Children's Medical Group Pc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 3, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2021 and 1st event 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 3 -- 2022), resulting in the first unsuccessful occurrence for Bacteriology # 0005. Findings include: Refer to D 2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) report, the laboratory failed to receive an overall testing event score of satisfactory performance in two consecutive PT events (events #3 of 2021 and #1 of 2022) which resulted in the 1st unsuccessful occurrence for Bacteriology. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspeciality of Bacteriology # 0005 on events #3 of 2021 and #1 of 2022 with scores of 50% and 0%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events #3 of 2021 and #1 of 2022 and revealed the 50% and 0% scores were reported. This resulted in the first unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for Bacteriology, analyte # 0005. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and -- 2 of 3 -- Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for Bacteriology, analyte # 0005. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 0005 , Bacteriology on event 3 of 2021 with a score of 50% and event 1 of 2022 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events #3 of 2021 and #1 of 2022 and revealed the 50% and 0% scores were reported. This resulted in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 10, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) documents and staff interview, the laboratory failed to check each batch of media for sterility as required. Findings include: 1. Review of (Streptococcus Select agar (SSA) QC logs revealed there was no sterility check documentation available at the time of survey for June through December 2018. 2. An interview with the laboratory coordinator in a medical office on 3/10/2020 at approximately 1:30 p.m. confirmed the lack of SSA sterility check documentation available at the time of survey for 2018 (June through December). 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 8, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 hematology document review and staff interview 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 -- perform instrument calibrations with the frequency required by Clinical Laboratory Improvement Amendments (CLIA).. Findings include: 1. Cell-Dyne Emerald calibration document review revealed the laboratory failed to supply documentation for calibration performed every six months in 2017. There was a gap in calibration documentation between 1/26/17 and 3/27/18. 2. An interview with Staff #2 (CMS 209) on 5/8/18 in a doctor's office at approximately 1:30 p.m. confirmed there was no calibration documentation for Cell-Dyne Emerald calibration for the period between 1 /26/17 and 3/27/18. -- 2 of 2 --