Adams County Health Center

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 a review of training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 9 /19/2022 with the laboratory lead, the laboratory failed to follow written policies and procedures to assess competency of testing personnel for 2021 and 2022. The findings include: 1. A review of training and competency records identified that one (1) of six (6) testing personnel listed on the CMS 209 had a start day after the previous survey (3 /31/2021) that the laboratory failed to have documentation of six month competency for hematology testing. 2. A review of training and competency records identified two (2) of six (6) testing personnel listed on the CMS 209 that the laboratory failed to have documentation of annual competency performed by a person that would qualify as a technical consultant (TC) in 2021 for hematology testing. 3. A review of training and competency records identified three (3) of six (6) testing personnel listed on the CMS 209 that the laboratory failed to have documentation of annual competency performed by a person that would qualify as TC in 2022 for hematology testing. 4. An interview with the laboratory lead on 9/19/2022 at 11:50 am confirmed that the TC did not perform the six month and annual competency assessments on the testing personnel. 5. The laboratory reports performing 4,215 hematology tests annually. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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 -- 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 a review of educational documents for testing personnel and an interview with the laboratory lead on 9/19/2022, the laboratory failed to have documentation of educational requirements for three (3) of four (4) testing personnel hired since the last survey on 3/31/2021 performing moderate complexity testing. See 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 a review of educational documents for testing personnel, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory lead on 9/19/2022, the laboratory failed to have documentation of educational requirements for three (3) of four (4) testing personnel (TP) hired since the last survey on 3/31/2021. The findings include: 1. A review of educational documents for TP listed on the CMS 209 performing hematology testing hired since the last survey on 3/31/2021 identified that the laboratory failed to have documentation of the minimum educational requirements for moderate complexity testing (high school diploma or equivalent) for three (3) of four (4) TP. 2. An interview with the laboratory lead on 9/19/2022 at 11:45 am confirmed that the laboratory did not have at least high school diplomas or equivalent on file for three (3) of four (4) TP. 3. The laboratory reports performing 4,215 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and an interview with testing person 1(TP1) on 03/31/2021, the laboratory failed to establish and follow a written procedure for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified by the laboratory. The findings include: 1. A review of the laboratory's procedure manual revealed that the laboratory failed to have a written procedure for quality assessment to establish an ongoing review process to monitor, assess, and correct problems identified in the laboratory. 2. An interview with TP1 on 03/31/2021 at 10:30 AM confirmed that the laboratory did not have a written procedure for quality assessment or a mechanism to monitor, assess, and correct problems identified by the laboratory. 3. The laboratory reports performing 2,500 waived tests annually, and 720 moderate complexity hematology tests annually. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) review and an interview with the laboratory lead, the laboratory failed to rotate the testing of American Association of Bioanalysts (AAB) proficiency testing (PT) samples for complete blood counts (CBCs) by the testing personnel who routinely perform patient testing since the last survey on January 26, 2017. Findings: 1. A review of AAB PT records revealed the laboratory failed to rotate the CBC PT samples by all testing personnel who perform patient testing since the last survey. 2. An interview on October 2, 2018 at 9:35 AM, with the laboratory lead, confirmed the laboratory failed to rotate the CBC proficiency samples from AAB by testing personnel who routinely test patient CBCs since the last survey. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a proficiency testing (PT) review, the laboratory failed to successfully participate in proficiency testing for the analyte hematocrit (HCT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) review and the laboratory's graded PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte hematocrit (HCT) in two out of three testing events. Findings: Analyte Year Event Score HCT 2018 1 60% HCT 2018 2 0% D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to retain the manufacturer's quality control assay reference sheets for the Horiba Pentra hematology analyzer since the last survey on January 26, 2017. Findings: 1. A review of the quality control records revealed the laboratory failed to retain the manufacturer's Minotrol quality control assay reference sheets since the last survey. 2. An interview on October 2, 2018 at 9:15 AM, with the laboratory lead, confirmed the testing personnel failed to retain the quality control assay sheets for the hematology analyzer. 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: -- 2 of 5 -- Based on a record review of personnel documents and the procedure manual, and an interview with the laboratory lead, the laboratory failed to establish and follow written policies and procedures to evaluate the competency of testing personnel performing complete blood counts since the last survey on January 26, 2017. Findings: 1. A review of competency assessment documents for the testing personnel and a review of the laboratory procedures and policies, revealed the laboratory failed to establish in writing and document the competency evaluations for 6 out of 6 testing personnel listed on the CMS-209 Personnel Report form by a qualified technical consultant. 2. An interview on October 2, 2018 at 9:15 AM, with the laboratory lead, confirmed the laboratory failed to establish and follow written policies and procedures to assess the competency of testing personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)