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Tag No.: A0115
Based on record review, interview, and observation, the facility failed to meet the Condition of Participation (CoP) for the patients right to be free from neglect and harm by failing to comply with the requirements as evidenced by the following:
A. The facility failed to ensure the patients' right to receive care in a safe setting, and to be free from neglect and harm, by not adhering to national standards of practice. Refer to 0144.
Tag No.: A0143
Based on record review, interviews and observations, the facility failed to maintain the personal privacy of patients including but not limited to, the patient's location in the hospital; demographic information the hospital has collected on the patient, such as name, age, address; or information on the patient's medical condition. The Protected Health Information (PHI) was not protected for 25 (P (Patient) 3 and P11 to P32) out of 32 patients. This failed practice can lead to direct inappropriate disclosure of PHI and is likely to lead to an increased risk of misuse and breach of PHI.
The findings are:
A. Record review of facility policy titled, "HIPPA Compliance" effective date: 04/08/2020 states, "Policy: Through standards and practices described in this policy, (Facility Name) will comply with the HIPPA Privacy Rule (45 C.F.R, Part 160 and Part 164, Subparts A and E). Procedure: 1. Definition of Protected Health Information: "Protected health information" means individually identified health information that is on paper, in electronic form or spoken. ePHI can be transmitted by electronic media; maintained in electronic media; or transmitted or maintained in any other form or medium. 45CFR 160.103. 4. Personnel Designated to Protect Patient Privacy: a. Privacy Officer: The CEO will designate a Privacy Officer, whose purpose description will include, among other things, the responsibility for ensuring that PHI is properly maintained and safeguarded as required by federal and state law. c. Health Information Management ("HMI") Director: (Facility Name) HIM Director's purpose description will include, among other things, the duty of oversight of HIPPA compliance. 5. Employee Training: a. New Hires: New hires will receive privacy training before they begin work and can access or use PHI. This policy is a mandatory review for each new employee. b. Existing Employees: Existing employees with access to PHI will receive annual training in the proper use of PHI, through Healthstream, which will maintain (Facility Name) documentation of their compliance. c. Medical Staff: All (Facility Name) Medical Staff members will receive HIPPA training during orientation and shall sign an attestation that they will comply with (Facility Name) policy(s) governing patient confidentiality. "
B. Record review of facility policy titled, "Patient Rights and Responsibilities" effective date: 06/30/2022 states, "Prerequisites and Requirements: e. Confidentiality: The individual patient's medical records, including all computerized medical information, shall be kept confidential in accordance with applicable federal, state, and local laws."
C. Observations made on flash tour of facility on 11/07/2022 at 3:00 pm showing patient's information in open areas as follows:
1) Patient (P) 3 findings RN (Registered Nurse) report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
2) P11 findings on nursing assignment shift report laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, code status, Oxygen level, and isolation precautions.
3) P12 findings on nursing assignment shift report laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, code status, Oxygen level, and isolation precautions.
4) P13 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
5) P14 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
6) P15 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
7) P16 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
8) P17 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
9) P18 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
10) P19 RN report sheet and nursing assignment sheet laying out in an open area at nursing station showing the following PHI: patient name, age, room number, diagnosis, medical history, medications, isolation precautions and code status.
11) P20 prescription form laying out in an open area at nursing station showing the following PHI: patient name, date of birth, age, allergies, medical record number, prescription details and diagnosis.
12) P21 New Patient Information Worksheet laying out in an open area at nursing station showing the following PHI: patient name, date of birth, age, sex, room number, diagnosis, and precautions.
13) P22 New Patient Information Worksheet laying out in an open area at nursing station showing the following PHI: patient name, date of birth, age, sex, room number, diagnosis, and precautions.
14) P23 Intensive Care Unit (ICU) Multidisciplinary Rounding sheet (patient-centered model of care, emphasizing safety and efficiency that enable all members of the team caring for patients to offer individual expertise and contribute to patient care in a concerted fashion) laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, admit diagnosis, code status, overnight events, pertinent/abnormal vital signs labs or blood cultures, Lines/tubes/PICC/central line/foley, 24-hour fluid balance, bowel movement, respiratory status, nutrition, and wound care.
15) P24 yellow sticky note laying out in an open area at nursing station showing the following PHI: patient name, age, date of birth, diagnosis, and isolation precautions.
16) P25 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
17) P26 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
18) P27 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
19) P28 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
20) P29 patient information sheet laying in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
21) P30 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
22) P31 patient information sheet laying out in an open area at nursing station showing the following PHI: patient sticker showing patient name, date of birth, age, sex, medical record number, financial record number, room number, diagnosis, O2/vent, Drips, Central line, isolation, foley and other information regarding patient treatment.
23) P32 open computer screen in an open area at nursing station showing the following PHI: patient name, date of birth, sex, allergies, Inpatient financial number, medical record number, patient history and physical note, code status, level of care, room number and advance directive.
D. Interview with Staff S2, Quality and S3, Infection Control Manager on 11/08/2022 at 9:30 am when asked "What is the expectation of HIPPA privacy?", S2 answered, "To safeguard information period. Keep it covered, log out." When asked if it is ok for documents with patient information to be sitting out in the open, S2 answered, "No, it isn't." When asked if it is ok for nurses to walk away from computer screens with patient information on the screen, S3 answered, "No, the expectation would be to close the computer."
E. Interview with S6, RN Manager on 11/09/2022 at 10:30 am, when asked what the expectation of HIPPA privacy is, S6 answered, "To follow all standards set by the state and federal." When asked, "Is it ok for documents with patient information to be sitting out in open areas?" S6 answered, "Absolutely not, not where they can be viewed." When asked, "Is it ok for nurses to walk away from computers with patient information on the screen?", S6 answered, "Not unless they hit control K and walk away. Not totally leaving the area, no."
Tag No.: A0144
Based on record review, interview, and observation, the facility failed to ensure the patients' right to receive care in a safe setting, and to be free from neglect and harm, for 2 patient (P1, P10) of 32 (P1-P32) patients reviewed. This failed practice may have led to a violation of the patients right to receive care in a safe setting, neglect, patient harm and death.
The findings are:
A. Record review of National Library of Medicine's peer reviewed article titled "Inotropes (a drug which increases or decreases the force of muscular contraction of the heart) and Vasopressors (a drug which causes the constriction of blood vessels to prevent low blood pressure, vascular collapse and death)" dated 08/18/2022 and written by [Authors names identified] reveals, "Inotropes and vasopressors are commonly used in the ICU. Since the conditions they address and the effects they render can be critical, an entire interprofessional team should be involved in their ordering, dosing, and administration, as well as subsequent monitoring. While these medications are ordered by clinicians, the monitoring of the patient is done by nurses trained in critical care."
B. Record review of facilities policy titled "Staffing Guidelines (PCS)," dated 03/30/2021, reveals, page 2 para 2,
a. "ICU Guidelines ... i. Criteria for 1:1 Staffing: ...
1. Need for multiple vasoactive drugs (a pharmaceutical drug that has effect either increasing or decreasing blood pressure and/or heart rate) with active titration to support arterial pressure or cardiac output ...
2. Patients who experience inadequate myocardial perfusion and exhibit ongoing symptoms of chest discomfort resulting in decreased cardiac output and severe hemodynamic instability ...
3. Patients in metabolic crisis with multi-system compromise who require continuous monitoring, assessment, and interventions ...
4. Patients who require pressure control ventilation in the acute stage of respiratory distress or ventilated patients in the critical stage of acute lung injury with high-PEEP (Positive End- Expiratory Pressure: the pressure applied at the end of each exhale to ensure the lungs stay open and continued oxygenation is not impaired) and oxygen demand ...ii. Criteria for 1:2 Staffing: ...
a. Need for vasoactive titration drugs to support arterial pressure or cardiac output ...
b. Support for circulatory instability due to hypovolemia from any cause which is unresponsive to modest volume replacement, including post-surgical or GI hemorrhage or hemorrhage related to coagulopathy ...
c. Sudden fall in level of consciousness (Glascow coma score greater than 2 points change) ...
d. Rule out myocardial infarction with any of the following:
b. Previous significant cardiac history b. EKG changes c. May have titratable infusions ...
c. Progressive Care Guidelines ... The staff of the PCU are considered a part of Critical Care and will abide by the regulations set for the ICU staff with the following considerations. 1. 1:4 ratio - 1:3 ratio if titrating drips, patient is vented or Nursing Assistant (NA) not available c. Criteria for 1:3 Staffing: ...1. Hemodynamically and metabolically stable a. GI bleed with stable H & H (hemoglobin and hematocrit) ... b. Stable non-vented patients requiring less than 80% FiO2."
C. Record review of facilities policy titled "Plan for the Provision of Care - Patient Care Services," dated 07/28/2022, reveals page 6.B.3 "Care of Patients: The care of patients is individualized to the patient's specific needs. A registered nurse, in collaboration with other disciplines, coordinates the plan of care for every patient and prescribes each patient's nursing care. The delivery of nursing care and nursing practice are defined and managed by professional nurses using shared decision-making principles."
Findings for Patient 1
Care in a Safe Setting:
D. Record review of P1 "History and Physical," dated 06/25/2022 at 12:27 am, reveals "History of present illness ... history of CAD (coronary artery disease) status post bypass x2 and mitral annuloplasty ring placement presents for evaluation of chest pain ... the patient is (sic) EKG shows ST depressions in the inferior lateral and high lateral leads."
E. Record review of P1, EMR (Electronic Medical Record), dated 06/24-06/30/2022, reveals patient was assigned to intermediate level of care for duration of admission, until 06/30/2022 at 2:00 pm, when P1 was transferred to the Intensive Care Unit for intubation prior to transfer to external facility.
F. Record review of P1 "Progress Notes" dated 06/28/2022 at 4:34 pm, reveals, "Pt (patient) and family re (reviewed) options of trial with current therapy here vs transfer to tertiary care center that has pulmonary availability and bronchoscopy capability. After further discussion pt prefers to transfer. No ICU (Intensive Care Unit) beds at [name of external hospital] in Albuquerque. Will tx (transfer) to [name of external hospital] in CO (Colorado) Springs as arranged by cardiology team. Pt will likely need to be intubated prior to transfer," signed by [name of Medical Doctor (MD)]."
G. Record review of P1 Electronic Medical Record (EMR) dated 06/24-06/30/2022, shows recommendation by MD for transfer to higher level of care on 06/28/2022, P1 is not transferred to higher level of care within facility or externally until 06/30/2022.
H. Record review of facilities policy titled "Admission and Discharge Policy - ICU" dated 09/27/2022, reveals page 1 para 2, "The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with potentially severe physiological instability requiring technical and/or artificial life support ... Admission Criteria:
a. Priority 1 Patients: Critically ill, unstable patients in need of intensive treatment such as ventilator support, continuous vasoactive drug infusion, etc. Examples of such admissions may include, but are not limited to patients in septic shock, carotid endarterectomy or neurosurgical patients receiving vasoactive drugs. Priority 1 patients have no limits placed on therapy.
b. Priority 2 Patients: patients who, at the time of admission, are not critically ill but whose condition requires the technologic monitoring services of the ICU. These patients would benefit from intensive monitoring ... and are at risk for needing immediate intensive treatment. Examples of such admissions may include, but are not limited to, patients with underlying heart, lung, or renal disease who have severe medical illness or have undergone major surgery."
I. Record review of facilities policy titled "Plan for the Provision of Care - Patient Care Services" dated 07/28/2022, reveals page 4.I, "ICU: patients who require intensive nursing care and monitoring, including those who are hemodynamically and metabolically unstable."
J. Record review of P1 "Nursing Narrative Note," dated 06/28/2022 at 7:23 pm documents, "Assumed care of this pt at 0700 (7:00 am) ... Pt (patient) unstable all day. RN (Registered Nurse) on the phone with [name of MD] r/t (related to) her chest pain, sob (shortness of breath) and increased o2 (oxygen) need, increasing trop (troponin, a measurement that indicates death of cardiac muscle tissue i.e. heart attack), blood in urine ... BP (blood pressure) mainly on lower end with maps (Mean Arterial Pressure: a measurement used to calculate perfusion to the organs) and Dopamine (a high-alert medication under the drug class Inotrope: used as a vasoactive life-support medication administered intravenously to maintain adequate blood pressure in order to sustain tissue perfusion, organ function and life) being titrated throughout the day. Family in room. RN (Registered Nurse) kept them up to date on procedures, process [sic], and patient condition. [P1] demeanor and appearance was declining through the day. She talks like she is going to die and has impending doom feeling ... RN reinserted Foley (a catheter device inserted directly into the bladder via the urethral canal to drain urine) this am because she was retaining urine and throughout the day the urine is dark red with some blood clots."
K. Record review of P1 Nursing Narrative Note dated 06/29/2022 at 12:33 am documents, "Assumed care of pt after receiving report. Pt arrived back to the room from cath lab. Multiple family members present at bedside ... Dopamine continues to infuse at 10 mcg (micrograms). Pt switched from 10L (Liters) non-rebreather to bi-pap due to shortness of breath. Son is currently at bedside."
L. Record review of P1 Nursing Narrative Note dated 06/29/2022 at 6:53 pm, documents, "Assumed care at 0700 (7:00 am) ... family in room all day. She was on hiflow NC (nasal cannula: a device used to supplement oxygen delivery to the lungs) today and still very tachypneic with her RR (respiratory rate: normal parameters for an adult are 12-18 respirations per minute) in the high 20's to mid 30's. She was lowered to 40/85 and did not tolerate and is now labored breathing after increasing her o2 back up. Putting her back on bipap for the night. She remains with a soft BP and dopamine infusing at 7.5 mcg/hr (micrograms per hour). She was just moved to levo (Levophed: trade name for norepinephrine, a high-alert vasoactive medication under the drug class adrenergic: administered by continuous infusion directly into the vein to maintain adequate perfusion to the organs in efforts to prevent vascular collapse and death) currently doing well on 5mcg (micrograms: a unit to measure dosage) with a map (mean arterial pressure) of 81 ... UOP (urine output) remains light amber to bloody in color and changing throughout the day between colors. MD aware."
M. Record review of Respiratory Therapy Progress Note dated 06/30/2022 at 12:43 pm, documents, "...RT called by RN and requesting to be put back on CPAP. Pt put back on CPAP at documented settings. Pt tachypneic in the mid 40's ... Per RN pt desated [sic] (oxygen saturation is read as a percent value out of 100%, anything below 88-90% is considered desaturation and begins to cause tissue/brain death) to the 50's when transferring from the bedside commode to her bed. MD called and made aware."
N. Record review of P1 EMR: Respiratory, dated 06/24-06/30/2022, reveals the following escalation in respiratory devices:
06/28/2022
a. 8:09 am: changed nasal cannula at 7 L/min (liters per minute) to a nonrebreather mask at 15 L/min.
b. 9:14 pm: nonrebreather oxygen increased from 35% FiO2 (fraction inhaled oxygen: measured out of 100%, in which the amount of oxygen inhaled in one breath would be 100%), increased to 60% Fio2
06/29/2022
a. 12:50 am: P1 changed from nonbreather mask to BiPAP (a machine that delivers positive pressure with each breath, considered a ventilatory intervention), FiO2 remains 60%.
b. 6:59 am: FiO2 increased from 60% to 65%.
c. 11:06 am: FiO2 increased from 65% to 100%.
O. Record review of P1 Progress Notes dated 06/30/2022 at 12:47 pm documents, "Hypotension ... likely due to sepsis from UTI (urinary tract infection) ... D/w (discussed with) Dr. [name of provider] ... Tx to ICU for closer monitoring and potential intubation," signed by [provider name] DO.
High-Alert Titratable Medications Administered on Intermediate Level Unit:
P. Record review of ISMP's peer reviewed article titled, "Analysis Identifies Multiple Common Causes of Norepinephrine Errors," dated 03/24/2022, states para 3, "Common Causal (of errors) Factors:
a. Prescribing ... prescribers were able to order either weight based or non-weight-based doses, which were occasionally mixed up. This nonstandard prescribing approach made it more likely that practitioners downstream would make errors, including pump programming errors, as both dosing options were available in the pump library. Also, delays from needing to clarify orders were reported when prescribers' orders included both weight-based ad non-weight-based dosing instructions ...
b. Administration. Common mistakes included wrong dose or concentration errors, wrong rate errors, and wrong drug errors. Most of these errors were caused by incorrectly programming smart infusion pumps, partly due to having weight-based and non-weight-based dosing options in the drug library; storage errors; leaving a discontinued or paused infusion connected to the patient and restarting the wrong infusion, or not labeling lines and tracing them when starting or restarting infusions ...
c. Monitoring. incorrectly monitoring the patient, titrating the norepinephrine infusion outside of the order parameters, and not anticipating when the next infusion bag was needed were the most common causes or errors related to monitoring."
Q. Record review of P1 Provider Orders, admission dated 06/24-06/30/2022 on intermediate level of care [name of unit], reveals,
a. "Dopamine IV ... ordered 06/28/2022 at 00:12 MDT (12:12 am) [pt weight], by [name of Doctor of Osteopathy (DO)], entered by [name of RN]; discontinued 06/29/2022 at 16:11 (6:11 pm). Order comment: Start at 2mcg/kg/min, Titrate by 3 mcg/kg/min every 5 minutes to a maximum of 20 mcg/kg/min. MAP (Mean Arterial Pressure, a calculable measurement that indicates adequate perfusion to the vital organs) goal 65.
b. Norepinephrine IV ... ordered 06/29/2022 at 18:03 MDT (6:03 pm) [pt weight], by [name of DO]. Order comment: Start at 2mcg/min Titrate by 3mcg/min every 5 minutes Maximum Dose is 30 mcg/min MAP goal of 65."
R. Record review of P1, electronic Medication Administration Record (eMAR), dated 06/24-06/30/2022, reveals the following actions documented against the vasoactive medications:
Norepinephrine:
06/29:
a. 7:00 pm: 5mcg/min (micrograms per minute: dose administered over a minute), (Begin Bag)
b. 6:00 pm: 5 mcg/min (Begin Bag)
06/30:
a. 3:57 am: 2 mcg/min
b. 10:26 pm: 1.5 mcg/min
c. 10:52 am: 0 mL/hr (milliliters per hour: volume administered over an hour)
d. 2:00 pm: 2 mcg/min
e. 2:30 pm: 5 mcg/min
f. 2:48 pm: 8 mcg/min
g. 3:00 pm: 7.5 mL/hr
h. 4:02 pm: 7 mcg/min
i. 4:39 pm: 6 mcg/min
j. 5:00 pm: 6 mcg/min
k. 6:06 pm: 5.63 mL/hr
l. 8:29 pm: 5.63 mL/hr
Dopamine:
06/29:
m. 12:22 am: 7.494 mcg/kg/min (micrograms per kilogram per minute: patient weight-based dose administered over one minute), (Begin Bag)
n. 9.4 mL/hr
o. 1:00 am: 9.4 mL/hr
p. 3:00 am: 9.4 mL/hr
q. 4:00 am: 9.4 mL/hr
r. 5:00 am: 9.4 mL/hr
s. 6:00 am: 9.4 mL/hr
t. 7:44 am: 9.4 mL/hr
u. 8:09 am: 7.5 mcg/kg/min
v. 8:17 am: 10mcg/kg/min
w. 8:37 am: 13 mcg/kg/min
x. 10:16 am: 10 mcg/kg/min
y. 4:00 pm: 5 mcg/kg/min (Begin Bag)
z. 5:51 pm: 10 mcg/kg/min
aa. 6:06 pm: 10 mcg/kg/min (Begin Bag)
S. Record review of facilities policy titled "Medication Errors," dated 09/01/2022 reveals page 2 para 6, "Classification: A severity rating is assigned to each medication event/error and adverse drug reaction according to the following scale:
a. None- No clinical change/no apparent injury; no additional lab diagnostic tests.
b. Minor- requires no medical treatment or has no effect on continuation of therapy. Minor change in condition; single lab or diagnostic test ordered; increased observation required for side effects.
c. Moderate- Vital signs changed; additional medications, diagnostics or treatment required; decreased level of consciousness; multiple lab or diagnostic tests needed for follow-up.
d. Major- Cardiac changes that require intervention; hospital acquired fracture; bleeding requiring intervention; transferred to higher level of care; lab values changed to critical level; unplanned surgical procedure due to complication; length of stay increased.
e. Catastrophic- residual physical impairment; cardiac arrest and/or respiratory arrest/failure; placed on respirator; critical lab values become more critical; death."
T. In an interview with Staff S16, Cardiology RN on 11/09/2022 at 12:13 pm, when asked if S16 has ever seen an adverse event like a medication running out (without intent), S16 states, "Probably, I mean, I've missed meds. I've missed meds for other patients too (when titrating a vasoactive drip)." When asked what adverse effects might be seen if these vasoactive infusions stopped running without intent, S16 states, "You would see a drop in blood pressure, decreasing consciousness, heart rate going up, or even decreased urine output, just depression in everything basically." When asked what the worst outcome would be, S16 states, "Flatlining or going into cardiac arrest or cardiac arrhythmia where you have to run a code (code blue: when someone is experiencing a medical emergency in which life-saving measures are taken to resuscitate a person that is imminently dying)."
U. Record review of [name of unit] "Bed Roster/Charge R Shift Report," dated 06/28-06/30/2022 reveals the following patient to nurse ratios for RN's assigned to the care of P1, who met the 3:1 patient to nurse staffing parameters while infusing a titratable high-alert medication:
a. 06/28 AM: 4:1
b. 06/28 PM: 6:1
c. 06/29 AM: 4:1
d. 06/29 PM: 5:1
e. 06/30 AM: 5:1
V. Refer to tag 0398 regarding facilities policy on patient to nurse staffing ratio.
W. Refer to tag 0405 regarding standard of practice on the safe use and administration of titratable high-alert medications.
X. Observation during record review of P(patient)1 Electronic Medical Record (EMR) on 11/09/2022 at 12:54 pm, observed pop-up window upon opening P1's chart, reading in large red font "Deceased."
Findings for Patient 10:
Y. Record review of facilities "Mortality Report," dated 01/01-11/09/2022, reveals page 14, "[name of P10] ... diagnosis description: Unspecified atrial fibrillation ... discharge date & time: 07/04/2022 01:57:00 PM ... discharge disposition: Expired."
Z. Record review of P10 Provider Orders, dated 07/01-07/04/2022, reveals "Amiodarone (a high-alert medication under the drug class antiarrhythmic: used to control abnormal and potentially lethal heart rhythms) 360 mg in Dextrose 5% (a diluent used as a carrier for the administration of injectable medication in an IV bag) in Water 200 mL ... order details: 0.5 mg/min."
AA. Record review of P10 eMAR, dated 07/01-07/04/2022, reveals the following administration of continuous infusion for Amiodarone:
a. 7/03 at 11:23 am: New bag running at 33.33 mL/hr
b. 7/03 at 11:29 am: New bag running at 33.33 mL/hr (time elapsed = 6 minutes (min))
c. 7/03 at 4:59 pm: New bag running at 33.33 mL/hr (time elapsed = 6 hours (hr) 30 min)
d. 7/03 at 10:19 pm: New bag running at 33.33 mL/hr (time elapsed = 5 hr 20 min)
e. 7/04 at 5:38 am: New bag running at 33.33 mL/hr (time elapsed = 7 hr 19 min)
f. 7/04 at 1:20 pm: New bag running at 33.33 mL/hr (time elapsed = 7 hr 42 min)
g. Amiodarone is dispensed in 200 mL IV solution bags (refer to finding Z, Provider orders). 200 mL/33.33 mL/hr = 6.00 hrs, therefore each new bag should be scanned and hung within a 6 hour timeframe. Record review indicates a lapse in medication administration for 30 min (AA.3), 1 hr 19 min (AA.5), and 1 hr 42 min (AA.6).
BB. Record review of P10 Provider Notes, dated 07/04/2022 reveals, "Patient was on amiodarone drip today he was restarted on a new bag of amiodarone drip at 1320 (1:20 pm) and around 1337 (1:37 pm) telemetry noticed large ST elevation (a change in electrical conduction inside the heart, indicating a heart attack) in telemetry leads while patient was mentioning that he is not feeling well and he wants to rest, patient was found to have bradycardia (low heart rate) and PEA (pulseless electrical activity: a lethal heart rhythm in which the heart is not pumping blood to the organs) arrest with sudden leading heart rate going down to 50 and below a CODE BLUE was called at 1337 (1:37 pm) ACLS (advanced cardiac life support: heroic life-saving measures performed by certified personnel in an effort to resuscitate someone) protocol was followed despite doing CPR (cardio pulmonary resuscitation: the physical act of performing chest compressions in an effort to perfuse blood to the major organs) we were not able to get restoration of spontaneous blood circulation hands code was called off at 1357 (1:57 pm) time of death was 1357 (1:57 pm)," signed by physician.
CC. Record review of P10 eMAR, dated 07/01-07/04/2022, shows no documentation of a pause, stop, change in rate, or discontinuation of Amiodarone infusion.
DD. Record review of P10 Nursing Notes, dated 07/04/2022 at 3:54 pm, reveals, "Assumed care of patient following shift change, patient was alert/oriented and pleasant. Patient denied any chest pain or pressure through out (sic) the day, only complained of "feeling tired". After hanging new bag of amio (amiodarone), patient stated he was going to enjoy my meatloaf then take a nap" as he was feeling tired and was ready for a nap- denied any other problems. At 1333 (1:33 pm) I was notified in person by telemetry that HR (Heart Rate) decreased to 49 BPM, Dr [name of provider] notified in person of rate change, I immediately went to patient room and found patient unresponsive and started CPR. See code sheet for CPR process. TOD called at 1357, wife [name of wife] notified," signed by RN.
EE. Record review of P10, Code Blue Record, dated 07/04/2022 reveals,
a. "1:37 pm: initiation of code blue: CPR, no pulse present ...
b. 1:42 pm: Defibrillation: ventricular fibrillation, no pulse present ...
c. 1:44 pm: Asystole, no pulse present ...
d. 1:47 pm: PEA, patient intubated, no pulse present ...
e. 1:49 pm: defibrillation, Ventricular fibrillation ...
f. 1:51 pm: asystole, no pulse present ...
g. 1:53 pm: asystole, no pulse present ...
h. 1:55 pm: asystole, no pulse present ...
i. 1:57: patient expired."
FF. In an interview with S(staff)13, ICU Nurse Manager, on 11/09/2022 at 11:00 am, when asked if S13 considered a lapse in a continuous infusion of a high-risk medication an adverse event, S13 states, "One-hundred percent. Because you're not infusing a medication during that time. That would be not following one of your patient rights of medication administration." When asked about possible outcomes when a lapse occurs, S13 states, "If it stops and lapses and is not infusing, especially at higher rates, if a pressor, then the blood pressor (BP) would drop out and you could have patient death. That would be the worst outcome."
Tag No.: A0385
Based on record review, interview, and observation, the facility failed to meet the Condition of Participation (CoP) for Nursing Services by failing to comply with requirements as evidenced by the following:
A. The facility failed to ensure an appropriate number of Licensed Staff to meet patient needs for 24-hour nursing care. Refer to 0392.
B. The facility failed to implement a nursing care plan for all admitted patients. Refer to 0396.
C. The facility failed to ensure adherence to hospital policies and procedures. Refer to 0398.
D. The facility failed to adhere to standards of practice in the administration of high-risk vasoactive medications. Refer to 0405.
Tag No.: A0392
Based on record review, interview and observation, the facility failed to meet the requirement by not providing adequate numbers of Licensed Registered Nurses to provide nursing care to all patients as needed. This failed practice could lead to patient neglect, harm, and death.
The findings are:
A. Record review of the Facilities policy titled "Vasoactive (a pharmaceutical drug that has effect either increasing or decreasing blood pressure and/or heart rate) and Cardiac Infusion Patient Management," dated 07/28/2021c, reveals page 4 para 7, "Staffing Guidelines ... Cardiology and PCU (Progressive Care Unit): adjust to 3:1 staffing, Nephrology: adjust to 3:1 staffing."
B. Record review of facilities policy titled "Staffing Guidelines (PCS)," dated 03/30/2021, reveals, page 3 para 3, "Progressive Care Guidelines ... The staff of the PCU are considered a part of Critical Care and will abide by the regulations set for the ICU staff with the following considerations. 3. 1:4 ratio - 1:3 ratio if titrating drips (increasing or decreasing a vasoactive drug infusion for therapeutic effect), patient is vented or Nursing Assistant (NA) not available. 4. Nursing Assistant will be utilized if six or more patients. Criteria for 1:3 Staffing: Patients meeting 1:3 criteria are recommended to be moved from ICU either the PCU for continued monitoring or to the appropriate floor once they do not meet ICU criteria."
C. Record review of facilities [name of unit] "Bed Roster/Charge RN Shift Report," dated 06/28/2022, reveals 5 patients (of a 21-patient census) designated as a 3:1 patient to nurse ratio (3:1). Record review further reveals 1 Charge RN assigned to 6 patients, 2 of whom are designated as a 3:1, and 1 RN assigned to 4 patients, 1 of whom is designated as a 3:1.
D. Record review of facilities [name of unit] "Bed Roster/Charge RN Shift Report," dated 06/29/2022, reveals 2 patients (of a 21-patient census) designated as 3:1. Record review further reveals 1 RN assigned to 5 patients, 1 of whom is designated as a 3:1 and 1 RN assigned to 4 patients, 1 of whom is designated as a 3:1.
E. In an interview with S(staff)16, RN on 11/09/2022 at 12:13 pm, When asked about typical patient ratio when assigned to a patient on a dopamine drip, S16 states, "If titrating a drip, it should be 3:1, but in reality, anywhere from 4-6 (patients)." When asked if S16 feels they can safely care for patients on a titrating vasoactive drip when assigned to 4-6 patients, S16 states, "No."
F. In an interview with S6, Cardiology Nurse Manager, on 11/09/2022 at 10:52 am, when asked if S6 felt the patients on the floor were safe when short staffed and patient assignments exceed outlined patient ratios, S6 states, "What we do with some of those 3:1 even though they're classified as 3:1 ... but technically stable. So, I tell the charge nurse to try to spread that out knowing that we still go off total numbers. So, say we have 4 nurses and 3 x 3:1, we can take that total of fifteen patients. So, this nurse will have 4 patients with a 3:1." When asked if this was not following the facilities policy on patient assignments, S6 states, "Well, by the letter of the law it wouldn't be. I tend to think they're getting better care this way."
G. In an interview with S13, ICU Nurse Manager on 11/07/2022 at 3:50 pm, when asked about the typical patient ratio when a patient is on a dopamine (or vasoactive medication) drip, S13 states, "Depends on the rate and if they have other things going on with them. But if that's all then they can be on a 3:1 in our step-down unit. The ratio applies in step-down, cardiology and ICU."
H. In an interview with S5, Director of Nursing (DON), on 11/09/2022 at 2:21 pm, when asked if they felt running vasoactive medications on an intermediate level floor to be standard practice, S5 states, "Yes, if they have shown competency." When asked what if they are over patient ratio, S5 states, "We make sure they're in the right place so that they can have the monitoring. If they're being monitored, if they can handle it (the extra patient load), is it ideal? No ... Ideally, we stick with our recommended ratios throughout the house. It's a challenge. If they're able to manage it with an extra one or two (patients), we do the best we can."
I. In an interview with S13, ICU Nurse Manager, on 11/07/2022 at 3:50 pm when asked about typical patient ratio for patients running a vasoactive drip, S13 states, "We are understaffed, as I imagine most of the state is."
Tag No.: A0396
Based on record review, and interview the facility failed to ensure that nursing care plans were implemented and met patient needs for 5 patients (P2, P4, P5, P6, P7) of 32 (P1-P32) patients reviewed. This failed practice is likely to lead to inconsistent care for the patient, neglect, and patient decline.
The findings are:
A. Record review of the facilities policy titled "Assessment of Patients/Documentation Requirements," dated 05/24/2022, reveals page 1, "Documentation ... appropriate IPOCs (Interdisciplinary Plans of Care) shall be initiated and/or ordered in the electronic health record as soon as possible preferably within 8 hours, but no longer than 24 hours from admission to unit or prior discharge if less than 24-hour stay."
B. Record review of P2 Electronic Medical Record (EMR), admission date 11/08/2022, shows no care plan implemented in patient chart.
C. In an interview with S(staff)12, RN Clinical Informaticist (a Nurse specializing in information technology and how it is and can be applied to the healthcare field) record review of P2's EMR on 11/08/2022 at 3:38 pm, S12 states, "She does not have a plan of care."
D. Record review of P4 EMR "Care Plan Review and Update," dated 11/04-11/08/2022 reveals, "Original order entered and electronically signed by SYSTEM, SYSTEM Cerner on 11/04/2022 at 15:01 (3:01 pm) ... BID (twice daily)."
E. Record review of P4 EMR, dated 11/04-11/08/2022 shows no care plan was selected or implemented by RN assigned to patient care.
F. In an interview with S12, RN Clinical Informaticist during record review of P4's EMR on 11/08/2022 at 4:19 pm, S12 states, "He does not have any (plan of care) ... no one selected plans of care for him."
G. Record review of P5 EMR, dated 06/27-07/03/2022, shows no care plan implemented in patient chart.
H. Record review of P6 EMR, dated 06/26-07/05/2022, shows no care plan implemented in patient chart.
I. Record review of P7 EMR, dated 06/27-07/12/2022, shows no care plan implemented in patient chart.
Tag No.: A0398
Based on record review and interview, the facility failed to ensure the adherence of policies and procedures by Administration, Management, and Licensed Nursing staff within the facility. This failed practice is likely to lead to adverse events, patient neglect, harm, and death.
The findings are:
A. Record review of the Facilities policy titled "Vasoactive (a pharmaceutical drug that has effect either increasing or decreasing blood pressure and/or heart rate) and Cardiac Infusion Patient Management," dated 07/28/2021c, reveals page 4 para 7, "Staffing Guidelines ... Cardiology and PCU (Progressive Care Unit): adjust to 3:1 staffing, Nephrology: adjust to 3:1 staffing."
B. Record review of facilities policy titled "Staffing Guidelines (PCS)," dated 03/30/2021, reveals, page 3 para 3, "Progressive Care Guidelines ... The staff of the PCU are considered a part of Critical Care and will abide by the regulations set for the ICU staff with the following considerations. 3. 1:4 ratio - 1:3 ratio if titrating drips (increasing or decreasing a vasoactive drug infusion for therapeutic effect), patient is vented or Nursing Assistant (NA) not available. 4. Nursing Assistant will be utilized if six or more patients. Criteria for 1:3 Staffing: Patients meeting 1:3 criteria are recommended to be moved from ICU either the PCU for continued monitoring or to the appropriate floor once they do not meet ICU criteria."
C. Record review of facilities [name of unit] "Bed Roster/Charge RN Shift Report," dated 06/28/2022, reveals 5 patients (of a 21-patient census) designated as a 3:1 patient to nurse ratio (3:1). Record review further reveals 1 Charge RN assigned to 6 patients, 2 of whom are designated as a 3:1, and 1 RN assigned to 4 patients, 1 of whom is designated as a 3:1.
D. Record review of facilities [name of unit] "Bed Roster/Charge RN Shift Report," dated 06/29/2022, reveals 2 patients (of a 21-patient census) designated as 3:1. Record review further reveals 1 RN assigned to 5 patients, 1 of whom is designated as a 3:1 and 1 RN assigned to 4 patients, 1 of whom is designated as a 3:1.
E. In an interview with S(staff)16, RN on 11/09/2022 at 12:13 pm, When asked about typical patient ratio when assigned to a patient on a dopamine drip, S16 states, "If titrating a drip, it should be 3:1, but in reality, anywhere from 4-6 (patients)." When asked if S16 feels they can safely care for patients on a titrating vasoactive drip when assigned to 4-6 patients, S16 states, "No."
F. In an interview with S6, Cardiology Nurse Manager, on 11/09/2022 at 10:52 am, when asked if S6 felt the patients on the floor were safe when short staffed and patient assignments exceed outlined patient ratios, S6 states, "What we do with some of those 3:1 even though they're classified as 3:1 ... but technically stable. So, I tell the charge nurse to try to spread that out knowing that we still go off total numbers. So, say we have 4 nurses and 3 x 3:1, we can take that total of fifteen patients. So, this nurse will have 4 patients with a 3:1." When asked if this was not following the facilities policy on patient assignments, S6 states, "Well, by the letter of the law it wouldn't be. I tend to think they're getting better care this way."
G. In an interview with S13, ICU Nurse Manager on 11/07/2022 at 3:50 pm, when asked about the typical patient ratio when a patient is on a dopamine (or vasoactive medication) drip, S13 states, "Depends on the rate and if they have other things going on with them. But if that's all then they can be on a 3:1 in our step-down unit. The ratio applies in step-down, cardiology and ICU."
H. In an interview with S5, Director of Nursing (DON), on 11/09/2022 at 2:21 pm, when asked if they felt running vasoactive medications on an intermediate level floor to be standard practice, S5 states, "Yes, if they have shown competency." When asked what if they are over patient ratio, S5 states, "We make sure they're in the right place so that they can have the monitoring. If they're being monitored, if they can handle it (the extra patient load), is it ideal? No ... Ideally, we stick with our recommended ratios throughout the house. It's a challenge. If they're able to manage it with an extra one or two (patients), we do the best we can."
I. In an interview with S13, ICU Nurse Manager, on 11/07/2022 at 3:50 pm when asked about typical patient ratio for patients running a vasoactive drip, S13 states, "We are understaffed, as I imagine most of the state is."
Tag No.: A0405
Based on record review and interview, the facility failed to ensure high-risk Vasoactive medications were administered in accordance with Federal and State laws, and accepted standards of practice according to the Institute for Safe Medication Practices, and the National Library of Medicine for 3 (P1, P5, P7) of 32 (P1-P32) patients reviewed. The deficient practice of employing a policy that allows the use of Titratable Vasoactive High-Alert medications at all levels of care does not meet standards of practice and is likely to lead to a violation of patient rights, patient harm, neglect, and death.
The findings are:
A. Record review of National Library of Medicine's peer reviewed article titled "Inotropes and Vasopressors" dated 08/18/2022 and written by [Authors names identified], reveals, "Inotropes and vasopressors are commonly used in the ICU. Since the conditions they address and the effects they render can be critical, an entire interprofessional team should be involved in their ordering, dosing, and administration, as well as subsequent monitoring. While these medications are ordered by clinicians, the monitoring of the patient is done by nurses trained in critical care ... a constant assessment of the patient is needed to ensure that the inotropes and vasopressors are tapered if not needed. These examples of interprofessional coordination can improve outcomes when patients receive vasopressive and inotropic medications with fewer adverse events."
B. Record review of National Library of Medicine's peer reviewed article titled "Cardiovascular Pharmacotherapy Update for the Intensive Care Unit" dated Jan-Mar 2007 and written by [Authors names identified], reveals, "Pharmacologic agents including vasodilators, inotropes, and vasopressors are frequently used in the critical care setting for management of the unstable cardiac patient. These medications are used to elicit varying effects on vascular resistance, myocardial contractility, and heart rate to help achieve desired hemodynamic and clinical endpoints. Therefore, it is important for the critical care nurse to have a practical understanding and working knowledge of cardiovascular pharmacotherapy in the intensive care unit setting."
C. Record review of the Institute of Safe Medication Practices featured article titled "Your High-Alert Medication List -Relatively Useless Without Associated Risk-Reduction Strategies," dated 04/04/2013, reveals para 2, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error ... The primary goals of implementing risk-reduction strategies are to: 1) prevent errors, 2) make errors visible, and 3) mitigate harm ... Be sure actions are comprehensive. A single risk-reduction strategy for each high-alert medication is rarely enough to prevent harmful errors. The keys to success are as follows:
1. Numerous Risk-reduction strategies must be layered together to address the targeted risk.
2. Risk-reduction strategies should impact as many steps of the medication-use process as feasible given the underlying causes (e.g., procuring, storing, prescribing, transcribing, preparing, dispensing, and administering the medication; monitoring the patient; being prepared for treating [or recovery from] an adverse event if it occurs).
3. Low-leverage risk-reduction strategies such as staff education, passive information, and the use of reminders should be bundled together with high-leverage risk-reduction strategies such as forcing functions and fail safes, maximizing access to information, limiting access or use, constraints and barriers, standardization and simplification. Table 1 (verbally illustrated in finding A.3.i) provides a description of key risk-reduction strategies listed roughly in descending order of effectiveness based on human factors. We highly encourage hospitals to reference this table whenever risk-reduction plans are being developed ...
i. Table 1 defines key strategies in descending order of effectiveness. Each strategy (row) is followed by a column with a description and examples.
1. The third strategy (of 16 strategies) states "Limit Access or Use: use constraints to restrict access to certain medications or error-prone processes; require special education or conditions for prescribing, dispensing, or administering a particular drug; require special authorization for participation in certain tasks. Examples: Sequester neuromuscular blocking agents in separate lidded ADC (automated dispensing cabinet) drawer to limit access; require special education/credentialing for the ordering, preparation, and use of certain high-alert medications (e.g., chemotherapy); Carefully select the drugs, concentrations, and quantities in floor stock/ADCs (e.g., restrict stock of liquid concentrated oral opioids to certain units) ... Limit the administration of certain medications unless certain criteria are met (staffing, monitoring)."
2. The eighth strategy (of 16 strategies) states "Externalize or Centralize Error-Prone Processes: transfer error-prone tasks to an external site or centralized area to help ensure they are completed in a distraction-free environment by those with expertise, with appropriate quality control checks in place (e.g., Intensive Care Unit)."
3. "Positive Performance Shaping Factors: an aspect of the human's individual characteristics, environment, task, or organization that specifically improves human performance, thus decreasing the likelihood if human error (e.g., available job aids, work environment, workflow, workload, time urgency). Examples: Limit distractions in the environment when staff are carrying out critical and/or complex tasks; no multi-tasking; provide hands-on experiences and/or simulation training to rehearse and reinforce new skills and knowledge; Establish realistic workloads; avoid global productivity Quotas; establish staffing patterns and workflow that guard against fatigue; promote a Just Culture to foster reporting and learning."
4. The fifteenth strategy (of sixteen strategies) states "Education & Competency Validation: a baseline strategy intended to impart upon staff and patient specific knowledge (what they may know) and the skills (the ability to apply the knowledge) about medications and their safe use, and verifying their knowledge and skills. Examples: Provide patients discharged on a high-alert medication with written information regarding the types of errors that have happened with the drug and how to avoid them. Educate staff about each high-alert medication/class of medications on the hospitals high-alert medication list, how errors happen, the steps the hospital is taking to avoid errors, and the staffs' role in error prevention."
D. Record review of sources determining current standards of practice show no articles, sources, or evidence cited for safe practice in the administration of titratable vasoactive High-Alert medications on floors outside the Intensive Care Unit (ICU) setting.
E. Record review of the Institute of Safe Medication Practices (ISMP) document titled "ISMP List of High-Alert Medications in Acute Care Settings," dated 2018, reveals "High-Alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients ... Classes/Categories of Medications: adrenergic agonists, IV (e.g., Epinephrine, phenylephrine, norepinephrine) ... adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol) ... Antiarrhythmics, IV (e.g., lidocaine, amiodarone) ... inotropic medications, IV (e.g., digoxin, milrinone) ... moderate sedation agents, IV (e.g., dexmedetomidine, midazolam, lorazepam) ... neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)."
F. Record review of facilities policy titled, "Vasoactive and Cardiac Infusion Patient Management," dated 07/28/2022, reveals page 1 para 1, "Patients receiving vasoactive and cardiac infusions will be managed effectively through defined activities, clear monitoring requirements, and by being placed in an environment that has the equipment and staffing available to do so," (refer to tag 0392). Diagram shows the following designated departments are allowed to infuse the following titratable high-alert (vasoactive and inotropic) medications: 1. ICU: Amiodarone, Diltiazem, Dopamine, Dobutamine, epinephrine, Esmolol, Isoproterenol, Labetalol, lidocaine, milrinone, Nitroglycerin, nitroprusside, norepinephrine, phenylephrine, Procainamide, Cardene, Vasopressin. 2. PCU & Cardiology: Amiodarone, Diltiazem, Dopamine, Dobutamine, Esmolol, Isoproterenol, Labetalol, lidocaine, milrinone, Nitroglycerin, nitroprusside, norepinephrine, phenylephrine, Procainamide, Cardene. 3. Nephrology: Dopamine.
G. Record review of facilities policy titled "Medication Errors," dated 09/01/2022 reveals page 1 para 5, "Definitions: Medication events/errors are defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the health care professional or patient. Adverse drug reactions are defined as any unexpected, unintended, undesired, or excessive response to a drug that: ...
3. Prolongs stay in a health care facility
4. Necessitates supportive treatment
5. Significantly complicates diagnosis
6. Negatively affects prognosis, or
7. Results in temporary or permanent harm, disability, or death."
H. Record review of facilities policy titled "Medication Errors," dated 09/01/2022 reveals page 2 para 6, "Classification: A severity rating is assigned to each medication event/error and adverse drug reaction according to the following scale:
1. None- No clinical change/no apparent injury; no additional lab diagnostic tests (PSE3).
2. Minor- requires no medical treatment or has no effect on continuation of therapy. Minor change in condition; single lab or diagnostic test ordered; increased observation required for side effects (PSE1).
3. Moderate- Vital signs changed; additional medications, diagnostics or treatment required; decreased level of consciousness; multiple lab or diagnostic tests needed for follow-up (PSE2).
4. Major- Cardiac changes that require intervention; hospital acquired fracture; bleeding requiring intervention; transferred to higher level of care; lab values changed to critical level; unplanned surgical procedure due to complication; length of stay increased (SSE2).
5. Catastrophic- residual physical impairment; cardiac arrest and/or respiratory arrest/failure; placed on respirator; critical lab values become more critical; death (SSE1)."
I. Record review of P1's Provider Orders, admission dated 06/24-06/30/2022 on intermediate level of care [name of unit], reveals:
1. "Dopamine IV ... ordered 06/28/2022 at 00:12 MDT (12:12 am) [pt weight], by [name of Doctor of Osteopathy (DO)], entered by [name of RN]; discontinued 06/29/2022 at 16:11 (6:11 pm). Order comment: Start at 2mcg/kg/min, Titrate by 3 mcg/kg/min every 5 minutes to a maximum of 20 mcg/kg/min. MAP (Mean Arterial Pressure, a calculable measurement that indicates adequate perfusion to the vital organs) goal 65.
2. Norepinephrine IV ... ordered 06/29/2022 at 18:03 MDT (6:03 pm) [pt weight], by [name of DO]. Order comment: Start at 2mcg/min Titrate by 3mcg/min every 5 minutes Maximum Dose is 30 mcg/min MAP goal of 65."
J. Record review of [name of unit] "Bed Roster/Charge R Shift Report," dated 06/28-06/30/2022 reveals the following patient to nurse ratios assigned to the care of P1, meeting 3:1 patient to nurse staffing parameters while infusing a titratable high-alert medication:
1. 06/28 AM: 4:1
2. 06/28 PM: 6:1
3. 06/29 AM: 4:1
4. 06/29 PM: 5:1
5. 06/30 AM: 5:1
K. Refer to 0398 regarding facilities policy on patient to nurse ratio.
L. Record review of P5's Provider Orders, dated 06/27-07/03/2022, reveals,
1. "Diltiazem IV ... ordered by [name of MD], entered by [name of RN], 06/27/2022 at 6:46pm. Order details ... TITRATE, start date 06/27/2022 6:46:00 PM MDT, Hold if HR less than 70 ... Order comment: Start dose at 5mg/hr (milligrams per hour) after initial bolus, titrate by 5mg/hr every 15 min (minutes) after second bolus given to a max dose of 15 mg/hr to maintain HR between 70-100 bpm (beats per minute). Stop diltiazem if HR drops below 70 bpm, sbp (systolic blood pressure) less than 90 mmHG (millimeters of mercury, a unit of measurement used to measure pressure) or there is a pause greater than 2 seconds."
M. Record review of P5's electronic Medication Administration Record (eMAR) dated 06/27-07/02/2022, reveals the following near hourly documentation for P5's titratable Diltiazem infusion:
1. "06/27/2022:
i. 6:47 pm, 5mL/hr (milliliter per hour)
ii. 7:12 pm, 12mL/hr
iii. 8:00pm, 15mL/hr
iv. 9:15pm, 0mL/hr
2. 06/28/2022:
i. 5:00 am, 5mL/hr
ii. 6:00 am, 5mL/hr
iii. 7:00 am, 5mL/hr
iv. 8:00 am, 5mL/hr
v. 8:50 am, 7.4mL/hr
vi. 9:00 am, 7.4mL/hr
vii. 10:00 am, 7.5 mL/hr
viii. 11:00 am, 2.708mL/hr
ix. 11:03 am, 5mL/hr
x. 11:30 am, 0mL/hr
xi. 12:00 pm, 0mL.hr
xii. 1:00 pm, 0mL/hr"
N. Record review of [name of unit] "Bed Roster/Charge R Shift Report," dated 06/27/2022 PM, reveals, RN assigned to care of P5, meeting 3:1 staffing parameters, is assigned a 4:1 patient to nurse ratio while infusing a titratable high-alert medication.
O. Record review of P7's Provider Orders, dated 06/27-07/12/2022, while admitted to the intermediate level [name of unit], reveals, "Nitroglycerin IV solution, titrate start 06/27/2022 at 12:11pm [pt weight], ordered by [name of medical doctor (MD)]; order comments: Start at 5mcg/min (micrograms per minute). Titrate by 5 mcg every 5 minutes as needed for chest pain. Do not exceed 200 mcg/min."
P. Record review of [name of unit] "Bed Roster/Charge R Shift Report," dated 06/27-06/30/2022 reveals the following patient to nurse ratios assigned to the care of P7, meeting 3:1 patient to nurse staffing parameters while infusing a titratable high-alert medication:
1. 06/27 AM: 3:1
2. 06/27 PM: 4:1
3. 06/28 AM: 6:1
4. 06/28 PM: 5:1
5. 06/29 AM: 5:1
6. 06/29 PM: 4:1
7. 06/30 AM: 5:1
8. 06/30 PM: 5:1
Q. In an interview with S(staff)13, ICU Nurse Manager, on 11/09/2022 at 11:00 am, when asked if S13 considered a lapse in a continuous infusion of a high-risk medication an adverse event, S13 states, "One-hundred percent. Because you're not infusing a medication during that time. That would be not following one of your patient rights of medication administration." When asked about possible outcomes when a lapse occurs, S13 states, "If it stops and lapses and is not infusing, especially at higher rates, if a pressor, then the blood pressor (BP) would drop out and you could have patient death. That would be the worst outcome."
R. In an interview with S16, Cardiology RN on 11/09/2022 at 12:13 pm, when asked if S16 has ever seen an adverse event like a medication running out (without intent), S16 states, "Probably, I mean, I've missed meds. I've missed meds for other patients too (when titrating a vasoactive drip)." When asked what adverse effects might be seen if these vasoactive infusions stopped running without intent, S16 states, "You would see a drop in blood pressure, decreasing consciousness, heart rate going up, or even decreased urine output, just depression in everything basically." When asked what the worst outcome would be, S16 states, "Flatlining or going into cardiac arrest or cardiac arrhythmia where you have to run a code (code blue: when someone is experiencing a medical emergency in which life-saving measures are taken to resuscitate a person that is imminently dying)."
Tag No.: A0620
Based on observation, record review and interview the facility failed to ensure daily patient nourishment refrigerator temperature log was completed causing a break in safety practices of food handling. This failed practice can lead to bacterial or viral food borne infection of all patients in the Emergency Department.
The findings are:
A. Record review of facility policy titled, "Temperature Procedure and Records - Food and Nutrition Services" effective date: 04/29/2022 shows, "Procedure: Unit Refrigerator Thermometers: 1. Staff will check refrigerator and freezer temperatures daily and record the observed temperature on the appropriate log."
B. Record review of facility policy titled, "Infection Control for Food & Nutrition Department" effective date: 10/21/2022 shows, "Procedure: 2. Storage of Food: e) Commercially prepared foods will be used by the expiration date indicated. Expired product will be discarded and recorded on the nonconforming product log (ISO Control of Nonconforming Product Policy #22737). F) Staff prepared products requiring refrigeration will be placed in covered containers or completely wrapped, labeled, dated, and stored in the refrigerator at 41 degrees F or below for a maximum of 3 days before being used or discarded. Discarded product will recorded on the nonconforming product log."
C. Record review of Temperature Log ICU (Intensive Care Unit) Unit Refrigerator/Freezer Temp Log Month/Year November 2022 shows: 7 of 7 days missing Freezer Temp, 1 of 7 days missing refrigerator temp, 1 of 7 days missing time of check, and 1 of 7 days missing nutrition assistant initials.
D. Observation on 11/07/22 at 3:00 pm of Intensive Care Unit refrigerator found when door was opened a foul odor was detected, inside a container of Jello was found with no expiration or preparation date, individual peanut butter container was found with no expiration date, an individual piece of cheese was found with no expiration date and there was extensive freezer burn.
E. Interview with Staff (S)3, Infection Control Manager and S5, Director of Nursing, on 11/07/22, when asked after refrigerator door was opened, "Do you smell that odor coming from the fridge?", S5 answered, "Yes, I think it's from the freezer. It looks like it hasn't been defrosted for a while." When asked, "Shouldn't all patient foods have an expiration date?", S3 answered, "All the things from dietary should have an expiration date."
F. Interview with S10, Manager of Food Service & Clinical Nutrition, on 11/08/22 at 9:45 am, when asked, "Are you in charge of the staff that monitors the unit refrigerators?", S10 answered, "Yes, we have 3 teams in the kitchen. The nutrition assistants, call center and taking food to the patients." When asked, "Who's in charge of the unit refrigerators?", answer was, "S18 keeps up with temperature logs." When asked why the ICU fridge was not checked on 11/07/22, S10 answered, "We were extremely short yesterday, but yes, that's not acceptable. Nutrition assistants go up stairs and keep up with the temp log." When asked, "On the temperature log the freezer temp is not being checked. How do you account for that?", S10 answered, "I can't." When asked who is responsible for marking food with expiration dates and removing expired food, S10 answered, "Well, the team is supposed to put dates on the food when they unload them and putting the date on there. There is another team that puts the labels on Jello."