Kneibert Clinic Laboratory

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of quality control (QC), procedures and interview with testing personnel #1 the laboratory failed to test serum pregnancy control materials in the same manner as patient specimens and interview with testing personnel #1 the laboratory failed to meet the condition of analytic systems. (Refer to D5465 ) **This is a repeat deficiency cited during previous survey conducted October 2, 2018. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (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, the laboratory's individual QC plan (IQCP), patient records and interview with testing personnel # 1, the laboratory failed to test pregnancy (HCG) control materials in the same manor as patient specimens for 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 -- 2019, 2020 and to date June 10, 2021. Findings: 1. Review of QC records showed the laboratory used urine matrix control material when performing serum HCG testing on patient specimens. 2. The Individual Quality Control Plan (IQCP) for Serum Beta hCG signed by laboratory director on October 10, 2018 stated "Serum Control: Roche Immunoassay controls will be used for positive serum control and a known patient with negative HCG will be used a negative control. Positive and negative controls will be performed daily if a patient is run." There was no documentation to show the laboratory performed the positive and negative serum controls as stated in the IQCP. 3. Review of patient records showed, the laboratory tested over 150 patients for serum HCG during 2019, 2020 and to date June 10, 2021. 4. Interview with testing personnel #1 on June 10, 2021 at 10:00 A.M. confirmed the laboratory failed to test control material for serum pregnancy in the same manner as patient specimens. 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 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: Review of calibration records for the chemistry analzers Cobas e 411 and the Cobas c 501 and interview testing personnel #1 showed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of the calibration records for September 2017 and to date October 2, 2018 for the analytes: CO2, alkaline 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 -- phophatase, sodium, potassium, chloride, Hgb A1C, total bilirubin, direct bilirubin, c- peptide, insulin, vitamin D, vitamin B12, ALT, AST, glucose, creatinine, triglycerides, albumin, BUN, HDL, total protein, amylase, cholesterol, T4, T3, TSH, digoxin, testosterone, PSA, serum pregnancy, calcium and folate analytes showed the laboratory failed to perform a calibration every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range. 2. Interview with testing personnel #1 on October 2, 2018 at 2:00 PM confirmed the laboratory failed to perform a calibration every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC), procedures and interview with testing personnel #1 the laboratory failed to test serum pregnancy control materials in the same manner as patient specimens. Findings: 1. Serum pregnancy patient testing is performed using patients serum. QC for serum pregnancy is performed using a urine matrix. 2. Interview with testing personnel #1 on October 2, 2018 at 2:00 PM confirmed the laboratory failed to test control material for serum pregnancy in the same manner as patient specimens. 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 review of 2018 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to successfully participate in PT. See D-tag 2096 unsatisfactory performance in two consecutive Albumin PT challenges. 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 2018 chemistry proficiency test (PT) results and phone interview with the laboratory manager revealed that the laboratory failed to achieve satisfactory performance for the chemistry analyte Albumin in two consecutive testing events. Findings: 1. Review of chemistry PT revealed the laboratory obtained an unsatisfactory score of 0 per cent for the chemistry analyte Albumin in the first testing event of 2018. 2. Review of chemistry PT revealed the laboratory obtained an unsatisfactory score of 60 per cent for the chemistry analyte Albumin in the second event of 2018. 3. Phone interview with the laboratory manager on July 26 , 2018 at confirmed the laboratory failed to achieve satisfactory performance for the chemistry analyte Albumin in two consecutive testing events. -- 2 of 2 --