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SUTTER ROSEVILLE MEDICAL CENTER ONE MEDICAL PLAZA ROSEVILLE, CA 95661 April 6, 2016
VIOLATION: MEDICAL SCREENING EXAM Tag No: A2406
Based on staff interviews, medical record and document review, document the Acute Care Hospital failed to provide evidence of:

1. An appropriate Medical Screening Exam (MSE) for 1 of 16 patients (Patient 1) greater than 20 weeks gestational age who presented to the L&D Unit for evaluation of labor; and

2. Current competency of 8 of 8 Labor and Delivery (L&D) Unit Registered Nurses (RNs 1, 2, 3, 4, 5, 6, 7, 8) to perform MSEs for one sampled patient (Patient 1) and 4 of 4 random patients (Random patients 1, 2, 3, 4)). Due to the absence of evidence that L&D RNs had been determined to be competent to perform MSEs, a situation of Immediate Jeopardy (IJ) was identified so the facility could put immediate remedies into place to ensure patient safety.


These failures resulted in :

1. The delivery of a 24 week 5 day old infant in the facility parking lot post discharge of undelivered Patient 1; and

2. The potential for unqualified nursing staff to conduct a MSE to determine the presence of active labor.

Findings:

1. In an interview with Patient 1 on 2/19/16, at 3:30 p.m., Patient 1 stated she was 24 weeks and 5 days pregnant when she went to the L&D Unit because she was experiencing uterine contractions every 7 minutes, spotting blood, and was concerned about decreased fetal movement. [RN 1 (who was in orientation), and RN 2 (RN 1's preceptor) were caring for her] Patient 1 stated RNs 1 and 2 did not undress her, instead she was instructed to lift her shirt, while RNs 1 and 2 placed a fetal monitor (a machine that electronically monitors uterine contraction intensity and duration, and fetal heart rate) on her abdomen. Patient 1 stated RNs 1 and 2 never looked to see if she was bleeding vaginally, and never performed a vaginal exam. She stated RNs 1 and 2 told her to give a urine sample. Later on, RNs 1 and 2 told her she had a "Raging UTI" (urinary tract infection). She informed RNs 1 and 2 she did not have any symptoms of a UTI, and had false positive UTIs in the past. Patient 1 stated the L&D RNs misdiagnosed her labor as a UTI. She was discharged from the L&D Unit only to return 20 minutes later to deliver a 24 week 5 day old premature infant in the facility parking lot.

Review of Patient 1's medical record indicated she had called the facility L&D Unit at 10:44 a.m. on 5/29/15, and stated she was experiencing "Cramping every 10 minutes, slight spotting, and decreased fetal movement". Patient 1 was advised to go to L&D to rule out pre term labor.

Patient 1 presented to the L&D Unit at 3:55 p.m., on 5/29/15. A MSE was initiated by L&D RNs 1 and 2 at 4:09 p.m., with the chief complaint of "Cramping since 8 a.m. today spotting off and on since around 8 a.m." and to "Rule out pre term labor."

Review of Patient 1's medical record indicated the following Physician's orders:
A. "Vital signs";
B. "Fetal Heart Rate Monitoring";
C. "Nursing Communication: Palpate uterus to determine intensity, frequency, and duration of contractions. Place Toco (a machine that measured uterine contraction intensity and duration) on patient to monitor electronically";
D. "Vaginal exam";
E. "Pulse Oximetry"; and
F. "Urinalysis and Culture if indicated".

Facility Policy and Procedure titled, "Medical Screening Exam Standardized Procedure Performed by Labor and Delivery Registered Nurse", dated 3/2015, indicated the following:
A. "Procedure:...3. Assess fetal position by vaginal exam; 7. Assess patient for edema (swelling); 8. Assess to determine membrane status:...b. Inspect pad and/or chux (a blue plastic padded surface used to collect fluid) for leakage of amniotic fluid... d. If known vaginal bleeding, assess for rupture of membranes without performing sterile vaginal exam or sterile speculum exam and contact physician; 9. Assess for presence and amount of vaginal bleeding or bloody show; 10. Perform assessments/tests of any additional patient complaints and/or any conditions listed:
a. Pre-term (24-34 weeks): i. send UA to lab...; ii. collect fFn (lab test that determined labor); iii. Start an IV of LR (lactated ringers solution) at 125 ml (milliliters)/hour if bleeding, abnormal (Category III) FHR (fetal heart rate)... ."

Review of Patient 1's medical record indicated some elements of a MSE were performed by RN's 1 and 2, which included Toco monitoring of contractions and fetal heart rate from 4:08 p.m. until 4:50 p.m., and palpation of the abdomen, for an unknown amount of time, once at 4:14 p.m. . Vital signs were taken once, at 4:13 p.m. A urinalysis was sent to the lab at 4:15 p.m.

There was no documented evidence the Policy and Procedure for MSE or Physician's orders had been implemented for the assessment of the uterine cervix, fetal position, rupture of membranes, or bleeding by vaginal examination. There was no documented evidence an assessment for edema, pulse oximetry, or that a fFn had been sent to the laboratory. There was no evidence Patient 1's abdomen had been palpated during contractions, except once at 4:14 p.m., for an unknown duration of time. Patient 1 was discharged at 6:35 p.m., which indicated no fetal monitoring for approximately one (1) hour and 45 minutes prior to discharge.

Review of the nursing flowsheet indicated at 4:13 p.m., Patient 1 was "Talking through contractions; Breathing well through contractions; Requesting pain relief". There was no documented evidence Patient 1's abdomen was palpated at 4:13 p.m. to check for contractions.

In an interview with the Women's and Children's Services Director (WCSD) on 2/10/16, at 10:30 a.m., the WCSD stated when patient's in suspected labor present to the L&D Unit, the staff would monitor bleeding by undressing the patient and have her sit on a chux or check the pad and panties. The WCSD stated the staff had to visualize the pad/chux to determine vaginal spotting/bleeding. The WCSD stated they monitor everyone upon arrival. The WCSD stated to check for contractions staff palpate the abdomen before and after the pain, while checking the monitor for signs of a contraction. Staff are also to visualize the perineum for any blood.

In an interview with the WCSD on 4/4/16, at 2:48 p.m., the WCSD stated if a patient was having contractions that weren't visualized on the monitor, the nurse would need to readjust the monitor. If the problem continued, staff would perform abdominal palpation several times when the mom stated she was feeling a contraction.

2. In an interview with the Chief of the Obstetrical Department (COD) on 4/6/16, at 11:10 a.m., the COD stated a standard had been approved for all L&D RNs to perform MSEs on L&D patients. The COD stated the physician's rely on the MSE assessment performed by the RN to determine if the patient was in active labor. The COD revealed the L&D RN must demonstrate competency prior to approval to perform the MSE.

There was no documented evidence RN 1 or RN 2 had been determined competent to perform a MSE.

2. Review of the MSE Standardized Procedure reflected the following:
"Policy:
1. Labor and Delivery Registered Nurses are responsible for completing all training and competency validation prior to performing the medical screening exam...
3. Name of Procedure: Medical Screening Exam (MSE) for:
a. Assessment of labor (true or false),
b. Identification of other emergency condition,
c. Patient dispositions of admission, transfer, or discharge home ...
5. Training and Experience:..
b. Completion of standard Labor and Delivery (L&D) Unit orientation..
d. Completion of an electronic fetal monitoring class,
e. Completion of MSE Competency Assessment Tool (Addendum A)...
6. Method for establishing initial competency:
a. The RN will perform all the competency requirements listed on the Medical Screening Exam Competency Assessment Tool for Labor and Delivery" (Addendum A)...
7. How and when evaluated for competency: ...
b. Annual chart audit (with results reviewed by the Labor and Delivery nursing management team) (Addendum B),
c. Completion of an EFM [electronic fetal monitoring] review course every two years...."

"Addendum A," the initial competency documentation tool, was attached to the Standardized Procedure. The form included 5 columns: "Competency," "How skill assessed," "Skill Level," "Date," and "Signature of Observer/Preceptor."

An attachment, "MSE Labor & Delivery RNs," contained the names of all unit nurses approved to perform the Standardized Procedure (SP). Included among the 62 RN names on the list were those of RNs 1 - 8.

In a 2:50 p.m., 4/4/16 interview, the Chief Nurse Executive (CNE) stated the facility committee approval process for the MSE SP last began in February, 2015 with the Obstetrics and Gynecology (medical specialty of women's health, especially with regard to the reproductive system) Committee, then was sent to the Interdisciplinary Practice Committee. After approval there, the SP was then sent to the Medical Executive Committee and the Governing Board, where final approval was given for nurses with documented competency to perform labor MSEs. The SP was reviewed through the committee process every 3 years and whenever changes were needed.

In a 9:35 a.m., 4/5/16 interview, the CNE stated that names of competent nurses were not submitted to committees annually as competency audits were completed, nor when newly-hired nurses demonstrated competency initially.

Review of facility documents reflected that the MSE Standardized Procedure, approved through the 4 medical staff and/or administrative leadership committees previously mentioned, gave competent nurses approval to perform MSEs.

A 4 p.m., 4/5/16 review of 8 random L&D RN personnel records was conducted with the Women's and Children's Services Director (WCSD) and the Clinical Manager, Labor and Delivery (CMLD) which revealed the following:

A) 7 of the 8 file (RNs 1 - 2 and 4 - 8) lacked evidence of completion of the initial competency "Medical Screening Exam Assessment Tool." In an 8th file (RN 3), the form was incomplete.

In a concurrent interview, the WCSD confirmed initial competencies were absent for RNs 1 - 2 and 4 - 8. The WCSD acknowledged that document columns for "How skill assessed," "Skill Level" and "Date" had not been completed on RN 3's MSE competency.

B) Annual chart audit forms for 5 RNs (RNs 4 - 8) did not reflect nursing management team review and were missing for all but the most recent 12 months.

When asked for copies of previous annual audits during the review, the CMLD stated that the Clinical Nurse Specialist (specialty educator) had discarded older audit forms as newer ones were added; the practice was recently changed to keep all audit forms in the personnel record.

During a telephone interview with the WCSD on 4/6/16 at 2:55 p.m., she stated annual audit forms for the annual MSE audits (Addenda B) were "spot checked" by the CMLD but acknowledged there was no evidence that management reviewed or approved the competencies.

C) 1 personnel file (RN 8's) contained no evidence of the nurse having taken an electronic fetal monitoring review course in the past two years.

In a concurrent 4 p.m., 4/5/16 interview, the CMLD stated that RN 8's "fetal monitoring course lapsed."

D) L & D Unit orientation documents were incomplete for 4 of 8 RNs (RNs 1, 2, 6 and 7)

During the personnel file review, the WCSD confirmed that RN 1's "Orientation Pathway...I, 2 [sic], III, and IV" documents did not have Administrative Signatures and were therefore not "satisfactorily completed".

The WCSD identified the "Self-Assessment and Verification of Competency" tool as evidence of RN unit orientation. Random RN 2's 8-page document reflected vertical lines drawn through columns titled "Self-Assessment Rating" and "Preceptor's Initials". Remaining columns titled "Competency Training Knowledge," "Competency Training Skill" and "Competency Training Judgment" were left blank.

During RN 6's file review with the CMLD, the "Self-Assessment and Verification of Competency" tool also revealed vertical lines drawn through "Self-Assessment Rating" and "Preceptor's Initials" columns on page 1; "Competency Training Knowledge," " Competency Training Skill," and "Competency Training Judgment" were blank. Pages 2 - 8 of the form had a line drawn down only the "Self-Assessment Rating" column and the 4 remaining columns were left blank. The CMLD stated, "The preceptor did not complete all the boxes."

The "Self-Assessment and Verification of Competency" for RN 7 reflected completion of the "Self-Assessment Rating" column only; columns titled "Competency Training Knowledge," "Competency Training Skill," "Competency Training Judgment" and "Preceptor's Initials" in the remainder of the form were blank. The CMLD confirmed, "There was no preceptor signature and no date."

In an 11:10 a.m., 4/6/16 interview, the Chief of Obstetrics/Gynecology (MD 1) described the OB/Gyn Committee's most recent approval process for the L & D MSE. He indicated the committee was presented a list of nurses for whom he assumed competencies were completed under the direction of the WCSD. He stated the Committee approved these nurses to perform the MSE based on having met the criteria outlined in the protocol. He added that physicians relied on MSE-competent RNs to provide information on which medical decisions were made. He stated that if documentation of nurses' competency was lacking, those nurses should not be allowed to perform MSEs.