Summary:
Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and interview with Testing Personnel # A (TPA), the laboratory failed to get at least 80 % for 2 (3rd event of 2017 and 2018) out of 6 events (1st, 2nd, 3rd testing events in 2017 and 2018) for Bacteriology. Findings included: Review of API proficiency records revealed that the laboratory failed the Bacteriology 3rd event of 2017 and 2018 with a 0 % score for Clostridium difficile Toxin or Antigen giving and overall score of 0 % for Bacteriology. During an interview on 01/04/19 at 2:30 PM, the TPA confirmed that the laboratory failed the events of reference. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and interview with Testing Personnel # A (TPA), the laboratory failed to score at least 80 % for 1 analyte (Sodium) for 1 (1st testing event in 2017) out of 6 events (1st, 2nd, 3rd testing events in 2017 and 2018) reviewed. Findings included: Review of API Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- proficiency testing (PT) records revealed a score of 60 % for Sodium for the 1st event of 2017. During an interview on 01/04/2019 at 2:30 PM, the TPA confirmed that the laboratory failed the Sodium score for PT. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Office Manager, the laboratory stored Oral Glucose Tolerance Beverage in a refrigerator where reagents and patient blood specimens were stored for an undetermined amount of time. Findings Included: During a tour of the Laboratory on 01/03/19 at 12:45 PM, 10 bottles of Oral Glucose Tolerance Beverage were observed in a refrigerator where reagents and patient blood specimens were stored. (Photographic evidence was obtained). During an interview on 01/03/19 at 2:14 PM the Office Manager confirmed that the Oral Glucose Tolerance Beverage had not been used in at least a year. These were discarded during the tour. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and interview with Testing Personnel # A (TPA), the facility failed to maintain documentation of the Laboratory Director or designee's signed attestation for 1 (3rd testing event in 2017) out of 6 events (1st, 2nd, 3rd testing events in 2017 and 2018) reviewed for Bacteriology, failed to retain the raw data from the proficiency testing for 2 (1st and 3rd testing event in 2018) out of 3 testing events (1st, 2nd, and 3rd testing event in 2018) in Bacteriology, and failed to retain the results of Chemistry Core for 1 (2nd testing event in 2018) out of 3 testing events (1st, 2nd, 3rd in 2018) reviewed. Findings included: Review of API proficiency records revealed that the laboratory failed to have documentation of the attestation signed by the Laboratory Director for the 3rd event of Bacteriology of 2017. Review of API proficiency testing documents revealed that the raw data for the Clostridium difficile testing performed in the 1st and 3rd testing event in 2018 was not retained. Review of API proficiency testing documentation revealed the results for the Chemistry Core was not retained for the 2nd testing event in 2018. During an interview on 01/04/2019 at 2:30 PM, the TPA confirmed that the aforementioned documents were not available. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. -- 2 of 9 -- This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview with Testing Personnel # A (TPA), the laboratory failed to verify accuracy at least twice a year for the following tests: Parathyroid hormone (PTH), Prostatic Antigen (PSA), Testosterone, 25 Hydroxy Vitamin D, Apolipoprotein A1 and B, Folate, Microalbumin (quantitative), Urine Creatinine (quantitative), Cyanocobalamine (Vitamin B12) for 1 (2017) out of 2 years (2017- 2018) reviewed. Findings included: The laboratory was enrolled in PT with API, for the following analyte: Parathyroid hormone (PTH), Prostatic Antigen (PSA), Testosterone, 25 Hydroxy Vitamin D, Apolipoprotein A1 and B, Folate, Microalbumin (quantitative), Urine Creatinine (quantitative), Cyanocobalamine (Vitamin B12) to evaluate twice a year. The laboratory failed to submit the results for the second event of 2017 and there was no documentation of the review of the results. The laboratory also failed Apoliprotein B 1st event in 2017 with 33 % with no