HospitalInspections.org

Based on document review and interview, the Governing Body failed to maintain oversight of laboratory Services to ensure safe delivery of care. Specifically, the Governing Body failed to ensure that systemic issues identified through the facility's Organization wide Performance Improvement Committee (OPIC), related to critical value turnaround time, that may negatively affect the quality of patient care were addressed timely.

These failures may have placed patients at risk for potential harm.

Findings include:

See Tag A 263
See Tag A 283
See Tag A 576
See Tag A1104

Based on document review, and interview, the facility failed to utilize its Quality Assessment and Performance Improvement (QAPI) Program to ensure that actions necessary to correct identified problems in the Laboratory Department were implemented. Specifically, actions aimed at improving turnaround time (TAT) of laboratory test results did not ensure improvement in the indicator.

The failure affected the effectiveness and safe delivery of care and may have placed patients at risk for potential harm.

Findings include:


See Tag A283

Based on document review, and interview, it was determined that the facility did not ensure implementation of actions necessary to correct identified problems in laboratory services related to critical call turnaround time and reporting of Arterial Blood Gas (ABG) through its Electronic Medical Record.


Findings include:


1. Review of Organization wide Performance Improvement Committee (OPIC) monthly minutes from October 2015 through March 2016 noted that the facility identified below 95% threshold for Critical Call Turn-Around-Time (TAT). Although corrective actions were put in place monthly, the facility's corrective action plan for each month were not effective in correcting the identified issues.
Review of the Department of Pathology and Laboratory Medicine Quality Management reports identified the following:
The Critical call TAT was not meeting the threshold of 95% with 30 minutes TAT. The facility attempted to implement corrective measures, the TAT remained well below the established threshold.
September 2015 - 83 %
October 2015 - 85.6%
November 2015 - 79%
January 2016 - 56%
February 2016 - 63%

2.The January 2016, report identified a problem of ABG results that could not be released and integrated from the Laboratory Information System (SOFT/LIS) to the Electronic Medical Record (EPIC). Review of 105 ABG results indicated no measures were implemented to fix the identified problem, and no follow-up measures were documented after the January 2016 meeting. As a result, the problem persisted through June 2016.

Interview with Staff A, Vice Chairman of Pathology and Quality on 6/6/16 at 2:30 PM, he acknowledged findings and stated the facility has not met the 95% threshold for Critical call TAT.

Based on medical record review, document review, and interview, the facility failed to ensure: 1) that all staff implement policies and procedures for timely reporting of Critical Values to ensure appropriate clinical actions are taken in response to the critical value; 2) laboratory tests are ordered and available for review by Licensed Independent Practitioners (LIP); 3) Laboratory Services implemented an effective plan to correct identified problems concerning patient care.

These failures may have negatively impacted the quality of care provided to patients.

Findings include:

1. Review of a sample of 826 Critical laboratory values (panic results) for the following days: 3/5 through 3/8/2016; 4/5 through 4/8/2016; 5/2 through 5/6/2016; and 6/6 through 6/8/2016 identified that 191 critical values were either not reported by Laboratory Technologists (LT) or reported with no documented evidence of receipt by Licensed Practitioners (LP) or physicians in accordance with the facility's policy.

Review of medical record for Patient #1 noted a 60-year-old with multiple medical conditions who presented to the Emergency Department on 4/2/16 with a chief complaint of fever and dry cough. The initial Troponin I (A protein that regulates heartbeat and can be used as an indicator of myocardial infarction) result verified by LT on 4/2/16 at 11:36 PM revealed a critical value of 0.221 nanogram/deciliter (ng/dl) (Panic range for Troponin I level is less than or equal to -1.000 ng/dl and higher than or equal to 0.200ng/dl). The Laboratory Technologist (LT) noted in the Laboratory Information System (LIS) that the critical report was called to and read back to a Registered Nurse on 4/2/16 at 11:36 PM.

There was no documentation in the medical record by the nurse regarding the information received from the LT and, when the physician was notified of the critical value. The ED physician note on 4/3/16 at 1:13 AM acknowledged patient's Troponin I level of 0.221 ng/dl. The time of the acknowledgement was over one hour after the critical value was verified and reported to the nurse.

Review of laboratory reports for Patient #1 from 4/3/16 to 4/6/15 identified that the following critical values for serial Troponin I were not reported to the Licensed Practitioner or physician by the LT: 7.520 ng/ml verified by LT on 4/4/16 at 5:51 PM; 3.420ng/dl verified by LT on 4/6/16 at 5:12 PM; and 3.780 ng/dl verified by LT on 4/6/16 at 9:07 PM.

Review of medical record for Patient #2 noted a 56-year-old male with a history of colorectal cancer, status post resection, and diverting colostomy. Critical value for Potassium 2.6 milliequivalents per liter (mEq/L) (Panic range for Potassium is less than or equal to 2.7 mEq/L and equal to or higher than 6.1 mEq/L) was verified by LT on 5/4/16 at 5:33 PM. The LT documented the following in the Laboratory Information System on 5/4/16 at 5:33 PM: "Called no answer". There was no indication that the critical value result was communicated to the LP or physician within 30 minutes of the time the result was verified by the laboratory.

The critical value result was acknowledged in a physician note on 5/4/15 at 9:20 PM; about four hours after the critical value for potassium was verified in the laboratory. The delay in communicating the critical value for Potassium to the LP or physician caused a delay in the treatment of the patient. The Medication Administration Record noted Potassium replacement therapy on 5/5/16 at 4:49 AM.

Similar findings regarding lack of reporting of critical values and lack of documentation of critical value communication in the electronic medical record were found in 189 other cases of critical value samples reviewed.


Review of facility's policy titled, "Critical Values Communication" last revised 6/2016 notes, Critical values, a life-threatening situation requiring immediate patient assessment and/or action may be the result of a "stat" or "routine test" and will be reported via phone by the laboratory or testing area to a LP or physician. The timeframe from the verification of critical value result by the testing area to reporting it to the LP or physician is within 30 minutes of the time the result is verified by the laboratory...Only a LP or physician may receive critical value phone results. The LP or physician who receives the result must document in the electronic medical record, read back, and verify results with the caller ... "

At interview with Staff B, Associate Vice President of Clinical Services on 6/6/16 at 3:00 PM, she stated that the facility's previous policy on Critical Value Communication revised 4/2015 and was in effect until 6/5/16 was unavailable for review.

However, at interview with Staff C, Vice President of Clinical Services on 6/6/16 at 11:30 AM, he stated the facility ' s previous policy requires reporting of critical values immediately and within 30 minutes of verification of the result by the Laboratory Technologist (LT).


2. Review of file containing 105 Arterial blood Gases (ABG) reports from February to May 2016 noted that the results were not available in the Electronic Medical Record for physician review.

During interview with Staff B on 6/6/16 at 12:30 PM, he stated the following: the 105 ABG reports were traced to specimens drawn by residents and respiratory therapist to monitor patients receiving mechanical ventilatory support or patients with acid base disturbances. He stated there were no physician orders for the 105 ABGs but the tests were conducted by the lab within thirty-minutes in order to maintain the integrity of the ABG specimens. The LT were unable to match the ABG results to physician orders in the EMR and therefore, these reports were not released. Staff B explained that laboratory reports are generated in the Laboratory Information System, which interfaces with the EMR. However, for laboratory reports to cross over to EMR there has to be a physician order in the EMR.

At interview with Staff C, Director of Respiratory Department on 6/8/16 at 11:54 AM, he stated the following: physician order for "Mechanical Ventilatory Support bundle" (Physician order set for management of patient on mechanical ventilator) authorized RT to draw ABGs to monitor patient receiving mechanical ventilator support. ABGs drawn by RT are attached to the physician order set for respiratory bundle.

Review of facility's policy titled, "Mechanical Ventilatory Support" bundle last revised 5/2013 noted the policy established 10/1990 authorizes credentialed respiratory care practitioners to draw arterial blood without an individual order being written for each procedure. The policy notes, " The duty to monitor changes in the clinical condition of patients receiving mechanical ventilation is a shared responsibility of the house staff and qualified respiratory therapists. "

During interview with Staff C on 6/8/16 at 3:00 PM, he stated the facility's preliminary review of the 105 ABG reports identified that some laboratory technologists were unaware that ABGs drawn by RT should be attached to the patient's order for "Mechanical Ventilatory Support bundle. The rest of the ABGs were drawn by residents during cardiopulmonary resuscitation and other emergencies and did not have a corresponding order in the EMR. He added that LTs ' attempt to identify and contact the residents failed. Staff C stated laboratory Manager/Supervisors are responsible for ensuring ABG reports are validated and released in the EMR.


3. Review of Laboratory Services monthly Quality Assessment and Performance Improvement reports from October 2015 through March 2016 noted that laboratory has not met 95% threshold for Critical Value TAT.
September 2015 - 83 %
October 2015 - 85.6%
November 2015 - 79%
January 2016 - 56%
February 2016 - 63%
Although corrective actions were put in place monthly, there was no evidence that the plan was effective to address the systemic issues identified with Critical Value TAT. There was no documentation of staff education to address the ongoing critical value communication issues with physicians and LPs.

Interview with Staff C on 6/6/16 at 12:15 PM regarding the 105 ABG results from February to May 2016 that were not released in the EMR, he reported that the problem was caused by the lack of orders for some ABGs and some LTs lack of education on how to release ABGs drawn by RTs.

There was no documentation of an effective plan to address the persistent failure by physicians to order ABGs and the training needs of LTs

33544

Based on medical record review and interview, the Emergency Department physician did not ensure: 1) timely diagnosis and treatment of a patient who presented with a head injury; 2) timely treatment of a patient with critical value of potassium. These findings were noted in 2 (two) of 15 patients' medical records reviewed (Patient #2 and 3).

The delay diagnosis and treatment of patients may have placed them at risk for harm.

Findings include:

1. Review of Laboratory Panic reports on 5/5/16 for Patient #2 noted Critical value for Potassium 2.6 milliequivalents per liter (mEq/L) (Panic range for Potassium is less than or equal to 2.7 mEq/L and equal to or higher than 6.1 mEq/L) was verified by Laboratory Technologists (LT) on 5/4/16 at 5:33 PM. The LT documented the following in the Laboratory Information System on 5/4/16 at 5:33 PM: "Called no answer".

Review of medical record for Patient #2 noted a 56-year-old male with a history of colorectal cancer, status post resection, and diverting colostomy. The Critical value for Potassium 2.6 mEq/L was acknowledged by a physician in a note on 5/4/15 at 9:20 PM; almost five (5) hours after the result was verified in the laboratory. There was no documentation of Potassium replacement therapy until on 5/5/16 at 4:49 AM. This was six (6) hours after the critical value for potassium was acknowledged and approximately eleven hours after the release of the critical value report.


Review of medical record for Patient #3 noted 6-months-old male who was brought to the Emergency Department (ED) on 5/14/16 at 11:27 AM by his father with a chief complaint of status post fall with head injury.

The triage assessment of the patient on 5/14/16 at 11:29 AM, noted the following: Infant alert, active, and playful. There are no neurological and respiratory systems deficits and stable vital signs.

Physician order for CAT scan of the head on 5/14/16 at 1:03 PM was not completed until almost four hours later at 4:52 PM. The CAT scan report revealed "deformity of the right parietal skull. No fracture lines are demonstrated, no overlying soft tissues swelling. The lack of overlying soft tissue swelling suggests subacute or chronic skull fracture an acute fracture. No intracranial hemorrhage".

The patient was transferred to another facility on 5/14/16 at 7:46 PM for pediatric neurological surgical consultation.

At interview with Staff G, Attending Pediatric physician on 6/8/16 at 9:30 AM, she stated the following: the patient was evaluated within one hour of arrival, and she determined a CT scan was needed to rule out fracture. The plan was to attempt CAT scan of the head without sedation due to patient ' s neurological stability.

During interview with Staff D, Chief Medical Officer on 6/8/16 at 9:45 AM, he concurred that the CAT scan could have been done sooner.