Memorial Community Health Inc

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of manufacturer's instructions for coagulation, lack of documentation, and interview with the laboratory manager, the laboratory failed to follow manufacturer's instructions for coagulation. Findings are: 1. Based on manufacturer's instructions "verification of reference range should be should be followed before new lots are put into use." 2. The laboratory confirmed innovin lot number change to lot #549759. The laboratory did not have documentation of when lot number change occurred. 3. Interview with the lab manager on 6/14/2022 at 1:20 PM confirmed the laboratory had changed innovin lot number and had not verified the reference range before new lot was put into use. 4. Based on the laboratory's list of tests for 2021, the laboratory tested 184 patients. 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 --

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 laboratory's list of tests performed, review of 2019 and 2020 proficiency testing, and interview with technical consultant the laboratory failed to enroll in an approved proficiency testing program for moderate complexity Human Chorionic Gonadotropin (HCG), qualitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed forty-two moderate complexity Human Chorionic Gonadotropin (HCG), qualitative serum tests from July 2019 through June 2020. 2. Review of the laboratory's 2019 and 2020 proficiency testing revealed the laboratory failed to enroll in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), qualitative serum. 3. Interview with technical consultant on 11/18/2020 at 12:05 PM confirmed the laboratory had not enrolled in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), qualitative serum for 2019 and 2020. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's list of tests performed, lack of documentation, and interview with the technical consultant the laboratory failed to verify the accuracy for moderate complexity wet preps and moderate complexity urinalysis, microscopy. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed one hundred nineteen moderate complexity wet prep tests and nine hundred nine moderate complexity urinalysis, microscopy tests from July 2019 through June 2020. 2. No documentation could be presented through proficiency testing or laboratory comparison to verify the accuracy of moderate complexity wet preps and moderate complexity urinalysis, microscopy. 3. Interview with the technical consultant on 11/18/2020 at 12:05 PM confirmed the laboratory had not enrolled in proficiency testing or had comparison testing performed for moderate complexity wet preps and moderate complexity urinalysis, microscopy for 2019 and 2020. -- 2 of 2 --