HospitalInspections.org

Based on review of the laboratory's quality assessment policy, review of patient test reports, review of email communication, and staff interview, the laboratory failed to have an effective, ongoing data-driven quality assessment and performance monitoring system by not tracking and trending incorrect test results for patients that were administered low molecular weight heparin.

Findings included:

Review on November 2, 2020 of the laboratory's "Quality Management Program" (GEN 8) revealed, "...Monitoring and Assessment ... 1. ... C. Safety Improvement Reports (SIR) are completed thru the hospital Quality and Patient Safety software for incidents and events. SIRs are reviewed through the hospital and corporate Quality Councils. ... 3. ... A. SIRs are to be completed for patient events, incidents and concerns related to transfusion and laboratory services. ... C. SIRs are completed for laboratory service issues such as ... laboratory errors that require corrected reports ....".

Review on November 2, 2020 of the laboratory's 2020 quality assessment records revealed, tthe laboratory performed quality assessment reviews on a routine basis (weekly, monthly, periodically) and utilized a dashboard to monitor performance indicators on a monthly basis. Review of the "General Laboratory Quality Assurance" checklist revealed the items listed for monthly review included Review/ Print Critical Value Report" and "Review/ Print Corrected Results Report". The Performance Improvement dashboard monitored "Total SIRs/Trends", "# Outstanding SIRs", and Corrected Reports (Clinical Lab)". The "Benchmark" (threshold) for corrected reports was listed as 30 or less per month, and review of the Performance Improvement dashboard revealed the laboratory met the benchmark for each month (January through September) of 2020.

Review on Novmeber 2, 2020 revealed, on July 23, 2020 at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.


Interview November 2, 220 at 11:00 AM with GS #2 revealed, reviews of maintenance, quality control, critical values, and corrected reports were performed monthly. And the list of corrected reports to determine which ones should be included in the number listed on the Performance Improvement dashboard. Most of them [reports] were not included in the number because they were not "true" corrected reports, and the procedure did not determine which ones should be included. Interview revealed, if a "significant" problem was identified during the review, an investigation would occur and the Director of Laboratory Services would be involved. Interview failed to revealed, how the laboratory determined what consituted as a "significant" problem and failed to revealed, the laboratory had a system in place for tracking incorrect test results for low molecular weight heparin.

Interview November 4, 2020 at 2:45 PM with the Corporate Director of Laboratory Services revealed, the "Quality Management Program" policy, for laboratory services, needs to be updated.

Based on policy and procedure review, medical record reviews, and staff interviews the hospital laboratory staff failed to ensure patient safety by not obtaining accurate test results, for low molecular weight heparin (anti-Factor Xa), by not manually diluting all laboratory specimens for results greater than 1.28 IU/mL for 5 of 8 patients (Patients #12, #17, #18, #21 and #20).

Findings included:

Review on 11/04/2020 of the hospital policy/procedure titled "BCS XP Heparin Low Molecular Weight (LMW)" revised 12/30/2016 revealed "... Dilution Protocol If the LMW Heparin is greater than 1.30, do a manual 1.2 dilution with Standard Human Plasma. Run your dilution as a patient and multiply your result by the dilution factor. ... Expected Values Reference interval values determined for the current Heparin lot number are 0.60 - 1.10 IU/mL (international units per milliliters). Reportable Heparin range is 0.05 -1.30 IU/mL. ...and results greater than 1.30 must be diluted 1:2 with Standard Human Plasma. ... Interpretation of Results: Results are reported as heparin concentration IU/mL. Results that exceed the linearity range of the calibration curve can be diluted with Standard Human Plasma and rerun. Record and report patient and quality control values according to laboratory procedure. ..."

1. Closed medical record review on Novmeber 3, 2020 revealed, Patient #12 was admitted to the hospital and orders included laboratory studies for Low molecular weight heparin (anti-Factor Xa). Xa testing was:
ordered/collected July 22, 2020 at 7:00 AM and resulted at 6:11 PM as 1.28 (normal range 0.60-1.10 IU/mL[international units per milliliter)
Ordered/collected July 22, 2020 at 7:38 PM and resulted at 11:21 PM as 1.28
Ordered/collected July 23, 2020 at 1:58 AM and resulted at 4:06 AM as 1.28
Ordered/collected July 23, 2020 at 7:00 AM and resulted at 2:01 PM as 1.28
Ordered/collected July 23, 2020 at 7:00 PM and resulted at 9:47 PM as 1.28
Ordered/collected July 23, 2020 at 11:45 PM and resulted July 24, 2020 at 8:54 AM as 1.28

Interview on November 2, 2020 at 11:15 AM with GS #2 revealed, on July 24, 2020, one of the testing personnel mentioned Patient #18 had the same LMW heparin result of 1.28 on more than one specimen. As a result, the specimen collected the morning of July 24, 2020 was pulled and re-ran. At that time, a problem was realized, a specimen dilution was performed, and a corrected report was issued. Additionally, at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.


Interview on November 4, 2020 at 10:20 AM with the Director of Pharmacy and Pharmacy Clinical Coordinator revealed, Lovenox was administered twice daily for patient populations that included obesity of greater than 190
kilograms, renal impairment, pregnancy and pediatrics. The first Xa laboratory test was completed 4 hours after the 3rd dose of Lovenox and then the test was ordered based on the anticoagulation/anti-Factor Xa protocol. As related to Patient #12, the patient was administered Lovenox as a bridge with Coumadin for irregular heart rhythm. On July 23, 2020 at 11:50 PM, the Pharmacist had concerns and documented "if next level comes back 1.28, we may need to check the possibility of an error. Every level has been 1.28." Interview revealed: 1.) only the Pharmacists were able to see messages typed into the laboratory system. 2.) the Pharmacist that identified the potential problem, should have reported the concerns to the on-coming Pharmacist. 3.) The Pharmacist that re-ran the July 24, 2020 laboratory speciment failed to document a reason and 4.) providers would request assistance from pharmacy with dosing anticoagulants.











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2. Closed medical record review on November 4, 2020 revealed on October 26, 2019, Patient #17 was admitted to the hospital. On October 29, 2019 at 9:15 AM, an anti-Factor Xa laboratory specimen was ordered/collected. At 10:29 AM, the result was greater than 1.30 IU/mL. Review failed to the reveal, the laboratory staff obtain an accurate result by re-testing and diluting the anti-Factor Xa laboratory specimen.

Interview on November 2, 2020 at 11:15 AM with GS#2 revealed, on July 24, 2020, one of the testing personnel mentioned that Patient #18 had the same LMW heparin result of 1.28 on more than one specimen. As a result, the specimen collected the morning of July 24, 2020 was pulled and re-ran. At that time, a problem was realized, a specimen dilution was performed, and a corrected report was issued. Additionally, at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.

Interview on November 4, 2020 at 10:20 AM with the Director of Pharmacy and Pharmacy Clinical Coordinator revealed, Lovenox was administered twice daily for patient populations that included obesity of greater than 190
kilograms, renal impairment, pregnancy and pediatrics. The first Xa laboratory test was completed 4 hours after the 3rd dose of Lovenox and then the test was ordered based on the anticoagulation/anti-Factor Xa protocol. As related to Patient #12, the patient was administered Lovenox as a bridge with Coumadin for irregular heart rhythm. On July 23, 2020 at 11:50 PM, the Pharmacist had concerns and documented "if next level comes back 1.28, we may need to check the possibility of an error. Every level has been 1.28." Interview revealed: 1.) only the Pharmacists were able to see messages typed into the laboratory system. 2.) the Pharmacist that identified the potential problem, should have reported the concerns to the on-coming Pharmacist. 3.) The Pharmacist that re-ran the July 24, 2020 laboratory speciment failed to document a reason and 4.) providers would request assistance from pharmacy with dosing anticoagulants.


3. Closed medical record review on November 4, 2020 revealed on March 14, 2020, Patient #18 was admitted to the hospital. On March 15, 2020 at 10:02 PM, an anti-Factor Xa laboratory specimen was collected. At 10:56 PM, the result was greater than 1.30 IU/mL. Review failed to the reveal, the laboratory staff obtain an accurate result by re-testing and diluting the anti-Factor Xa laboratory specimen.

Interview on November 2, 2020 at 11:15 AM with GS#2 revealed, on July 24, 2020, one of the testing personnel mentioned that Patient #18 had the same LMW heparin result of 1.28 on more than one specimen. As a result, the specimen collected the morning of July 24, 2020 was pulled and re-ran. At that time, a problem was realized, a specimen dilution was performed, and a corrected report was issued. Additionally, at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.

Interview on November 4, 2020 at 10:20 AM with the Director of Pharmacy and Pharmacy Clinical Coordinator revealed, Lovenox was administered twice daily for patient populations that included obesity of greater than 190
kilograms, renal impairment, pregnancy and pediatrics. The first Xa laboratory test was completed 4 hours after the 3rd dose of Lovenox and then the test was ordered based on the anticoagulation/anti-Factor Xa protocol. As related to Patient #12, the patient was administered Lovenox as a bridge with Coumadin for irregular heart rhythm. On July 23, 2020 at 11:50 PM, the Pharmacist had concerns and documented "if next level comes back 1.28, we may need to check the possibility of an error. Every level has been 1.28." Interview revealed: 1.) only the Pharmacists were able to see messages typed into the laboratory system. 2.) the Pharmacist that identified the potential problem, should have reported the concerns to the on-coming Pharmacist. 3.) The Pharmacist that re-ran the July 24, 2020 laboratory speciment failed to document a reason and 4.) providers would request assistance from pharmacy with dosing anticoagulants.











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4. Closed medical record review on November 4, 2020 revealed, Patient #20 was admitted to the hospital and orders included laboratory studies for Low molecular weight heparin (anit-Factor Xa). On July 14, 2020 at 2:02 AM, anti-Factor Xa laboratory specimen was ordered/collected. At 2:45 AM, the result was 1.28. Review failed to the reveal, the laboratory staff obtain an accurate result by re-testing and diluting the anti-Factor Xa laboratory specimen.

Interview on November 2, 2020 at 11:15 AM with GS#2 revealed, on July 24, 2020, one of the testing personnel mentioned Patient #18 had the same LMW heparin result of 1.28 on more than one specimen. As a result, the specimen collected the morning of July 24, 2020 was pulled and re-ran. At that time, a problem was realized, a specimen dilution was performed, and a corrected report was issued. Additionally, at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.

Interview on November 4, 2020 at 10:20 AM with the Director of Pharmacy and Pharmacy Clinical Coordinator revealed, Lovenox was administered twice daily for patient populations that included obesity of greater than 190
kilograms, renal impairment, pregnancy and pediatrics. The first Xa laboratory test was completed 4 hours after the 3rd dose of Lovenox and then the test was ordered based on the anticoagulation/anti-Factor Xa protocol. As related to Patient #12, the patient was administered Lovenox as a bridge with Coumadin for irregular heart rhythm. On July 23, 2020 at 11:50 PM, the Pharmacist had concerns and documented "if next level comes back 1.28, we may need to check the possibility of an error. Every level has been 1.28." Interview revealed: 1.) only the Pharmacists were able to see messages typed into the laboratory system. 2.) the Pharmacist that identified the potential problem, should have reported the concerns to the on-coming Pharmacist. 3.) The Pharmacist that re-ran the July 24, 2020 laboratory speciment failed to document a reason and 4.) providers would request assistance from pharmacy with dosing anticoagulants.



5. Closed medical record review on Novmeber 4, 2020 revealed, Patient #21 was admitted to the hospital and orders included laboratory studies for Low molecular weight heparin (anti-Factor Xa). On August 2, 2020 at 1:17 AM, anti-Factor Xa laboratory speciment was ordered/collected. At 1:49 AM, the result was 1.28 IU/mL. Review failed to the reveal, the laboratory staff obtain an accurate result by retesting and diluting the anti-Factor Xa laboratory specimen.

Interview on November 2, 2020 at 11:15 AM with GS#2 revealed, on July 24, 2020, one of the testing personnel mentioned a patient had the same LMW heparin result of 1.28 on more than one specimen. As a result, the specimen collected the morning of July 24, 2020 was pulled and re-ran. At that time, a problem was realized, a specimen dilution was performed, and a corrected report was issued. Additionally, at 3:35 PM, an email was sent to all testing personnel to notify them of the problem. The emailed stated, "We have had a few LMW Heparins over the last few days that needed dilutions performed.. The BCS will give a >(greater than) 1.28 result, it will cross into epic as 1.28 with a 'Out of instrument operating range' error and will not auto-verify. This is your indication a dilution is needed. Perform a 1:2 dilution with standard plasma, program to run on anzlyzer, and multiply your result by 2, you can result up to 2.56. If your diluted result is >1.28, multiply using your dilution factor (2) and then report >2.56 in EPIC by placing a comment with result." On July 27, 2020, GS #2 opened a ticket with IT (Information Technology) to add a > (greater than) sign to patient test results as needed to ensure accurate LMW heparin results were reported. The tick was closed by IT on 08/03/2020, indicating the issue was resolved. Interview revealed, GS #2: 1.) failed to document the identified problem in the quality assessment records, 2.) failed to request review by the laboratory director, 3.) failed to complete a safety improvement report, and 4.) failed to provide remidial training for testing personnel and 5.) failed to review any other patients to see if their LMW heprin results could have been affected.

Interview on November 4, 2020 at 10:20 AM with the Director of Pharmacy and Pharmacy Clinical Coordinator revealed, Lovenox was administered twice daily for patient populations that included obesity of greater than 190
kilograms, renal impairment, pregnancy and pediatrics. The first Xa laboratory test was completed 4 hours after the 3rd dose of Lovenox and then the test was ordered based on the anticoagulation/anti-Factor Xa protocol. As related to Patient #12, the patient was administered Lovenox as a bridge with Coumadin for irregular heart rhythm. On July 23, 2020 at 11:50 PM, the Pharmacist had concerns and documented "if next level comes back 1.28, we may need to check the possibility of an error. Every level has been 1.28." Interview revealed: 1.) only the Pharmacists were able to see messages typed into the laboratory system. 2.) the Pharmacist that identified the potential problem, should have reported the concerns to the on-coming Pharmacist. 3.) The Pharmacist that re-ran the July 24, 2020 laboratory speciment failed to document a reason and 4.) providers would request assistance from pharmacy with dosing anticoagulants.

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