Mcpherson Medical And Surgical Associates

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on the review of the CMS116 test lists, proficiency testing enrollment, lack of documentation of accuracy checks from 9/29/22 to 12/31/23 and interview with technical consultant (TC) #3, the laboratory failed to verify the accuracy of wet preps and KOH testing twice a year for 9/29/22 to 12/31/23. Findings: 1. Review of the CMS116 test lists and proficiency testing enrollment for 2022 and 2023 revealed the laboratory was not enrolled in proficiency testing for wet preps and KOH testing. 2. Request was made for documentation of accuracy checks for wet preps and KOH testing from 9/29/22 to 12/31/23. No documentation for this request was made available at the time of survey. 3. Based on the CMS116 test volumes listed, approximately 435 patient results were reported from 9/29/22 to 12/31/23. 2. Interview with TC #3 on 8/20/24 at 11:50 a.m. confirmed, the laboratory failed to verify the accuracy of wet preps and KOH testing twice a year for 9/29/22 to 12/31 /23. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on the review of the CMS116 test lists, quality control (QC) records and patient test records for the Amnisure Rupture of Fetal Membrane (ROM), lack of an individual quality control plan (IQCP) and interview with TC #3, the laboratory failed to perform a positive and negative control material each day of patient testing on Amnisure ROM test system. Findings: 1. Review of the CMS116 test list revealed Amnisure ROM testing was performed. This is listed by the FDA as a moderate complexity assay. 2. The surveyor requested QC and patient records for review. Review of these records revealed QC was not performed each day of patient testing. Both QC and patient results are reported as positive or negative. 3. Surveyor asked how often external QC was performed. TC #3 stated the Positive and Negative QC was performed monthly. Testing was discontinued 5/16/24. No IQCP was made available at the time of survey for the reduced QC interval. 4. Review of patient test reports revealed 10 patient results were reported from 11/8/22 to 5/8/24 without external QC testing. 6. Interview with the TC#3 on 8/20/24 at 11:05a.m. confirmed, the laboratory failed to perform a positive and negative control material each day of patient testing on Amnisure ROM test system. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the review of the CMS-116 test lists, lack of comparison study documents, and interview with TC #3, the laboratory failed to perform comparison studies on automated white blood cell differentials (WBC Diff) and manual WBC Diff for 2023 and to date of survey 2024. Findings: 1. Review of the CMS116 test lists revealed that WBC diff is performed by both an automated method on the Sysmex XN-330 analyzer and by a visual manual count performed using a microscope. 2. The surveyor requested documentation of twice a year comparisons of the two methodologies for 2023 and to date of survey 2024. No documentation of a twice yearly comparison studies was provided at the time of survey. 3. Approximately 1,850 manual WBC diff patient results were reported from 1/1/23 to date of survey. 4. Interview with TC#3 on 8/20/24 at 12:05 p.m. confirmed, the laboratory failed to perform comparison studies on automated WBC Diff and manual WBC Diff for 2023 and to date of survey 2024. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC), hematology QC and interview with the technical supervisor the laboratory failed to retain QC records for at least 2 years. Findings: 1. Review of chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA and thyroid stimulating hormone QC showed no instrument printouts or way to access QC in computer for the last 2 years. 2. Review of hematology complete blood count QC showed no instrument printouts or way to access QC in computer for the last 2 years. 3. Interview with the technical supervisor on December 14, 2018 at 11:30 AM confirmed the laboratory could not provide QC for review for chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA, thyroid stimulating hormone and hematology complete blood count for the last 2 years. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of Beckman Coulter Access 2 chemistry analyzer validation and interview with the technical supervisor on December 14, 2018 at 11:30 PM confirmed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) are appropriate for the laboratory's patient population. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of quality control and interviews, the director failed to provide overall management and direction; failed to ensure that quality control was adequate (refer to D6093); failed to ensure quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur (refer to 6094). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of chemistry and hematology quality control (QC) and interview with the technical supervisor the laboratory director failed to ensure QC was within acceptable limits for the last 2 years. Findings: 1. Review of chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA and thyroid stimulating hormone QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of laboratory director reviewing QC. 2. Review of hematology complete blood count QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of laboratory director reviewing QC. 3. Interview with the technical supervisor on December 14, 2018 at 11:30 AM confirmed the laboratory director could not provide documentation of QC review for chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA, thyroid stimulating hormone and hematology complete blood count for the last 2 years. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of chemistry and hematology quality control (QC) and interview with the technical supervisor the laboratory director failed to ensure quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings: 1. Review of chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA and thyroid stimulating hormone QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of laboratory director reviewing QC and identifying failures in quality. 2. Review of hematology complete blood count QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of laboratory director reviewing QC and identifying failures in quality. 3. Interview with the technical supervisor on December 14, 2018 at 11:30 AM confirmed the laboratory director could not provide documentation of QC review and identifying failures in quality for chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA, thyroid stimulating hormone and hematology complete blood count for the last 2 years. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not 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 chemistry and hematology quality control (QC) and interview with the technical supervisor the technical supervisor failed to review QC for the last 2 years. Findings: 1. Review of chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA and thyroid stimulating hormone QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of technical supervisor reviewing QC. 2. Review of hematology complete blood count QC showed no instrument printouts or way to access QC in computer for the last 2 years. The laboratory could not provide documentation of technical supervisor reviewing QC. 3. Interview with the technical supervisor on December 14, 2018 at 11:30 AM confirmed the technical supervisor could not provide documentation of QC review for chemistry analytes beta human chorionic gonadotropin, vitamin B12, Ferritin, Free T4, PSA, thyroid stimulating hormone and hematology complete blood count for the last 2 years. -- 3 of 3 --