Clearfield Professional Group Ltd

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with testing personnel (TP) #1, the laboratory director (LD)/designee and testing personnel (TP) failed to sign 4 of 6 AAB-MLE PT attestation statement documents for chemistry and hematology testing performed in 2023. Findings include: 1. The AAB/MLE PT Program Guide general instructions for reporting results states, " The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes. In addition to the analysts' signatures, the director or the director's designee must sign only once for each reporting form." 2. On the day of survey, 04/23/2024 at 9:48 am., review of AAB-MLE PT attestation records revealed the following 4 of 6 AAB-MLE PT attestation statement documents were not signed by the LD/designee or TP in 2023: - Chemistry: Events #1 & #2 - Chemistry module (CH) M1 & M2 - Urine Microalbumin/Creatinine (UM) - Prostate 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 -- Specific Antigen (PSA) - Endocrinology 2 (25-Hydroxyvitamin D) - Hematology: Events #1 & #2 - Nonchemistry M1 & M2 (Hematology with 5-Part Diff DxH 500 series) 3. TP #1 confirmed the findings above on 04/23/2024 at 10:30 am. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel competency records, the CLIA laboratory personnel report (CMS 209), and interview with Testing Personnel (TP) #1, the Technical Consultant (TC) (CMS 209 personnel #3) failed to evaluate the annual competency of 1 of 2 testing personnel (TP) who performed Chemistry and Hematology testing in 2022 and 2023. Findings include: 1. On the day of survey 04/23 /2024 at 8:50 am, review of the laboratory's personnel competency records and CMS 209 form revealed the TC failed to evaluate the annual competency of TP #2 (CMS 209 personnel #2) who performed testing on the Envoy 500 + Chemistry analyzer and the Beckman DxH 520 Hematology analyzer in 2022 and 2023. 2. TP #1 (CMS 209 personnel #1) performed the annual competency assessment of TP #2 in 2022 and 2023. 3. Review of personnel credentials revealed TP #1 does not meet the education requirements under 493.1411 of TC for moderate complexity testing. 4. TP #1 confirmed the findings above on 04/23/2024 at 10:30 am. -- 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: Based on review of the CASPER 155 Report and graded results from the proficiency testing organizations American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) and American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte Urea Nitrogen (BUN). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and graded results from American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), and American Proficiency Institute (API) proficiency testing (PT) organizations, the laboratory failed to successfully participate in PT for the routine chemistry analyte: Urea Nitrogen (BUN). The laboratory had unsatisfactory scores for the 2nd and 3rd event of 2023. Findings include: Analyte Year Event Score PT Agency BUN 2023 2 20%. AAB-MLE BUN 2023 3 20% API -- 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: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Free Thyroxine. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: Free Thyroxine (F4). The laboratory had unsatisfactory scores for the 1st event of 2022 and the 3rd event of 2022. Findings include: Analyte Year Event Score F4 2022 1 0%. F4 2022 3 0%. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the Testing Personnel (TP)#1, the laboratory failed to attain a score of at least 80% for 15 of 18 analytes in the MLE PT Routine Chemistry in 2020 and 2021. Findings Include: 1. On the day of survey, 04/28/2022, review of the MLE PT records revealed the following analytes had less than 80% score in 2020 for routine chemistry: - 2020 Event 2: - Alanine Aminotransferase (ALT): 40% - Albumin: 40% - Alkaline Phosphate: 60% - Total Bilirubin: 20% - Calcium: 60% - Total Cholesterol: 20% - high-density lipoprotein (HDL) Cholesterol: 60% - Creatine: 20% - Glucose: 20% -Total Iron: 20% - Potassium: 40% - Sodium: 20% - Total Protein: 40% - Blood urea nitrogen (BUN): 20% - Uric Acid: 20%. - 2020 Event 3: - Chloride: 40% -2021 Event 2: - Blood urea nitrogen (BUN): 60%. 2. The TP 1 confirmed the findings above on 04/28/2022 at 12:30 pm. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the Testing Personnel (TP)#1, the laboratory failed to 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 -- attain a score of at least 80% for 2 of 6 analytes in the MLE PT Hematology in 2021. Findings Include: 1. On the day of survey, 04/28/2022, review of the MLE PT records revealed the following analytes had less than 80% score in 2021 for Hematology: - 2021 Event 1: - Hematocrit: 40 % - 2021 Event 2: - Hemoglobin: 0% - White Blood Cell (WBC): 40%. 2. The TP 1 confirmed the findings above on 04/28/2022 at 12:30 pm. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) records and interview with the Testing Personnel (TP) #1, the laboratory failed to perform two control materials of different concentrations each day of patient testing for 4 of 4 endocrinology analytes and 2 of 2 urine chemistry analytes from 04/28/2020 to the day of survey. Findings include: 1. On the day of survey, 04/28/2022, review of The Qualigen Fastpack (TSH, Free T4, PSA, and Vitamin D) and the Afinion Urine ACR (creatinine and albumin) records revealed, the laboratory did not perform two levels of control material each day of patient testing form 04/28/2020 to 04/28/2022. 2. The TS #1 confirmed the findings above on 09/25/2020 ay 10:45 am. 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

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: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Chloride, Sodium, Blood Urea Nitrogen, Hemoglobin, TSH and White Blood Cells, and specialties Endocrinology and Hematology. Refer to D2096, D2107, D2108, D2130 and D2131. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in a proficiency testing for the Routine Chemistry analytes listed below. The laboratory had unsatisfactory scores for the 2nd event of 2021, 3rd event of 2021 and the 1st event of 2022. Findings include: Analyte Year Event Score% CHLORIDE 2021 3 40 CHLORIDE 2022 1 0 SODIUM 2021 3 20 SODIUM 2022 1 0 BUN 2021 2 60 BUN 2022 1 0 D2107 ENDOCRINOLOGY CFR(s): 493.843(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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte:Thyroid Stimulating Hormone (TSH). The laboratory had unsatisfactory scores for the 3rd event of 2021 and the 1st event of 2022. Findings include: Analyte Year Event Score TSH 2021 3 20%. TSH 2022 1 0%. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to achieve an overall testing score of satisfactory performance in the subspecialty Endocrinology. The laboratory had unsatisfactory scores for the 3rd event of 2021, and 1st event of 2022. Findings include: Subspecialty Year Event Score% Endocrinology 2021 3 60 Endocrinology 2022 1 0 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: White Blood Cell (WBC), and Hemoglobin (HGB). The laboratory had unsatisfactory scores for the 2ndd event of 2021, and 1st event 2022. Findings include: Analyte Year Event Score % HGB 2021 2 0 HGB 2022 1 0 WBC 2021 2 40 WBC 2022 1 0 D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to achieve an overall testing score of satisfactory performance in the Specialty Hematology. The laboratory had unsatisfactory scores for the 2nd event of 2021, and 3rd event of 2021. Findings include: Subspecialty Year Event Score Hematology 2021 2 73% Hematology 2022 1 0% -- 3 of 3 --

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: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in a proficiency testing for the analyte: Chloride, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score Chloride 2020 1 20%. Chloride 2020 3 40%. -- 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 laboratory procedure review and interview with Testing Personnel 1, on (12 /10/2019), the Laboratory Director failed to document annual laboratory procedure manual review as required by the laboratory procedure manual review sheet from (02 /21/2018), to the date of the survey . Findings include: 1. The laboratory procedure manual annual review sheet failed to include the current Laboratory Director and current Laboratory Testing Personnel signatures, from (02/21/2018) to the date of the survey. 2. During the survey (10:30 12/10/2019), Testing Personnel 1 confirmed the above finding. 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 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: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Total Cholesterol. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in a proficiency testing for the analyte: Total Cholesterol (Total Chol), which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2019 and the 3rd event of 2019. Findings include: Analyte Year Event Score Total Chol 2019 2 60%. Total Chol 2019 3 60%. -- 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: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate proficiency testing for the analyte Hematocrit. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: Hematocrit. The laboratory had unsatisfactory scores for the 3rd event of 2018, and 1st event 2019. Findings include: Analyte Year Event Score Hematocrit 2018 3 40 Hematocrit 2019 1 60 -- 2 of 2 --

Summary Statement of Deficiencies 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 review of Select medical products operation manual, and interview with the Testing Personnel (TP) # 1 and #2, the laboratory failed to perform manufacture specified calibrations on the Select Medical Products PSS 868 HX 6 Place Horizontal Spin Centrifuge since the initial installment of the centrifuge to 2017. Findings include: 1. Select Medical Products PSS 868 HX 6 Place Horizontal Spin Centrifuge Operations Manual's Calibration section states "According to Code of Federal 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 -- Regulations Title 21, centrifuge requires verification or calibration as follows: 1) Before initial use; 2) after repair or adjustments; 3) 6 months after use. The centrifuge timer timer however should be checked at least every 3 months." 2. On the date of survey, 02/21/2018, review of the Select medical products operation manual, revealed that the centrifuge calibration was not performed per manufactures instructions. 3. In the past 12 month period 34,976 Hematology specimen have been tested. 4. TP #1 and #2 confirmed the findings above on 02/21/2018 around 02:15 PM. 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