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525 EAST 68TH STREET

NEW YORK, NY 10065

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on interviews, review of medical records and other documents, it was determined the facility failed to maintain an accurate medical record for each patient. Specifically, laboratory technicians altered critical laboratory results to non-critical values without justification. This finding was noted in 5 of 5 records reviewed from a list of altered laboratory results (Patient #1, #2, #3, #4 and #5).

Findings include:

1. Patient #1 was evaluated in the Emergency Department on 1/19/15 with complaints of elevated blood pressure, chest pain, and general malaise. A "Basic Metabolic Panel" (a panel of blood tests that serves as an initial broad medical screening tool) obtained in the Emergency Department on 1/19/15 revealed the patient's serum potassium level was 5.7 millimoles per liter (mmol/L) on 1/19/15 at 11:01 AM. However, a report generated by the facility comparing the posted report with the analyzer print out revealed the posted report was altered from 9.5 mmol/L to 5.7 mmol/L. High critical value for serum potassium is greater than or equal to 6.0 mmol/L.

At interview with Staff #2 on 3/11/15 at 10:30 AM, she stated the facility's investigation revealed Staff #1, a laboratory technologist who altered the potassium value from 9.5 mmol/L to 5.7 mmol/L did not have a clear justification for making the changes. She stated the patient's serum potassium level (9.5 mmol/L) is a critical value that should have been reported immediately by Staff #1 in accordance with the facility's policy.

The facility's "Critical Value Definition Policy" last revised 9/19/10 notes that a critical value is a test result that is indicative of a life threatening situation that requires immediate attention and clinical intervention. The facility's policy titled "Critical Results Reporting" last revised December 2014 notes "The turnaround time for reporting Critical results is measured from the time the critical result is available until it is reported to a licensed independent practitioner who is able to act on the result. Critical results are to be reported within 60 minutes from the time the result is determined to be critical".

2. Patient #2 is a 69-year-old male who was admitted on 1/4/15 for evaluation of right lower extremity pain related to peripheral vascular disease. The patient had multiple other medical conditions including type II Diabetes Mellitus. A Basic Metabolic Panel ordered on 1/20/15 at 2:46 PM and results on 1/20/15 at 3:45 PM revealed serum Blood Glucose of 51 milligram/deciliter (mg/dl).

The review of the report generated by the facility comparing the posted lab value with the analyzer print out revealed the posted result had been altered from a critical low value of 28 mg/dl to a non-critical value of 51 mg/dl. Critical low value for serum glucose is less than or equal to 50 mg/dl.

Nursing Flowsheet on 1/20/15 noted the patient had received intervention in the inpatient unit for glucometer readings of 50 mg/dl at 12:15 PM and 50 mg/dl at 1:00 PM. However, the critical value observed by Staff #1 was not documented in the patient's record and was not reported to a clinical staff as required by the facility's policy on Critical Results Reporting.

3. Patient #3 is a 98 year old male admitted on 1/9/15 with diagnosis of septic shock and chronic kidney disease. A critical lab value of 102 mg/dl for Blood Urea Nitrogen (BUN) was altered to a non-critical value of 98 mg/dl by Staff #1. Critical value for BUN is greater than or equal to 100 mg/dl.

4. Patient #4, a 25 year-old male was admitted on 2/6/15 with the diagnosis of ketoacidosis. A critical high value of 8 mmol/dl for Carbon dioxide (CO2) was altered by staff #1 to a non-critical value of 11 mmol/dl. Critical low value for CO2 is less than or equal to 10 mmol/L.

5. For Patient #5, a critical low value of 120 mmol/L for serum sodium (Na) obtained on 1/11/15 at 9:45 AM was altered by Staff #1 to a non-critical value of 121 mmol/L. Critical low value for Na is less than or equal to 120 mmol/L.

At interview with Staff #3 on 3/11/15 at 11:10 AM, he reported that Staff #1 was investigated following an incident on 2/6/15 in which she altered a low critical value of 8 mmol/L for carbon dioxide (CO2) to a non-critical result of 11 mmol/L. Further investigation by the facility revealed Staff #1 altered critical results entries 453 times since hired in 8/8/2011. Staff #3 stated the facility has terminated Staff #1 from employment and her Clinical Laboratory Technologist license was reported to the New York State Education Department, Office of Professional Discipline on 3/5/15.

During the survey conference on 3/11/15 at 9:40 AM, Staff #3 reported that the facility has expanded its investigation to include all laboratory technologists. He stated the investigation so far has revealed two additional laboratory technicians who altered laboratory test results without apparent justification.

On 3/17/15, the facility's administrative staff updated the survey team of the ongoing investigation of all laboratory technicians employed by the hospital. The facility completed their analysis for 111 laboratory technical staff back to 2011 at three of the hospital campuses and have identified 14 staff members who changed a total of 1462 laboratory test results without apparent justification. Most changes were made to potassium or glucose levels.