Obgyn Associates Montgomery

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the Policy and Procedure manual, and an interview with Testing Personnel 4 (TP4), the laboratory failed to establish a policy to monitor and assess competency of physicians who performed Provider Performed Microscopy (PPM). The surveyor noted no documentation of physician assessments from the date of the last survey, 12-13-2022 to the date of the current survey, 02-06-2025. The findings include: 1. A review of the Policy and Procedure manual revealed no procedure on how to monitor and assess the competency of physicians who performed PPM, and reported results utilized in the diagnosis and treatment of patients. 2. During the exit conference on 02-06-2025 at 4:38 PM, TP4 confirmed the above findings. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a review of the policy and procedure manual, and an interview with Testing Personnel 4 (TP), the laboratory failed to establish a maintenance and function checks policy for the four microscopes used in the performance of Provider Performed Microspcopy (PPM). The surveyor noted the missing policy was from the last survey date of 12-13-2022 through the current survey date of 02-06-2025. Findings are: 1. A review of the laboratory's policy and procedure manual revealed no written procedure on the maintenance and function checks required for the four PPM microscopes. 2. The TP4 confirmed the above findings during the exit conference on 02-06-2025 at 4: 38 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Testing Personnel 4 (TP4), the Technical Consultant failed to ensure eight of the eight Testing Personnel (TP) who performed Provider Performed Microscopy (PPM) had annual competency assessments documented from 2023-2025. The findings include: 1. A review of the personnel records revealed eight of the TP listed on the CMS-209 (Laboratory Personnel Report) performing PPM had no annual competency assessments from the date of the previous survey, 12-13-2022 to the date of the current survey, 02-06-2025. 2. The TP4 confirmed the above findings during the exit conference on 02-06-2025 at 4:38 PM. -- 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 a review of the Cobas e411 calibration verification records and an interview with the Technical Consultant, the laboratory failed to perform calibrations verifications at least every six months as per CLIA regulations. This was noted one (2020) out of three (2018-2020) years reviewed by the surveyor. The findings include: 1. A review of the Cobas e411 calibration verification records (2018 - 2020) revealed the following: a) Estradiol, Follicle-Stimulating Hormone (FSH), Beta Human 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 -- Chorionic Gonadotropin (HCG), Insulin, Luteinizing Hormone (LH), Progesterone, and Thyroid-Stimulating Hormone (TSH) last calibration verification was 12/30/2019. It had been 1 year and 2 months since the last calibration verification. b) Prolactin and Thyroxine (T4) last calibration verification was 01/02/2020. It had been been 1 year and 2 months since last calibration verification. c) Free Triiodothyonine (FT3), Free Thyroxine (FT4), T-Uptake, and Testosterone last calibration verification was 06/30 /2020. It had been 8 months since last calibration verification. 2. During an interview on 03/10/2021 at 1:30 PM, the Technical Consultant confirmed the laboratory had not performed calibration verifications since the dates listed above for each analyte. The Technical Consultant also confirmed only two levels are used for each analyte calibration. -- 2 of 2 --