Linda E Lopez-Rosario Md Pa

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's AAB (American Academy of Bioanalysts) proficiency testing records from 2016 (events 1, 2, and 3) and 2017 (events 1, 2, and 3), and confirmed in interview of facility personnel, the laboratory failed to test proficiency testing samples the same number of times it tests patient samples. The findings were: 1. Review of the laboratory's, "List of Call Values," no laboratory director approval date, revealed the laboratory defined the following alert values: TEST LOW VALUE HIGH VALUE WBC 3.0 k/ul 18. k/ul HGB 10 g/dL 18 g/dL HCT 30% 54% PLT 120 k/uL 1000 k/uL 2. The "List of Call Values," also stated, "Hematology specimen should be run twice for any critical values not on range base of the values mention above." 3. Review of the laboratory's proficiency testing records from AAB 2016 (events 1, 2, and 3) and 2017 (events 1, 2, and 3) revealed the following critical values that were not repeated: 2017 (event 1) ID: Q1 2017 1 WBC = 1.7 HGB = 6.3 HCT = 16.5 PLT = 56 2017 (event 1) ID: Q1 2017 3 WBC = 20 2017 (event 1) ID: Q1 2017 4 WBC = 1.7 HGB = 6.2 HCT = 16.5 PLT = 59 2017 (event 1) ID: Q1 2017 5 WBC = 20.3 2017 (event 2) ID: Q2 2017 2 WBC = 1.8 HGB = 6.2 HCT = 16.5 PLT = 60 2017 (event 2) ID: Q2 2017 4 WBC = 1.8 HGB = 6.2 HCT = 16.6 PLT = 57 2017 (event 2) ID: Q2 2017 5 WBC = 21.7 HGB = 19.8 HCT = 55 2017 (event 3) ID: Q-3 2017 2 WBC = 2.0 HGB = 5.9 HCT = 16.8 PLT = 58 2017 (event 3) ID: Q-3 2017 3 WBC = 20.5 HGB = 19.0 HCT = 54.1 2017 (event 3) ID: Q-3 2017 4 WBC = 2.0 HGB = 5.9 HCT = 16.5 PLT = 54 2017 (event 3) ID: Q- 3 2017 5 WBC = 20.5 HGB = 19.1 HCT = 54.0 2016 (event 1) ID: 1 Q1 WBC = 19.7 HGB = 18.1 2016 (event 1) ID: 3 Q1 WBC = 1.9 HGB = 6.2 PLT = 55 2016 (event 1) ID: 4 Q1 WBC = 1.8 HGB = 6.2 PLT = 59 2016 (event 2) ID: 2NDQ 1 WBC = 1.8 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- HGB = 6.2 HCT = 16.7 PLT = 59 2016 (event 2) ID: Q2-16 3 WBC = 21.5 HGB = 19.5 HCT = 54.7 2016 (event 2) ID: Q1-16 5 WBC = 1.8 HGB = 6.1 PLT = 55 2016 (event 3) ID: Q3 #1 WBC = 1.9 HGB = 6.4 PLT = 57 2016 (event 3) ID: Q3 #3 WBC = 1.8 HGB = 6.5 PLT = 59 2016 (event 3) ID: Q3 #4 WBC = 20.7 HGB = 19.0 HCT = 54.2 2016 (event 3) ID: Q3 #5 WBC = 20.6 HGB = 19.2 HCT = 54.3 4. The laboratory was asked to provide documentation of testing proficiency testing samples the same number of times that it tests patients. No documentation was provided. 5. An interview with the office manager on 01/24/2018 at 1000 hours in the break room confirmed the findings. Key: WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet -- 2 of 2 --