Memphis Pathology Laboratory Dba Ael-Jackson Ms

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 review of the Centers for Medicare and Medicaid Services (CMS) data system for proficiency testing, the laboratory's proficiency testing (PT) records for 2022 and 2023, and the laboratory's monthly patient test counts, the laboratory failed to enroll in an HHS approved proficiency testing program for routine chemistry testing, performed on the Alfa Wassermann ACE Alera chemistry analyzer, for 2 of 3 events for 2023, for serum qualitative human chorionic gonadotropin (HCG) testing, performed on the Fisher Healthcare Sure-Vue Serum/Urine HCG Stat test, for 2 of 3 events of 2023, and for complete blood count (CBC) testing, performed on the CDS Medonic M-Series hematology analyzer, for 1 of 3 events of 2023. Findings include: 1. Review of the CMS data system for proficiency testing and the laboratory's PT records for 2022 and 2023 revealed no documentation of the performance of proficiency testing for the following tests listed in Subpart I: a) Routine chemistry tests, performed on the Alfa Wassermann ACE Alera chemistry analyzer, for Events 2 and 3 of 2023 (2 of 3 events in 2023), including albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, calcium, chloride, high-density lipoprotein (HDL) cholesterol, total cholesterol, creatinine, glucose, potassium, sodium, total protein, triglycerides, blood urea nitrogen. b) Serum 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 -- qualitative HCG test, performed on the Fisher Healthcare Sure-Vue Serum/Urine HCG Stat test, for Events 2 and 3 of 2023 (2 of 3 events in 2023). c) CBC testing, performed on the CDS Medonic M-Series hematology analyzer, for Event 2 of 2023 (1 of 3 events for 2023). 2. Review of the laboratory's monthly test counts for 2023 revealed the patient test count for routine chemistry tests listed in Subpart I, serum qualitative HCG test, and CBC tests were as follows: a) The patient test count for routine chemistry tests, listed in Subpart I, from 2/1/2023 through 9/30/2023 was 14,039. The last routine chemistry proficiency testing performed in 2023 was performed on 1/12/2023. b) The patient test count for serum qualitative HCG from 2/1 /2023 through 9/30/2023 was 55. The last serum qualitative HCG proficiency testing performed in 2023 was performed on 1/12/2023. c) The patient test count for CBC tests from 4/1/2023 through 9/30/2023 was 5,752. The last CBC proficiency testing performed in 2023 was performed on 3/9/2023. -- 2 of 2 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of records (Quality Control and Preventive Maintenance for the Ace Alera Chemistry Analyzer and the Boule Medonic Hematology Analyzer, Proficiency Testing, Quality Assurance) during survey on 1/23/2020 and interview with the current laboratory director/technical consultant (LD/TC) at 2:30 pm 1/23/2020, the previous laboratory director (LD) did not provide oversight for the laboratory for a period of 18 months before a new LD was hired as a replacement. Findings include: 1) There was no review of records documented by the previous Laboratory Director (LD) after 1/31/2018. The new LD first documented review of records in August 2019. 2) All records after 1/31/2018 were signed in August 2019 or later by the new LD named on 7/18/2019. 3) Interview with the current LD/TC confirmed that there was no active LD for a period of 18 months from 1/31/2018 until 8/8/2019. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of records (Quality Control and Preventive Maintenance for the Ace Alera Chemistry Analyzer and the Boule Medonic Hematology Analyzer, Proficiency Testing, Quality Assurance) during survey on 1/23/2020 and interview with the current laboratory director/technical consultant (LD/TC) at 2:30 pm 1/23/2020, there was no documented review of records by the previous Technical Consultant (TC) for a period of 18 months. Findings include: 1) There was no review of records documented by the previous Technical Consultant (TC) after 1/31/2018. The new TC first documented review of records in August 2019. 2) All records after 1/31/2018 were signed in August 2019 or later by the new TC. 3) Interview with the current LD /TC confirmed that there was no documented review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records for a period of 18 months from 1/31/2018 until 8/8/2019. -- 2 of 2 --