Bolivar Phys Pract Dba Cleveland Medical Clinic

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 the review of Siemens Dimension EXL 200 records to include assay package inserts, calibration records from installation and confirmation from the laboratory manager, the laboratory failed to perform calibration verification at least every 6 months for Sodium (Na), Potassium (K), and Chloride (Cl) for three of three six-month periods. Findings include: 1. Review of the Siemens Dimension manufacturer's calibration package insert sheet list that Na, K, and Cl are calibrated using less than 3 calibration materials. Calibration verification is required every 6 months on assays that are calibrated with less than 3 calibrator levels. 2. Review of the Siemens Dimension EXL 200 calibration records revealed no documentation of 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 -- calibration verification on Na, K, and Cl since installation on 7/11/2023. Three of three six-month calibration verifications were not available on the day of survey. 3. The laboratory manager confirmed in an interview on 1/14/2025 at 5:00 p.m. that calibration verifications had not been performed for Na, K, and Cl on the Siemens Dimension EXL 200 since instrument installation. -- 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: A. Based on review of Biosite Triage Meter records from 12/3/18 through 4/14/21, and confirmation with testing personnel (TP) #1, the laboratory failed to perform calibration verification on the Biosite Triage Meter chemistry analyzer every 6 months for D-dimer. Findings include: 1. Review of the laboratory Biosite Triage Meter D-dimer records from 12/3/18 through 4/21/21 revealed calibration verification had not been performed every 6 months as required by the manufacturer. 2. Review of 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 -- the Biosite Triage Meter D-dimer records from 12/3/18 through 4/14/21 revealed calibration verification had been performed on 12/26/18, 6/5/19, 12/11/19 and 9/22 /20. The time period from 12/11/19 to 9/22/20 and 9/22/21 until 4/21/21 exceed the manufacturer's calibration verification requirements. 3. Interview with TP #1 at 2:00 pm on 4/21/21 confirmed that calibration verification had not been performed on the D-dimer every 6 months. B. Based on review of the Abbott i-Stat records from 1/14 /20 through 3/31/21, and confirmation with TP #1, the laboratory failed to perform calibration verification on the Abbott i-Stat chemistry analyzer every 6 months for the Chem 8 profile (Sodium, Potassium, CO2, Blood Urea Nitrogen (BUN), Chloride, Glucose, Creatinine, Calcium and Hematocrit). 1. Review of the Abbott i Stat records from 1/14/20 through 3/31/21 revealed calibration verification had not been performed on the Chem 8 panel since categorized as nonwaived testing on 1/14/20. 2. Interview with TP #1 at 2:00 pm on the day of survey confirmed that calibration verification had not been performed on the Chem 8 panel every 6 months since 1/14 /20. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS) database proficiency testing report, and confirmation with TP #1 at 3:30 pm on 4/21/21, the laboratory director failed to ensure the laboratory was enrolled and participated in an HHS approved proficiency testing (PT) program for the Chem 8+ panel (categorized as non-waived on 1/14/2020) performed on the Abbott i-Stat Meter for 2020 and 2021. Findings include: 1. Review of the CMS database proficiency testing report revealed no scores for Chem 8+ (Sodium, Potassium, Chloride, CO2, BUN, Creatinine, Glucose, and Calcium) for years 2020 or 2021. 2. Review of the laboratory proficiency records since installation of the Abbott i- Stat meter on 1/14/2020 through the day of survey revealed no evidence of proficiency testing performed on the i-Stat Chem 8+ cartridge. 3. Interview with TP #1 at 3:30 pm on the day of survey confirmed the laboratory did not enroll in proficiency for the Chem 8+ panel for the years 2020 or 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records from last survey, 10/14/18 through 6/20/18, and interview with staff at 4:00 PM on 10/3/18, the laboratory failed to document the quality control (QC) results for the Henry Schein One Step+ Serum pregnancy test kit. Findings include: On the day of survey, there was no documentation of Quality Control (QC) results for serum pregnancy testing available. Review of the pregnancy log and interview with staff revealed serum pregnancy patient results were written on the pregnancy log along with patient name, doctor, internal QC result and testing personnel initials. The control lot number and expiration date was also recorded on the log, but the QC results (positive and negative) were not documented for each day of testing . The laboratory performed 13 serum pregnancy testing on patients from 9/17 until 9/18. 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 --