Mid-South Internal Medicine Specialist Pc

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of calibration records, laboratory procedure manual, lack of procedures, manufacturer's instructions for use, manufacturer's operators manual, patient test reports, and staff interviews, the laboratory failed to have a procedure for the Tosoh G8 instrument that included calibration and calibration verification frequency requirements for the glycated hemoglobin A1c (Hgb A1c) analyte (Refer to D5403 Citation One), failed to have a procedure that included critical results for the Ortho Vitros 5600 instrument used for patient chemistry testing (Refer to D5403 Citation Two), failed to perform required calibrations following reagent lot number changes on the Ortho Vitros 5600 instrument (Refer to D5437), and failed to maintain compliance for the allegation of compliance submitted for the previous survey (08/07/2023) for calibration verifications on the Tosoh G8 instrument for the Hgb A1c analyte (Refer to D5439). D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Based on observation of the laboratory, review of the manufacturer's operator's manual, lack of records, laboratory procedures, and staff interviews, the laboratory failed to have a procedure for the Medonic M Series complete blood count (CBC) instrument that included flagged results for the automated white blood cell (WBC) differential (Refer to D5403 Citation Three), and failed to follow the established procedure and maintain compliance for the allegation of compliance submitted for the previous survey (08/07/2023) to compare results between the two Medonic M Series CBC instruments twice a year (Refer to D5775). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on laboratory observation, review of laboratory procedure manual, and staff interview, the laboratory failed to follow the procedure for labeling patient samples on the dates of the survey (09/23-09/24/2024). The findings include: 1. Observations of the laboratory on 09/23/2024 at 9:00 a.m. and 3:00 p.m. revealed patient blood samples that were collected and placed in the processing area in test tube racks. During the observation, testing persons one and two stated that nursing personnel collected patient blood samples and brought the tubes and test requisitions to the laboratory so that the testing personnel could place the electronic order, label patient tubes with a printed barcode, and perform testing. 2. A random selection of patient blood samples revealed the following for six of the six tubes reviewed: Patient 1: K2 EDTA used for CBC and Hgb A1c testing, and a Serum Separator tube used for chemistry testing labeled with the patient's first initial and last name only. Patient 2: K2 EDTA used for CBC and Hgb A1c testing, and a Serum Separator tube used for chemistry testing labeled with the patient's first initial and last name only. Patient 3: K2 EDTA used for CBC and Hgb A1c testing, and a Serum Separator tube used for chemistry testing labeled with the patient's full first and last name only. 3. A review of the laboratory procedure titled "Specimen Collection and Handling" in the section "Acceptable Samples" revealed that "Specimens must be properly labeled with the patient's complete name and secondary identifier, date and time of collection, and initial of a phlebotomist." 4. An interview with the laboratory director and testing persons one and two on 09/24/2024 at 11:00 a.m. confirmed the laboratory failed to follow the established procedure for specimen labeling. Word Key: K2 EDTA- dipotassium ethylenediaminetetraacetic acid D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step -- 2 of 6 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's QC records, review of patient records, and interview with the laboratory lead, the laboratory failed to ensure new QC lots without established ranges were tested concurrently with previous QC lots for the Free Triiodothyronine (FT3) analyte, with use of the new lots beginning on 09/13/23 until the date of the survey on 09/21/23, with 68 patients reported during the period. The findings include: 1. Review of the laboratory's QC records for the Ortho Vitros 5600 revealed the following: a. The current QC lot numbers in use for the Biorad Immunoassay Control were 85351, 85352 and 85353. b. The laboratory started using the new lots on 09/13/23. c. The manufacturer package insert did not have QC ranges for the FT3 analyte. d. There was no overlap testing of the new QC lot in parallel with the old lot of QC. 2. Review of patient records revealed the laboratory had reported 68 patients since 09/13/23 when the laboratory began using the new QC lot without any established ranges for the FT3 analyte. 3. Interview with the laboratory lead on 09/21 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 -- /23 at 2 pm revealed the following: The laboratory switched to new lots for the Biorad Immunoassay Plus QC material on 09/13/23. The manufacturer communicated to the laboratory that no ranges existed for the FT3 analyte. The laboratory discarded all the old lot of QC and did not run the new QC lot in parallel with the old lot while establishing the targets for the new control. The laboratory used the QC ranges from the previous lot number for ranges for the FT3 analyte. This confirmed the survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory participation in two consecutive proficiency testing (PT) events for the cholesterol analyte, resulting in the first unsuccessful PT occurrence for the cholesterol analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the cholesterol analyte in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the cholesterol analyte. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the cholesterol analyte: 2020 event three: 60 % 2021 event one: 40 % 2) Review of the laboratory's proficiency testing records revealed the following: 2020 event three: Sample numbers CH-12 and CH-13 scored as unacceptable, resulting in an overall score of 60% for the cholesterol analyte. 2021 event one: Sample numbers CH-01, CH-02 and CH-05 scored as unacceptable, resulting in an overall score of 40% for the cholesterol analyte, and the first unsuccessful PT occurrence for the cholesterol analyte. -- 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 the laboratory's maintenance records and quality control (QC) records for the Tosoh G8 glycated hemoglobin (Hgb A1c) instrument, and interview with the laboratory liaison, the laboratory failed to retain the identity of persons performing maintenance and quality control, and quality control lot numbers in 2019 and 2020 for the Tosoh G8 instrument. The findings include: 1) Review of the laboratory's maintenance and QC records for the Tosoh G8 Hgb A1c instrument revealed the following: Maintenance log for December 2019: No identity of the person /persons who performed the daily maintenance. Quality control records for December 16 through December 18, 2019 and January 9 through January 13, 2020: No identity of the person who performed the quality control; no record of QC lot number. 2) Interview with the laboratory liaison on February 24, 2020 at 2:45 pm confirmed the laboratory failed to retain all analytic records for the Tosoh G8 Hgb A1c instrument in 2019 and 2020. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the 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 -- laboratory liaison, the laboratory failed to retain proficiency testing records for two years for testing events 2018 event three for hematology and 2019 event two for miscellaneous chemistry. The findings include: 1) Review of the laboratory proficiency testing records obtained from the laboratory's proficiency testing program revealed the following: 2018 event three hematology performance evaluation report was available 12.20.2018. 2019 event two miscellaneous chemistry performance evaluation report was available 11.21.2019. 2) Review of the laboratory's onsite proficiency testing records revealed the following: No performance evaluation report for 2018 event three hematology. No proficiency testing records for 2019 event two for miscellaneous chemistry. 3) Interview with the laboratory liaison on February 24, 2020 at 2:45 pm confirmed the laboratory failed to retain all proficiency testing records in 2018 and 2019. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's procedure manual, testing personnel records and interview with the laboratory liaison, the technical consultant failed to ensure all testing personnel were trained for the use of new instruments in 2018 and 2019. The findings include: 1) Observation of the laboratory on February 24, 2020 at 8:30 a.m. revealed the Tosoh G8 in use for patient testing for glycated hemoglobin (Hgb A1c) and the Medonic M series instrument in use for patient testing for complete blood count instrument (CBC). Both instruments were new since the last survey date. Use of the Medonic M series began in 2018; the Tosoh G8 was placed into use in 2019. 2) Review of the laboratory's procedure manual quality assurance plan revealed that personnel would be properly trained in the use of any new instrument before patient samples are tested. 3) Review of the laboratory procedure manual revealed training and education is the responsibility of the technical consultant. 4) Review of testing personnel records revealed no documented training for testing personnel number three for use of the Tosoh G8 Hgb A1c instrument, and testing personnel numbers three and four for the use of the Medonic M series CBC instrument. 5) Interview with the laboratory liaison on February 24, 2020 at 2:45 p.m. confirmed the technical consultant failed to ensure training for the use of new instruments for testing personnel numbers three and four in 2018 and 2019. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of patient test reports and instrument logs for the Medonic M series complete blood count (CBC) instrument, the laboratory procedure manual, and -- 2 of 3 -- interview the laboratory liaison, testing personnel failed to follow laboratory policy for quality control in 2019 when testing personnel performed and reported patient number ten prior to performing quality control. The findings include: 1) Review of patient number ten test report and the daily instrument log for the Medonic M series CBC instrument revealed patient testing performed prior to performance of quality control as follows: Patient number ten performed and reported at 9:30 am on 01.31.2019; quality control performed at 2:00 pm. 2) Review of the laboratory procedure manual revealed that at least two levels of quality control must be performed and acceptable before patient testing can be performed. 3) Interview with the laboratory liaison on February 24, 2020 at 2:45 pm confirmed testing personnel failed to ensure quality control was acceptable prior to reporting patient CBC results in 2019. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Quality Assessment (QA) Program Outline, the laboratory personnel records and interview with the technical consultant, the laboratory failed to follow the QA program outline for competency of testing personnel for the Abbott Drew 3 complete blood count (CBC) instrument and Qualigen instrument in 2017. The findings include: 1) Observation of the laboratory on July 13, 2018 at 9:20 a.m. revealed the Abbott Drew 3 CBC instrument and two Qualigen IP FastPak System instruments in use for patient testing. 2) Review of the QA Program Outline revealed, "Competency of Testing Personnel Training /Competency will be performed and documented by the technical consultant initially, at 6 months, and annually thereafter". 3) Review of the laboratory personnel records revealed testing personnel number one hire date is March 2017. The March 21, 2017 initial and October 24, 2017 six month competency records did not have the CBC instrument and the Qualigen instrument marked as trained or competent for testing personnel number one. Testing personnel number two hire date is October 20, 2017 did not have the initial training completion date. 4) Interview on July 13, 2018 at 3:45 p.m. with the technical consultant confirmed the initial and six month competency for the CBC instrument and the Qualigen instrument were not marked for testing personnel number one. Testing personal number two did not have the date of initial training completion documented. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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 -- 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Individual Quality Control Plan (IQCP), the 2018 Qualigen instrument quality control (QC) records, the 2017, the 2018 proficiency testing (PT) records, the patient testing reports, and interview with the technical consultant, the laboratory failed to include IQCP risk assessment, QC plan, and quality assessment (QA)when weekly QC is not performed and when there are PT failures. The findings include: 1) Observation of the laboratory on July 13, 2018 at 9:10 a.m. revealed two Qualigen IP FastPack System instruments (labeled instrument A and instrument B) in use for patient testing. 2) Review of the IQCP revealed the plan did not include reassessment of the verification process when there is unsatisfactory or unsuccessful PT scores, and the plan did not include risk assessment, QC plan and QA for what to do when the weekly QC is not performed. 3) Review of the 2018 Qualigen QC records revealed no weekly QC performance on June 4 and June 27, 2018 for the thyroid stimulating hormone (TSH), prostatic specific antigen (PSA) and Vitamin D analytes. 4) Review of the 2017 and 2018 PT records revealed the following: TSH 2018 event 1=80%; PSA 2017 event 2=67%, 2018 event 1= 67%; Vitamin D 2017 event 2= 67%, 2018 event 1 67%. 5) Review of the patient testing reports revealed TSH, PSA, and Vitamin D were reported during the period of PT unsatisfactory scores and the during the weeks when weekly QC was not performed. 6) Interview with the technical consultant on July 13, 2018 at 3:15 p. m. confirmed the IQCP did not include what the laboratory is to do when weekly QC is not performed. The IQCP PT did not include reassessment of the verification process when unsatisfactory or unsuccessful PT scores were received. -- 2 of 2 --