Christopher B Kruse Md, Llc

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and thermometers and interview with the Testing Personnel (TP) on the CMS-209 form provided on the CMS-209 at the time of the survey, the laboratory failed to provide a written procedure for and documentation of calibration for all thermometers used in the laboratory from 8/30/21 to the date of the survey. The findings include: 1. The laboratory could not provide a written procedure for the calibration or replacement of the Excursion-Trac refrigerator thermometer nor the Habor thermohygrometer used for room temperature and humidity in the laboratory. 2. The laboratory could not provide documentation of calibration for the Excursion-Trac refrigerator thermometer from Nov-21 when calibration expired to the date of the survey. 3. The laboratory could not provide documentation of calibration for the Habor thermohygrometer used for room temperature and humidity. 4. The TS confirmed on 12/12/23 at 1:30 pm that they could not provide a written procedure for performing calibration of the thermometers nor provide documention of calibration. 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 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 lack of the Competency Assessment (CA) records, review of the personnel files and interview with the Laboratory Director (LD), the laboratory failed to perform a CA on Testing Personnel (TP) # 2 and # 3 in the calendar year 2018. The LD confirmed on 2/14/19 at 11:00 pm that CA was not performed on TP. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing personnel (TP), the laboratory failed to document QC for Biopsies slides reviewed from technical component laboratory from July 2018 to the date of the survey. The TP#1 on CMS form 209 confirmed on 2/14/19 at 1:00 pm that the laboratory failed to failed to document QC for Biopsies slides. 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 -- D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the testing Personnel (TP), the Laboratory Director (LD) failed to specify in writing the list of job responsibilities for data entry from 4/18/17 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 2/14/18 at 12:30 pm that job responsibilities were not established for data entry. -- 2 of 2 --