Consolidated Medical Practices Of Memphis, Pllc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of patient Complete Blood Count with automated White Blood Cell differential (CBC w/Diff) test records, a review of the Beckman Coulter DxH 900 instructions for use, a review of the laboratory procedure manual, and staff interview, the laboratory procedure for CBC w/Diff failed to include instructions for resolving issues with patient CBC w/Diff results that were flagged by the instrument for two of two patients with flagged results performed on 07/14/25. The findings include: 1. Laboratory observation on 07/14/25 at 9:00 a.m. revealed two Beckman Coulter DxH 900 instruments used for performing patient testing for CBC w /Diff. 2. A review of two patient CBC w/Diff records with instrument flags reported on 07/14/25 revealed the following: The instrument printout for patient specimen accession number 2100243 revealed "R" flags on all WBC differential parameters, with "Suspect RBC Frag/Micro" and "System High Event Rate: D." A review of the final patient test report revealed that the flags and instrument messages did not cross the interface to the final patient test report, and there was no documented review or

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 review of the laboratory's procedure manual, observation of the laboratory, review of manufacturer's control package inserts, laboratory temperature records, lack of documentation, quality control (QC) data, manufacturer reagent package inserts, control assay sheets, the laboratory's QC ranges, patient test reports, maintenance records, and staff interview, the laboratory failed to ensure procedures were approved, signed and dated by the laboratory director (Refer to D5407), failed to ensure temperature ranges for storage of controls was consistent with manufacturer's requirements (Refer to D5413), failed to label controls with corrected expiration date after opening (Refer to D5415), failed to verify the calibration of chemistry analytes performed on the Beckman Coulter DxC 700 AU (Refer to D5439), failed to follow manufacturer's requirement for frequency of quality control performance for the creatinine analyte (Refer to D5445), failed to ensure the laboratory used quality control (QC) ranges for assayed quality controls that were consistent with manufacturer's ranges Refer to (D5469), and failed to have an effective quality assessment process in place to correct problems with the performance of instrument maintenance (Refer to D5793). D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 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 7 -- 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure manual, observation of the laboratory, review of manufacturer's control package inserts, laboratory temperature records, control assay sheets, the laboratory's QC ranges, patient test reports, maintenance records, and staff interview, the laboratory failed to ensure procedures were approved, signed and dated by the laboratory director (Refer to D5407), failed to ensure temperature ranges for storage of controls was consistent with manufacturer's requirements (Refer to D5413), failed to label controls with corrected expiration date after opening (Refer to D5415) and failed to ensure the laboratory used QC ranges for assayed quality controls that were consistent with manufacturer ranges (Refer to D5469). D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and staff interviews, the laboratory failed to provide written instructions for collecting, processing and preserving patient specimens to the other laboratories that submitted samples for patient testing. The findings include: 1. Observation of the laboratory on 05/07/24 at 9 a.m. revealed multiple test systems used for patient testing for chemistry, hematology, immunology, and endocrinology. Samples collected at other physician office practices were observed being accessioned into the laboratory's information system. 2. The laboratory was asked to provide a copy of the instructions provided to the other physician office practices that submit samples for patient testing. No document was available. 3. The technical consultant confirmed during the interview on 05/07/24 at 5 p.m. that the laboratory did not have a client services manual that was provided to the facilities that collect and process patient specimens prior to sending them to the laboratory for testing. She stated that approximately 22 other clinics send samples to their laboratory for testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and staff interview, the laboratory director failed to approve, sign and date the procedures used for testing performed on the Beckman Coulter DxC 700 AU and Beckman Coulter DxI 800 chemistry/endocrinology instruments. The findings include: 1. A review of the laboratory's procedure manual revealed that the laboratory used manufacturer package inserts as a part of operating procedures for the Beckman Coulter DxC 700 AU and -- 2 of 7 -- the Beckman Coulter DxI 800 instruments. The laboratory director had not approved, signed, or dated the procedures on the survey date. 2. The technical consultant confirmed the survey findings during interview on 05/07/24 at 5:00 p.m. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer control package inserts, review of the laboratory freezer temperature records, and staff interview, the laboratory failed to define frozen storage temperature ranges that were consistent with manufacturer requirements, resulting in the storage of controls outside the manufacturer's requirements for five of five months reviewed in 2024. 1. Observation of the laboratory on 05/07/24 at 9:00 a.m. revealed storage of Biorad controls in the freezer labeled "Upright." Observed controls were Immunoassay Plus, Tumor Marker, Immunology, and Multiqual. The observed freezer temperature range on the temperature recording chart was "0-30C." 2. Review of the manufacturer package insert for all four control types revealed an acceptable frozen storage temperature of -20C to -70C. 3. Review of the 2024 upright freezer temperature records revealed recorded temperatures that were higher than -20C for one of twenty-one days in January 2024, two of twenty-five days in February 2024, twenty-six of twenty-six days in March 2024, twenty-seven of twenty-seven days in April 2024, and six of six days in May 2024. 4. The technical consultant confirmed the survey findings during a phone interview on 05/16/24 at 12:15 p.m. Word Key: C= Celsius D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the control manufacturer package inserts, and staff interview, the laboratory failed to label controls with a corrected expiration date after opening. The findings include: 1. Observation of the laboratory on 05/07/24 at 9 a.m. revealed Biorad control vials stored in the laboratory refrigerator that were labeled with an open date but no corrected expiration date. The control vials observed were Liquichek Tumor Marker, Liquichek Specialty Immunoassay, Liquicheck Immunoassay Plus, Liquichek Immunology Control, Liquid Assayed Multiqual, and Liquichek Microalbumin Control. 2. A review of the Biorad manufacturer control -- 3 of 7 -- package inserts revealed the following: Liquichek Tumor Marker: All analytes were stable for 30 days when stored tightly capped at 2-8C, except CA 125 (10 days), IGF-1 /Somatomedin C (15 days), and ProGRP (Progastrin-Releasing Peptide) (5 days). Liquichek Specialty Immunoassay: All analytes were stable for 30 days when stored tightly capped at 2-8C, except PTH (Intact) which was stable for 7 days. Liquicheck Immunoassay Plus Control: All analytes stable for 14 days after opening when stored tightly capped at 2-8C, except for Estradiol, which was stable for five days after opening, and Folate, which was stable for four days after opening. Liquichek Immunology Control: All analytes stable for 45 days after opening when stored tightly capped at 2-8C, except for Beta-2-Microglobulin which was stable for 21 days and Rheumatoid factor which was good for 10 days. Liquid Assayed Multiqual: All analytes stable for 14 days after opening when stored tightly capped at 2-8C, except for Alkaline Phosphatase, AST/SGOT, Bilirubin (Neonatal and Bilirubin (Total) (nine days), Direct Bilirubin, HDL Cholesterol, Cholinesterase, Creatine Kinase (CK) Phosphorus and Triglycerides (seven days), LAP Acrylamidase (three days). Liquichek Microalbumin Control: Stable for 90 days after opening for all analytes when stored tightly capped at 2-8C. 3. The technical consultant confirmed during interview on 05/07/24 at 5 p.m. that the laboratory failed to label control vials with corrected expiration dates after opening. Word Key: C=Celsius PTH=Parathyroid Hormone AST/SGOT=Aspartate aminotransferase HDL=High Density Lipoprotein D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on laboratory observation, review of manufacturer package inserts, a lack of documentation and staff interview, the laboratory failed to verify the calibration of chemistry tests performed on the Beckman Coulter DxC 700 AU chemistry instrument every six months in 2023 and 2024. The findings include: 1. Observation of the laboratory on 05/07/24 at approximately 9 a.m. revealed two Beckman Coulter DxC 700 AU chemistry instruments used for performing patient testing for general chemistry analytes (system ID# 82682974 and 82604907). During observation, the -- 4 of 7 -- technical consultant stated the laboratory runs three levels of quality control each morning, after calibration, after reagent lot change. She also stated a second QC run is performed if the laboratory is performing testing after 5 p.m. When asked if the three levels are routinely performed twice daily, she stated they are not. 2. A review of the manufacturer's calibrator package inserts revealed that the following analytes are calibrated using less than three levels of calibrator: Albumin, Bicarbonate, Direct Bilirubin, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, HDL Cholesterol, Phosphorus, Iron, Lipase, Magnesium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid. 3. The laboratory was asked to provide documentation of verification of calibration that included at least three levels that spanned the reportable range for the tests performed on the Beckman Coulter DxC 700 and was performed at least every six months. No documentation was available. 4. The technical consultant confirmed during an interview on 05/07/24 at 5 p.m. that the laboratory failed to verify the calibration of analytes performed on the Beckman Coulter DxC 700 AU chemistry instrument every six months in 2023 and 2024. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 manufacturer's reagent package insert, review of quality control data, and staff interview, the laboratory failed to perform QC for the creatinine analyte with the frequency required by the manufacturer in April 2024. The findings include: 1. Observation of the laboratory on 05/07/24 at 9:00 a.m. revealed two Beckman Coulter DxC 700 AU chemistry instruments used for patient testing for chemistry analytes. 2. A review of the manufacturer's reagent package insert for creatinine revealed the following under the calibration and quality control (QC) sections: "Run QC at a minimum of every 8 hours." 3. A review of the April 2024 QC data for creatinine revealed that creatinine QC was not performed every eight hours as the manufacturer required. 4. The technical consultant confirmed by electronic mail received on 05/14/24 at 10:05 a.m. that the laboratory did not follow the manufacturer's requirements for performing creatinine QC every eight hours in April 2024. 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 -- 5 of 7 -- 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 observation of the laboratory, review of the Biorad QC limit assay sheets, review of the laboratory's QC ranges, review of patient test results and staff interview, the laboratory failed to ensure it used QC ranges that were consistent with the QC limits provided by the manufacturer for the controls used for chemistry and endocrinology. The findings include: 1. Observation of the laboratory on 05/07/24 at 9:00 a.m. revealed the Beckman Coulter DxC 700 AU in use for patient testing. 2. Review of the Biorad quality control limit assay sheets for the Liquichek Microalbumin Control parent lot 96880, Liquichek Immunoassay Plus-parent lot 85320, and Multiqual parent lot 45930, revealed the following statement in all three package inserts: "The mean values and corresponding + 3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are specific for this lot of product." 3. A review of the laboratory's QC ranges compared to the manufacturer-assigned values revealed the laboratory used standard deviations to determine QC ranges that exceed the manufacturer's standard deviation as follows: December 2023 QC Liquichek Microalbumin Control Parent Lot=96880 Level One - Lot 96881 Level Two - Lot 96882 Creatinine Level One - Manufacturer 1 SD = 2.07, Lab 1 SD = 3.1 Level Two - Manufacturer 1 SD = 5, Lab 1 SD = 7.5 Microalbumin Level One - Manufacturer 1 SD = .19, Lab 1 SD = .29 Level Two - Manufacturer 1 SD = .22, Lab 1 SD = .34 __________________________________ January 2024 Quality Control Liquicheck Immunoassay Plus Control Parent Lot = 85320 (Level One Lot 85321, Level Two Lot 85322, Level Three Lot 85323) Prostate Specific Antigen (PSA) Level One - Manufacturer 1 SD = .028, Lab 1 SD = .041 Level Two - Manufacturer 1 SD = .26, Lab 1 SD = .38 Level Three- Manufacturer 1 SD = .1.87, Lab 1 SD = 2.55 Human Chorionic Gonadotropin (hCG) Level One - Manufacturer 1 SD = .37, Lab 1 SD = .55 Level Two - Manufacturer 1 SD = 1.2, Lab 1 SD = 1.8 Level Three- Manufacturer 1 SD = 22.5, Lab 1 SD = 33.75 Thyroid Stimulating Hormone (TSH) Level One - Manufacturer 1 SD = .028, Lab 1 SD = .049 Level Two - Manufacturer 1 SD = .26, Lab 1 SD = .48 Level Three- Manufacturer 1 SD = .1.87, Lab 1 SD = 2.83 ___________________________________ March 2024 Quality Control: Multiqual Parent lot=45930 (Level One-lot 45931, Level Two-lot 45932, Level Three-Lot 45933) Sodium: Level One - Manufacturer 1 SD = 3.16, Lab 1 SD = 4.75 Level Two - Manufacturer 1 SD = 2.66, Lab 1 SD = 4.0 Level Three- Manufacturer 1 SD = 2.66, Lab 1 SD = 4.0 Potassium: Level One - Manufacturer 1 SD = .05, Lab 1 SD = .08 Level Two - Manufacturer 1 SD = .07, Lab 1 SD = .11 Level Three- Manufacturer 1 SD = .11, Lab 1 SD = .17 Chloride: Level One - Manufacturer 1 SD = 1.42, Lab 1 SD = 2.15 Level Two - Manufacturer 1 SD = 1.6, Lab 1 SD = 2.4 Level Three- Manufacturer 1 SD =1.8, Lab 1 SD = 2.75 Glucose: Level One - Manufacturer 1 SD = 1.8, Lab 1 SD = 2.8 Level Two - Manufacturer 1 SD = 3.66, Lab 1 SD = 5.5 Level Three- Manufacturer 1 SD =11.17, Lab 1 SD = 16.75 Total Bilirubin: Level One - Manufacturer 1 SD = .04, Lab 1 SD = .06 Level Two - Manufacturer 1 SD = .14, Lab 1 SD = .21 Level Three- Manufacturer 1 SD =.3, Lab 1 SD = .45 4. Review of patient test reports revealed the following patients reported during the periods when the incorrect QC ranges were in use: Patient number 290088 - urine albumin/creatinine -- 6 of 7 -- ratio reported on 12/06/23. Patient 140157-prostate specific antigen reported on 01/05 /24. Patient numbers 250789 and 118074-comprehensive metabolic panel (CMP) reported on 03/08/24. 5. The technical consultant confirmed the following during interview on 05/07/24 at 5 p.m.: The laboratory's protocol was to use the control ranges provided by the manufacturer. The laboratory had used the manufacturer's range as a two-standard deviation range instead of a three-standard deviation range, as indicated in the manufacturer's package insert. This confirmed the survey findings. SD=Standard Deviation D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 observation of the laboratory, review of patient number ten test report, the laboratory's 2018 proficiency testing records, email communication with the laboratory proficiency testing provider, and interview with the lead testing personnel, the laboratory failed to enroll in proficiency testing for the antinuclear antibody (ANA) analyte in 2018. The findings include: 1) Observation of the laboratory on February 19, 2019 at 8:30 am revealed the Biorad PhD lx (serial number PB7G193502) in use for patient testing for ANA. 2) Review of the first patient reported from the Biorad PhD lx instrument (patient number 10) revealed a test start date of March 22, 2019. 3) Review of an email communication from the laboratory's proficiency testing provider revealed that proficiency testing for the ANA analyte was available for shipment on April 2, 2018. 4) Review of the laboratory's 2018 proficiency testing records revealed the laboratory did not enroll and participate in proficiency testing for the ANA analyte in 2018. 5) Interview with the lead testing personnel on February 19, 2019 at 2:30 pm confirmed the laboratory failed to enroll in proficiency testing for the ANA analyte in 2018 with patient testing 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 6 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, calibration records for the complete blood count (CBC) instrument, and interview with the lead testing personnel, the laboratory failed to follow procedure for six month calibration of the CBC instrument in 2018. 1) Review of the laboratory procedure titled "HEMATOLOGY QUALITY CONTROL POLICY" revealed that the CBC instrument is to be calibrated "At least once every six months." 2) Review of the calibration records for the CELL-DYN Ruby CBC instrument (serial number 55382BG) revealed that calibration due June 2018 was not performed. 3) Interview with lead testing personnel on February 20 at 11:20 am confirmed six month calibration for CELL-DYN Ruby CBC instrument (serial number 55382BG) was not performed in June 2018. The laboratory failed to follow procedure for six month calibration of the CBC instrument in 2018. ____________________________________ 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 observation of the laboratory, review of laboratory instrument comparison records, and interview with the lead testing personnel, the laboratory failed to perform twice a year comparison for the Tosoh G8 instruments in 2018. The findings include: 1) Observation of the laboratory on February 19, 2019 at 8:30 am revealed two Tosoh G8 instruments in use for patient testing for glycated hemoglobin (Hgb A1c) (serial numbers 12431207 and 10245408). 2) Review of instrument comparison records for the Tosoh G8 instrument revealed comparison were not performed twice a year in 2018. 3) Interview with the lead testing personnel on February 20, 2019 at 10:30 am confirmed comparisons between the two Tosoh G8 instruments used for performing Hgb A1c was not performed twice in 2018. ______________________________________ 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 -- 2 of 6 -- 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 review of patient test reports and interview with the lead testing personnel, the patient test report for complete blood count (CBC) and erythrocyte sedimentation rate (ESR) failed to include units of measure in 2017, 2018, and 2019. The findings include: 1) Review of patient numbers one (dated 7.10.17), three (dated 1.12.18), and eight (2.6.19) CBC final test reports revealed no units of measure for neutrophil number, lymphocyte number, monocyte number, eosinophil number, basophil number, red blood cell count, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count. 2) Review of patient numbers two (dated 7.8.2017), seven (dated 6.9.18), and eleven (dated 2.20.19) final report revealed no units of measure for ESR. 3) Interview with the lead testing personnel on February 20, 2019 at 11:45 am confirmed the laboratory failed to include units of measure for CBC parameters and ESR on the final patient test report in 2017, 2018, and 2019. ____________________________________ 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 observation of the laboratory, review of patient data logs and patient number 10 test report, verification of performance specification (VoPS) studies for the Tosoh G8 and Biorad PhD lx instrument and interview with the lead testing personnel, the laboratory director failed to ensure the technical consultant approved VoPS prior to patient testing for the Tosoh G8 instrument in 2017 and the Biorad PhD lx instrument in 2018. The findings include: 1) Observation of the laboratory on February 19, 2019 at 8:30 am revealed the Tosoh G8 instrument (serial number 10245408-Tosoh G8 #2) and the Biorad PhD lx (serial number PB7G193502) in use for patient testing. 2) Review of the patient data log for Tosoh G8 instrument (serial number 10245408- Tosoh G8 #2) revealed that patient testing for glycated hemoglobin (Hgb A1c) began on June 27, 2017. 3) Review of the VoPS studies performed for the Tosoh G8 revealed approval by the technical consultant on December 14, 2017. 4) Review of the first patient reported from the Biorad PhD lx instrument (patient number ten) revealed a test start date of March 22, 2018. Patient testing for the Biorad PhD lx includes anti- nuclear antibody (ANA), Sjogren's antigen A/Sjogren's antigen B (SSA/SSB) -- 3 of 6 -- antibody, Smooth muscle/Nuclear ribonucleoprotein (Sm/RNP) antibody, double stranded deoxyribonucleic acid (ds-DNA) antibody, topoisomerase 1 (SCL-70) antibody, and cyclic-citrullinated peptide antibody (anti-CCP). 5) Review of the VoPS studies performed for the Biorad PhD lx revealed no approval by the technical consultant. 6) Review of the policy titled "Technical Consultant Responsibilities" revealed the technical consultant is responsible for "verification of test procedures and establishment of test performance characteristics." 7) Interview with the lead testing personnel on February 19, 2019 at 2:30 pm confirmed the laboratory director did not ensure the technical consultant approved VoPS prior to patient testing for the Tosoh G8 number two instrument in 2017 or the Biorad PhD lx instrument in 2018. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of verification of performance specification (VoPS) records for the Tosoh G8 instrument, and interview with the lead testing personnel, the laboratory director failed to ensure VoPS procedures were approved in 2017. The findings include: 1) Observation of the laboratory on February 19, 2019 at 8:30 am revealed the Tosoh G8 instrument (serial number 10245408- Tosoh G8 #2) in use for patient testing for glycated hemoglobin (Hgb A1c). 2) Review of the VoPS for the Tosoh G8 instrumend performed June 8, 2017 revealed no approval signature of the laboratory director. 3) Interview with the lead testing personnel on February 19, 2019 at 2:30 pm confirmed the laboratory director failed to approve the VoPS studies performed for the Tosoh G8 instrument in 2017. __________________________________ D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require