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Based on review of medical records, policy and procedures, and staff interviews it was determined that the facility failed to ensure that one of 20 sampled patients (P#1) received an appropriate, ongoing medical screening examination within the capabilities and capacity of the facility, including ancillary services, sufficient to determine the presence of an emergency medical condition when P#1 presented to the Emergency Department (ED) on 8/16/22.

Findings were:

Cross-refer A-2406, as it relates to the facility's failure to provide P#1 with an appropriate medical screening examination.

Based on review of medical records, policy and procedures, 2021 3rd Quarter Mortality Report, and interviews, it was determined that the facility failed to provide an appropriate medical screening examination within the capability of the hospital ' s emergency department, including ancillary services routinely available to the emergency department, sufficient to determine the presence of an emergency medical condition when for one (P#1) out of 20 sampled patients presented to the ED on 8/16/21 and was discharged prior the results of diagnostic laboratory tests results. As the facility had significant laboratory problems due to the chemistry analyzer not working.

Findings:

A medical record review revealed that P#1 was a 20-year-old who presented to the ED and was registered as a patient on 8/16/21 at 8:29 a.m. for complaints of nausea, vomiting, and generalized fatigue (weakness).

A review of the 'Emergency Provider Report' revealed results of Influenza (Flu) Type A and Influenza Type B laboratory testing for P#1 at 8:29 a.m. Both tests were negative.

A medical screening examination (MSE) was initiated by Nurse Practitioner (NP) AA at 8:38 a.m. P#1 had reported generalized fatigue for the past four days and denied having a fever. P#1 reported vomiting and diarrhea on 8/15/21, with two additional episodes of vomiting and three episodes of diarrhea the morning of 8/16/21. Further review revealed that P#1 reported generalized body aches with a pain level of 7 out of 10. P#1 was placed in a room at 8:46 a.m.

Further review of the medical record revealed that a complete blood count (CBC) (a blood test used to measure several components/features of blood cells and count), a comprehensive metabolic panel (CMP) (a blood test that provides an overview of kidney health, electrolyte balances, acid-base balance, levels of blood proteins and glucose), a COVID test, Influenza (Flu) test, urinalysis (UA), Ketorolac (a medication used to treat moderate to severe pain), sodium chloride 1000 milliliters (mL) (intravenous fluids), and Ondansetron (a medicine used to treat nausea/vomiting) were ordered by NP AA with Medical Doctor (MD) BB as the attending physician at 8:40 a.m. A review of the 'Emergency Provider Report' revealed CBC results at 9:01 a.m.

On 8/16/21 at 9:29 a.m., P#1 was triaged by clinical staff. A review of the rapid initial assessment revealed that the nurse documented that P#1 complained of nausea, vomiting, weakness, diarrhea, and generalized body aches. Further review revealed that the nurse documented that P#1 rated generalized body aches as a 7 out of 10. A review of vital signs recorded during triage revealed a heart rate (HR) of 104 (over 100 is high), respiratory rate (RR) of 18 (normal 12-16), and blood pressure (BP) of 177/97 (normal 120/80).

A review of the orders by NP AA revealed that the laboratory completed the order status of the CBC at 9:35 a.m. The laboratory completed the order status of the COVID test at 10:59 a.m.
A continued review of the medical record revealed that NP AA reported at 12:40 p.m. that she notified P#1 about the delay in laboratory results due to laboratory machines malfunctioning. P#1 reported feeling nauseous again, and Zofran (medication to treat nausea) was ordered. NP AA noted that P#1 agreed to wait for laboratory results.

A review of the 'Emergency Provider Report' revealed that the results of a urinalysis (UA) on 8/16/21 at 1:21 p.m. included the following abnormal results:
Protein- 200 mg/dL (normal was negative mg/dL)
Blood- Moderate
Urine Red Blood Cells- 4 mg/dL (normal was 0-2 mg/dL)
Urine Glucose- greater than 1,000 mg/dL (normal was negative mg/dL)
Ketones- greater than 150 mg/dL (normal was negative md/dL).

Continued review revealed that a 'Lab Imaging Statement' revealed that laboratory studies were reviewed and considered in the medical making decision (MDM). In addition, 'Re-evaluation and MDM' noted significant delays in the laboratory. Further review of the documentation in the medical record also stated that all vital signs available at this time of the entry has been reviewed and that the patient ' s condition was listed as "stable". Also, at 1356 the primary impression of the patient ' s condition was listed as "Nausea and vomiting."

At 1:50 p.m., NP AA noted that P#1 did not want to wait any longer for laboratory results. P#1 stated nausea had subsided and requested to be discharged home. NP AA documented that discharge instructions and education were provided and P#1 was encouraged to follow up if symptoms worsened. P#1 verbalized understanding.

A review of orders revealed that the laboratory completed the order status of the UA at 2:05 p.m.

A continued review of the medical record review revealed that P#1's vital signs at 2:06 p.m. were: HR was 98, RR was 18, and his BP was 165/95. P#1 was discharged from the facility at 2:07 p.m.

A review of orders revealed that the laboratory completed the order status of the CMP and was logged at 8:40 a.m., in process at 9:11 a.m., re-logged at 10:11 a.m., and then canceled at 2:22 p.m. by the laboratory with a comment that the patient (P#1) was discharged.

A review of the 'Emergency Provider Report' that included laboratory results was electronically signed by NP AA at 7:53 p.m.

An additional medical record review revealed that P#1 presented to the facility via emergency medical services (EMS) on 8/17/21. A further review revealed that P#1 was logged in the mortality sheet on 8/17/21 at 3:43 p.m. by the facility and expired at 9:40 p.m.

A review of the facility's policy titled, "EMTALA Definitions and General Requirements," policy #11390205, last reviewed 03/2022, revealed that the purpose of the policy was to detail that a facility with an ED would provide an appropriate medical screening exam (MSE) and any necessary stabilizing treatment, within the capability of the hospital's ED, to any individual who came to the ED and requested such examination.

Further review revealed that the definition for capabilities of the medical facility or main hospital provider meant the physical space, equipment, supplies, and services, including ancillary services available at the hospital. The hospital was responsible for treating the individual within the capabilities of the hospital as a whole, not necessarily in terms of the particular department at which the individual presented.

The definition of "Emergency Medical Condition (EMC)" meant:
1. A medical condition manifesting itself by acute symptoms of sufficient severity, such that the absence of immediate medical attention could reasonably be expected to result in:
a. Placing the health of the individual in serious jeopardy
b. Serious impairment to bodily function
c. Serious dysfunction of any bodily organ or part

A continued review revealed that an "MSE" was the process required to reach reasonable clinical confidence, the point at which it could be determined whether or not an EMC existed. The screening was to be conducted to the extent necessary by physicians and/or other QMPs to determine whether an EMC exists.

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A review of the facility's policy titled, "EMTALA - Medical Screening Exam and Stabilization," policy #11388314, last reviewed 03/2022, revealed that the purpose was to detail guidelines for providing an appropriate MSE and any necessary stabilizing treatment or appropriate transfer.

An MSE was extended to include ancillary services available to the ED to determine whether an EMC existed, regardless of the individual's ability to pay.

The Emergency Medical Treatment and Labor Act (EMTALA) obligations were triggered when there had been a request for medical care by an individual within a dedicated ED (DED), when an individual requested emergency medical care on hospital property, or when a prudent layperson would recognize that an individual on hospital property required emergency treatment/examination, though no request for treatment was made.

If an EMC was determined to exist, then the hospital must provide either:
1. Further medical examination and any necessary stability treatment with the capabilities of the staff/facilities available at the hospital
2. Appropriate transfer to another medical facility

Further review revealed that triage was not equivalent to an MSE as the former entails the clinical assessment of the individual's presenting signs and symptoms at the time of arrival in order to prioritize when a physician or QMP would screen the individual. The MSE must be appropriate to the individual's presenting signs and symptoms and the capability and capacity of the hospital. The individual would be continuously monitored according to the individual's needs until it was determined whether or not an EMC was present, and if so, the individual was stabilized or appropriately admitted. The medical record would reflect the amount and extent of monitoring that was provided prior to the completion of the MSE and until discharge. The extent of the necessary examination to determine whether an EMC exists was generally within the judgment and discretion of the physician or QMP.

An MSE may vary depending on the individual's signs and symptoms:
1. Depending on the individual's presenting symptoms, an appropriate MSE could involve a wide spectrum of actions, ranging from a simple process involving only a brief history and physical examination to a complex process that also involved performing ancillary studies and procedures.

A determination of whether an individual was stable was not based on the clinical outcome of the individual's medical condition. An individual had been provided sufficient stabilizing treatment when the QMP treating the individual in the DED had to determine, within reasonable clinical confidence, that no material deterioration of condition was likely, within reasonable medical probability.

Further review revealed that an individual was considered stable and ready for discharge when, within reasonable clinical confidence, it was determined that the individual had reached the point where continued care could be reasonably performed as an outpatient, provided the individual was given a plan for appropriate follow-up care with discharge instructions. The EMC that caused the individual to present to the DED must be resolved, but the underlying medical condition may persist.

A review of the facility's policy titled "Specimen Criteria," Policy #8158994, last reviewed 12/2012, revealed that the purpose of the policy was to detail adequate collection of specimens for laboratory analysis. Further review revealed that if any suboptimal specimens were received in the laboratory, special notations were made on the request form to clearly indicate the conditions of the specimen. It may be that the specimen could not be recollected; if this was the case, then run the specimen and explain it on a report form. Staff was to notify appropriate leadership. If the specimen could be recollected in a reasonable amount of time, it should be recollected.

The facility ' s Policy and procedure titled "Critical Values" Policy StatID 10086673, Original effective 09/1998, Last Review 10/2019. The policy revealed in part, "Purpose: A critical value is a diagnostic result that reflects a significant variance from the normal as to represent a pathophysiologic state that is potentially life threatening unless some action is taken in a very short period time and for which an appropriate action is possible ...A. Laboratory Critical Results: 1. The lab values identified as critical values will be called by laboratory personnel to the nurse assigned to the patient immediately as the results become available . 2. The nurse will document the results validating the read-back process. 3. The nurse will contact the attending physician within 1 hour."

An attempt to reach the complainant by telephone on 9/12/22 at 10:20 a.m., was made by this surveyor. A second attempt to reach the complainant by telephone on 9/13/22 at 1:45 p.m., was made by this surveyor. A message was left in the complainant ' s voicemail. The complainant returned the call on 9/13/22 at 2:15 p.m. The complainant reported no further comment than what was established on the original complaint.

An interview was conducted with NP AA on 9/13/22 at 8:41 a.m. in the conference room. NP AA started as an ED nurse at the facility in 2010 and began practicing as a midlevel provider in 2017 or 2018. When asked about the incident in question regarding P#1, NP AA recalled that it was very busy in the ED that day. P#1 presented as what NP AA termed "well-sick," with vague complaints of nausea, vomiting, and lethargy. NP AA stated that P#1 was exposed to COVID. NP AA screened P#1 and placed P#1 in the "sick pit" area for a flu, COVID, and blood tests (CBC, CMP, and UA). P#1 was returned to the waiting room to wait for results. NP AA recalled giving P#1 intravenous (IV) fluids for dehydration, Ketorolac (an intravenously administered non-steroidal anti-inflammatory medication for pain), and Ondansetron (an intravenously administered antiemetic medication for treating nausea). NP AA stated that though P#1's bloodwork was sent to the laboratory, the laboratory was down due to a malfunction. When asked what happened in the laboratory, NP AA stated that she thought both chemistry analyzers were down, and she had attempted to send the labs to another facility. NP AA said that she updated P#1, and P#1 stated that he felt better after taking a nap. NP AA asked P#1 if he would wait a little longer for the laboratory results. NP AA said she tried to talk P#1 into waiting four times and consulted MD BB about P#1 every time P#1 asked to leave. NP AA explained that because P#1 received IV fluids, and medications, was not presenting as critically ill, and did not have a known medical history, NP AA was "okay "with discharging P#1, albeit hesitant. NP AA spoke to Medical Doctor (MD) BB to clear P#1 for discharge. NP AA was asked if she realized that the UA showed a urine glucose level greater than 1,000. NP AA stated that the UA never resulted while on shift and that results were released afterward. NP AA said that the laboratory canceled both orders. NP AA stated she was made aware when she returned to work the following day. When NP AA was called on her way to work regarding P#1 returning to the facility, she knew immediately which patient it was because P#1 was the only one on whom they could not get laboratory results on that day. Other patients did not have issues receiving their results, but NP AA stated that those patients waited five to six hours for their results that day. NP AA said that it was unfortunate because had she known of the UA results, she would have performed a fingerstick blood glucose test on P#1 while P#1 was still in the ED. NP AA explained that if you viewed the time log where the UA was ordered, it said that the laboratory canceled it. NP AA claimed that the collection time for the UA and the result time appeared as the same time. NP AA stated that the time stamp for the release of the results showed a time before it was ordered and that this has been an ongoing issue. NP AA said that the CMP sample was thrown away because it appeared hemolyzed (when the red blood cells in whole blood rupture and the blood sample is potentially compromised). NP AA further explained that it was later revealed that P#1 was an undiagnosed diabetic with profoundly poor kidney function and was unaware of this fact, presumably due to a lack of primary care. However, NP AA stated that P#1 did not endorse the typical subjective symptoms of new-onset diabetes, such as polydipsia (excessive thirst) and polyuria (excessive urination). NP AA recalled that P#1 only had vague symptoms of vomiting, diarrhea, and dehydration coupled with moderately elevated blood pressure and heart rate. When asked if the facility debriefed after the incident, NP AA stated that they did debrief but that, truthfully, "Nothing has changed" operationally. NP AA said laboratory operations had not since improved and generally remained the same. NP AA stated that the ED used to have iStat machines for running bloodwork during lab downtime, but they were not approved by the Food and Drug Administration (FDA), so the facility stopped using them. NP AA stated that they told Administration that they needed a backup plan. NP AA said that if the iStat machine were available, they would at least have the components of a basic chemistry, such as blood sugar and potassium levels.

A telephone interview was conducted with MD BB on 9/13/22 at 9:48 a.m. MD BB stated that on 8/16/21, the ED was very busy and was holding 20-27 patients requiring inpatient beds. MD BB said ED RNs had assumed care for 7 to 8 patients, which was very uncommon. This was why MD BB could recall the day. MD BB said that NP AA ordered medication and laboratory tests for P#1. MD BB explained that the laboratory was experiencing difficulties, resulting in laboratory test delays. MD BB said that the CMP was the only laboratory test that did not result for P#1. MD BB stated that the UA did not result until after P#1 was discharged. MD BB said that NP AA reported P#1 requesting discharge due to the wait time. MD BB said NP AA spoke to him about P#1's request for discharge despite the lack of the CMP results. MD BB stated he reviewed P#1's vital signs and laboratory tests that did result and assessed P#1. He said that P#1 requested to be discharged. MD BB stated that P#1 was in a stable condition and that a follow-up call would be performed if anything appeared abnormal with P#1's laboratory tests. MD BB stated that after P#1 was discharged, it was noted that P#1's blood work was hemolyzed. MD BB said that the combination of the hemolyzed blood and the fact that P#1 was discharged led to the cancellation of the CMP by the laboratory. He said P#1 did produce urine for the UA right before discharge, which is why the results of the UA resulted after P#1 was discharged. MD BB said if the UA resulted prior to P#1's discharge, MD BB would request a finger stick for a blood glucose level. MD BB stated that P#1 had no medical history that prompted him to consider a high blood glucose, nor did P#1 present with signs or symptoms such as a high frequency of urination or intake of fluids. MD BB stated that even with a hemolyzed blood sample, the blood glucose would not be affected and that the laboratory should have continued to run the sample or asked him for further direction. There was no documentation in the medical record to indicate that Patient #1 was called and informed of the abnormal UA results.

An interview was conducted with Charge Nurse (CN) FF on 9/13/22 at 10:32 a.m. in the conference room. CN FF stated she had worked at the facility for five years. CN FF said that in the past, clinical staff had experienced delays in laboratory results due to an issue with the laboratory. CN FF stated that if a blood sample was hemolyzed, the laboratory was supposed to call the RN to perform another blood draw. If the incident occurred again, a phlebotomist had to perform the blood collection. CN FF stated that in reporting critical laboratory values, the laboratory used to call the RN assuming care of the patient. However, this had recently changed to where the laboratory would not call the MD first. CN FF said that to her knowledge, if the laboratory did not have a functioning machine, the facility was supposed to send pending laboratory orders out to another facility. CN FF stated that the ED had two point-of-care (POC) blood glucose monitors. CN FF explained that all RNs and ED technicians could access and utilize the machines if requested by a provider.

An interview was conducted with Registered Nurse (RN) EE on 9/13/22 at 11:01 a.m. in the conference room. RN EE stated she had been an employee at the facility for 36 years. RN EE agreed that delays in laboratory processing affected the provision of patient care. When a blood sample was hemolyzed, RN EE stated that the laboratory would notify them and come to redraw the sample. RN EE further said that if the patient's laboratory tests were still pending, particularly a CMP along with a UA, and the patient requested discharge (a standard discharge, not leaving against medical advice [AMA]), they would inform the patient that it would be in the best interest of the patient's health and safety to stay and wait until the results of the laboratory tests were back. RN EE said that most patients would be amenable to staying and waiting if this was communicated. RN EE stated that the lab notifies the provider or the nurse of critical results and there is a "critical events" icon under interventions in their charting system where they are supposed to document critical lab values. When asked if the lab documents a critical value, RN EE stated that they will document which nurse or provider they report it to.

An interview was conducted with Interim Laboratory Director (LD) II on 9/13/22 at 11:23 a.m. in the conference room. LD II said he had been employed at the facility for a month. LD II explained she was a temporary contract employee but had a cumulative 30 years of experience in the profession. LD II explained that the instrumentation would detect if a blood sample were hemolyzed. Specimen integrity issues were called in, and a phlebotomist obtained a redraw. LD II further explained that there was not much you could do with a hemolyzed sample because the results could be compromised, and they did not want to give out incorrect values with known specimen integrity issues. When asked if she knew if a serum (blood) glucose level would be affected by hemolysis, LD II said she was unsure but believed that blood glucose level would be affected. LD II said that specimen integrity issues caused the most delays in the laboratory. Other factors that affected timeliness included the workflow of the department and instrumentation downtime. LD II stated that when an analyzer was down, the contractors were contacted so that maintenance could be performed on it while the other machine was functioning. LD II explained that it was uncommon for laboratory technicians to cancel laboratory orders even when the patient was discharged. LD II said that she had not witnessed orders being canceled by laboratory technicians since working at the facility. The only instance in which she could foresee that happening was if a specimen was compromised and a new specimen was to be obtained. LD II explained that the way the processing time was perceived was different between the providers and the laboratory technicians. The providers counted the time of the processing from the time the order was placed to the time of the result. The laboratory metrics were based on the order received time to the resulting time. LD II explained that the laboratory notified the provider or a nurse with a critical laboratory result. LD II stated they had not called a critical result on a UA and LD II was not sure what the facility's policy was for calling critical results for UAs. LD II stated that if there are no interruptions, a UA should take no more than 15 or 20 minutes to result, as it is automated. There was no documentation in the medical record to indicate that the UA critical laboratory value for Patient #1was called to the nurse, or the physician as stated in the facility ' s policy.

An interview was conducted with Laboratory Technician (LT) GG on 9/13/22 at 11:52 a.m. LT GG stated that LT GG had been with the facility since 2016, departed in 2017, but returned in 2020. LT GG said it was very uncommon, but the laboratory had experienced a time when chemistry blood analyzers had malfunctioned. LT GG stated that the current policy for hemolyzed samples was to report it to the leading technician, note the level of hemolysis, then contact the ordering provider and let the provider decide. LT GG stated that glucose was not affected by hemolysis. LT GG said that LTs had received training on the new policy.

An interview was conducted with Emergency Department Medical Director (MD) HH on 9/13/22 at 12:11 p.m. MD HH had been employed at the facility for 11 years but practiced overall as a doctor for 24 years. MD HH stated that when it came to convincing patients to wait in the ED, it was not fair to "hold a patient hostage" in the ED. MD HH further explained that even if a blood sample were hemolyzed, they would still request that they hold the affected results from the sample but release the results unaffected by hemolysis. MD HH claimed this was a new revision of a policy that has been in effect for "a couple of years." When asked if they ever go back and review results that populate after a patient's discharge, MD HH stated that results were not imported after the chart was signed out. He continued to explain that you would not always be aware of results that populated later unless you had a reason to go back and look. MD HH explained that the laboratory had a list of critical results, but urine glucose of greater than 1,000 was not on their list.

The facility failed to that ensure that an appropriate medical screening examination was provided that was within the capability of the hospital emergency department to include ancillary services (laboratory) as evidenced by the hospital ' s laboratory chemical analyzers were not working causing a significant delay in reporting of CMP. Additionally, critical lab results of the urine analysis were resulted, while the patient was being discharged; and the Laboratory failure to report the urinalysis critical laboratory value to the nurse assigned to Patient #1, as stated in the policy. As this resulted in Patient #1 ' s incomplete medical screening examination on 8/16/2021.