Garden County Health Services

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on surveyor review of quality control records, patient testing records, and interview with the technical consultant the laboratory failed to perform quality control (QC) on the MedTox system detection of drugs of abuse each day of patient testing from 11/1/2023 - 9/9/2025. Findings are: 1. Review of MedTox QC records from 11/1 /2023 - 9/9/2025 revealed QC was performed monthly on the MedTox system detection of drugs of abuse. 2. Review of MedTox patient testing records revealed one hundred and twenty four patients were tested from 11/1/2023 - 9/9/2025. 3. Interview with the technical consultant confirmed the laboratory did not perform QC each day of patient testing from 11/1/2023 - 9/9/2025 on the MedTox sytem detection of drugs of abuse. 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 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: The laboratory failed to achieve satisfactory scores for the hematology analyte Cell Identification/White Blood Cell Differential for the 2019 first event and 2019 third event. See D2130. This results in the unsuccessful performance in proficiency testing for this analyte. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2019 and the laboratory's graded Proficiency Testing results from American Proficiency Institute, this laboratory had unsatisfactory performance for the analyte Cell Identification/White Blood Cell Differential. Findings are: 1. 2019 first event, analyte - Cell Identification/White Blood Cell Differential, score 60%. 2. 2019 third event, analyte - Cell Identification /White Blood Cell Differential, score 60%. -- 2 of 2 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on lack of documentation the laboratory failed to have proof of education on one testing personnel performing moderate complexity testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on lack of documentation and interview with general supervisor, on 9/18/2019 at 12:45 PM, the laboratory failed to have proof of education on one testing personnel 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 -- performing moderate complexity testing. Findings are: 1. No proof of education documentation for one testing personnel performing moderate complexity testing was presented during time of survey. 2. Interview with general supervisor confirmed no documentation was available. -- 2 of 2 --