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METHODIST HOSPITAL OF SACRAMENTO 7500 HOSPITAL DRIVE SACRAMENTO, CA 95823 Jan. 21, 2011
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
Based on interviews and record review, the hospital failed to comply with CFR 489.24, the EMTALA requirements, when the facility failed to ensure that patients requesting emergent medical care were provided a prompt and appropriate medical screening examination. (Refers to A-2406.)

The effect of this deficiency resulted in the failure of the hospital to deliver statutorily mandated compliance with 42 CFR 489.24.






Findings:

1. The hospital failed to ensure one of 29 sampled patients were provided an appropriate and timely Medical Screening Exam (MSE) to determine the presence of an emergent medical condition (EMC).

Patient 1, a two year old, presented to the Emergency Department (ED) on 11/29/10 and:

a) was not initially assessed and placed at the appropriate level of acuity (Emergent versus Urgent) therefore delaying the initiation of the MSE.

b) did not receive ongoing re-assessments and monitoring to determine ongoing changes in condition which should have been reported to the physician or designee.

Patient 1 was transferred to a higher level of care and as a result of septic shock and suffered the loss or partial loss of her limbs.

2. The hospital failed to ensure that Qualified Medical Personnel provided MSE's to obstetrical patients presenting to Labor and Delivery in 2010 when there was no evidence of an evaluation of competency for eight of eight of the OB nursing staff.
Based on observation, interviews and record review, the hospital failed to comply with CFR 489.24, the EMTALA requirements. (Refers to A-2406)
VIOLATION: MEDICAL SCREENING EXAM Tag No: A2406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interviews and record review, the hospital failed to comply with CFR 489.24, the EMTALA requirements when the facility failed to ensure:

1. One of 29 sampled patients (Patient 1) was triaged appropriately in order to determine the presence of an emergent condition therefore delaying the completion of a timely Medical Screening Exam (MSE) when Patient 1 presented to the Emergency Department (ED) on 11/29/10 at 1:39 p.m.

2. Provide evidence that 8 of 8 Registered Nurses in Labor and Delivery (RN4, RN5, RN6, RN7, RN8, RN9, RN10, RN11) had completed an annual skills review to determine competency to provide a MSE to patients presenting to the Obstetrical Department for assessment of active labor.

Findings:

Patient 1, a two year old, presented to the Emergency Department (ED) from an Urgent Care Clinic (UCC) on 11/29/10 at 1:39 p.m. with a chief complaint of nausea, vomiting, diarrhea, sore throat and earache for two days. Patient 1 had been seen immediately prior in a nearby UCC with a recommendation to go to the ED to rule out meningitis. In a form identified by Registration staff as the facility facesheet (a summary of patient history and demographics) of Patient 1 the chief complaint was noted to be "rule out meningitis, vomiting".

In an interview with the physician (DO1) who treated Patient 1 at the UCC on 11/29/10 at 12:57 p.m., he stated he recalled Patient 1. He said Patient 1 was only at the UCC for a short time ("five to ten minutes at the most") as he felt it was "crucial" for her to be seen in the ED immediately. DO1 stated he was concerned regarding the high fever (103F) and the petechial rashes (spots caused by bleeding under the skin) on both cheeks. He described the rash as "purpural" (purplish spots or patches on the skin due to bleeding within the skin, do not change color under direct pressure). DO1 stated it "looked like a [DIAGNOSES REDACTED] [an acute infection of the bloodstream] rash". DO1 stated he completed a referral form addressed to the ED physician that described the complaints as "fever, petechial rash on face, lethargy and headache" and recommended Patient 1 undergo further evaluation to "rule out meningitis". He further stated he told the Patient 1's parents of the need to rule out meningitis and gave them a copy of the referral form.

In a concurrent review of a form titled Urgent Care and addressed Dear ER Physician, Patient 1 was noted to have been seen at the clinic with complaints of "fever, petechial rash, lethargy and headache" with a "fever 103". DO1 acknowledged he had signed the form with a documented recommendation to "rule out meningitis".

In an interview with a Registration Clerk (RC1) on 1/18/11 at 12 p.m., he stated that when someone was admitted through the ED, they have "the person write down on a slip of paper [identified by Registration staff as the Emergency Department Sign-In Slip] what the main problem is". RC1 stated if the patient brought a referral form from a physician office or clinic, the referral form would be given back to the patient and he would let the triage nurse know there was a referral. When RC1 was asked to read what the UCC physician had recommended for Patient 1, he stated "the doctor ruled out meningitis, fever 103". When asked to repeat this statement, he repeated, "the doctor ruled out meningitis, fever 103". RC1 stated there was no facility policy on what to report to the triage nurse regarding any chief complaints or referrals.

In an interview with a Registration Clerk (RC2), she acknowledged she was the Registration Clerk who had completed a stat registration for Patient 1 on 11/29/10 at 1:39 p.m. RC2 stated she was training with RC1 at that time and had been working in the ED for a week and a half following eight days in Admitting. RC2 stated "the patient fills out a piece of paper with their problem and I type it into the computer" (identified as the ED Sign-In Slip). RC2 also stated "If they come with a paper from Urgent Care, I would let triage know immediately if needed". RC2 also stated "I would tell the patient to hold on to the form and give it to the doctor". RC2 stated there was no policy to guide the registration clerks on potential emergent conditions or what to report to the triage nurse regarding a referral form. RC2 stated the ED Sign-In Slip would be placed with the chart labels in an area designated for the triage nurse to retrieve.

In review of a form titled Emergency Department Sign-In Slip dated 11/29/10 at 1:21 p.m., Patient 1's chief complaint was documented by the family member as "skin changing color, throwing up, 102 temp".

Patient 1 was triaged in the ED by a licensed nurse (RN1) at 1:56 p.m. and assigned to a Level 3 or Urgent status. In a review of the ED Triage Form, RN1 noted the chief complaint of nausea, vomiting, fever, sore throat and ear pain for two days. RN1 documented Patient 1's respirations were 32 breaths per minute and described in a concurrent narrative "respirations regular and unlabored". In a further assessment, RN1 described Patient 1's skin as "warm and dry" and in a section designated for Skin Integrity Major Factors, noted "none". The vital signs documented at the time of triage were: heart rate 160 H, respirations 32 H, temperature 39.0 H. (The computer program was set up to use H to define a higher value than normal) There was no documentation of Patient 1's blood pressure or capillary refill assessment (measurement of adequacy of circulation) at the time of triage or throughout the ED stay until discharge. There was no documentation the physician had been notified of the elevated heart rate, temperature and respirations. There was no assessment of pain or any GI (gastrointestinal) problems i.e. vomiting. There was no reference to any rash or bruising on the face or body.

In an interview with RN1 on 1/20/11 at 2:10 p.m., he stated he was assigned as the Triage Nurse on the day shift (7a-7p) on 11/29/10 but had "no specific recollection" of Patient 1. RN1 did not recall being given a referral letter from the UCC but stated that if he had, it would have been "entered into the triage notes" and "put into the chart". RN1 stated, in general, the communication between Registration and the Triage Nurse was "hit and miss" and there were often "errors" in information entered by Registration staff therefore it was important to see the patient as soon as possible to "seek out errors". RN1 stated when he was assigned to triage he does not undress a child to check for rashes unless indicated. RN1 did not recall reviewing the ED Sign-In Slip that noted the "skin changing color". RN1 acknowledged the surge in the ED (a large number of patients presenting during the same time period) may have impacted his ability to perform timely re-assessments. When RN1 was asked if he was familiar with the Pediatric Fever assessment criteria located on a flip card index for triage nurses, he stated "I've seen it before". When asked why he did not check for capillary refill due to Patient 1's fever, he stated capillary refill was "done at the bedside". Further in the interview, RN1 stated again "capillary refill is a bedside procedure, not done in triage". RN1 stated there was "no box" on the computerized medical record to record a capillary refill.

In further review of the medical record, there was inconsistent documentation of Patient 1's vital signs and re-assessments related to the chief complaint and symptoms from 1:56 p.m. until Patient 1 was transferred at 10:34 p.m. (There was no documentation in the medical record to reflect the time Patient 1 was placed in an ED bed)

1. Temperatures were documented at 1:46 p.m., (102.2F), 3:35 p.m. (102.5F (90 minutes after tylenol), 5:29 p.m. (100.4F) and 9 p.m. (99.1F)
The policy for re-assessments was 30 minutes for emergent or abnormal or 60 minutes for urgent.
2. Heart rates were documented at 1:46 p.m. (160), 5:29 p.m. (122), 6:30 p.m. (140), and 9 p.m. (113).
The policy for re-assessments was 30 minutes for emergent or abnormal or 60 minutes for urgent.
3. Respirations were documented at 1:46 p.m. (32), 5:29 p.m. (28), 6:30 p.m. (24) and 9 p.m. (24).
The policy for re-assessments was 30 minutes for emergent or abnormal or 60 minutes for urgent.
4. Blood pressure - none noted throughout stay
5. Capillary refill done only prior to transfer
6. Central pulses - none noted throughout stay
7. There was no documentation of any intake or output (to rule out dehydration)
8. There was no re-assessement of pain following the administration of two doses of morphine.

In review of an area designated for ED Physical Assessment, RN2 noted respiratory efforts as regular and unlabored at 5:38 p.m. There was no evidence of any prior or further nursing physical assessments by RN2.

In an interview with RN2 on 1/20/10 at 9:10 a.m., he stated he recalled Patient 1 as it was an "extremely busy day" with "parades of ambulances" and "lots in the waiting room". RN2 stated he never received any communication from triage during Patient 1's wait in the ED and he did not receive a report from the TN when Patient 1 was placed in a bed in the ED. RN2 further stated "I am unaware of patients until they land in my room". RN2 stated he does not know the assigned triage level of patients until "I look it up" and "do my own assessment". RN2 stated Patient 1 was "not as animated as a two year old should be" and was just "laying still which is not normal for a two year old". RN2 stated he was "struck by her non-resistance". RN 2 stated Patient 1 "continued to moan when she nodded on and off". RN2 stated Patient 1 was fully dressed and he "opened and peeked" beneath her clothing. RN2 stated Patient 1's "whole body was purpura" which he further described as "appeared bruised uniformly". RN2 stated the bruising on Patient 1's face looked like rosacea (a skin condition characterized by redness or pimples) but the color was purple. RN2 stated he was not given and did not see a referral form from the physician at the UCC. RN2 stated he informed PA2 "in passing" that he had "a very sick child" but did not recall how much time passed before PA2 initially saw the child at the bedside. RN2 stated he was "constantly" re-assessing Patient 1 but acknowledged that with his additional work load he did not have the time to document his assessments or re-assessments.

In review of a policy titled emergency room Triage, no date, the five classifications to determine the priority of care were defined:

Level 1: RESUSCITATION Conditions that are threats to life or limb requiring immediate aggressive interventions. **THE ED MD IS IMMEDIATELY INFORMED OF ALL PATIENTS**

Level 2: EMERGENT Conditions that are a potential threat to life, limb or function. Requires rapid medical intervention or delegated acts. **THE ED MD IS IMMEDIATELY
INFORMED OF ALL EMERGENCY PATIENTS**

Level 3: URGENT Condition that could potentially progress to a serious problem requiring emergency intervention.

Level 4: DELAYED Conditions that when related to patient age, distress or potential for deterioration and/or complications would benefit from intervention or reassurance.

Level 5: MINOR Conditions that may be acute but non-urgent as well as chronic problems with or without evidence of deterioration.

This policy did not stipulate time frames for the patient to be seen by the physician or PA at each of the five levels of care.

In review of the Triage Reassessment Guidelines, an addendum to the emergency room Triage policy, there was stipulation the reassessment times were determined by the level assigned and would include a re-assessment of the chief complaint, any change in condition, a re-assessment of any abnormal vital signs and response to medication or treatment. The policy further stated "All re-assessments are to be documented on the ED record" and "all abnormal vital signs will be brought to the attention of the Emergency Department Provider and will be repeated within 30 minutes".

1. Level 1 Resuscitation Every 5 minutes*
2. Level 2 Emergent Every 15 minutes*
3. Level 3 Urgent Every 60 minutes
4. Level 4 Delayed Every 90 minutes
5. Level 5 Minor Every 120 minutes

* Resuscitation and Emergency patients will be placed into a treatment area and the reassessments will be completed at the bedside by the primary RN in accordance with the policy Assessment and Reassessment.

In review of an undated facility policy titled Patient Assessment/Reassessment and Care Planning, no date, the re-assessment of ED patients was defined as:
" Reassessment is determined by Triage Classification, related to chief complaint and symptoms. At the time of re-assessment, all abnormal vital signs will be reported to the ED provider and repeated within 30 minutes." The minimum time frame requirements for reassessment were the same as defined in the Triage Reassessment Guidelines.

In review of an index card titled Pediatric Fever, dated 12-05, an assessment tool used by the TN to determine the level of care to be assigned, there was stipulation to evaluate capillary refill, central pulses, presence of headache and purpura to determine if the level of care was Emergent. There was no evidence RN1 had assessed or re-assessed Patient 1 appropriately to determine an emergent versus an urgent condition was present.

In review of a Standardized Procedure titled Pediatric Fever Management in Triage, revised 07/09, there was criteria to prompt the triage nurse to notify the ED provider to see the patient immediately for many factors including:
1. Fever >38.3 with history of high risk factors
4. Rash with purple or red spots or dots
5. Inconsolable crying
8. Abnormal or unexplained bruising
10. Behavior changes
11. Somnolence or confusion
12. Difficult to arouse or unresponsive
13. Limp, weak or not moving
14. Dehydration

In an interview with a Physician Assistant (PA1) on 1/20/11 at 4:10 p.m., he stated he was the first provider to see Patient 1. PA1 stated "I was asked to go into the triage area and assess things "due to a surge". PA1 stated he was assigned to be the PIT (Provider in Triage) on 11/29/10 at approximately 1 p.m. and he was assisting the TN with the re-assessment of patients in the waiting areas. During the interview, PA1 identified an untitled, undated form with a time noted as 3:35 p.m., as his PIT notes. PA1 defined the form as his "PIT notes" (Provider in Triage) and acknowledged "there were no notes from me" on this form for the assessment of Patient 1 (the sections noted for history and physical, impession and condition were left blank). In a review of this form there were orders documented for "Zofran, p.o.[oral] fluids". PA1 recalled ordering the Zofran as Patient 1's family had said she had been vomiting prior to the ED visit. PA1 stated "if she still vomits it would indicate how sick she is". PA1 stated Patient 1 was "ruddy cheeked" but "not outside normal". PA1 stated he did not undress the child to examine Patient 1's body further and did not perform a physical assessment. PA1 described Patient 1 as an "unremarkable, ill child". PA1 did not recall seeing the referral letter from the UCC physician.

In review of an untitled form acknowledged by PA2 as the MSE, dated 11/29/10 at 4:48 p.m. and co-signed by PA2 and the ED physician (MD1), PA2 noted Patient 1 had bruising on her cheeks, ear lobes and over her body which the parents stated had started the prior evening. PA2 documented Patient 1 had complained of a sore throat and earache and had a fever for two days. PA2 documented she had consulted with the physician regarding Patient 1 but the date and time space on the form was left blank.

In an interview with PA2 on 1/20/11 at 10 a.m., she stated she was walking past the "hall chairs" about four hours after Patient 1's arrival to the ED and was confronted by Patient 1's father who stated he "had been waiting a long time". PA2 stated the father told her his child was sick and inquired how long it might be before she would be seen. PA2 stated "I knew she needed a room" and started caring for Patient 1 immediately. PA2 stated Patient 1 was warm and crying. PA2 stated she noted "bruising" on Patient 1's cheeks, ears and legs and revealed "it was extensive enough to concern me". PA2 stated the "bruising" was "not a rash" and it was "non-blanchable". PA2 described the bruising further as patches and called it "purpural". PA2 stated the bruising was "more intense" on the extremities. She further stated from "far away" she might look "flushed", but "not if examined closely" and..."it didn't blanch". PA2 stated Patient 1 was "roomed" (taken to an ED bed) about 20 minutes later and she immediately notified one of the ED physicians (MD1) to see the patient. PA2 stated MD1 assumed the care of Patient 1 "when the labs came back". PA2 stated she never received any communication from the TN or PA1 regarding Patient 1. PA2 stated the family "did not give me a letter from Urgent Care, but communicated clearly they were here to rule out meningitis".

In review of a dictated report dated 11/29/10 at 9:34 p.m., MD1 documented Patient 1 to have slight jaundice (yellow coloring) of the skin with bruising on the cheeks, earlobes, thorax, buttocks and lower extremities. MD1 documented the results of blood tests done, including abnormal liver tests, and recommended Patient 1 be transferred to another facility for "further intensive care".

In an interview with MD1 on 1/21/11 at 1 p.m., he stated PA2 "probably saw the child around 5:30 or so" and "got me involved about 6 p.m". MD1 stated he observed "bruising" and called it "disturbing purpura". MD1 revealed he had never been informed of or given a letter of referral from the UCC physician. MD1 stated he assessed Patient 1, reviewed the results of the laboratory tests and made direct contact with a pediatric intensive care specialist to prepare for transfer. MD1 stated "I would have loved to have had the kid in front of me hours earlier".

In review of a policy titled Administrative Policy, EMTALA, REVISED 4/2008, the role of the physician in performing the MSE was defined. The policy, however, did not stipulate the anticipated time for the patient to be seen by the physician or PA for the different triage levels assigned (1 through 5).

In a further review of this policy there was definition of the Triage Assessment. The policy stipulated an initial assessment would be performed within 15 minutes of the arrival of every patient and a complete triage assessment would be conducted as soon as possible. The policy noted the complete assessment would determine the accuracy of the chief complaint, the physical findings, vital signs and past medical history. The policy stipulated, when applicable, the Standardized Procedure for Pediatric Fever would be initiated. The policy stipulated complete reassessments of waiting patients would be based on the chief complaint and triage classification. The policy referred to the Reassessment Guidelines for further reference.

In an Initial Tour of the ED with the Director of Emergency Services (DES) on 1/18/11 at
10:40 a.m., the waiting room, registration, triage and patient care areas were observed. The DES stated there were 23 beds in the ED and the average number of patients seen was 4500 per month. The DES stated on 11/29/10 there was one TN assigned and the triage room and registration clerk were located next to each other in one central area. The DES stated a "stat" (immediate) registration was done at the time the patient arrived with the name, date of birth and chief complaint obtained in order to begin the medical record. The DES stated prior to 12/15/10, the ED Sign-In Slip completed by the patient or designee would be passed on to the Triage Nurse with the patient's "stickers" (labels to be placed on the record for patient identification). The DES stated all nurses working in the ED (except orientees or preceptors) were assigned to triage. She stated nurses hired without triage experience took a class during orientation and experienced nurses were oriented in the triage area. The DES stated there was no competency or annual competency review or any ongoing training for triage nurses as they were only assigning the acuity of the patient, not participating in the MSE. The DES also stated there was no ongoing training for the management of pediatric patients with the exception of PALS (Pediatric Advanced Life Support) certification. There were no ED policies or guidelines for the stipulation of training requirements for triage nurses.

In an interview with the DES on 1/20/11 at 3:10 p.m., she demonstrated the computerized medical record for the ED which included a prompt to be used for pediatric patients. The DES acknowledged RN1 had not activated the prompt and therefore had not seen the screen for the assessment of a pediatric patient. The DES also acknowledged RN1 had not accessed the appropriate screen for assessing pain for a child. The DES stated at the time of Patient 1's visit there was no box for recording the capillary refill but stated this should have been documented in a narrative. The DES also revealed there was no ED surge plan to be implemented when ED was at maximum census and wait times were long.

2. During an Initial Tour on 1/18/11, the Director of Womens' and Childrens' Services (DWCS) stated there were approximately 100 births a month in the Family Birth Center (FBC). The DWCS stated patients were instructed to come directly to the FBC unless the main entrance was locked in which case they would enter the facility through the ED. ED staff would then send them directly to the FBC where they were to be immediately assessed by a labor and delivery RN in the FBC Triage Room. The DWCS stated the medical staff had delegated the responsibility of assessing the competency of the labor and delivery nurse to the labor and delivery nurse manager. The standardized procedure was reviewed annually by the Interdisciplinary Practice Committee, OB Committee and the Medical Executive Committee.

In review of the Medical Staff Rules & Regulations, Emergency Care and Services - Qualified Medical Personnel, approved 7/30/09, there was stipulation all patients who present to the hospital including... the Emergency Department and the Labor and Delivery unit, and who request an examination and treatment for...active labor, shall be evaluated for the existence of...active labor. This screening exam may be performed by the following persons:

"2. In the Labor and Delivery Unit: by either a Physician or by a registered nurse (RN) who has been determined by the L&D nurse manager to be qualified and experienced in obstetrical nursing and who is required to follow standardized procedures approved by the Medical Staff."

In review of an FBC policy titled Medical Screening Exam (OB) Standardized Procedure, revised 10/08, there was stipulation for the Initial Competency Validation and an Ongoing Competency Validation. Both validations required an annual review of skills with completion of a written post test. The policy further stipulated: A list of RN's authorized to perform this standardized procedure will be maintained in Nursing Administration.

In an interview with RN3 on 1/18/11 at 11 a.m., she stated that all of the labor and delivery nurses have been trained to triage obstetrical patients and there was an annual exam for competency. RN3 provided a copy of the OB Triage Record and stated the assessment included a non-stress test (monitoring the status of the fetus and the contractions of the uterus) and a cervical exam when indicated.

In an interview with the DWCS on 1/18/11 at 11:30 a.m., the DWCS was unable to provide evidence of the annual competency training or test results for the labor and delivery nurses (RN4, RN5, RN6) who triaged the three obstetrical patients reviewed (Patients 6, 7, 8). The DWCS stated the record keeping had been disorganized and some of the nurses had not turned in their paperwork.

In an interview on 1/21/11 at 11 a.m., the DWCS was unable to produce evidence that five of five nurses (RN7, RN8, RN9, RN10, RN11) working in labor and delivery that shift had completed the annual competency evaluation for the MSE in 2010. The DWCS stated the former manager had not maintained the records where they were readily retrievable and she could not locate any of the files for the annual competency for labor and delivery nurses. The DWCS was able to produce competencies for the five nurses which had been done in January of 2011 but the dates were outside of the window of review for the survey (July through December)