Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the test report failed to indicate the address of the laboratory location where the test was performed for five of five patient test reports reviewed (Patients #1 - #5). Findings included: 1. Review of "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification" form (CMS-116) indicated this laboratory, CLIA number 15D0680842, had a "facility address" of "1025 Michigan Ave, Logansport, IN 46947." 2. Review of patient test reports indicated the following patients had complete blood count (CBC) testing. The analyzer printouts included CLIA number 15D0680842, but indicated an address of "1101 Michigan Ave" with no city or state indicated on the printouts. The patient test reports, located in the patients' electronic medical records, indicated an address of "1101 Michigan Avenue Logansport, IN 46947" and did not indicate the testing location of the CBC test: a. Patient #1, CBC test performed on 2-1-2019 at 10:00 AM. b. Patient #2, CBC test performed on 2-5-2019 at 9:40 AM. c. Patient #3, CBC test performed on 2-11-2019 at 11:41 AM. d. Patient #4, CBC test performed on 2-6-2019 at 10:16 AM. e. Patient #5, CBC test performed on 2-13-2019 at 2:14 PM. 3. In interview on 2-18-2019 at 3:30 AM, SP1 indicated the CBC testing for Patients #1 through #5 were performed at 1025 Michigan Ave., Logansport, IN 46947 and 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 -- acknowledged the address on the analyzer printout was incorrect. SP1 further acknowledged the patient test reports, in the patients' electronic medical records, did not indicate the address of the laboratory where the test was performed. 4. The annual test volunme for CBC was 2,596. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory failed to enroll in a proficiency testing (PT) program for one of one specialty (hematology) and six of six analytes (red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, and cell identification) during testing events one and two in 2018. Findings include: 1. Review of "CASPER Report 0155D" indicated the laboratory received a score of "0" for testing events one and two in 2018 for the specialty of hematology and six analytes (red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, and cell identification), resulting in unsuccessful performance for the specialty and analytes. 2. In a phone interview on 8-23-2018 at 10: 30 AM, SP1, hematology supervisor, indicated the laboratory did not enroll in a PT program for the specialty of hematology, including the six analytes performed by the laboratory under the specialty of hematology (red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, and cell identification) for 2018, nor was the laboratory enrolled at the time of the phone interview. 3. In a phone interview on 8-23-2018 at 11:04 AM, SP2 indicated the laboratory had continued performing hematology testing on patient samples during 2018 and was currently performing hematology testing on patient samples at the time of the phone interview. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --