Millard Henry Clinic

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 the 2023 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Chloride (Cl) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 review of the 2023 CMS Casper Reports 096D, 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Chloride (Cl). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 20% for the analyte Cl in the first proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte Cl in the second proficiency testing event of 2023. 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 review of 2023 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. 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 review of the 2023 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test of Cl. -- 2 of 2 --

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for "Quality Control" (QC), review of quality control Levy-Jennings charts for January 2021 and May 2021, review of the technical consultants QA review notes, lack of documentation and interview it was determined that the laboratory failed to recognize or take

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of manufacturer's package inserts, review of the laboratory's temperature and humidity records, observation and interview it was determined that the laboratory did not provide proper storage conditions for three of three boxes of Biorad Multiqual quality control material and did not maintain laboratory humidity level required for the operation of the Advia Centaur XP immunology analyzer on ninteteen of twenty-six days of operation in January 2019. Findings follow: 1. The laboratory failed to provide proper storage conditions for Biorad Multiqual quality control material. A) Review of the manufacturer's package insert for Biorad Multiqual quality control material revealed the statement "for optimum performance, avoid storing this product in a frost-free freezer". B) During a tour of the laboratory on 8/16 /19 at approximately 10:45 AM, three boxes of Biorad Multiqual quality control material lot # 45790, expiration date 2020-03-31 were observed stored in a frost-free freezer. C) In an interview on 8/16/19 at approximately 10:45 AM, the laboratory staff member identified as number two on the CMS 209 form, confirmed that the Multiqual quality control material was stored in a frost-free freezer. 2. The laboratory failed to maintain the required operating humidity level for the Advia Centaur XP immunology instrument. A) Review of the manufacturer's manual for the Advia Centaur XP immunology analyzer revealed an operating humidity requiirement of 20% to 80%. B) 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 -- Review of the laboratory's room humidity records for January 2019 revealed an acceptable range of 10% to 85% and a recorded room humidity of 19% on 1/2/19, 1/5 /19, 1/9/19/ 1/10/19, 1/11/19, 1/12/19, 1/14/19, 1/15/19, 1/16/19, 1/21/19, 1/22/19, 1 /23/19, 1/24/19, 1/25/19, 1/26/19, 1/29/19, 1/30/19 and 1/31/19. C) In an interview on 8/16/19 at approximately 10:45 AM, the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the proper acceptable humidity range should be 20% to 80% and the humidity level was below the required level on the days identified above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of the manufacturer's manual for the Atellica CH Analyzer, paient THC result logs for 2019, and interview with laboratory staff it was determined that the laboratory did not refer eighty-seven of eighty-seven positive THC results for confirmatory procedures as directed by the manufacturer. Findings follow: A) Review of the manufacturer's manual for the THC assay performed on the Atellica CH analyzer revealed,"The THC assay provides only a preliminary analytical test result. A more specific chemical method must be used to obtain a confirmed analytical result". B) Review of the THC patient result logs revealed that eighty-seven positive THC results were reported from 1/1/19 through 7/31/19 on patients identified as numbers one through eighty-seven on the patient result log. C) In an interview on 8/15 /19 at approximately 01:45 PM, the laboratory staff member, identified as number two on the CMS 209 form, stated that positive THC tests are not referred unless the ordering physician requests confirmation and the positive results on the patient identified above had not been referred for confirmation. D5783

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --