Every finding on record at Maxim Healthcare Services, Inc

The following reflects the findings of the California Department of Public Health during the investigation of facility reported incident #98590. Representing the Department of Public Health: Health Facilities Evaluator Nurse, 32525 The inspection was limited to the specific facility reported incident investigated and does not represent the findings of a full inspection of the agency.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview, clinical record and policy and procedure review, the Home Health Agency (HHA) failed to ensure the health and safety of the patients was maintained when a Licensed Nurse (LN 1) administered a hand sanitizer solution instead of water via a gastric tube to a 6-month-old baby (G572) and LN 1 failed to call the emergency services and to notify the physician as soon as possible when she administered a hand sanitizer solution (G590). The cumulative effect of these systemic practices resulted in the baby having a significant change of condition related to the alcohol ingredient contained in the sanitizer solution and was admitted to Pediatric Intensive Care Unit (PICU, specialized unit of the hospital where very sick children are admitted for life support treatments including intubation-breathing with assistance of a ventilator). CoP Violation

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the health and safety of the patients was maintained when a Licensed Nurse (LN 1) administered a hand sanitizer solution instead of water via a gastric tube to a 6-month-old baby (Patient 1). This failure resulted in the baby having a significant change of condition related to the alcohol ingredient contained in the sanitizer solution and was admitted to Pediatric Intensive Care Unit (PICU, specialized unit of the hospital where very sick children are admitted for life support treatments including intubation-breathing with assistance of a ventilator). Findings: According to the ‘Referral’ documents dated 3/17/23, Patient 1 was accepted for home health care with an expected date of discharge from the hospital documented as 3/19/23. The documents further indicated he was born prematurely at a gestation of less than 24 weeks and a birth weight of 550-749 grams (about 1.21 to 1.65 pounds) and was hospitalized since birth. Review of a report from the home health agency received by the Department on 4/6/23 indicated, a Licensed Nurse (LN 1) had administered hand sanitizer via a gastric (stomach) tube to Patient 1 instead of water following medication administration on 4/5/23 at 2 p.m. A review of Patient 1’s Plan of Care (POC) physician orders dated 4/3/23 through 6/1/23 indicated the nurse was to visit the patient 24-32 hours per week. According to the POC, the tube feedings were scheduled at 9 a.m., 12 noon, 3 p.m., 6 p.m., and 9 p.m. and, the GT was to be flushed with 3-5 ml after medication and feeding were administered. The type of flush was not indicated in the order. The POC orders included a night tube feeding of 147 ml at a rate of 33 ml per hour to be administered by the family between 11 p.m. to 7 a.m. The POC included vitamin D 0.5 ml three times per week and famotidine (used for acid reflux/heartburn) 0.3 ml once daily to be administered via GT. The POC indicated the patient was a full code status (indicates if a person’s heart stopped beating or stopped breathing, all resuscitation procedures will be provided to keep them alive including CPR). The POC indicated the goal was to keep the patient out of the hospital. According to Patient 1’s Skilled Nursing Note (SNN) dated 4/5/23, LN 1 started the shift at 8:02 a.m. and left shift at 3:29 p.m. A further review of the SNN indicated he was on a continuous feeding via gastric tube running at 70 milliliters (ml, a measure of volume) per hour for a total of 120 ml (equivalent to one cup or 4 ounces). The note indicated the feeding was completed at 2 p.m., “feeding complete went to wack [sic wake] baby up and he did not respond, … when i flush his tube after feeding it was not water in the bottle itbwas[sic it was] alcohol i had flush his g [gastric] tube with alciohol not water, i got him in my arms and started stimulating his muscles, he [sic] o2[oxygen] sat [saturation, amount/percentage of oxygen in blood obtained using an external device, normal range 95-100 %] would go down to 90 then up again to 98 then down to 94 and back and forth foran[sic] hour … 15:26 [3:26 p.m.) 911 arrived and took him and mom to the hospital … i did get the baby to throw up at one time, he was still limp.” A review of Patient 1’s ‘Intake and Output ‘documented by LN 1 on 4/5/23 indicated, she administered 120 ml of Similac (type of baby formula) advanced feeding documented intake time was at 11:24 a.m. and 120 ml documented intake time was at 12 p.m. for a total of 240 ml. LN 1 documented she flushed the GT with 40 ml and 30 ml of water at 11:24 a.m. and 12 p.m. respectively for a total of 70 ml of water flushes. Under the output portion of the documentation, the urine output of 200 ml and no emesis was documented. The total intake was documented as 310 ml (240 ml feeding and 70 ml flushes). During a telephone interview with LN 1 on 4/19/23, at 1:13 p.m., she stated she was a nurse while she worked for the agency and was assigned to Patient 1. LN 1 stated she visited Patient 1 twice, once on 4/3/23 and once on 4/5/23 for day shift. LN 1 further stated she did not wish to be interviewed before she consulted her attorney, and she hung up the call. An interview conducted with a Registered Nurse (RN) and the Director of Patient Care Services (DPCS) on 4/19/23 at 2:41 p.m., the RN stated she and another RN completed the initial assessment and the POC for Patient 1 on 4/3/23 in the morning and the baby was doing well. The RN reported the primary caregiver was the baby’s mother and the agency nurse was to visit 3 days per week. The RN indicated LN 1 was present during the visit on 4/3/23 and she reviewed the patient’s POC with her. The RN reported among the supplies provided by the agency during the admission visit was a hand sanitizer solution which was placed on a table near the baby’s crib. The DPCS stated LN 1 called the agency on 4/5/23 after 3 p.m., and she and the RN put her on speaker. The DPCS stated LN 1 was hysterical, was crying and reported she had used a hand sanitizer solution to flush the baby’s gastric tube instead of water. The DPCS stated LN 1 had asked a family member who was in the home to call the baby’s parents using her phone. The DPCS stated the parents called 911 while on their way home and the baby was taken to the hospital. During an interview with the hospital’s Case Manager (CM) on 4/21/23, at 9:21 a.m., the CM stated Patient 1 was admitted to PICU on 4/5/23 and he was still intubated (breathing with the assistance of a ventilator). The CM reported a lab ethanol level done on 4/5/23 indicated it was 210 milligrams/deciliter (mg/dl, unit of measurements) and indicated it was critically high. A review of Patient 1’s ‘Physician’ documentation dated 4/5/23 indicated, “At approx (approximately) 1440 [2:40 p.m.] today, MOC [mother of child] received a call from their new home health nurse stating that patient was acting altered. The home health nurse admitted to accidentally flushing patient’s GT with 10 ml of 70% ethanol at approximately 1246 [12:46 p.m.] MOC called EMS [emergency services], and upon arriving home, tried using a syringe to pull out some gastric contents, but was unable to get much out … Patient was brought to [name] ED [emergency department], where he was found to be tachypneic [rapid breathing] and with altered mental status. Patient was intubated … mechanical ventilation … for altered mental status requiring intubation after accidental ethanol intoxication … Plan … ethanol level now …” A review of Patient 1’s ethanol (alcohol in blood) level lab result dated 4/5/23 at 11:35 p.m. indicated 210 mg/dl critical high and the reference range was noted as <10 mg/dl. A review of the agency’s ‘Plan of Care’ policy dated 8/19/22 indicated, “The plan of care will describe specific services to be provided based on the clinical assessment and will include amount, frequency, and duration of services and expected outcomes for the patient/client … Care/services will be provided according to the agreed to plan of care.” The policy indicated physician orders were required for each client admitted by the agency for services and included expected patient outcomes and treatment orders. A review of the agency’s ‘Medication Administration’ policy dated 10/7/22 indicated the nurse administering the medication will review the label for name. A review of the agency’s undated ‘Protocols’ titled, “… Tubes: Enteral Feeding” directed,” Flushing guidelines … recommends using purified water (sterile water for irrigation) when caring for patients who are chronically ill or immunocompromised … Flush tubes with 30 ml of water or per MD [Medical Doctor] order … If being used for continuous feedings, as ordered … If being used for bolus feedings, before and after feedings … After checking residual [aspiration/withdrawal of stomach contents] volume … Before/after/between all medications using tap (if approved) or purified.” An interview conducted with the DPCS 0n 4/19/23, at 3:42 p.m., DPCS stated she would have expected LN 1 to check the labels before administering any medications, formula, or flushes. The DPCS further indicated she would have expected LN 1 to call 911 immediately after she noted the baby was not acting right and his parents as soon as possible. The DPCS indicated the agency was encountering some challenges investigating the incident as the family and LN 1 were no longer cooperative with being interviewed.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency Licensed Nurse (LN 1) failed to call the emergency services and to notify the physician as soon as possible when she administered a hand sanitizer solution instead of water via a gastric tube to a 6-month-old baby (Patient 1). This failure resulted in the baby having a significant change of condition related to the alcohol ingredient contained in the sanitizer solution and was admitted to a Pediatric Intensive Care Unit (PICU, specialized unit of the hospital where very sick children are admitted for life support treatments including intubation-breathing with assistance of a ventilator). Findings: According to the ‘Referral’ documents dated 3/17/23, Patient 1 was accepted for home health care with an expected date of discharge from the hospital documented as 3/19/23. The documents further indicated he was born prematurely at a gestation of less than 24 weeks and a birth weight of 550-749 grams (about 1.21 to 1.65 pounds) and was hospitalized since birth. Review of a report from the home health agency received by the Department on 4/6/23 indicated, a Licensed Nurse (LN 1) had administered a hand sanitizer via a gastric (stomach) tube to Patient 1 instead water following medication administration on 4/5/23 at 2 p.m. A review of Patient 1’s Plan of Care (POC) physician orders dated 4/3/23 through 6/1/23 indicated the nurse was to visit the patient 24-32 hours per week. The POC indicated the patient was on gastric tube (GT) feeding and flushing. The POC indicated the patient was a full code status (indicates if a person’s heart stopped beating or stopped breathing, all resuscitation procedures will be provided to keep them alive including CPR). A review of Patient 1's Skilled Nursing Visit (SNN) note dated 4/5/23 by LN 1 had no documented evidence that she called emergency services or the physician when she administered the hand sanitizer instead of the water. A further review of the note indicated the feeding was completed at 2 p.m., “feeding complete went to wack [sic wake] baby up and he did not respond, … when i flush his tube after feeding it was not water in the bottle itbwas[sic it was] alcohol i had flush his g [gastric] tube with alciohol [sic] not water, i got him in my arms and started stimulating his muscles, he [sic] o2[oxygen] sat [saturation, amount/percentage of oxygen in blood obtained using an external device, normal range 95-100 %] would go down to 90 then up again to 98 then down to 94 and back and forth foran[sic for an] hour …" An interview conducted with a Registered Nurse (RN) and the Director of Patient Care Services (DPCS) on 4/19/23 at 2:41 p.m., the DPCS RN stated LN 1 was assigned to Patient 1 on 4/3/23 and 4/5/23 for morning shift. The RN stated she and another RN completed the initial assessment and the POC for Patient 1 on 4/3/23 in the morning and the baby was doing well. The RN reported the primary caregiver was the baby’s mother and the agency nurse was to visit 3 days per week. The RN indicated LN 1 was present during the visit on 4/3/23 and she reviewed the patient’s POC with her. The RN reported among the supplies provided by the agency during the admission visit was a hand sanitizer solution which was placed on a table near the baby’s crib. The DPCS stated LN 1 called the agency on 4/5/23 after 3 p.m., and she and the RN put her on speaker. The DPCS stated LN 1 was hysterical, was crying and reported she had used a hand sanitizer solution to flush the baby’s gastric tube instead of water. The DPCS stated LN 1 had asked a family member who was in the home to call the baby’s parents using her phone. The DPCS stated the parents called 911 while on their way home and the baby was taken to the hospital. A review of Patient 1’s ‘Physician’ documentation dated 4/5/23 indicated, “At approx (approximately) 1440 [2:40 p.m.] today, MOC [mother of child] received a call from their new home health nurse stating that patient was acting altered. The home health nurse admitted to accidentally flushing patient’s GT with 10 ml of 70% ethanol at approximately 1246 [12:46 p.m.] MOC called EMS [emergency services], and upon arriving home, tried using a syringe to pull out some gastric contents, but was unable to get much out … Patient was brought to [name] ED [emergency department], where he was found to be tachypneic [rapid breathing] and with altered mental status. Patient was intubated … mechanical ventilation … for altered mental status requiring intubation after accidental ethanol intoxication … Plan … ethanol level now …” A review of Patient 1’s ethanol (alcohol in blood) level lab result completed at the hospital on 4/5/23 at 11:35 p.m. indicated 210 mg/dl critical high and the reference range was noted as A review of the agency’s ‘Plan of Care’ policy dated 8/19/22 indicated, “The primary care physician shall be notified immediately of any changes in the client’s condition that indicates a need to alter the medical plan of care.” A review of the agency’s ‘Medication Administration’ policy dated 10/7/22 indicated the nurse administering the medication will review the label for name. A review of the agency’s undated ‘Protocols’ titled, “… Tubes: Enteral Feeding” directed,” Flushing guidelines … recommends using purified water (sterile water for irrigation) when caring for patients who are chronically ill or immunocompromised … Flush tubes with 30 ml of water or per MD [Medical Doctor] order … If being used for continuous feedings, as ordered … If being used for bolus feedings, before and after feedings … After checking residual [aspiration/withdrawal of stomach contents] volume … Before/after/between all medications using tap (if approved) or purified.” An interview conducted with the DPCS 0n 4/19/23, at 3:42 p.m., DPCS stated she would have expected LN 1 to check the labels before administering any medications, formula, or flushes. The DPCS further indicated she would have expected LN 1 to call 911 immediately after she noted the baby was not acting right and his parents as soon as possible. The DPCS indicated the agency was encountering some challenges investigating the incident as the family and LN 1 were no longer cooperative with being interviewed. The DPCS stated the agency did not have a specific policy on significant change of condition.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on interview, clinical record and policy and procedure review, it was determined that the Home Health Agency (HHA) failed to ensure care and services provided met professional standards of clinical practice (G984) when a Licensed Nurse (LN 1) administered a hand sanitizer solution instead of water via a gastric tube to a 6-month-old baby (Patient 1). The cumulative effect of this practice resulted in the baby having a significant change of condition related to the alcohol ingredient contained in the sanitizer solution and was admitted to Pediatric Intensive Care Unit (PICU, specialized unit of the hospital where very sick children are admitted for life support treatments including intubation-breathing with assistance of a ventilator). CoP Violation

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure care and services provided met professional standards of clinical practice when a Licensed Nurse (LN 1) administered a hand sanitizer solution instead of water via a gastric tube to a 6-month-old baby (Patient 1). This failure resulted in the baby having a significant change of condition related to the alcohol ingredient contained in the sanitizer solution and was admitted to Pediatric Intensive Care Unit (PICU, specialized unit of the hospital where very sick children are admitted for life support treatments including intubation-breathing with assistance of a ventilator). Findings: According to the ‘Referral’ documents dated 3/17/23, Patient 1 was accepted for home health care with an expected date of discharge from the hospital documented as 3/19/23. The documents further indicated he was born prematurely at a gestation of less than 24 weeks and a birth weight of 550-749 grams (about 1.21 to 1.65 pounds) and was hospitalized since birth. Review of a report from the home health agency received by the Department on 4/6/23 indicated, a Licensed Nurse (LN 1) had administered hand sanitizer via a gastric (stomach) tube to Patient 1 instead of a saline solution following medication administration on 4/5/23 at 2 p.m. A review of Patient 1’s Plan of Care (POC) physician orders dated 4/3/23 through 6/1/23 indicated the nurse was to visit the patient 24-32 hours per week. According to the POC, the tube feedings were scheduled at 9 a.m., 12 noon, 3 p.m., 6 p.m., and 9 p.m. and, the GT was to be flushed with 3-5 ml after medication and feeding were administered. The type of flush was not indicated in the order. The POC orders included a night tube feeding of 147 ml at a rate of 33 ml per hour to be administered by the family between 11 p.m. to 7 a.m. The POC included vitamin D 0.5 ml three times per week and famotidine (used for acid reflux/heartburn) 0.3 ml once daily to be administered via GT. The POC indicated the patient was a full code status (indicates if a person’s heart stopped beating or stopped breathing, all resuscitation procedures will be provided to keep them alive including CPR). The POC indicated the goal was to keep the patient out of the hospital. According to Patient 1’s Skilled Nursing Note (SNN) dated 4/5/23, LN 1 started the shift at 8:02 a.m. and left shift at 3:29 p.m. A further review of the SNN indicated he was on a continuous feeding via gastric tube running at 70 milliliters (ml, a measure of volume) per hour for a total of 120 ml (equivalent to one cup or 4 ounces). The note indicated the feeding was completed at 2 p.m., “feeding complete went to wack [sic] baby up and he did not respond, … when i flush his tube after feeding it was not water in the bottle itbwas[sic] alcohol i had flush his g [gastric] tube with alciohol not water, i got him in my arms and started stimulating his muscles, he [sic] o2[oxygen] sat [saturation, amount/percentage of oxygen in blood obtained using an external device, normal range 95-100 %] would go down to 90 then up again to 98 then down to 94 and back and forth foran[sic] hour … 15:26 [3:26 p.m.) 911 arrived and took him and mom to the hospital … i did get the baby to throw up at one time, he was still limp.” A review of Patient 1’s ‘Intake and Output ‘documented by LN 1 on 4/5/23 indicated, she administered 120 ml of Similac (type of baby formula) advanced feeding documented intake time was at 11:24 a.m. and 120 ml documented intake time was at 12 p.m. for a total of 240 ml. LN 1 documented she flushed the GT with 40 ml and 30 ml of water at 11:24 a.m. and 12 p.m. respectively for a total of 70 ml of water flushes. Under the output portion of the documentation, the urine output of 200 ml and no emesis was documented. The total intake was documented as 310 ml (240 ml feeding and 70 ml flushes). During a telephone interview with LN 1 on 4/19/23, at 1:13 p.m., she stated she was a nurse while she worked for the agency and was assigned to Patient 1. LN 1 stated she visited Patient 1 twice, once on 4/3/23 and once on 4/5/23 for day shift. LN 1 further stated she did not wish to be interviewed before she consulted her attorney, and she hung up the call. An interview conducted with a Registered Nurse (RN) and the Director of Patient Care Services (DPCS) on 4/19/23 at 2:41 p.m., the RN stated she and another RN completed the initial assessment and the POC for Patient 1 on 4/3/23 in the morning and the baby was doing well. The RN reported the primary caregiver was the baby’s mother and the agency nurse was to visit 3 days per week. The RN indicated LN 1 was present during the visit on 4/3/23 and she reviewed the patient’s POC with her. The RN reported among the supplies provided by the agency during the admission visit was a hand sanitizer solution which was placed on a table near the baby’s crib. The DPCS stated LN 1 called the agency on 4/5/23 after 3 p.m., and she and the RN put her on speaker. The DPCS stated LN 1 was hysterical, was crying and reported she had used a hand sanitizer solution to flush the baby’s gastric tube instead of water. The DPCS stated LN 1 had asked a family member who was in the home to call the baby’s parents using her phone. The DPCS stated the parents called 911 while on their way home and the baby was taken to the hospital. During an interview with the hospital’s Case Manager (CM) on 4/21/23, at 9:21 a.m., the CM stated Patient 1 was admitted to PICU on 4/5/23 and he was still intubated (breathing with the assistance of a ventilator). The CM reported a lab ethanol level done on 4/5/23 indicated it was 210 milligrams/deciliter (mg/dl, unit of measurements) and indicated it was critically high. A review of Patient 1’s ‘Physician’ documentation dated 4/5/23 indicated, “At approx (approximately) 1440 [2:40 p.m.] today, MOC [mother of child] received a call from their new home health nurse stating that patient was acting altered. The home health nurse admitted to accidentally flushing patient’s GT with 10 ml of 70% ethanol at approximately 1246 [12:46 p.m.] MOC called EMS [emergency services], and upon arriving home, tried using a syringe to pull out some gastric contents, but was unable to get much out … Patient was brought to [name] ED [emergency department], where he was found to be tachypneic [rapid breathing] and with altered mental status. Patient was intubated … mechanical ventilation … for altered mental status requiring intubation after accidental ethanol intoxication … Plan … ethanol level now …” A review of Patient 1’s ethanol (alcohol in blood) level lab result dated 4/5/23 at 11:35 p.m. indicated 210 mg/dl critical high and the reference range was noted as <10 mg/dl. A review of the agency’s ‘Plan of Care’ policy dated 8/19/22 indicated, “The plan of care will describe specific services to be provided based on the clinical assessment and will include amount, frequency, and duration of services and expected outcomes for the patient/client … Care/services will be provided according to the agreed to plan of care.” The policy indicated physician orders were required for each client admitted by the agency for services and included expected patient outcomes and treatment orders. A review of the agency’s ‘Medication Administration’ policy dated 10/7/22 indicated the nurse administering the medication will review the label for name. A review of the agency’s undated ‘Protocols’ titled, “… Tubes: Enteral Feeding” directed,” Flushing guidelines … recommends using purified water (sterile water for irrigation) when caring for patients who are chronically ill or immunocompromised … Flush tubes with 30 ml of water or per MD [Medical Doctor] order … If being used for continuous feedings, as ordered … If being used for bolus feedings, before and after feedings … After checking residual [aspiration/withdrawal of stomach contents] volume … Before/after/between all medications using tap (if approved) or purified.” An interview conducted with the DPCS 0n 4/19/23, at 3:42 p.m., DPCS stated she would have expected LN 1 to check the labels before administering any medications, formula, or flushes. The DPCS further indicated she would have expected LN 1 to call 911 immediately after she noted the baby was not acting right and his parents as soon as possible. The DPCS indicated the agency was encountering some challenges investigating the incident as the family and LN 1 were no longer cooperative with being interviewed. A review of the Lippincott Manual of Nursing Practice (9th edition) under Safe Nursing Care- Patient Safety (pp. 4) indicated that patient safety had moved to the forefront of health care as a result of the Insitute of Medicine (IOM) report ... To err is Human: Building a safer Health Care System published in (2000). IOM in, "In reviewing studies of adverse events and patient deaths in hospitals across the country, the report found that about 50% were due to medical errors and could have been prevented."