 25 stated, the labor epidural vital signs assessments were documented every 15 minutes for the first two hours then every 30 minutes once the labor epidural was inserted.

During a concurrent interview and record review on 3/28/23, 10:48 a.m., with RN 25, Pt 34's EHR, dated 3/27/23 was reviewed. The LDA flowsheet indicated on 3/27/23 at 4:14 p.m., a labor epidural was administered by the anesthesiologist (MD 20). The record indicated, Pt 34's labor epidural catheter was removed on 3/28/23 at 3:43 a.m. During a review of Pt 34's LDA flowsheet, dated 3/27/23 to 3/28/23, the flowsheet indicated, the pain assessments were not documented according to the policy which should be documented every 30 minutes while the labor epidural was infusing. RN 25 stated, she did not know she had to document the patient's pain assessments with the vital signs when the labor epidural was initiated. RN 25 stated, if the pain assessments were not documented, the pain assessments were considered not assessed. RN 25 stated, the importance of documenting the patient's pain with their vital signs was to determine if the labor epidural was effective in treating the patient's pain.

During a concurrent interview and record review on 3/28/23, at 11 a.m., with RN 25, Pt 36's EHR, dated 3/28/23 was reviewed. The LDA flowsheet indicated, on 3/28/23 at 8:30 a.m., a labor epidural was administered by the anesthesiologist (MD 19). The record indicated; Pt 36's labor epidural was still infusing at 12:30 p.m. During a review of Pt 36's LDA flowsheet, RN 25 did not find Pt 36's pain assessments. RN 25 stated Pt 36's pain assessment should have been documented according to the facility policy .

During a concurrent interview and record review on 3/28/23, at 11:15 a.m., with RN 25, Pt 37's EHR, dated 3/28/23 was reviewed. The LDA flowsheet indicated, on 3/28/23 at 2:40 a.m., a labor epidural was administered by the anesthesiologist (MD 20). The LDA flowsheet indicated, the labor epidural was still infusing at 11:30 a.m. on 3/28/23. RN 25 stated, the first documented epidural "Safety Check" assessment was at 8 a.m. and was not documented initially when the epidural was administered. RN 25 stated, the epidural "Safety Check" assessment should have been documented initially and every four hours while the epidural was infusing. RN 25 stated, the pain assessment was not documented when the epidural was administered and should have been documented per the hospital's policy.

2. During a concurrent interview and record review on 3/27/23, at 2:25 p.m., with the ACNO, the hospital's P&P titled, "Epidural Injections & Continuous Infusions," dated 10/13/22 was reviewed. The P&P indicated: " ...After removal, discontinue line documentation in EHR and initiate a Puncture Wound to document post removal site assessments ..." The ACNO stated, the epidural assessments should have been documented per hospital policy and procedure.

During an interview on 3/28/23, at 11:25 a.m., with RN 25, RN 25 stated, once the labor epidural was removed, she would need to add an LDA for Puncture Wound site to continue assessing the epidural injection site for complications.

During a concurrent interview and record review on 3/28/23, at 11:30 a.m., with the ACNO, Pt 35's EHR, dated 3/20/23 was reviewed. The LDA flowsheet indicated, on 3/20/23 at 12:22 p.m., Pt 35's labor epidural catheter was removed. The ACNO did not find epidural puncture wound site assessment, and stated Pt 35's epidural site was not assessed from the time Pt 35's epidural catheter was removed until Pt 35's discharged on 3/21/23. The ACNO stated the epidural puncture site should have been assessed.

During a concurrent interview and record review on 3/28/23, at 11:35 a.m., with the ACNO, Pt 1's EHR, dated 11/24/22 was reviewed. The LDA flowsheet indicated, on 11/24/22 at 10 p.m., Pt 1's labor epidural catheter was removed. The ACNO stated, there was no epidural puncture wound site assessment to evaluate the epidural site from the time it was discontinued until Pt 1 was discharged on 12/1/22. The ACO stated, the expectations were for the RNs to assessed and document the epidural puncture site per the hospital's policies and procedures. The ACNO stated, the RNs should document their assessments even if the assessments were within normal limits. The ACNO stated, the vital signs, pain, and epidural assessments should be documented every four hours. The ACNO stated, clinical supervisors and directors was responsible to ensure RNs were assessing and documenting according to hospital policies and procedures. The ACNO stated, the importance of assessment and documentation of the epidural puncture wound site assessment was to ensure the patient's epidural sites were assessed and the medical records was accurate.

During a review of the hospital's P&P titled, "Epidural Injections & Continuous Infusions," dated 10/13/22, the P&P indicated, " ...To provide guidelines for effective and safe care of patient with epidural analgesia (a process of relieving or reducing pain) and anesthesia ...the RN will position patients with labor epidurals in a manner that facilitates uterine ( a hollow, pear shape organ in a woman's pelvis) displacement to the right or left and prevents supine (lying on the back) hypotension [abnormally low blood pressure] ...Follow Labor Epidural Analgesia order set for monitoring/assessment frequency of pulse, respirations, blood pressure, neurovascular checks and analgesic effect on pain ...The RN will assess transparent epidural site dressing for integrity every 4 hours ...The RN will assess catheter site for redness, swelling or unusual bleeding and hematoma every 4 hours ..."

During a review of the hospital's order sets (OS) titled, "Labor Epidural Analgesia Order," dated 2/7/23, the OS indicated, " ...Vital Signs: For continuous epidural infusion, after initiation of epidural, with each epidural medication bolus or rate increase: blood pressure, heart rate, analgesic effect on pain and respiratory rate every 3 min x5 (15 minutes) then every 15 minutes x4, then every 30 minutes for the duration of the epidural infusion. Once epidural infusion has been terminated, continue to monitor maternal blood pressure and heart rate every 15 min for one hour ...Neurovascular (relating to the nerves and blood vessels) checks/sensory function every 4 hours ... pulse oximetry (a noninvasive method of monitoring a person's oxygen saturation (is a measure of how much oxygen in the blood): Record oxygen saturation hourly by clinical staff ..."

During a review of the hospital's P&P titled, "Pain Assessment & Management-Patients 14 and Older," dated 4/8/21, the P&P indicated, " ...To establish standards of nursing care and practice that defines the role and responsibilities of the Registered Nurse (RN) to provide pain management at all facilities within the [hospital's name] hospital system ...minimize the incidence and severity of acute and chronic pain, and promote patient comfort ...Pain is whatever the experiencing person says it is ...assess and reassess pain using ...scales as appropriate ...a. 0-10 pain intensity scale ...Evaluation/Reassessment of Pain Management ...Patients receiving oral pain medication are reassessed within 60 minutes after administration of oral pain medication, and patients receiving intravenous pain medication are reassessed within 30 minutes after administration of intravenous pain medication ...Document ...EHR ...1. If pain is identified as an issue, the initial assessment will include pain intensity (0-10), verbal pain descriptors, or the behavioral pain score, patient's acceptable level of pain, location, quality, duration, and any associated symptoms. 2. Subsequent reassessments should include ...intensity, location, response to treatment modalities, and type of pain assessment scale used ..."

During a professional reference review from Lippincott Williams & Wilkins, Inc., an article titled, "Epidural analgesia: What nurses need to know," dated 8/2012, the article indicated, "...Closely monitor patients receiving epidural analgesia, including vital signs, pain intensity rating, sedation score, and degree of motor and sensory block...Assess the patient for signs and symptoms of complications associated with the use of epidural analgesia including hypotension, nausea and vomiting, urinary retention (difficulty urinating and emptying the bladder), and motor block (weakness in the legs)...Assess sensory and motor function to determine the level of analgesia and to quickly identify possible complications such as dural (the tough outer layer tissue that covers the spinal cord (is a long tube like band tissue that connects the brain to the lower back) penetration of the catheter or epidural hematoma (a pool of clotted blood that forms in a tissue) or abscess (swollen area within body tissue containing a pus)...The epidural catheter-site dressing, which isn't routinely changed, should remain clean, dry, and intact. Notify the anesthesia provider of any abnormalities, such as drainage, that may indicate Cerebrospinal fluid (CSF - clear colorless body fluid that surrounds the brain and spinal cord) or catheter dislodgment. If you suspect a complication related to the epidural analgesia infusion, stop it and contact the anesthesia provider or pain management team immediately...When administering epidural analgesics, performing an independent double check at the bedside to verify the patient, drug, dose and concentration, administration route, and rate of administration will help to prevent errors..."

During a professional reference review from the University of Southern Mississippi, an article titled, "Continuous Epidural Analgesia for Postoperative Pain Management: A Policy Analysis," dated 9/28/18, the article indicated, "...Although extremely effective, epidural analgesia can result in serious complications if medications are not carefully administered and if pain and neurological status are not closely assessed...In the postoperative period, nurses are responsible for managing epidurals and appropriately assessing the patient ' s pain. Therefore, nurses should be appropriately educated and trained on epidural analgesia...Epidural analgesia is associated with fewer side effects than alternative pain management techniques; however, when epidural catheters are managed improperly or pain is inadequately assessed, epidural anesthesia fails to provide the pain relief that is vital to patient recovery... inappropriate pain assessment was one of the most significant obstacles to patients achieving adequate postoperative pain control...Vital signs, pain assessments, epidural catheter status, and insertion site must be evaluated at regular, predetermined intervals..."



45929

3. During a review of PT 9's "Diagnoses List" (DL), the "DL" (undated) indicated, PT 9 was admitted to the facility with diagnoses which included polysubstance abuse, untreated hepatitis (an infection of the liver), and bradycardia (slow heart rate).

During a review of PT 9's "Patient Care Timeline" (PCT), dated 3/18/23, the "PCT" indicated, PT 9 arrived at the Emergency Department (ED) on 3/18/23, at 1:11 p.m. with a chief complaint of AMS, drowsiness, jaundice (yellow skin, caused by the liver not working properly), and disclosed the use of alprazolam (a drug used to treat anxiety and panic attacks) to treat his stomach pain which started a few days ago.

During a review of PT 9's "Physician Orders" (PO), dated 3/18/23, at 1:51 p.m., the "PO" indicated, an order for urine analysis (UA) and urine tox screen STAT.

During a concurrent interview and record review on 3/24/23, at 9:55 a.m., with Emergency Department Manager (EDM), PT 9's "PO", dated 3/18/23 at 1:51 p.m., was reviewed. The "PO" indicated Urine Drugs of Abuse Screen (UDAS) STAT. The EDM stated, the UDAS STAT order was auto canceled on 3/23/23, at 1:05 a.m. PT 9's "PCT", dated 3/18/23, was reviewed. The "PCT" indicated, PT 9's urine specimen was collected at 1:51 p.m. The EDM stated, she could not find the results for PT 9's urine specimen. The EDM stated, she did not know what happened to PT 9's UDAS result.

During a concurrent interview and record review, on 3/24/23, at 11:47 a.m., with the Manager of Laboratory (MLAB), PT 9's "PO," dated 3/18/23 was reviewed. The MLAB stated when the laboratory department receives a urine specimen, the specimen would be logged with the date, and time of arrival, and entered in the laboratory processing system. The MLAB stated the laboratory department had no record of receiving PT 9's UDAS. The MLAB stated PT 9's UDAS would automatically cancel within the fifth day from the physician's order.

During a concurrent interview and record review on 3/24/23, at 2:00 p.m., with the EDM, the EDM stated, orders in [EMR brand] showed up on the nurses' task list and if someone accidentally clicked on the specific task on the list, the task disappears from the list. The EDM stated, clicking on the specimen order on the task list would also generate a specimen ID number. PT 9's PCT, dated 3/18/23 was reviewed. The EDM stated, the time of the urine tox screen order was 1:51 p.m. and the specimen collection creating the specimen ID was at 1:51 p.m. The EDM stated, Registered Nurse (RN) 14 was caring for the patient and orienting RN 13. The EDM stated, she spoke to RN 14, who stated RN 13 and RN 14 did not collect a urine specimen on their shift, which ended at midnight on 3/18/23, as PT 9 was unable to urinate. The EDM stated, it was safe to assume the task for urine specimen was removed from the nurses' task list and specimen ID created in error.

During a concurrent interview and record review on 2/27/23, at 2:09 p.m., with Registered Nurse Clinical Supervisor (RNCS) 1 for the ED, RNCS 1 reviewed PT 9's "PO", dated 3/18/23, at 1:51 p.m. The "PO" indicated UDAS STAT. The facility Policy and Procedure (P&P), titled, "Provides Orders", dated 12/13/22 was reviewed. The "P&P" indicated, " ... STAT ... tests, studies or procedures are initiated and finalized within 1 hour of the request ...". RNCS 1 stated PT 9's UDAS was ordered STAT and should have been completed within one hour of the order. RNCS 1 stated the P&P was not followed. RNCS 1 stated, PT 9 could have experienced adverse drug interactions from the unknown medications PT 9 used prior to coming to the emergency department in combination with medications used for sedation for a procedure PT 9 had on 3/19/23 at 10:22 a.m.

During a review of PT 9's PCT, dated 3/19/23, the PCA indicated, anesthesia for PT 9's procedure was started on 3/19/23, at 10:22 a.m. (21 hours and 11 minutes after PT 9's arrival to the ED).

During a review of a professional reference, titled "Anesthesia", retrieved from https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/types-of-anesthesia-and-your-anesthesiologist, undated, the Professional reference indicated, " ...There are various forms of anesthesia. The type of anesthesia you get will depend on the type of surgery and your medical condition. Sedatives (to make you sleepy) and analgesics (to ease the pain) may also be used as part of the anesthesia process ... Local anesthesia is an anesthetic agent given to temporarily stop the sense of pain in a particular area of the body. You remain conscious during a local anesthetic ... Regional anesthesia is used to numb only the portion of the body ... General anesthesia is an anesthetic used to induce unconsciousness ... Use of street drugs (such as marijuana, cocaine, or amphetamines). People are often reluctant to disclose the use of illegal drug, but you should remember that all conversations between you and your surgeon and anesthesiologist are confidential. It is crucial that he or she know about your past, recent, and current use of these substances, as these drugs can effect healing, and responses to anesthesia. It is important to keep in mind that the only interest your doctor has in this information is learning enough about your physical condition to provide you with the safest anesthesia possible.

During a review of a professional reference, "Alcohol & recreational drug use: Will it help or hurt with anesthesia before surgery?" (ARDU), dated 2021, retrieved from https://johnparkmd.com/alcohol-recreational-drug-use-will-it-help-or-hurt-with-anesthesia-before surgery/#:~:text=Some%20recreational%20drugs%20slow%20breathing,heart%20rate%20and%20nervous%20system, the ARDU indicated, " ... Some recreational drugs slow breathing and heart rate. Some cases can prove toxic or fatal if these drugs are still in the system and combined with anesthesia. The opposite can happen for drugs like cocaine, LSD, and ecstasy, which accelerate the heart rate and nervous system. The result can be dangerous swings in blood pressure both before and after surgery... anesthesia involves powerful drugs that suppress functions such as breathing, heart rate, and circulation. The liver must metabolize [process] all these substances, which may not be able to keep up with anesthesia. Patients who fail to stop or disclose drug or alcohol use risk severe complications ..."

Based on observations, interviews and record review, the facility failed to ensure food was stored in accordance with professional standard of practice when one of eight nutrition supply carts stored three enteral liquid formula (a liquid nutrient-rich formula which flows through a tube into one's stomach) bottles past the "use by" date (the last date recommended for the use for the product while at peak quality) ready for patient use.

These failures resulted in the potential for patients to receive a diminished quality feeding and place patients at risk for food borne illness.

Findings:

During a concurrent observation and interview on 3/20/23, at 3:20 p.m., with Registered Nurse Manager (RNM) 1, in the fourth-floor medical surgical unit (an area in the hospital which provides care to adults with a wide variety of medical conditions) nutrition room, the nutrition supply cart stored three bottles of two types of enteral liquid nutrition with a used by date of 3/1/23. RNM 1 stated, the Materials Management Department staff stocked the enteral liquid formula on the cart.

During an interview on 3/21/23, at 2:41 p.m., with the Material Management Supervisor (MMS), the MMS stated, the Materials Distribution Technicians (MDT) stocked each nutrition room with enteral liquid formula and arranged the enteral liquid formula on the cart with the oldest units in the inventory to the front to be used first for patients and the newest inventory in the back. The MMS stated, the inventory is checked for the use by date every time the inventory items are touched. The MMS stated, the MDTs should have checked all supply carts twice a month to remove the past used by date and near used by date. The MMS stated the Material Management leaders perform random checks of the carts for food items near or past the use by date.

During a concurrent interview and record review on 3/21/23, at 2:45 p.m., with the MMS, the MMS reviewed the photos of the enteral liquid formula bottles with the use by date of 3/1/23 stored on the nutrition supply cart on 3/20/23. The MMS stated, the enteral liquid formula should have been removed from the cart by the week of 2/27/23.

During an interview on 3/22/23, at 10:05 a.m., with MDT 1, MDT 1 stated, the use by date for food items stored on the nutrition supply carts should be checked twice a month and food items with a past or near use by dates should be removed. MDT 1 reviewed the photos of the enteral liquid formula with a use by date of 3/1/23 stored on the nutrition supply cart on 3/20/23 and stated, the enteral liquid formulas should have been removed.

During an interview on 3/23/23, at 10:58 a.m., with Registered Nurse Clinical Supervisor (RNCS) 2, RNCS 2 stated, the enteral liquid formula past the use by date had lost its quality and patients who consumed the enteral liquid formula could experience nausea, vomiting, or abdominal cramps. RNCS 2 stated, the enteral liquid formulas with a use by date of 3/1/23 stored on the nutrition room supply cart on 3/20/23 should have been removed from the cart.

During an interview on 3/23/23, at 11:00 a.m., with Registered Nurse Manager (RNM) 1, RNM 1 stated, the expectation was for the RNCS to perform daily checks and remove food items past the use by date to prevent being given to a patient. RNM 1 stated, the enteral liquid formulas marked with a use by date of 3/1/23 stored on the nutrition supply cart on 3/20/23 were missed.

During an interview on 3/23/23, at 4:26 p.m., with the Material Management Manger (MMM), the MMM stated, the MDTs failed to check the use by date for enteral liquid formula stored in the nourishment room.

During a review of a professional reference, "Food Product Dating" (FPD), dated 10/2/19, retrieved from https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-product-dating, FPD indicated, " ... A 'Use-By' date is the last date recommended for the use of the product while a peak quality..."

During a review of a professional reference, "Best before and use-by dates" (BBUBD), dated 1/20/23, retrieved from https://www.food.gov.uk/safety-hygiene/best-before-and-use-by-dates, BBUBD indicated, " ... A use-by date on food is about safety. This is the most important date to remember. Never eat food after the use-by date... it could make you very ill ..."

Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment according to hospital's policy and procedure, titled, "Hazardous Materials and Waste Management Plan," and CDC's standards of practice for infection control when three of four emergency department soiled utility room (a room designated to store waste products) had used bedpans (a container used to collect urine and feces), urinals (a container used to collect urine), were inside a biohazard bin not contained inside a biohazard bag, and a used sanitary wipes (premoistened towelettes used to clean the skin after bowel movement) were found inside a regular trash bin not contained inside a trash bag.

This failure had the potential for cross contamination to patient and staff to biohazard waste (any biological or chemical substance that is dangerous to humans, animals, or the environment. This can include body fluids, human tissue and blood) which can lead to infection and diseases.

Findings:

During a concurrent observation and interview on 3/20/23, at 11:40 a.m., with EDM, in the ED Yellow East Zone soiled utility room, there were two used bedpans and three used urinals in the biohazard bin not contained inside a biohazard bag. The EDM stated, the used bed pans and urinals should have been contained inside a biohazard bag prior to transport to the soiled utility room and discarded inside the biohazard bag.

During a concurrent observation and interview on 3/20/23, at 12:00 p.m., with EDM, in the ED Red Zone soiled utility room, there was one used bedpan and used sanitary wipes with brown sediments in the regular trash bin not contained inside a biohazard bag. The EDM stated, the used bed pans and sanitary wipes with brown sediments should have been contained inside a biohazard bag prior to transport to the soiled utility room and discarded inside the biohazard bin.

During an interview on 3/20/23, at 12:15 p.m., with PCT 1, PCT 1 stated, the used bedpans and urinals should have been contained inside a biohazard bag prior to transport to the soiled utility room and discarded inside the biohazard bin. PCT 1 stated, the biohazard waste should be contained at the site of origin to minimize exposure of biohazardous waste to patients and staff and prevent the spread of infection.

During an interview on 3/24/23, at 9:16 a.m., with the Director for Infection Prevention (DIP), the DIP stated, biohazard bins were distinct receptacle for securing biohazardous waste for proper disposable. The DIP stated, biohazardous waste included blood products and infectious waste (type of waste that contains blood, fluids from blood products or components used in treatment of human that may be contaminated or infected with a disease). The DIP stated, biohazardous waste should be securely placed inside a biohazard bag prior to discarding inside the biohazard bins to avoid potential exposure to patients. The DIP stated, biohazard exposure could cause pathogenic (infectious) illness to patients.

During an interview on 3/24/23, 9:20 a.m., with the Infection Preventionist (IP), IP stated, bodily fluid such as stool (feces), urine, bodily secretions (saliva, tears, sweat, etc.) were identified as infectious or non-infectious. IP stated, non-infectious waste can be discarded in regular trash bins. IP stated, biohazardous wastes should be securely contained. Non-infectious patient waste solids (stool) should be disposed of in a hopper (toilet) closest to the patient. IP stated, if a hopper was not available, the waste needed to be securely contained and discarded in the closest hopper. Non-infectious waste such as sanitary wipes can be discarded in a regular trash bin in the patient's room. IP stated, all waste product requiring disposable to the utility room need to be securely contained to minimize exposure to prevent spread of infection.

During a review of the hospital's policy and procedure (P&P) titled, "Hazardous Materials and Waste Management Plan," dated 12/9/22, the P&P indicated, "I. Objectives. The objectives of the Management Plan for Hazardous Materials and Waste Management at [name of hospital] are to emphasize safety within the premises, to promote safety awareness as a means of prevention, and to comply with applicable federal, state, ad local laws relating to hazardous materials and waste management. The hazardous materials and waste management program is designed to minimize the risks associated with exposures to hazardous materials and waste, to identify hazards, recommend appropriate corrective action, and evaluate implemented corrective action ... Infection Prevention Policies: The Medical Waste Management policy identifies how medical waste will be handled, i.e., responsibilities and procedures are outlined. Medical waste is the responsibility of any employee who handles it ... The Medical Waste Act of 2017 (Sections 117600-118360) is used to determine the biohazardous waste disposal and procedural activities for the hospital ... as well as a definition of bio-hazardous waste ... Bio-hazardous waste is contained separately from other waste and is contained as close to the site of origin as possible. It is contained in a biohazard bags or rigid puncture-resistant containers. The container used is labeled with the Bio-hazardous Waste symbol on all sides. The red bags are tied securely in a gooseneck knot to prevent spilling or leaking or contents during storage, handling or transport..."

During a professional reference review retrieved from https://www.cdph.ca.gov/programs/ceh/drsem/cdph%20document%20library/emb/medicalwaste/medicalwastemanagementact.pdf titled, "Medical Waste Management Act," dated 1/2017, the professional reference indicated, " ... "Biohazardous waste" includes all of the following: (A) (D) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans or animals that are required to be isolated by the infection control staff, the attending physician and surgeon, the attending veterinarian, or the local health officer, to protect others from highly communicable diseases or diseases of animals that are communicable to humans..."

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations..."

Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when:

1. Four of four surgical areas, the main hospital operating rooms (OR), obstetric (OB-the branch of medicine and surgery concerned with childbirth and the care of women giving birth) operating rooms, outpatient surgical rooms, and breast center (area of the hospital associated with the care of breast cancer of other care needs of the breast) were operating under OSHA guidelines (Occupational Safety and Health Administration-ensures safe and healthful working conditions for workers by setting and enforcing standards and by providing training, outreach, education and assistance) for properly storing, monitoring, educating, and handling formalin (a colorless solution of formaldehyde in water, used chiefly as a preservative for biological specimens - any material derived from a human mostly from organ tissue. Formalin is a hazardous flammable chemical that has been known to cause eye, skin, and respiratory tract irritation if inhaled, and can have long term effects which can cause cancer). The hospital had not performed monitoring of formalin vapor exposure limits (1 TWA (8-hour time weighted average): less than or equal to 0.5 parts of formaldehyde per million parts of air. 2. STEL (short term exposure limit): 2.0 parts formaldehyde per million of air for 15 minutes) since July of 2015 for the surgical departments where staff handled formalin. (refer to A951 finding 1)

2. The facility failed to follow their policy for Universal Protocol to perform a time-out (a pre-procedural process in which the entire operating room team stops and reviews the patient identity, the procedure, the surgical site before the start of the procedure) in accordance with the Association of periOperative Registered Nurses (AORN-defines the standards that help keep healthcare workers and surgical patient safe) for Patient (PT) 2. PT 2 had a "Physician Order" (PO) for a left breast ultrasound guided biopsy (use of sound waves to help locate a lump or abnormality and remove a tissue sample for examination) for a left breast mass and was scheduled on 6/29/22. PT 2 was prepared, positioned, consented and site marked for a right breast ultrasound guided biopsy and a right breast biopsy performed without the entire surgical team performing a time-out. The surgical procedure error was noted after the procedure was completed . (Refer to A951 finding 2)

The cumulative effect of these systemic problems resulted in failure of the hospital ensuring safety from hazardous chemicals for staff, and patients undergoing surgical procedures were cared for in a safe manner.


45929

Based on observation, interview, and record review, the hospital failed to implement standards of practice for surgical services and hospital policy and procedures for patient care, when:

1. Four of four surgical areas, the main hospital operating rooms (OR), obstetric (OB-the branch of medicine and surgery concerned with childbirth and the care of women giving birth) operating rooms, outpatient surgical rooms, and breast center (area of the hospital associated with the care of breast cancer of other care needs of the breast) were not operating under OSHA guidelines (Occupational Safety and Health Administration-ensures safe and healthful working conditions for workers by setting and enforcing standards and by providing training, outreach, education and assistance) for properly storing, monitoring, educating, and handling formalin (a colorless solution of formaldehyde in water, used chiefly as a preservative for biological specimens . Formalin is a hazardous flammable chemical that has been known to cause eye, skin, and respiratory tract irritation if inhaled, and can have long term effects which can cause cancer). The hospital had not performed monitoring of vapor exposure limits (1 TWA (8-hour time weighted average): less than or equal to 0.5 parts of formaldehyde per million parts of air. 2. STEL (short term exposure limit): 2.0 parts formaldehyde per million of air for 15 minutes) since July of 2015 for the surgical departments where staff handled formalin.

These failures had the potential risk of placing surgical staff, obstetric staff of exposure to a hazardous chemical that could cause harm such as skin irritation, respiratory distress, and have long term effects associated with an increased risk of cancer of the nose, sinuses, and lung cancer in humans. Formalin has the potential to cause fire hazards due to being flammable .

2. Patient (PT) 2 had a "Physician Order" (PO) for a left breast ultrasound guided biopsy (use of sound waves to help locate a lump or abnormality and remove a tissue sample for examination) for a left breast mass and the surgical team did not perfomed a time out (an immediate pause by the medical team to confirm the correct patient, procedure, and site) correctly, and the biopsy was performed on Pt 2's right breast.

This failure also resulted in PT 2 to undergo an unnecessary procedure and the potential for omitting the ordered procedure.

Findings:

1. During a concurrent observation and interview on 3/21/23, at 8:45 a.m., with the Manager Breast Imaging (MBI) and Mammography Technician (MT) 1, in the breast center, near the pathology room (section in the OR where specimens are handled and stored) there was no signage indicating formalin was a hazardous chemical. The sub-sterile supply room (typically placed between two operating rooms to provide emergent sterilization of unwrapped items to be used immediately in the operating room) had no signage of formalin being stored. MT 1 stated, there was prefilled containers (30 milliliter) of formalin used for small human specimens (ie:breast biopsies-sample of breast tissue for testing) in the sub-sterile area. MT 1 stated she would be exposed to open containers of formalin for approximately 10 minutes. MT 1 stated, she would handle approximately two to three specimens per day by using prefilled formalin containers. MT 1 stated, she was not aware of any specific ventilation (In healthcare facilities, the ventilation system should also help prevent diseases by removing air particles that cause disease) needed to handle formalin. There was no fume hood (large piece of equipment used to prevent the release of hazardous substances into the general laboratory space by controlling and then exhausting hazardous and/or odorous chemicals) noted in the breast center.

During an interview on 3/21/23, at 9 a.m., with MT 2, MT 2 stated, she would be exposed to prefilled containers of formalin about two to three minutes a day. MT 2 stated, she did not know of any specific ventilation needed for handling formalin, nor was there a fume hood used when handling formalin.

During an interview on 3/21/23, at 9:19 a.m. with Registered Nurse (RN) 5 in the outpatient OR, RN 5 stated, she would collect three to four specimens per day in the OR and bring them into the sub-sterile room 1 to label the specimen. RN 5 stated, she did not know what the proper ventilation for storing or handling of formalin was in the sub-sterile rooms.

During an interview on 3/21/23, at 9:30 a.m., with RN 4 in the outpatient endoscopy (procedure in which an instrument is introduced into the body to give a view of its internal parts) department, RN 4 stated, he would collect specimens in prefilled containers of formalin and did not know of symptoms related to exposure of formalin and when to report them to the surgical department. RN 4 stated he would be exposed to formalin throughout the working shift.

During an interview on 3/21/23, at 8:40 a.m., with the Director of Surgery (DOS) in the main OR, the DOS stated there were approximately 20 specimens handled per day and placed in small, prefilled containers of formalin ranging from 90 to 180 milliliters (ml) of formalin. The DOS stated, the small, prefilled containers of formalin were stored in the seven sub-sterile rooms between the OR rooms .

During an interview on 3/21/23, at 9:05 a.m., with OR Registered Nurse (RN) 20, RN 20 stated, she would bring in the prefilled container of formalin into the OR to collect the specimen and take back to the sub-sterile room s. RN stated she would handle specimens with formalin approximately 20 times in a week for four days a week.

During an interview on 3/21/23, at 9:25 a.m., with RN 21, RN 21 stated, she would take prefilled containers in the OR for specimen collection after surgery to verify the specimen with the surgeon and then place the specimen in the formalin container. RN stated, she did not know of the long-term effects of formalin exposure and did not know if sub-sterile rooms had proper ventilation for storing or handling of formalin nor the use of the fume hood to handle formalin.

During an observation on 3/20/23, at 10:45 a.m., in the Labor and Delivery (L&D) Department, inside a dirty utility room (where the used items end up, in order to be cleaned or disposed of. Generally, these will be containers which have been used to collect and hold human waste) there was a gallon container of formalin stored in a bottom cabinet.

During an observation on 3/20/23, at 11 a.m., with OB technician (OBT) 1, in dirty utility room near the triage area (utilized in the healthcare community to categorize patients based on the severity of their injuries and, by extension, the order in which multiple patients require care and monitoring) in the L&D , OBT 1 had a white bucket with a placenta (a temporary organ that develops during pregnancy. It attaches to the lining of the uterus and delivers oxygen and nutrients to the growing baby through the umbilical cord) in white bucket. OBT 1 opened a cabinet to get a gallon of formalin and poured the formalin in the bucket until it covered the placenta. OBT 1 had goggles, face mask, and gloves. There was no fume hood in the utility room during pouring of the formalin in the white bucket.

During an observation on 3/20/23, at 12 p.m., in an empty OR in the OB department, there were 30 ml and 90 ml prefilled formalin containers stocked in a clear cabinet located in the OR .

During an interview on 3/21/23, at 8:46 a.m. with OBT 1, OBT 1 stated, she would handle specimens such as placentas in the OB, by using a white bucket to place the placenta and then pour a gallon container of formalin until it covered the placenta. OBT 1 stated, she would use formalin on approximately two to four specimens in a working day. OBT 1 stated, she would be exposed to formalin about five minutes at a time for each specimen with formalin. OBT 1 stated, she would pour the formalin in the white bucket inside a dirty utility room in the L&D and did not know of any special ventilation required for handling formalin. OBT 1 stated, the specimens would be left in the dirty utility room for the pathology courier (picks up and delivers medical specimens and packages for a laboratory) to pick up the specimens two times a day.

During an interview on 3/21/23, at 9 a.m., with RN 6, RN 6 stated, she would handle specimens with formalin by pouring into a white bucket in the dirty utility room , where the formalin was stored. RN 6 stated, she would handle approximately two to five specimens a day and be exposed to formalin for two to five minutes at a time.

During an interview on 3/21/23, at 9:16 a.m., with RN 7, RN 7 stated, she would pour formalin in bucket for collection of placenta specimens. RN 7 stated, she would handle the formalin in the dirty utility room which did not have a fume hood and did not know of the ventilation requirements needed to pour formalin.

During an interview on 3/21/23, at 9:40 a.m., with RN 15, RN 15 stated, there were prefilled containers of formalin in the OR ready to be used for collection of specimens. RN 15 stated, collection of specimens would be done in the OR by opening the container, placing the specimen in the container filled with formalin and closing the top, to be sent to the dirty utility room for pathology team to collect and take to pathology center. RN 15 stated, she stated she would collect approximately two to three specimens a day and was exposed to formalin for five seconds at a time. RN 15 stated there was no fume hood in the OR, nor in the dirty utility room to collect specimens with formalin. RN 15 stated, collection of specimens with the use of formalin had stayed the same since she had been working in the OR.

During an interview on 3/21/23, at 10:06 a.m., with RN 22, RN 22 stated, she would collect specimens like a placenta to place in a white bucket, transport to the dirty utility room and pour enough formalin to cover the placenta. RN 22 stated, the specimen would stay in the dirty utility room in the L&D until the pathology courier would come to transport the specimens to the pathology lab. RN 22 stated she would be exposed to formalin about 30 seconds every time she would handle specimens requiring formalin. RN 22 stated, she did not know of any ventilation requirements for handling the formalin or need for a fume hood.

During an interview on 3/21/23, at 10:15 a.m., with the OB Director (OBD), the OBD stated, formalin was used in the OB department and stored in the dirty utility room inside the cabinets. The OBD stated, there were prefilled containers in the OR for smaller specimens. The OBD stated she was not aware of ventilation requirements in the dirty utility room and did not have any fume hoods in the dirty utility room for handling formalin. The OBD stated, there had been no changes to the process of since she had taken over as the OBD in the last several months.

During a concurrent observation and interview on 3/21/23, at 8:50 a.m., with the Manager of Lab (MLAB), and the Director of Lab (DLAB), in the lab/pathology department, there was a fume hood in the lab used for handling biohazardous organisms that were contagious (biological substances that pose a threat to the health of living organisms, primarily that of humans. This can include medical waste or samples of a microorganism, viruses, or toxins (from a biological source) that can affect human health). The MLAB stated the fume hood was used for controlling certain viruses and protect the safety of lab technicians. The MLAB stated, there was no handling of formalin in the lab. The MLAB stated, when specimens with formalin were sent to the lab, they were sealed in a biohazard bag and documented on a log indicating tracking of specimen. The MLAB stated, the pathology courier would transport specimens from the lab back to the pathology center for further testing. The MLAB stated there were no fume hoods in other areas of the hospital for the use of formalin.

During an interview on 3/21/23, at 1:40 p.m., with the Director of Plan Facilities (DPF), Manager of Plant Facilities (MPF), DOS, and Manager of Surgery (MOS), the DPF stated, the sub-sterile rooms, and dirty utility rooms in the OR had 13 air exchanges (number of times that the total air volume in a room or space is completely removed and replaced in an hour) per hour where formalin was stored and poured. The DPF stated he was not aware of use of a fume hood for use of formalin. The DPF stated there was no current monitoring of formalin vapors in any sub-sterile, or dirty utility rooms where formalin was used. The DPF stated, there was no fume hoods in the utility rooms in L&D, nor in sub-sterile rooms in the OR . The DPF stated formalin was safe to handle without a fume hood due to the low frequency of use in the sub-sterile and dirty utility rooms. The DPF stated, he did not know about formalin being safe without a fume hood as more information needed to be gathered to determine the safety of using formalin. The DOS stated, he was not aware of sub-sterile rooms being monitored for formalin vapor. The MOS stated, there were ignition sources ( include electrical sparks, static electricity, naked flames, hot surfaces, impact, friction) in the OR that could pose a potential risk for fire hazards such as oxygen, and electrocautery equipment (uses high-frequency electrical energy to cut tissue or stop bleeding). The MOS stated, it was important to look at the hospital's surgical practices to be able to ensure safety in the OR. The MOS stated, frequency of specimens requiring formalin were approximately 5% of all specimens collected. The MOS stated, implementing a new process for formalin use was plausible given that the volume of specimens collected with formalin was low. The MOS stated education on formalin was not specific to formalin, but all types of hazardous chemicals used in the OR. The MOS stated, she did not know of education on use of fume hoods for handling formalin, nor on reporting symptoms of formalin exposure. The MOS, and DOS stated, they were aware of no signage of formalin flammability and handling of a potential carcinogen (substance capable of causing cancer in living tissue).

During a concurrent interview and record review, on 3/21/23, at 2:15 p.m., with the Safety and Quality Officer for Lab (SQL) and the Occupational Safety Officer (OSO), the "Formaldehyde Vapor Analysis Report", dated 7/30/2015, indicated, " ...7/22/15 ...Exposure Time (hour) ...0.50 (ppm-parts per million-measurement of the mass of a chemical or contaminate per unit volume of air)...Concentration 1.2 ppm...It is not possible to determine if the level is below 2.0 ppm for every 15 minutes ..." The SQL stated, formalin vapor monitoring was done back in 7/22/2015 of the OR sub-sterile rooms and found no levels to be above the exposure limits of formalin. The SQL stated, because vapor monitoring was done in 2015, and was deemed to be safe for staff, there had been no further monitoring of rooms. The SQL stated, because the formalin was diluted in water, there was no requirement to use under a fume hood. The OSO stated, a third-party vendor had performed the vapor monitoring back in July of 2015 with the use of formaldehyde monitoring badges (badge used to measure personal exposure level to certain chemicals. Badges can be placed in rooms to measure the concentration of chemicals in the air)... The OSO stated, because of the exposure limit levels being below the required concentration of formalin, there was no need for further action. The OSO stated, OSHA was the standard the hospital used for formalin.

During an interview on 3/22/23, at 2:15 p.m., with the DOS, and MOS, the DOS stated, prefilled containers of formalin had been stored in the seven sub-sterile rooms in the OR. The DOS stated, there had been no fume hood in the OR when pouring formalin into buckets containing large specimens, as there had been no reports of staff reporting symptoms of formalin exposure. The DOS stated, he did not know what the current formalin vapor concentration was in the sub-sterile rooms where the formalin was stored and handled. The MOS stated, she was not aware of any changes to the structure of surgical areas since July of 2015 when formalin vapor monitoring was performed. The MOS stated, handling of spills, and storage was based on the safety data sheet (SDS) of the formalin product used in the hospital.

During an interview on 3/22/23, at 3 p.m., with the Environmental Safety Specialist (ESS), the ESS stated, the environmental safety department had done hospital rounds throughout the hospital and had found safety concerns for education on how to safely handle formalin. The ESS stated, formalin was used infrequently in the surgical areas and did not require use of fume hoods . The ESS stated, there had not been a current formalin vapor monitoring since 2015. The ESS stated he had spoken to the OB department as to how to handle large specimens and formalin, and whether pouring in the utility room in the L&D was a safe practice. The ESS stated, OSHA guidelines were the standards required to handle formalin. The ESS stated, the hospital had a system database [name of system database] that was used to look up different hazardous chemicals used in the hospital for proper handling and cleanup of spills.

During an interview on 3/24/23, at 11:08 a.m., with the Pathology Lab Director (PLD), the PLD stated, in the pathology lab center , there were lab technicians who handle formalin containers and pour them into specimens. The PLD stated, the formalin used was a 10% concentration as used in the hospital. The PLD stated, lab technicians did have personal protective equipment such as masks, gowns, and face shields when handling formalin but had no special ventilation system in the lab such as a fume hood. The PLD stated, vapor monitoring had been performed at the lab center several years before but did not meet the threshold of exposure limits for formalin. The PLD stated, he would not know the current exposure limit of the pathology lab center. The PLD stated no staff had reported any symptoms of formalin exposure since he had been working in the pathology lab . The PLD stated, the handling and storage of formalin requirements would come from OSHA guidelines as well as the SDS on the formalin. The PLD stated, formalin was a hazardous chemical that required regulations to keep the staff safe from exposure.

During a review of the hospital policy and procedure (P&P) titled "Laboratory Chemical Hygiene Plan", dated 2/28/23, the P&P indicated, " ...Formaldehyde/Formalin (10% solution) A. Introduction - OSHA has determined that formaldehyde is an irritant, a sensitizer ( a substance that causes exposed individuals to develop an allergic reaction in normal tissue after repeated exposure to the substance), and a known human cancer hazard. The OSHA Formaldehyde Standard (29 CFR 1910.1048-code of federal regulations) sets exposure limits, outlines monitoring and training when using formaldehyde. 1. Laboratory Management is responsible for requesting that formaldehyde exposure assessments for appropriate areas are performed, that annual formaldehyde training is performed with designated staff, and ensuring that formaldehyde producing chemicals/containers are properly labeled . 2. Designated employees are responsible for participating in annual formaldehyde safety training, using assigned personal protective equipment, using prescribed engineering controls, and notifying manager of unusual conditions or changes in work practices that would make [hospital name] formaldehyde exposure assessments non-representative. C. Exposure limits: 1 TWA (8-hour time weighted average): less than or equal to 0.5 parts of formaldehyde per million parts of air. 2. STEL (short term exposure limit): 2.0 parts formaldehyde per million of air for 15 minutes. D. Monitoring 1. Periodic vapor monitoring is performed one of two ways. An onsite assessment would include air monitoring and possibly observation of work practices and engineering controls typically used for each task. Additionally, passive monitoring badges (vapor monitoring badges) have been used and sent for testing. 2. Results are posted for review by designated Laboratory staff within 15 days of receipt in the Laboratory and is used for annual formaldehyde safety training purposes. 3. If permissible levels are exceeded, corrective action will be taken. This might include evaluation of ventilation system and wearing of respirators (an apparatus worn over the mouth and nose or the entire face to prevent the inhalation of dust, smoke, or other chemical substances). which may be temporarily required until the problem is resolved. The area in question will be re-monitored to determine if permissible levels have been obtained. 4. If any employee reports signs and symptoms of respiratory or dermal conditions associated with formaldehyde exposure, exposure levels for that person will be monitored immediately. 5. If results from 2 consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level (exposure limits of formalin vapor) and the STEL the annual monitoring can be terminated. Sampling will resume in the event there is change in production, equipment, process, personnel, or control measure which may result in new or additional exposure to formaldehyde ..."

During a review of the "Safety Data Sheet ... [name of formalin product]", dated 2/22/2016, the SDS indicated, " ...2. Hazard(s) identification ...Signal Word Danger (within a specific hazard class, "Danger" is used for the more severe hazards) ... 7. Handling and storage ...Handling ... Use only under a chemical fume hood. Wear personal protective equipment. Do not breathe vapors or spray mist. Avoid contact with skin, eyes, and clothing. Pay attention to flashback (when a vapour trail ignites and burns). Take precautionary measures against static discharges (the release of static electricity when two objects touch each other). Contents under pressure. No information available. Do not take internally. Avoid contact with clothing ...Storage ... Keep containers tightly closed in a dry, cool, and well-ventilated place. Keep container tightly closed in a cool, well-ventilated place. Keep away from heat and sources of ignition. Keep away from heat. Keep in properly labeled containers ...

During a review of the Occupational Safety and Health Standards (OSHA), dated 2/8/2013, indicated, " ...Subpart Title: Toxic and Hazardous Substances Standard Number: 1910.1048 ...Scope and application. This standard applies to all occupational exposures to formaldehyde, i.e., from formaldehyde gas, its solutions, and materials that release formaldehyde. Each employer who has a workplace covered by this standard shall monitor employees to determine their exposure to formaldehyde. 1910.1048(d)(1)(ii) Exception. Where the employer documents, using objective data, that the presence of formaldehyde or formaldehyde-releasing products in the workplace cannot result in airborne concentrations of formaldehyde that would cause any employee to be exposed at or above the action level or the STEL under foreseeable conditions of use, the employer will not be required to measure employee exposure to formaldehyde. 1910.1048(d)(1)(iii) When an employee's exposure is determined from representative sampling, the measurements used shall be representative of the employee's full shift or short-term exposure to formaldehyde, as appropriate. 1910.1048(d)(1)(iv) Representative samples for each job classification in each work area shall be taken for each shift unless the employer can document with objective data that exposure levels for a given job classification are equivalent for different work shifts. 1910.1048(d)(5) Accuracy of monitoring. Monitoring shall be accurate, at the 95 percent confidence level, to within plus or minus 25 percent for airborne concentrations of formaldehyde at the TWA and the STEL and to within plus or minus 35 percent for airborne concentrations of formaldehyde at the action level. 1910.1048(d)(6) Employee notification of monitoring results. The employer must, within 15 working days after the receipt of the results of any monitoring performed under this section, notify each affected employee of these results either individually in writing or by posting the results in an appropriate location that is accessible to employees. If employee exposure is above the PEL (permissible exposure limits- regulatory limits on the amount or concentration of a substance in the air), affected employees shall be provided with a description of the corrective actions being taken by the employer to decrease exposure ...1910.1048(e) Regulated areas-1910.1048(e)(1) Signs. 1910.1048(e)(1)(i) The employer shall establish regulated areas where the concentration of airborne formaldehyde exceeds either the TWA or the STEL and post all entrances and access ways with signs bearing the following legend: DANGER FORMALDEHYDE MAY CAUSE CANCER CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION AUTHORIZED PERSONNEL ONLY 1910.1048(e)(2) The employer shall limit access to regulated areas to authorized persons who have been trained to recognize the hazards of formaldehyde. 1910.1048(e)(3) An employer at a multiemployer worksite who establishes a regulated area shall communicate the access restrictions and locations of these areas to other employers with work operations at that worksite. 1910.1048(f) Methods of compliance - 1910.1048(f)(1) Engineering controls and work practices. The employer shall institute engineering and work practice controls to reduce and maintain employee exposures to formaldehyde at or below the TWA and the STEL. 1910.1048(f)(2) Exception. Whenever the employer has established that feasible engineering and work practice controls cannot reduce employee exposure to or below either of the PELs, the employer shall apply these controls to reduce employee exposures to the extent feasible and shall supplement them with respirators which satisfy this standard ...1910.1048(g) Respiratory protection -1910.1048(g)(1) General. For employees who use respirators required by this section, the employer must provide each employee an appropriate respirator that complies with the requirements of this paragraph. Respirators must be used during: 1910.1048(g)(1)(i) Periods necessary to install or implement feasible engineering and work-practice controls. 1910.1048(g)(1)(ii) Work operations, such as maintenance and repair activities or vessel cleaning (the process of removing hydrocarbon vapours, liquids or residues), for which the employer establishes that engineering and work-practice controls are not feasible. 1910.1048(g)(1)(iii) Work operations for which feasible engineering and work-practice controls are not yet sufficient to reduce employee exposure to or below the PELs. 1910.1048(g)(3) Respirator selection. 1910.1048(g)(3)(i) Employers must: 1910.1048(g)(3)(i)(A) Select, and provide to employees, the appropriate respirators specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134. 1910.1048(g)(3)(i)(B) Equip each air-purifying, full facepiece respirator with a canister or cartridge approved for protection against formaldehyde. 1910.1048(g)(3)(i)(C) For escape, provide employees with one of the following respirator options: A self-contained breathing apparatus operated in the demand or pressure-demand mode; or a full facepiece respirator having a chin-style, or a front-or back-mounted industrial-size, canister or cartridge approved for protection against formaldehyde. 1910.1048(g)(3)(ii) Employers may substitute an air-purifying, half mask respirator for an air-purifying, full facepiece respirator when they equip the half mask respirator with a cartridge approved for protection against formaldehyde and provide the affected employee with effective gas-proof goggles. 1910.1048(g)(3)(iii) Employers must provide employees who have difficulty using negative pressure respirators with powered air-purifying respirators permitted for use under paragraph (g)(3)(i)(A) of this standard and that affords adequate protection against formaldehyde exposures ...1910.1048(m) Communication of hazards - 1910.1048(m)(1) Hazard communication - General. 1910.1048(m)(1)(i) Chemical manufacturers, importers, distributors, and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (§ 1910.1200) for formaldehyde. 1910.1048(m)(1)(ii) In classifying the hazards of formaldehyde at least the following hazards are to be addressed: Cancer; skin and respiratory sensitization; eye, skin, and respiratory tract irritation; acute toxicity effects; and flammability. 1910.1048(m)(1)(iii) Employers shall include formaldehyde in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of formaldehyde and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (n) of this section. 1910.1048(m)(1)(iv) Paragraphs (m)(1)(i), (m)(1)(ii), and (m)(1)(iii) of this section apply to chemicals associated with formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde, and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm. 1910.1048(m)(1)(v) In making the determinations of anticipated levels of formaldehyde release, the employer may rely on objective data indicating the extent of potential formaldehyde release under reasonably foreseeable conditions of use ...1910.1048(n) Employee information and training -1910.1048(n)(1) Participation. The employer shall assure that all employees who are assigned to workplaces where there is exposure to formaldehyde participate in a training program, except that where the employer can show, using objective data, that employees are not exposed to formaldehyde at or above 0.1 ppm, the employer is not required to provide training. 1910.1048(n)(2) Frequency. Employers shall provide such information and training to employees at the time of initial assignment, and whenever a new exposure to formaldehyde is introduced into the work area. The training shall be repeated at least annually. 1910.1048(n)(3) Training program. The training program shall be conducted in a manner which the employee is able to understand and shall include: 1910.1048(n)(3)(i) A discussion of the contents of this regulation and the contents of the Material Safety Data Sheet. 1910.1048(n)(3)(ii) The purpose for and a description of the medical surveillance program (is the analysis of health information to look for problems that may be occurring in the workplace that require targeted prevention). required by this standard, including: 1910.1048(n)(3)(ii)(A) A description of the potential health hazards associated with exposure to formaldehyde and a description of the signs and symptoms of exposure to formaldehyde. 1910.1048(n)(3)(ii)(B) Instructions to immediately report to the employer the development of any adverse signs or symptoms that the employee suspects is attributable to formaldehyde exposure. 1910.1048(n)(3)(iii) Description of operations in the work area where formaldehyde is present and an explanation of the safe work practices appropriate for limiting exposure to formaldehyde in each job; 1910.1048(n)(3)(iv) The purpose for, proper use of, and limitations of personal protective clothing and equipment; 1910.1048(n)(3)(v) Instructions for the handling of spills, emergencies, and clean-up procedures; 1910.1048(n)(3)(vi) An explanation of the importance of engineering and work practice controls for employee protection and any necessary instruction in the use of these controls; and 1910.1048(n)(3)(vii) A review of emergency procedures including the specific duties or assignments of each employee in the event of an emergency. 1910.1048(o)

During a review of the professional reference tilted "Formaldehyde and Formalin Standard Operating Procedures (S.O.P)" https://ehs.howard.edu/sites/ehs.howard.edu/files/2020-05/Formaldehyde%20and%20Formalin%20SOP%20%28new%29.pdf, dated 5/6/2020, the professional reference indicated, "Guidelines for Handling Formaldehyde What is Formaldehyde? Formaldehyde is a colorless, flammable gas at room temperature with a characteristic pungent odor. It has been used by both clinical diagnostic and research laboratories as a preservative or tissue fixative for over a century and as a chemical