Arthritis & Osteoporosis Center Inc

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 laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in 5 of 6 Chemistry testing events in 2022, 2023 and 2024. Findings include: 1. On the day of survey, 08/01/2024 at 9:00 am, review of the laboratory's API PT records revealed the laboratory scored below 80 percent for each analyte in the following chemistry testing events: - 2022 Chemistry-core 3rd event: Sodium 0% - 2023 Chemistry-core 1st event: Bilirubin, total 60% - 2023 Chemistry-core 2nd event: Sodium 60% - 2024 Chemistry-core 1st event: Parathyroid hormone 50% - 2024 Chemistry-core 2nd event: Bilirubin, direct 40% 2. TP #1 confirmed the findings above on 08/01/2024 at 11:47 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of documents and interview with Testing Personnel (CMS 209 TP# 1) the laboratory failed to perform and document maintenance on laboratory equipment 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 -- and test systems in 2023. Findings include: 1. On day of the survey, 08/01/2024 at 9: 31 AM, review of laboratory equipment and test system maintenance records revealed: - BS-200 Mindray (S/N WN-47105465F) maintenance was performed on 11 /08/2022 and due on 11/08/2023 - 3of 3 Drucker Centrifuges 642E (S/N 210113GD033, 200313FH096 and 180613DH558) performed on 10/13/2022 and due on 10/13/2023 - 1 of 1 Summit /Accucold Refrigerator (S/N ARS23ML-20040023) performed on 10/13/2022 and due on 10/13/2023 - 1of 1 Whirlpool Refrigerator /Freezer (S/N EP3521460) performed on 10/13/2022 and due on 10/13/2023 - 1 of 1 Frigidaire Freezer (S/N WB93536151) performed on 10/13/2022 and due on 10/13 /2023 - 1 of 1 Summit/Acuucold Freezer (S/N 2020-07-100) performed on 10/13/2022 and due on 10/13/2023 - 1 of 1 Boekel Incubator (S/N 042202843) performed on 10 /13/2022 and due on 10/13/2023 - 1of 1 Digi-Sense RT thermometer (S/N 19236536) performed on 10/13/2022 and due on 10/13/2023 2. Observation during the laboratory tour on 08/01/2024 at 11:45 AM, revealed that the laboratory failed to calibrate or replace the following: - 1 of 1 AccuTherm refrigerator/freezer thermometer that expired 04/29/2023 - 1 of 1 Fisher Brand Traceable thermometer for Incubator temperature expired 04/14/2023 3. The laboratory failed to provide documentation of maintenance performed in 2023. 4. TP#1 confirmed the above findings on 08/01/2024 at 12:00 PM. -- 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 American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte Sodium. 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 review of the CASPER 155 report and graded results from the American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte: Sodium, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 3rd event of 2022, and the 2nd event of 2023. Findings include: Analyte Year Event Score Sodium 2022 3 0%. Sodium 2023 2 60%. -- 2 of 2 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analytes Albumin, Calcium, Cholesterol HDL, Cholesterol, Total, Carbon dioxide, Glucose (non waived), Total Protein, Triglycerides, Urea Nitrogen. 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 a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing for the Routine Chemistry analytes listed below. The laboratory had unsatisfactory scores for the 1st event of 2020, the 3rd event of 2020 and the 1st event of 2021. Findings include: Analyte Year Event Score% ALBUMIN 2020 1 0 ALBUMIN 2020 3 0 ALBUMIN 2021 1 60 CALCIUM 2020 1 0 CALCIUM 2020 3 0 CALCIUM 2021 1 40 CHOLES TOTAL 2020 1 0 CHOLES TOTAL 2020 3 0 CHOLES TOTAL 2021 1 0 CHOLES, HDL 2020 1 0 CHOLES, HDL 2020 3 0 CHOLES, HDL 2021 1 20 CARBON DIOXIDE 2020 1 0 CARBON DIOXIDE 2020 3 0 CARBON DIOXIDE 2021 1 20 GLUCOSE 2020 1 0 GLUCOSE 2020 3 0 GLUCOSE 2021 1 0 TOTAL PROTEIN 2020 1 0 TOTAL PROTEIN 2020 3 0 TOTAL PROTEIN 2021 1 0 TRIGLYCERIDE 2020 1 0 TRIGLYCERIDE 2020 3 0 TRIGLYCERIDE 2021 1 40 UREA NITROGEN 2020 1 0 UREA NITROGEN 2020 3 0 UREA NITROGEN 2021 1 20 -- 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 American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for all Routine Chemistry analytes performed. 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 American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing for the Routine Chemistry analytes listed below. The laboratory had unsatisfactory scores for the 1st event of 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score% ALT 2020 1 0 ALT 2020 3 0 ALBUMIN 2020 1 0 ALBUMIN 2020 3 0 ALK PHOS 2020 1 0 ALK PHOS 2020 3 0 AST (SGOT) 2020 1 0 AST (SGOT) 2020 3 0 BILIRUBIN 2020 1 0 BILIRUBIN 2020 3 0 CALCIUM 2020 1 0 CALCIUM 2020 3 0 CHLORIDE 2020 1 0 CHLORIDE 2020 3 0 CHOLESTEROL TOTAL 2020 1 0 CHOLESTEROL TOTAL 2020 3 0 CHOLES, HDL 2020 1 0 CHOLES, HDL 2020 3 0 CK, TOTAL 2020 1 0 CK, TOTAL 2020 3 0 CREATININE 2020 1 0 CREATININE 2020 3 0 GLUCOSE 2020 1 0 GLUCOSE 2020 3 0 IRON 2020 1 0 IRON 2020 3 0 LDH, TOTAL 2020 1 0 LDH, TOTAL 2020 3 0 MAGNESIUM 2020 1 0 MGGNESIUM 2020 3 0 POTTASIUM 2020 1 0 POTTASIUM 2020 3 0 TOTAL PROTEIN 2020 1 0 TOTAL PROTEIN 2020 3 0 TRIGLICERIDE 2020 1 0 TRIGLICERIDE 2020 3 0 BUN 2020 1 0 BUN 2020 3 0 URIC ACID 2020 1 0 URIC ACID 2020 3 0 -- 2 of 2 --

Summary Statement of Deficiencies 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, review of temperature logs and interview with the testing personnnel, on the date of the survey (06/24/2020), the laboratory failed to meet laboratory defined criteria for proper storage of chemistry reagents from (06/01/2019) through (06/24/2020). Findings include: 1. The laboratory defined refrigerator temperature range was (2 to 8 C). 2. The laboratory defined freezer temperature range was (-12 to -20C). 3. At (10:00 06/24/2020), the surveyor observed chemistry reagents for the Mindray BS200 and the Theratest EL analyzers were stored in the GE#2 refrigerator/freezer. 4. Review of the temperature logs revealed the GE#2 refrigerator temperature was out of range (57 of 389 days). 5. Review of the temperature logs revealed the GE#2 freezer temperature was out of range (181 of 389 days). 6. The laboratory testing personnel confirmed the above findings.at (10:30 06 /24/2020). 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 American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Sodium. 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 performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Sodium. The laboratory had unsatisfactory scores for the 2nd event of 2018 and the 1st event of 2019. Findings include: 1. API 2018 Event 2 for Sodium the score was 40%. 2. API 2019 Event 1 for Sodium the score was 60%. -- 2 of 2 --