HospitalInspections.org

Based on observations, interviews, and record review, that facility failed to have a well-organized and effective nursing service when:

1. Licensed nurses (LN) did not document the status of Pt 1, including late, and prolonged decelerations, did not complete accurate electronic fetal monitoring assessments, did not notify the physician, and did not document complete cervical exams for Pt 2 in accordance with the Association of Women's Health Obstetric and Neonatal Nurses (AWHONN, is a leader in research, education, and advocacy in the field of women's health, obstetrics, and neonatal health) guidelines and hospital policy and procedure (P&P) for two of 14 sampled patients (Pt), Pt 1 (baby) and Pt 2 (mom of Pt 1). (Refer to A398 Finding 1)

2. LNs did not assess pain (Pt 40, Pt 55) and/or reassessed pain (Pt 22, Pt 29) after pain medication was administered in accordance with the hospital's P&P titled, "Pain Management" for four of 36 sampled patients (Pt 22, Pt 29, and Pt 40). (Refer to A398 Finding 2)

3. One of two patients (Pt 40) were not assessed by LNs in the Labor and Delivery (L&D) unit when a magnesium sulfate medication infusion was administered, according to the P&P "Guidelines for Magnesium Sulfate Administration" and "Severe Intrapartum or Postpartum Hypertension Emergency". (magnesium sulfate - a high-risk medication used in pregnancy for patients diagnosed with preeclampsia [high blood pressure and signs of liver or kidney damage after the 20th week of pregnancy] to help prevent seizures-[a sudden, uncontrolled burst of electrical activity in the brain]). (Refer to A398 Finding 3)

4. LNs did not follow physician orders for notification of elevated blood pressures (BP) for one of seven patients (Pt 29) in the L&D unit according to the "P&P" titled,"Severe Intrapartum or Postpartum Hypertension Emergency". (Refer to A398 Finding 4)

5. One of seven (Pt 40) patients did not have documented fundal (top of uterus), or lochia (vaginal discharge after birth, bleeding) assessments by LNs after delivery in the L&D and Postpartum (PP) units from 2/1/24 at 8:15 p.m. to 2/3/24 at 9:11 a.m., according to facility procedure and AWHONN standards of practice. (Refer to A398 Finding 5)

6. One of three sampled glucometers in the telemetry (heart monitoring) unit had quality controls (QC) performed by LNs with control solutions that did not have the date the control solution would expire written on the vial according to the facility's policy and procedure (P&P) titled, "Blood Glucose Monitoring Using [Brand Name of glucometer] Inform II System,". (QC-a system of maintaining standards, glucometers- a device for measuring the concentration of glucose in the blood, control Solutions-solution use to test the functionality of meter and strips). (Refer to A398 Finding 6)

7. LNs in the Emergency Department did not complete ongoing assessments or reassess vitals for 13 of 22 sampled patients (Pt 54, Pt 55, Pt 60, Pt 61, Pt 62, Pt 63, Pt 64, Pt 65, Pt 66, Pt 67, Pt 68, Pt 69, and Pt 70) in accordance with hospital "P&P" titled, "Assessment and Documentation" and "Triage." (Refer to A398 Finding 7)

The cumulative effect of these deficient practices resulted in the facility's inability to provide care in a safe and effective manner.

Based on observations, interviews and record review, the facility failed to comply with state regulations when they placed five portable air conditioner (A/C) units in the Laboratory (Lab), Pharmacy and Sterile Processing Department (SPD) without following the process of Policy Intent Notice (PIN) for approval with California Department of Health Care Access and information (HCAI).

This failure resulted in potential for non-compliant equipment and potential harm to staff or patients.

Findings:

During a concurrent observation and interview on 7/31/24 at 12:05 p.m. in the Lab with the Lab Manager (LM), three portable A/C units were in use. The LM stated they had been using the portable A/C units for approximately two weeks. The LM stated the hospital's main Heating, Ventilation and Air Conditioning (HVAC) system had not been able to keep up with local heat wave and the portable A/C units were put in place.

During a concurrent observation and interview on 7/31/24 at 12:35 p.m. in the Pharmacy with the Pharmacy Director (PD), one portable A/C unit was in use. The PD stated the portable A/C unit had been in use for approximately a month.

During a concurrent observation and interview on 8/1/24 at 9:50 a.m. in the SPD with the Operating Room Manager (ORM), one portable A/C unit was in use. The ORM stated the portable A/C unit had been in use for approximately two years. The ORM stated the room gets warm when all the washers and sterilizers (a machine used to sterilize surgical instruments) are in operation.

During a review of "Invoice 1", dated 7/7/24; "Invoice 2", dated 7/13/24: and "Invoice 3" dated, 7/13/24; "Invoice 1" indicated two Portable A/C units were placed in the Lab. "Invoice 2" indicated one unit was placed in Pharmacy. "Invoice 3" indicated one unit was placed in the Lab.

During an interview on 8/1/24 at 3:04 p.m. with the Director of Facility Services (DFS), the DFS stated he has never had to notify HCAI of the intent to use portable A/C units and has never had to get authorization for the units.

During the review of "HCAI Email 1 (HCAI 1)", dated 8/5/24, from the Regional Compliance Officer (CO) for the office of Statewide Hospital Planning and Development of HCAI, the CO was asked the hospital was required to get approval for portable A/C units prior to installing. The CO stated, " ... Yes, they are to follow Policy Intent Notice (PIN) 72 for approval of the authorization of Emergency Work ...".

During the review of "HCAI Email 2 (HCAI 2)", dated 8/5/24, from the CO, the CO was asked in the hospital notified HCAI prior to installing the portable A/C units. The CO stated, " ... I am unable to locate anything within the Facility file, so I understand they have not ...".

During a review of "Policy intent Notice (PIN) 72 (PIN 72)", dated 6/15/22, the "PIN 72" indicated, " ... Emergency Work Authorization ... HCAI will consider and may issue an Emergency Authorization to Proceed (EAP) with emergency work prior to plan approval and building permit based on emergency conditions and necessity ... Where an emergency situation arises, the facility shall take the following actions: I. Immediate Action ... The facility may take the necessary emergency actions to abate and make safe the emergency condition that poses an imminent danger to life, injury, or property damage. Such emergency actions may proceed prior to contacting HCAI and the HCAI Regional Compliance Officer (RCO) must be contacted immediately thereafter ... Beyond emergency actions to abate the emergency conditions and make safe the emergency conditions, emergency repairs, restoration, or replacement of an element of the building, structure, utility system, or equipment shall be authorized by HCAI prior to proceeding with work ...".

Based on interviews and record review, the facility failed to inform six of seven patients (Patient [Pt] 8, 11, 16, 27, 30, 40) and or patient's representatives of their rights when non- English speaking patients Pt 11 and Pt 27 did not receive information in a language of their preference in accordance with hospital policy and procedure and an interpreter was not utilized when obtaining an informed consent and consents were not in the patient's preferred language in accordance with hospital policy.

These failures had the potential for ineffective communication, misunderstandings, and patient harm.

Findings:

During a review of Pt 11's "Face Sheet (FS, a document containing patient information)", dated 8/1/24, the "FS" indicated Pt 11's preferred language was Spanish. The "FS" indicated Pt 11 was coming to the hospital for a blood transfusion (procedure in which whole blood or parts of blood are put into a patient's bloodstream through a vein) of 8/1/24.

During a review of Pt 11's "Consent for Treatment and Conditions for Admission (COA)", dated 7/30/24, the "COA" indicated the "COA" was written in English and no interpreter signed the document.

During a review of Pt 27's "Face Sheet (FS)," dated 7/28/24, and "Condition of Admission [COA - form with hospital admission information]" dated 7/28/24, the "FS" indicated, Pt 27's preferred language was SP (Spanish), and the "COA" was in Spanish.

During a review of Pt 27's "Consent to Surgery/Special Procedures (CSSP) 1" form, dated 7/30/24, the "CSSP 1" form indicated Pt 27 was consented for a procedure, hemodialysis [mechanical cleaning of the blood]. The "CSSP 1" form was in English, and no translator information was completed on the form. Pt 27's "CSSP 1" was signed by Pt 27 and hospital staff witnessed the patient's signature on 7/30/24 at 7:56 p.m.

During a review of Pt 27's "CSSP 2" form, dated 8/1/24, the "CSSP 2" form indicated Pt 27 was consented for a procedure for amputation of his right third toe, with possible amputation of right second and fourth toes. The "CSSP 2" form was in English, and no translator information was completed on the form. Pt 27's "CSSP 2" was signed by Pt 27 and hospital staff witnessed the patient's signature on 8/1/24 at 2:06 p.m.

During an interview on 8/9/24 at 9:13 a.m. with Manager (MGR) 10 stated, the facility's "CSSP" form for procedures and surgeries have specific elements that must be completed. MGR 10 stated "CSSP" was another name for "Informed Consent". MGR 10 stated the "CSSP" must be in the patient's preferred language if available. MGR 10 stated if the patient's native language was not English facility staff must use an interpreter and the interpreter number must be included on the form. MGR 10 stated if any of the items were missing the "CSSP" was incomplete.

During an interview on 8/9/24 at 11:22 with the Chief Nursing Officer (CNO), the CNO stated it was her expectation staff follow hospital policies and procedures.

During a review of the facility's policy and procedure titled, "Interpreters", dated 2/19/19, "Interpreters" indicated, " ... [name of hospital] utilizes an on-demand video remote interpretation service (VRI) and a language interpretation lines to ensure patients are provided with highly skilled and medically trained interpretation services. This service is offered 24 hours a day, 7 days a week, 365 days a year ... staff will arrange to use the on-demand video remote interpretation (VRI) service of language interpretation line ... with a patient or patient representative who is not fluent in English and/or when a patient or patient representative has communicated his or her primary language is not English (the documented primary language is considered the patient's preferred language for receiving information) ...".

During the review of a professional reference titled, "Safety First: The Importance of Interpreters & Translated Documents in Preventing Patient Harm" (undated), the reference indicated, " ...Communication barriers between providers and limited English proficiency (LEP) or non-English proficiency (NEP) patients during health care delivery is a major safety concern. Poor, ineffective communication can lead to patient dissatisfaction, misunderstanding about treatments, and even worse, poor health outcomes and patient harm. Studies even suggest that adverse events experienced by LEP patients are more likely to be caused by communication issues when compared to English proficient patients ...".

Based on interviews and record review, the facility failed to inform four patients (Patient [Pt] 8, Pt 16, Pt 30 & Pt 40) of the provider's name performing the procedure in accordance with hospital policy.

These failures had the potential for ineffective communication, misunderstandings, and patient harm.

Findings:

During a review of Pt 8's "CSSP" dated 7/15/24, for a central line [intravenous line inserted into a large deep vein] placement, the "CPPS" indicated the line for the name of the practitioner performing the procedure was blank.

During a review of Pt 8's "Procedure Note (PN)", dated 7/15/24, the "PN" indicated a central venous catheter was placed in Pt 8's internal jugular vein (a large vein in the neck) by Physician 1.

During a review of Pt 16's "CSSP" form, dated 7/31/24, the "CSSP" form indicated, " ... Your physician has recommended the following operation or procedure bilateral [left and right] peripheral [away from center] angiogram [x-ray using a dye to show blood flow], ... angioplasty [unblocking a blood vessel], ... with possible IVC [inferior vena cava, a large vein] filter and procedural sedation [medication to help calm and relax] ... Name of the practitioner who is performing the procedure or administering the medical treatment ...". This area was left blank, no physician name was completed. Pt 16 signed the "CSSP" on 7/31/24 at 7:25 a.m. Facility staff signed the "CSSP" as a witness but did not complete the date and time for their signature.

During a review of Pt 30's "CSSP" form, dated 08/1/24, the "CSSP" form indicated, " ... Your physician has recommended the following operation or procedure Primary [first time] Cesarean Section [C/S-surgical delivery of baby through cut in mother's stomach and uterus] ... Name of the practitioner who is performing the procedure or administering the medical treatment ...". This area was left blank, no physician name was completed. Pt 30 signed the "CSSP" on 8/1/24 at 11:46 a.m. and facility staff signed the "CSSP" as a witness and included the date and time of witness signature.

During a review of Pt 40's "CSSP" form, dated 2/1/24, the "CSSP" form indicated, " ... Your physician has recommended the following operation or procedure Primary Cesarean Section ... Name of the practitioner who is performing the procedure or administering the medical treatment ...". This area was left blank, no physician name was completed. Pt 40 signed the "CSSP" on 2/1/24 at 5:00 p.m. and facility staff signed the "CSSP" as a witness. Facility staff signed the "CSSP" as a witness but did not complete the date and time for their signature.

During an interview on 8/9/24 at 9:09 a.m. with Manager (MGR) 10 stated, the facility's "CSSP" form for procedures and surgeries have specific elements that must be completed. MGG 10 stated "CSSP" was another name for "Informed Consent". MGR 10 stated the "CSSP form must include, the type of procedure being performed word for word, the name of physician who is performing the procedure, the date and time patient signs the form, and a witness signature. MGR 10 stated if the patient was a minor the parent or guardian must sign the "CSSP" MGR 10 stated the "CSSP" must be in the patient's preferred language if available. MGR 10 stated if the patient's native language was not English facility staff must use an interpreter and the interpreter number must be included on the form. MGR 10 stated if any of the items were missing the "CSSP" was incomplete.

During a review of the facility's policy and procedure titled, "Consents: (1) Surgical, Diagnostic or Invasive Procedures (2) Authorization to Treat Minors (Consents)", dated 6/21/19, "Consents" indicated, " ... Patient or designated patient representative shall give informed consent for specified surgical, diagnostic and invasive procedures ... Definition: Informed Consent ... is a process whereby the patient, or his or her surrogate decision maker, is given sufficient information in lay terms and in preferred language which will enable him or her to reach a meaningful, informed decision regarding whether to give consent for the complex treatment or procedure which is proposed ... Surgical, diagnostic and invasive procedure consent forms ... Will contain patient's name, surgeon's name of his/her designee, procedure, time, date and patient's signature ...".

Based on interviews and record review, the facility failed to promote the patients' right to receive care in a safe environment when two of eleven sampled patient care staff had previously tested positive for tuberculosis (TB, a disease cause by a bacteria that can spread through the air when an infected person coughs, sneezes, or spits. The disease can settle in the lungs and spread to other parts of the body), and their annual TB screening evaluation was not completed in accordance with hospital policy and procedure.

These failures had the potential to place patients at risk for contracting TB.

Findings:

During a concurrent interview and record review on 8/7/24 at 8:00 a.m. with the Chief Human Resources Officer (CHRO), Registered Nurse (RN) 22's "HCP (Health Care Personnel) Screening for Tuberculosis (TBS, a form with questions regarding exposure and symptoms of TB)", dated 10/25/23, was reviewed. The CHRO stated the "TBS" form was used to screen all employees for TB annually. RN 22's "TBS" indicated RN 22 tested positive for TB in 2000. The bottom section of the form indicated a title, " ... Test Administrator Use Only ...". The CHRO stated this section of the form was to document actions taken by Human Resource (HR) personnel who evaluated the screening form information. The choice of actions listed in this section of the "TBS" indicated, " ... Single TST [Tuberculin Skin Test, a small injection under the skin of tuberculin purified protein derivative {PPD} to test to for TB exposure] ... Two-Step TST [two TST a month a part, for people frequently tested for TB] ... IGRA [Interferon Gamma Release Assay, a blood test that measures the body's immune response to the bacteria that causes TB] results ... sent for CXR [chest x-ray] ... Yes ... No ... CXR ... Negative ... Positive ...Consult Physician ... Referral physician ... NA [not applicable] ... Yes ... Name ... Comments ...". The section of the "TBS" for actions taken was blank and a line drawn through the section. No signature was present.

During a concurrent interview and record review on 8/7/24 at 8:15 a.m. with the CHRO, Labor & Delivery Technician (LDT) 1's "TBS", dated 10/11/23, was reviewed. The CHRO stated the "TBS" indicated LDT 1 documented " ... No ..." in response to " ... Have you ever had a positive TB Skin or blood test? ...". The LDT 1's "TBS" indicated the section for actions taken was blank and a line was drawn through the section. No documentation of PPD skin testing of LDT 1 was evident. No signature was present.

During a concurrent interview and record review on 8/7/24 at 9:27 a.m. with the CHRO, the policy and procedure titled, "Tuberculosis Screening for Employees (TSE)", dated 6/17/16, was reviewed. The "TSE" indicated, " ... All employees and volunteers will have an annual TB evaluation ... The evaluation will be administered annually under the direction of the Human Resources Department .... Employees and volunteers with no prior history of positive PPD will have a PPD skin test ... persons with a prior history of PPD are to complete a TB Evaluation Questionnaire ... PROCEDURE: Follow-Up Positive PPD Results ... Positive PPD as stated history ... This process is managed by occupational health clinic ... Obtain baseline PA [posterior-anterior, back to front] chest x-ray. If the chest -ray shows no evidence of current or past TB, the employee is considered to have latent tuberculosis [have no symptoms and cannot spreads TB, but if not treated may develop active TB in the future and spread the disease to others] ... Encourage to follow up with their medical provider if they have never had prophylaxis [treatment to attempt to prevent disease] for TB ...". The CHRO stated persons with a history of a positive PPD were not given a PPD skin test if they had no symptoms.

During a concurrent interview and record review on 8/7/24 with the CHRO, LDT 1's "TBS", dated 10/11/23, was reviewed. The CHRO stated LDT 1 documented "no" for a history of positive PPD skin test therefore she should have had a skin test done. The CHRO stated she wanted to check records and believed there was a mistake and LDT 1 was given a PPD skin test. The CHRO stated she needed to revise the "TBS" form to include a signature for the HR personnel reviewing the "TBS" and actions taken. The CHRO stated anyone could have drawn the line through the action items, even the employee.

During a concurrent interview and record review on 8/7/24 at 10:23 a.m. with the CHRO, five of LDT 1's "Tuberculosis Exposure Questionnaires (TEQ)", dated 10/7/15, 10/9/18, 10/17/19, 10/28/20, and 10/26/22, were reviewed. The CHRO stated the 10/7/15, 10/9/18, & 10/26/22 "TEQs" indicated a prior positive PPD history. The CHRO stated the 10/17/19 & 10/28/20 "TEQs" indicated a negative PPD history. The CHRO stated there were inconsistencies in LDT 1's responses to LDT 1's PPD result history. The CHRO stated there were also inconsistencies on the five "TEQs" regarding whether a baseline CXR (used to detect abnormalities indicating current or past TB disease) on file including yes, no, and no response indicated. The CHRO stated the "TEQ" dated 10/17/19 indicated yes and no to the same question of if a baseline CXR was on file. The CHRO stated the five past "TEQs" did not indicate any review by HR personnel, and no one was looking at the "TBS" and "TEQs" closely. The CHRO did not have evidence of a 2023 PPD for LDT 1.

Based on observation, interview and record review, the facility failed to ensure all licensed nurses adhered to the hospital's policies and procedures (P&P), when:

1. Licensed nurses (LN) did not document the status of Patient (Pt) 1, including late, and prolonged decelerations, did not complete accurate electronic fetal monitoring assessments, did not notify the physician, and did not document complete cervical exams for Pt 2 in accordance with the Association of Women's Health Obstetric and Neonatal Nurses (AWHONN, is a leader in research, education, and advocacy in the field of women's health, obstetrics, and neonatal health) guidelines and hospital policy and procedure (P&P) for two of 14 sampled patients (Pt), Pt 1 (baby) and Pt 2 (mom of Pt 1).

These failures resulted in inadequate fetal monitoring of Pt 1, and an incomplete clinical assessment which led to a decline in oxygenation and may have possibly contributed to the death of Pt 1.

2. LNs did not assess pain (Pt 40, Pt 55) and/or reassessed pain (Pt 22, Pt 29) after pain medication was administered in accordance with the hospital's P&P titled, "Pain Management" for four of 36 sampled patients (Pt 22, Pt 29, Pt 40 and Pt 55).

These failures placed Pt 22, Pt 29, Pt 40, and Pt 55 at risk for inadequate pain management and could negatively affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of patients.

3. One of two patients (Pt 40) was not assessed by LNs in the Labor and Delivery (L&D) unit when a magnesium sulfate medication infusion was administered, according to the P&P "Guidelines for Magnesium Sulfate Administration" and "Severe Intrapartum or Postpartum Hypertension Emergency". (magnesium sulfate - a high-risk medication used in pregnancy for patients diagnosed with preeclampsia [high blood pressure and signs of liver or kidney damage after the 20th week of pregnancy] to help prevent seizures-[a sudden, uncontrolled burst of electrical activity in the brain]).

These failures had the potential for Pt 40's blood pressure to go unmonitored and untreated.

4. LNs did not follow physician orders for notification of elevated blood pressures (BP) for one of seven patients (Pt 29) in the L&D unit according to the "P&P" titled, "Severe Intrapartum or Postpartum Hypertension Emergency".

These failures had the potential for Pt 40 and Pt 29 to have worsening symptoms of gestational hypertension (high blood pressure in pregnancy) which could lead to a decline in health status including confusion, stroke, and seizure.

5. One of seven (Pt 40) patients did not have documented fundal (top of uterus), or lochia (vaginal discharge after birth, bleeding) assessments by LNs after delivery in the L&D and Postpartum (PP) units from 2/1/24 at 8:15 p.m. to 2/3/24 at 9:11 a.m., according to facility procedure and AWHONN standards of practice.

This failure placed Pt 40 at risk for uterine atony (loss of tone), hemorrhage (dangerous complication of excessive bleeding).

6. One of three sampled glucometers (a small, portable device that measures the amount of glucose, or sugar, in a person's blood) in the telemetry (heart monitoring) unit had quality controls (QC) performed by LNs with control solutions (liquids used to test the accuracy and performance of blood glucometers) that did not have the date the control solution would expire written on the vial according to the facility's policy and procedure (P&P) titled, "Blood Glucose (the main sugar found in your blood) Monitoring Using [Brand Name of glucometer] Inform II System,". (QC-a system of maintaining standards, glucometers- a device for measuring the concentration of glucose in the blood, control Solutions-solution use to test the functionality of meter and strips).

This failure placed patients at risk for inadequate blood glucose monitoring and management.

7. LNs in the Emergency Department (ED) did not complete ongoing assessments or reassess vital signs for 13 of 22 sampled patients (Pt 54, Pt 55, Pt 60, Pt 61, Pt 62, Pt 63, Pt 64, Pt 65, Pt 66, Pt 67, Pt 68, Pt 69, and Pt 70) in accordance with hospital "P&P" titled, "Assessment and Documentation" and "Triage."

This failure placed patients (Pt 54, Pt 55, Pt 60, Pt 61, Pt 62, Pt 63, Pt 64, Pt 65, Pt 66, Pt 67, Pt 68, Pt 69, and Pt 70) at risk for not having their nursing needs met and possibly delay in addressing the reason for their ED visit.

Findings:

1. During a review of Pt 2's "Electronic Medical Record (EMR - a digital collection of patient's medical information, that is stored on a computer)," dated 6/24/24 to 6/25/24, the "EMR" indicated Pt 2 was a gravida (the total number of confirmed pregnancies) 1 para (the number of live births) 0, 39 weeks pregnant. The "EMR" indicated Pt 2 was admitted to Labor and Delivery (L&D) on 6/24/24 at 12:39 p.m. for spontaneous rupture of membranes (bag of water broke around baby naturally), and an induction of labor (IOL-when a medical provider starts labor). Pt 2 was transferred to the L&D unit on 6/24/24 at 12:46 p.m. Pt 2's plan for induction was misoprostol (a medication used to soften the cervix and induce labor) PO (by mouth) every four hours. In the L&D unit Pt 2 was placed on continuous fetal monitoring, to monitor her baby's heart rate (HR) and contractions (tightening and relaxing of uterus [womb]). Pt 2's first fetal assessment was documented in L&D on 6/24/24 at 1 p.m., and the baseline Fetal Heart Rate (FHR) of 125 beats per minute (bpm - normal 110-160), accelerations (an increase in HR-shows fetal wellbeing), no decelerations (a decrease in HR below baseline), and moderate variability (fluctuations in baseline that are irregular 6-25 bpm -normal). Pt 2's first L&D fetal assessment was a Category 1 (normal-indicates no fetal lack of oxygen). Pt 2's first cervical exam in L&D on 6/24/24 at 3:05 p.m. was incompletely documented. Pt 2 began having late decelerations (gradual decrease in FHR after contraction -sign of placenta [provides oxygen to baby in the uterus] not working effectively) and were not accurately reflected in the documentation or reported to the physician. Pt 2 continued having intermittent (less than half of the contractions) and recurrent (50 percent or more of contractions) decelerations as labor progressed. Pt 2's LNs reported some late and prolonged decelerations to physicians and the physicians assessed Pt 2 and reviewed the "Fetal Monitoring Strip (FMS- a tracing on paper that shows FHR and contractions)" but did not act on the decelerations by providing a Cesarean Section (C/S, surgical delivery of a baby through a cut in abdomen and uterus). Pt 1 was delivered by operative vaginal delivery (a vacuum extractor applies suction and traction to the baby's head to help pull baby out) on 6/25/24 at 12:29 p.m. Pt 1 was diagnosed with metabolic acidosis (too much acid in the blood) after delivery and time of death was 6/25/24 at 10:20 p.m.

During a review of Pt 2's "EMR", dated 6/24/25 to 6/25/25, and "Fetal Monitoring Strip, " dated 6/24/25 to 6/25/25 the "EMR" indicated Pt 2's LN reported decelerations to physicians on 6/24/24 at 7:24 p.m., 9:52 p.m., 6/25/24 at 1:26 p.m., 2:47 p.m., 8:44 a.m., 11:40 a.m. and 11:46 a.m. Pt 2's physicians assessed her and reviewed her "FMS" on 6/24/24 at 7:24 p.m., 6/25/24 at 2:50 a.m., 4:48 a.m., 6:06 a.m., 6:28 a.m., 8:20 a.m.,9:00 a.m., 10:04 a.m., 11:10 a.m., 11:24 a.m., and from 12 p.m. to delivery at 12:29 p.m. Pt 2 had a Category 2 (not clearly known but
not a 1 or a 3) "FMS" with recurrent decelerations and minimal variability (when the beat to beat amplitude is less than or equal 5 bpm - may indicate decreased oxygenation) beginning 6/25/24 at 9:30 a.m. that progressed to a category 3 (absent variability with recurrent late, variable, or prolonged decelerations-sign of acidemia) by 6/25/24 at 11:40 a.m. and physicians did not act on it by providing a C/S.

During a review of Pt 1's (baby) "EMR", dated 6/25/24, the "EMR" indicated Pt 2 had APGAR score ( a test given to newborns soon after birth, 7 and higher indicates a good score) of 2 at one minute, 2 at five minutes, and 2 at 10 minutes, and 2 at 20 minutes. Pt 1 was brought to the warming table immediately after delivery. Pt 1 was blue/pale, floppy (soft and not able to keep a firm shape or position), apneic (a condition in which a person involuntary and temporarily stops breathing) and had a heart rate of 100 beats per minute (normal is 120-160) after one minute of life. Pt 1 was intubated (a tube inserted to provide oxygen into the lungs). Pt 1's "EMR" indicated, Medical Doctor (MD) 4 requested transfer to a higher level of care Neonatal Intensive Care Unit (NICU). Pt 1's "EMR" indicated a transfer hospital's NICU team arrived and attempted to stabilize Pt 1 for transport. Pt 1's "EMR" indicated Pt 1 could not be stabilized. Pt 1's "EMR" indicated the transport team met with Pt 2 and family to discuss withdrawing care. Pt 1's "EMR" indicated on 6/25/24 at around 5:45 p.m. Pt 2 and family agreed to withdraw care for Pt 1. Pt 1's "EMR" indicated Pt 1 was extubated (breathing tube removed) by the transport team. Pt 1's "EMR" indicated time of death was called on 6/25/24 at 10:20 p.m.

During a review of Pt 1's "H&P", dated 6/25/24, " ... 39 4/7 [39 weeks and 4 days] gestation born by SVD with vacuum assist. Required prolonged resuscitation ... Team arrived to take baby to [other hospital] but because of poor clinical exam and labs, decision to withdraw care was made in consultation with family ..."

During a review of Pt 1's "H&P," addendum dated 6/26/24, the "H&P" addendum indicated, " ... Baby noted to be spontaneously breathing and well perfused around an hour after baby was taken off the ventilator (a machine that helps people breathe) and extubated (tube that that supplied oxygen was removed) ... Heart stopped at 10:20 p.m. as narrated by parents and RN [Registered Nurse] ..."During a review of Pt 1's "Notification of Death", dated 6/27/24, the "Notification of Death" indicated, " ... Preliminary cause of death ...Metabolic acidosis ... [a condition in which there is too much acid in the body's fluids, especially in the blood] ...".

During a review of Pt 2's "Surgical Pathology Report (a medical report that describes the characteristics of a tissue specimen that is taken from a patient)," dated 7/1/24, the report indicated, " ... Trivascular [three vessels-normal] umbilical cord with acute fundisitis [an infection of the umbilical cord itself] fetal membranes with acute chorioamnionitis [an infection of the placenta and the amniotic fluid] ..."

During a concurrent interview and record review on 8/5/24 at 2:55 p.m. with Registered Nurse (RN) 5, Pt 2's "Electronic Medical Record ("EMR")" dated 6/24/24 and 6/25/24 and "FMS", dated 6/24/24 and 6/25/24 were reviewed. RN 5 stated LNs applied a fetal monitor to Pt 2 when she (Pt 2) arrived in L&D. RN 5 stated fetal monitoring was used to detect fetal wellbeing, and patient contractions. RN 5 stated LNs were expected to accurately document all components of a fetal assessment including, the baseline fetal heart rate (FHR), baseline variability, presence of accelerations, and any decelerations. RN 5 stated LNs must document a minimum of every 30 minutes. RN 5 stated when patients had decelerations LNs had "interventions" they were supposed to do. RN 5 stated the interventions were, repositioning the patient, turning off oxytocin (a medication used to start labor, making contractions stronger and closer together) if infusing, beginning a bolus (large amount) of lactated ringer (electrolyte solution), and giving the patient oxygen by mask (medical device that fits over a person's nose and mouth to provide oxygen). RN 5 stated LNs must notify physicians of prolonged, late, and recurrent decelerations. RN 5 verified in Pt 2's "FMS," documentation, dated 6/24/24, a late deceleration at 1:35 p.m. was not accurately reflected in the documentation at 2 p.m. or reported to the physician. RN 5 stated in Pt 2's "FMS" documentation, on 6/24/24, recurrent late decelerations were not accurately reflected in the documentation from 4:30 p.m. to 5:30 p.m. or reported to the physician. RN 5 stated Pt 2's "FMS," dated 6/24/24, at 5 p.m. and 5:30 p.m., indicated, uterine tachysystole (more than six contractions in 10 minutes), LNs documented a normal contraction pattern (no tachysystole). RN 5 stated LNs should have notified Pt 2's physician about her recurrent late decelerations and uterine tachysystole (abnormal contraction pattern). RN 5 stated physicians must be notified when patients had decelerations. RN 5 stated complete documentation was important for a clear clinical picture. RN 5 stated LNs must document all components of the fetal assessments to be considered complete and accurate.

During a concurrent interview on 8/5/24 at 3:30 p.m. with RN 5, Pt 2's "FMS" documentation, dated 6/24/24, was reviewed, the "FMS" documentation indicated multiple cervical exams that had incomplete documentation. RN 5 stated LNs must document, who performed the exam, dilation (opening of cervix - measured in centimeters, the lower, narrow end of the uterus (womb) that connects the uterus to the vagina (birth canal), effacement (thinning), station (position of baby's presenting part in relation to the mother's pelvis), and cervical position (cervix moves closer to birth canal, to the front when close to delivery), when completing a cervical exam. RN 5 stated on 6/24/24 at 3:05 p.m. the station was not documented, at 4:01 p.m. the effacement and station were not documented. RN 5 stated accurate documentation of cervical exams were important to determine the progress of labor. RN 5 stated without accurate documentation of cervical exams the provider would not know if a patient's cervix had changed within the designated timeframe for a safe vaginal delivery or if a C/S should be considered.

During a concurrent interview and record review on 8/7/24 at 10:10 a.m. with Manager (MGR) 9, Pt 2's ""EMR"," dated 6/25/24, were reviewed. Pt 2's "EMR" indicated MGR 9 was the shift manager on the day Pt 2 delivered. MGR 9 stated she went into Pt 2's delivery room when MD 3 was at the end of the bed and Pt 2 was pushing. MGR 9 stated MD 3 was beginning to start a vacuum delivery (a medical procedure that uses a vacuum to help move a baby through the birth canal during vaginal childbirth) MGR 9 stated there was a phone call into the department that MD 2 (Pt 2's primary physician) was almost to the unit. MGR 9 stated MD 2 entered the room as MD 3 was applying the vacuum to Pt 1's head inside of Pt 2's vagina. MGR 9 stated whenever a vacuum delivery was going to take place many staff members attended the delivery. MGR 9 stated the Neonatal Intensive Care Unit (NICU) nurses would attend the deliveries, and generally a charge nurse, as well as the primary nurse. MGR 9 stated she made the phone call to MD 4 (pediatrician) to attend delivery due to Pt 2 needing a vacuum delivery. MGR 9 stated NICU, was called to attend due to decelerations and a vacuum. MGR 9 stated when she called MD 4, she was told it would be 20 minutes till the physician arrived, MGR 9 stated the physician arrived in 26 minutes but still arrived before the baby was delivered. MRG 9 stated she was not at Pt 2's bedside during any of the discussions about a possible C/S.

During an interview on 8/7/24 with MGR 9, at 10:30 a.m., MGR 9 stated, Fetal assessment documentation included: FHR baseline, variability, accelerations, and decelerations. MGR 9 stated assessing fetal wellbeing was important. MGR 9 stated fetal assessments were documented into a patient's medical record and were reported to the physician. MGR 9 stated cervical exam documentation included, dilation, effacement, presentation, station, position, who did it, and if there was any bleeding. MGR 9 stated, cervical exam documentation was important to determine patient progress. MGR 9 stated cervical exams allow the clinical team with assessing labor progress. MGR 9 stated her expectation was for LNs to have complete and accurate documentation.

During an interview on 8/7/24 at 11:46 a.m. with MD 1, MD 1 stated, he was Pt 2's physician on 6/24/24 from 5:00 p.m. until 6/25/24 at 8:30 a.m. MD 1 stated his role was to typically watch patient's overnight for the primary physician. MD 1 stated he was Pt 2's physician until the beginning of her second stage of labor (complete cervical dilation and ends with delivery of baby). MD 1 stated Pt 2's fetal heart tracing initially had a few intermittent (less than half of the contractions) variables then two or three prolonged variables. MD 1 stated Pt 2's tracing also showed intermittent late decelerations MD 1 stated he had LNs do frequent cervical exams, to ensure she was making labor progress. MD 1 stated despite the intermittent prolonged decelerations Pt 2's baby had moderate variability (fluctuations in the baseline heart rate that are irregular in amplitude and frequency of 6-25 bpm). MD 1 stated he discussed a C/S on 6/25/24 around 2 a.m. with Pt 2. MD 1 stated he told Pt 2 if her baby continued to have decelerations, she may need a C/S. MD 1 stated he did not tell Pt 2 he "recommended a C/S" because he believed the fetal heart tracing still looked "ok", the tracing still had variability at the time he discussed the C/S with Pt 2.

MD 1 stated, how long he would allow a patient to push was dependent on the fetal heart tracing. MD 1 stated he had a four-hour maximum time that he would allow a patient to push before a C/S or operative vaginal delivery (vacuum delivery) would be indicated (Pt 2 pushed for over 5 hours.) MD 1 stated the fetal head had to be at a +2 station (two centimeters from the pelvic outlet towards the vaginal opening, the head is +4 to +5 when it is coming out) or more in the birth canal for a vacuum to be applied for delivery. MD 1 stated Pt 2 was still pushing when he left the unit (Pt 2 pushed for 2 hours with MD 1 as physician). MD 1 stated at one point he did a cervical exam with scalp stimulation (baby's scalp is stimulated vaginally in an attempt to cause an increase in the baby's heart rate) and believed an acceleration occurred. MD 1 stated upon review of the "FMS" there was no acceleration, just a slow return to fetal HR baseline. MD 1 stated the exam "could" have been an indication there was acidosis. MD 1 stated he reported to MD 3 Pt 2's recurrent and periodic late decelerations, prolonged decelerations, and variables. MD 1 stated he reported to MD 3 Pt 2 had prolonged rupture of membranes. MD 1 stated chronic hypoxia (body's tissues don't have enough oxygen), reflected by the recurrent late decelerations (decrease in the fetal heart rate) and a long second stage and neonatal sepsis (bloodstream infection) caused by the chorioamnionitis (a serious infection that affects a person during pregnancy) can cause metabolic acidosis (there is too much acid in your blood). MD 1 stated metabolic acidosis was the cause of death for the baby.

MD 1 stated his expectation was for LNs to document the frequency of decelerations, FHR baseline, variability decelerations, accelerations, and possibly the category. MD 1 stated he expected LNs to document cervical exams, including dilation, station, and effacement. MD 1 stated he believed accurate documentation was important. MD 1 stated his expectation was for LNs to notify him when there was a change from Category 1((baseline 110-160 moderate variability, and accelerations, no decelerations except early) that lasted more than 10 minutes. MD 1 stated he expected to be informed of late, variable, and prolonged decelerations.

During a review of Pt 2's "FMS" documentation, dated 6/25/24, the "FMS" documentation indicated Pt 2 began pushing on 6/25/24 at 6:06 a.m. and stopped pushing on 6/25/24 at 8:30 a.m. to "labor down [allow body to move baby down without active pushing]". Pt 2 began pushing again on 6/25/24 at 10:04 a.m. and delivered Pt 1 at 12:29 a.m. Pt 2 pushed for a total of 4 hours and 49 minutes.

During an interview on 8/7/24 at 1:56 p.m. with MD 2, MD 2 stated she was Pt 2's primary physician and her delivery physician. MD 2 stated she arrived in the L&D unit on 6/25/24 at around 12 p.m. and went directly to Pt 2's room. MD 2 began the delivery of Pt 1. MD 2 stated Pt 1 had a very tight cord around the neck that needed to be cut prior to the baby being delivered. MD 2 stated Pt 1 delivered on 6/25/24 at 12:29 p.m. and went straight to the resuscitation team. MD 2 stated her expectation was to receive report from LNs on any fetal heart tracing that was not a Category 1. MD 2 stated her expectation was to receive notification from LNs when interventions were being done for a Category 2 (indeterminant, not a Category 1 or a Category 3) strip. MD 2 stated her expectation was notification for late, variable, and prolonged decelerations. MD 2 stated she relied on LNs to chart accurately. MD 2 stated LNs were the physician's eyes and ears on the floor and helped to decide the plan of care for the patient.

During an interview on 8/7/24 at 3:39 p.m. with RN 15, Pt 2's "EMR" dated 6/24/24 and 6/25/24 and "FMS" dated 6/24/24 and 6/25/24 were reviewed. RN 15 stated she was Pt 2's primary nurse on 6/24/24 from 7:00 p.m. to 6/25/24 at 7:30 a.m. RN 15 stated she started and stopped Pt 2's oxytocin (medication to start contractions) multiple times due to Pt 2's baby having decelerations. Pt 2's "EMR" indicated oxytocin was started on 6/24/24 8:38 p.m. stopped at 9:44 p.m., started on 6/25/24 at 12:30 a.m. stopped at 1:14 a.m., started at 1:51 a.m. and stopped at 2:40 a.m. for the final time. Pt 2's "FMS" indicated on 6/25/24 RN 15 documented "Variable, Late, see notes", no notes were in the documentation. RN 15 stated she talked with Pt 2 about the possibility of a C/S due to a recurrent deceleration and even though Pt 2 preferred a vaginal birth (when a person gives birth through their vagina) she told RN 15 she wanted to do whatever was best for her baby.

During a concurrent interview and record review on 8/7/24 at 5:05 p.m. with RN15, Pt 2's, "EMR," dated 6/25/24 and "FMS" dated 6/25/24 were reviewed. The "FMS" indicated on 6/25/24 at 3:13 p.m. Pt 2 had a 3-minute-long prolonged deceleration that RN 15 completed interventions for (turned patient) but failed to notify the physician about. RN 15 verified on 6/25/24 Pt 2's "FMS" indicated, recurrent late decelerations that were not accurately reflected in the documentation from 3 a.m. to 4 a.m. RN 15 stated she should have documented late decelerations and notified Pt 2's physician. RN 15 stated she should have escalated the "FMS" to the charge nurse more times and had more conversations with the physician about the total number of FHR decelerations.

During a concurrent interview on 8/8/24 at 8:33 a.m. with RN 16, Pt 2's "EMR", dated 6/25/24 and "FMS," dated, 6/25/24 were reviewed. RN 16 stated she was Pt 2's delivery nurse on 6/25/24. RN 16 stated when she received report from RN 15 Pt 2 was pushing. RN 16 stated by 9:30 a.m., Pt 2's "FMS" remained a Category 2 but had minimal variability. RN 16 stated at around 8:30 a.m. Pt 2 stopped pushing until around 10:04 a.m. RN 16 stated MD 3 spoke to Pt 2 about a C/S around 9 a.m. and Pt 2 stated she was ok with a C/S if it was necessary. RN 16 stated at around 10:15 a.m. she informed the scrub tech to "open the OR [get the OR ready for a C/S]" because of recurrent decelerations while pushing. RN 16 stated she informed MD 3 that the OR was completely ready to take the patient to surgery if needed. MD 3 continued telling RN 16 "a little bit more, a little bit more". RN 16 stated Pt 2 pushed another 30 minutes after a lengthy deceleration. RN 16 stated she told her charge nurse she wanted the physician to evaluate the "FMS", "FMS" documentation at 11 a.m., 11:40, and 11:52 verified that physician was at bedside and viewing tracing. RN 16 stated, by 11:40 a.m. the "FMS" was a Category 3 strip. RN 16 stated MD 2 came into room at 12:03 p.m. RN 16 stated the baby delivered at 12:29 p.m. RN 16 stated baby had an odor, like chorioamnionitis (infection affects a person during pregnancy) RN 16 stated Pt 1 was floppy, not crying, and was blue/gray. RN 16 stated she should have escalated, how concerned she was about Pt 2's "FMS" to the Chief Nursing Officer (CNO) since the supervisor was aware and the director was not in the unit. RN 16 stated contacting the physicians when patients have recurrent decelerations was important because the physician would then have a clear picture how long a baby had been having decelerations.

During an interview on 8/8/24 at 12:04 p.m. with MD 3, MD 3 stated he got report from MD 1 on 6/25/24 at 8:30 a.m. and was Pt 2's physician until MD 2 (delivery physician) took over at 12 p.m. MD 3 stated Pt 2's fetal strip had some decelerations, that were "not bad". MD 3 stated Pt 2 was allowed to "labor down" for an hour or so. MD 3 stated close to 10 a.m. LNs contacted him by telephone and asked if they could start pushing with Pt 2 again. MD 3 stated he spoke to Pt 2 and told her he "might consider doing a C/S due to no progressing, and decels (decreases in the fetal heart rate)". MD 3 stated he told Pt 2, "let's try again, and see if you progress." MD 3 stated, "the family was adamant (stubbornly refuse to change your mind about something) they did not want a C/S." MD 3 stated between 11:30 a.m. to 11:40 a.m. Pt 2's baby was beginning to lose variability. MD 3 stated, "now the baby is in a little bit of distress, the variability was starting to go" and he knew he needed to do something right away. MD 3 stated by then the baby was too low in her pelvis (the area of the body below the abdomen that is located between the hip bones and contains the bladder and rectum) to take her to the Operating Room (OR). MD 3 stated, "would have been futile to take her to the OR". MD 3 stated MD 2 called him and said she was on her way. MD 3 went into Pt 3's room and applied the vacuum to Pt 1's head. MD 2 came into Pt 2's room and told MD 3 she would take over care. MD 3 stated maybe he should have forced the C/S a little more, but the nurses told him Pt 2 did not want a C/S. MD 3 stated Pt 1's preliminary cause of death was metabolic acidosis. MD 3 stated chorioamnionitis, the extended length of time Pt 2 pushed (over five hours), or the tight cord Pt 1 had around the neck would cause metabolic acidosis.

During an interview on 8/9/24 at 11:33 a.m. with the CNO, the CNO stated she expected LNs to document completely and accurately. The CNO stated failure to document completely or accurately could affect care if the physician was not told about any issues that were not accurately documented. The CNO stated her expectation was for LNs to follow P&P and standards of practice.

During a review of the facility's P&P titled, "Fetal Heart Rate Monitoring", dated 10/4/23, indicated, " ... continuous fetal monitoring is being used, the following intervals apply: ...Low risk ...Assess and document every 30 minutes in the active phase (he cervix opens from 6 cm to 10 cm) of the first stage of labor, and every 15 minutes during the active pushing second stage of labor ... At each interval, record a complete assessment of the FHR tracing, include a baseline rate, baseline variability, presence of accelerations, periodic or episodic decelerations, and changes or trends in the FHR pattern over time. Assign a category to describe the tracing from the three-tier system ... Category I (normal) ... Category II (indeterminant) ... Category III (abnormal) ... If an indeterminant or abnormal FHR pattern is identified, begin physiological-based interventions as appropriate ... Reposition the patient ... Discontinuing oxytocin ... Intravenous fluid bolus the administration of an entire dose of medicine into the veins over a short period of time) ... Notify the patient's care provider and document maternal and fetal response to interventions, and a change to Category II or III ... documentation ... Vaginal exam and who performed it ... physician communication ...". During a review of the facility's P&P titled, Guidelines for Oxytocin Induction or Augmentation of Labor (the process of stimulating the uterus to increase the frequency, duration and intensity of contractions after the onset of spontaneous labour), dated 2/28/18, indicated ... Tachysystole ... More than 5 uterine contractions in a 10 minute period averaged over 30 minutes. ... Contractions that last over 120 seconds ...".

During a professional review titled, "Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term," (found at Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term - Downe, S - 2013 | Cochrane Library) dated 7/15/13, indicated " ...Used at regular intervals, either alone or as a component of the partogram (a pre?printed form providing a pictorial overview of the progress of labour), the aim is to assess if labour is progressing physiologically, and to provide an early warning of slow progress. Abnormally slow progress can be a sign of labour dystocia (painful, slow, or difficult delivery), which is associated with maternal and fetal morbidity and mortality ...".

During a professional review titled, First and Second Stage Labor Management, (found at (https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2024/01/first-and-second-stage-labor-management) dated 3/14, indicated " ...ACOG [American College of Obstetricians and Gynecologists] recommends that prolonged second stage of labor be defined as more than 3 hours of pushing in nulliparous [a female who has never given birth to a live baby] individuals and 2 hours of pushing in multiparous [producing many or more than one at a birth] individuals. An individualized approach should be used to diagnose second-stage arrest; incorporating information regarding progress, clinical factors that may affect the likelihood of vaginal delivery, discussion of risks and benefits of available interventions, and individual patient preference is recommended when time in the second stage is extended beyond these parameters ... Arrest in the second stage can be identified earlier if there is lack of fetal rotation or descent despite adequate contractions, pushing efforts, and time ... ACOG recommends that cesarean delivery be performed in patients with active phase arrest of labor ... Cervical examinations are indicated to determine labor progress, but there is insufficient evidence to provide guidance on the frequency of cervical examinations in labor to assist with labor progress or dystocia ...".

2. During a concurrent interview and record review on 8/1/24 at 2:15 p.m. with Registered Nurse RN) 1 and RN 6, Pt 22's "History and Physical (H&P)," dated 7/25/24 was reviewed. The H&P indicated past medical history of osteoporosis (bone mass decrease), peripheral neuropathy (nerve damage that causes weakness, numbness, and pain), and diabetes (disease where sugar is too high in blood) was evaluated before surgery in preparation for right total knee arthroplasty due to osteoarthritis (a joint disease in which the tissues in the joint break down over time). The H&P indicated Pt 22 was admitted to the hospital for a right total knee arthroplasty (total knee replacement) on 7/31/24.

During a review of Pt 22's "Provider Order (PO)," dated 7/31/24, the "PO" indicated, " ...acetaminophen-hydrocodone [a narcotic pain medication used to treat pain] 325 milligrams [mg- a unit of measurement]-5 mg oral tablets [325 mg acetaminophen and 5 mg hydrocodone] ...Volume dose: 1...Volume dose unit: tab [tablet] ...Route of administration: Oral ... Frequency: Q4hr [every four hours] ... PRN [as needed] ... PRN reason: Pain Moderate ...".

During a concurrent interview and record review on 8/1/24 at 2:30 p.m. with RN 1 and RN 6 Pt 22's "Medication Administration Record (MAR) [a record of drugs administered to a patient]" flowsheet, dated 7/31/24 to 8/1/24 was reviewed. The "MAR" indicated on 8/1/24 at 11:37 a.m. Pt 22 was administered one tablet of acetaminophen-hydrocodone 5mg-325mg. RN 1 stated the "MAR" flowsheet indicated Pt 22's pain was not reassessed within the one-hour timeframe per policy. RN 1 stated Pt 22's "MAR" flowsheet indicated Pt 22's next pain assessment was on 8/1/24 at 2:39 p.m. when she was administered another dose of pain medication. RN 1 stated Pt 22's pain should have been re-assessed on 8/1/24 by

Based on observations, interviews and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection in accordance with hospital policy and professional standards when:

1. Unused items were stored in a dirty utility room (a room where used items are placed to be cleaned or disposed of) contrary (opposite) to professional standards.

2. A urine sample used for a pregnancy test was left on the counter in the dirty utility room approximately two hours after the sample was collected contrary to professional standards.

3. Used IV (intravenous) tubing from a patient was discarded in a regular trash can rather than a biohazard (a biological substance that poses a threat to the health of living organisms) disposal container contrary to hospital policy and procedure.

4. Four IV catheters (a needle with a tube, used to start IV lines), one medication tubing set (use to connect a medication to an IV), and three saline locks ( a cap that allows access to an IV and keeps blood from flowing out freely) in sterile packaging, were on the floor and two syringes (a tube with a nozzle and bulb) and two sterile IV start kits ( sterile supplies used to start and IV) were open from their sterile packaging and left unattended on the counter of the clean supply room of the Postpartum (PP, after birth) Unit. A syringe and electrocardiogram (ECG, a record or display of a person's heartbeat) electrodes (electric conductor on sticker to attach to a patient) in their packages were on the floor in the clean supply room in the telemetry (heart monitoring) unit contrary to professional standards.

5. A package containing a wound drainage (fluid that leaks from wounds) collector with barrier (a type of wound dressing, to keep the wound area clean and dry) was found open in a wound treatment cart on the medical surgical (MS) unit contrary to hospital policy.

6. A patient nutrition room food refrigerator had a sticky brown substance, and crumbs were in two drawers where patient food was held in the telemetry unit contrary to hospital policy and procedure.

These failures had the potential for cross contamination (the process by which bacteria [microscopic living organisms that cause infections] are unintentionally transferred from one object or to another object or person with a harmful effect) and transmission of infection.

Findings:

1. During a concurrent observation and interview on 7/31/24 at 2:55 p.m. with the Director of Critical Care (DCC) in the Progressive Care Unit's (PCU) dirty utility room an unused sharps container was found in a cabinet. The DCC stated anything in this room is considered dirty and the unused sharps container should not be in this room.

During an interview on 8/9/24 at 11:00 a.m. with the Infection Preventionist (IP), the IP stated any item in the dirty utility room was considered dirty and clean items should not be stored in the dirty utility due to cross contamination.

During a review of a professional reference from the Agency for Healthcare Research and Quality (AHRQ) titled, "Infection Prevention (IP)" (undated), "IP" indicated, " ... Providing a sanitary environment ... There is a clear separation of clean and dirty work areas. Clean areas are used for storage and preparation of medications and unused supplies; dirty areas are used for contaminated equipment ...".

2. During a concurrent observation and interview on 7/31/24 at 12:36 p.m. with Preoperative Shift Manager (PSM) in the dirty utility room, a specimen cup filled with urine was on the counter. The time and date on the label of the specimen was 7/31/2024 10:48 a.m. The PSM stated that the result of the test took a few minutes. The PSM stated specimen should have been discarded immediately after test results. The SPM stated the specimen was not properly disposed.

During an interview on 8/9/24 at 11:00 a.m. with the Infection l Preventionist (IP), the IP stated all departments are expected to follow policy and procedure to prevent infection. The IP stated the urine should have been discarded immediately after results to prevent cross contamination.

During an interview on 8/9/24 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected staff to follow policy and procedure (P&P) to prevent infection.


3. During a concurrent observation and interview on 7/31/24 at 4:06 p.m. with Emergency Department Shift Manager (EDSM) in the emergency department Rapid Patient Movement (RPM) area, an IV tubing was found discarded in a regular trash can outside a patient room. The EDSM stated the IV tubing should not be discarded in the regular trash and should be discarded in a designated blue pharmaceutical waste bin.

During an interview on 8/9/24 at 11:00 a.m. with the IP, the IP stated all departments are expected to follow policy and procedure to prevent infection. The IP stated the IV tubing should be discarded into blue bin and no other trash or garbage cans. The IP stated there a possibility of cross contamination of various infections when IV tubing is not properly disposed and policy for disposal of IV tubing was not followed. The IP stated staff, patients, and visitors would be at risk due to improper disposal of IV tubing.

During an interview on 8/9/24 at 11:30 a.m. with the Chief Nursing Officer (Chief Nursing Officer), the CNO stated she expected staff to follow hospital Policy and Procedure (P&P) for proper disposal of IV tubing and P&P was not followed. The CNO stated there could have been cross-contamination by the disposal of IV tubing in the regular trash and someone could get sick.

During a review of the hospital's P&P titled, "Pharmaceutical Waste Management" (undated) indicated, " ... " ... Non RCRA (Resource Conservation and Recovery Act, enacted in 1976, is the principal Federal law in the U.S. governing the disposal of solid waste and hazardous waste) pharmaceutical Waste (blue bin) ...Description and example of waste ...Examples of Non-RCRA Waste ...Full or partial IV's with Rx (prescription medication) instilled ...".

4. During concurrent observation and interview on 7/31/24 at 12:46 p.m. with Manager (MGR) 1 and the Director of Medical Surgical (DMS) unit in the postpartum (PP) unit clean utility room, Four 18-gauge (g-a unit of measurement) Intravenous catheters, one medication tubing set, and three saline locks in sterile packages, were on the floor of the clean supply room. Two 3 milliliter (mL-a unit of measurement) syringes (a tube with a nozzle and bulb) and two sterile IV start kits (containing, dressing, gauze, antiseptic, tourniquet, tape, and identification label) were opened from their sterile packaging and left on a counter in the clean supply room. MGR 1 stated, clean and sterile patient supplies on the clean utility floor were an infection control issue. The DMS stated sterile packaging such as IV kits should not be opened in the clean supply room and unused items left on counters. MGR 1 stated, syringes should be opened in the patient rooms to prevent cross contamination and lower chances of infection. The DMS stated, all items dropped on the floor in the clean utility room were considered dirty and could not be used on patients The DMS stated, items could not be used because of potential microorganisms that could be on the packaging from the floor.

During concurrent observation and interview on 7/31/24 at 3:46 p.m. with Registered Nurse (RN) 3 in the telemetry unit clean utility room, a syringe, and ECG electrodes were observed in their packages on the floor. RN 3 stated clean supplies on the floor in the utility room was an infection control issue. RN 3 stated taking supplies that were on the floor into a patient room then using them can spread infection.

During an interview on 7/31/24 at 3:47 p.m. with the DMS, the DMS stated clean supplies should not be used on patients if they were on the floor. The DMS stated clean patient supplies dropped on the floor can have microorganisms that can cause infections in patients.

During an interview on 8/9/24 at 11:00 a.m. with the IP, the IP stated clean or sterile supplies should not be on the floor in the clean utility storage rooms. The IP stated supplies should be stored from eight to 10 inches above the floor. The IP stated supplies that were on the ground then used on patients could lead to infection. The IP stated supplies should not be opened and left in the supply room. The ICP stated sterile packages should be opened in the patient room. The IP stated any items opened and left unattended would no longer be considered safe to use on a patient. The IP stated opening a sterile package and leaving the contents in the supply room may lead to infection if the supplies were then used on a patient.

During a review of the facility's P&P titled, "Guidelines for storage in Clean & Soiled Utility Rooms", dated 7/24/2021, indicated, " ... All patient care supplies must be stored at least 6 inches from the floor and sterile supplies must be stored no closer than 8-10 inches from the floor ...".

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections", dated 8/2013, the professional reference indicated, " ... Hospital surfaces are frequently contaminated with important healthcare-associated pathogens [bacteria]. Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial [originating from the hospital] pathogens ...".

During a review of the professional reference titled, "GOOD STORAGE AND DISTRIBUTION PRACTICES FOR MEDICAL PRODUCTS", dated 8/2019, the professional reference indicated, " ... Storage and distribution are important activities in the supply chain management of medical products ... Medical products should be stored off the floor ...".

5. During a concurrent observation and interview on 7/31/24 at 2:54 p.m. with the DMS in the medical surgical (MS) clean utility room, a package containing a wound drainage collector with barrier was found open in a wound treatment cart. The DMS stated an open wound supply item was an infection control issue. The DMS stated staff could not ensure microorganisms were not in the open package. The DMS stated her expectation was wound supplies were not opened until taken to bedside and used on the patient.


During an interview on 8/9/24 at 11:05 a.m. with the IP, the IP stated clean and sterile packages should be opened in the patient room and used soon after opening. The IP stated any items opened and left unattended would no longer be considered safe to use on a patient. The IP stated a microorganism may be on the supplies. The IP stated opening a package and leaving the contents in the supply room or wound cart may lead to infection.

During a review of the facility's P&P titled, "Standard for Impaired Skin Integrity (Potential/Actual)", dated 8/18/90, indicated, " ... wound cleansing and wound treatment products ...".

6. During a concurrent observation and interview on 7/31/24 at 3:50 p.m. with RN 3 in the telemetry unit nutrition room patient food refrigerator, a sticky brown substance and crumbs were observed in both bottom drawers. RN 3 stated, environmental services (EVS) were responsible for cleaning the refrigerator, but nursing staff should notify EVS if necessary to ensure cleanliness. RN 3 stated, microorganisms grow in unclean areas and can attach to the packaging on patient food items that are stored in the refrigerator. RN 3 stated infection risk may increase when microorganisms were present on items given to patients.

During an interview on 8/9/24 at 11:10 a.m. with the IP, the IP stated patient food refrigerators should not be stick dirty or grimy. The IP stated anything that was "gross visually" should be cleaned right away. The IP stated dirty areas around food was an infection control issue for patients.

During a review of the facility's P&P titled, "Infection Control", dated 7/22/16, indicated, " ... For reach-in refrigerators, spills are cleaned immediately ... Shelves are washed in soapy water, rinsed, sanitized, and left to air dry ...".

During a review of the professional reference titled "Controlling Hospital-Acquired Infection: Focus on the Role of the Environment and New Technologies for Decontamination", dated 10/27/14, the professional reference indicated, " ... a large number of reports include cleaning as an important control component for outbreaks of norovirus, VRE, C. Difficile, MRSA, and Multidrug-resistant (MDR) Gram-negative bacilli ... Removing visual and invisible dirt from the hospitals of today and for the future requires sufficient trained staff, ongoing monitoring ...".