Optum Medical Care Pc

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the review of the CAP Proficiencies Testing records, the laboratory failed to retain copies of the signed attestation forms, test result forms, and a signed PT summary report. Confirmed findings on an interview with office manager on 3/9/2023 about 11:15am. Findings: The laboratory failed to retain copies of the above documents and records; therefore, it could not determine if the proficiency testing samples were tested in the same manner as patient specimens. And rotated among six testing personnel. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) policy, the laboratory failed to perform and document annual QA review for calendar year 2022. Confirmed findings on an interview with office manager on 3/9/2023 about 10:30am. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of laboratory's Standard Operating Procedure (SOP), the laboratory director failed to perform annual review and sign the procedure manual as required by the SOP. Confirmed findings on an interview with office manager on 3/9 /2023 about 11:30am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the review of thermometer calibration certificate, the room temperature /humidity thermometer calibration expired on 2/22/2023. Confirmed findings on an interview with office manager on 3/9/2023 about 11am. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of hematology calibration records, the laboratory failed to perform calibration of the hematology analyzer at the frequencies required by the laboratory's -- 2 of 3 -- calibration policy. Confirmed findings on an interview with office manager on 3/9 /2023 about 11am. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Control (QC) records, the laboratory failed to perform a verification of current lot number to new lot number of the hematology analyzer Sysmex XN-430. FINDINGS: 1. The new QC lot to lot validation documentations of hematology analyzer were not available upon request during the survey since the hematology analyzer implementation date to survey date. 2. The general office manager confirmed during interview on 3/9/2023 at 10:45 am, the new lot to lot validation of QC material for hematology analyzer was not performed. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment (QA) procedure, it failed to perform and document annual QA review and confirmed in an interview with the general office manager, the laboratory director failed to establish a maintain QA for all phases for the general laboratory system. Refer to D5291. -- 3 of 3 --

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 the surveyor's review of the laboratory's Quality Assessment (QA) polices /procedures and an interview with the office manager and physician operation lab manager, the laboratory failed to establish the a written QA policy, to include a monthly and annual QA review for the refrigerator temperature log. refer D6021 Findings: 1. January 11, 2022 at approximately 11 am, the refrigerator temperature logs were reviewed and were of range for the dates of 4/9/2021, 4/10/2021, and 5/8 /2021. The office manager and physician operation lab manager confirmed refrigerator temperature logs reviews were not performed. 2. The annual QA form for the above dates were reviewed and found it did not include refrigerator temperature log reviews. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's QA polices/procedures and an interview with the office manager and physician operation laboratory manager, the laboratory failed to ensure a written QA policy was established and maintained for the calendar year 2021. Refer to: D5291 -- 2 of 2 --

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cell Identification (Cell I.D.) /White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2019 first event = 40% 2019 second event = 0% This is considered unsuccessful PT performance. Refer to D2130. D2121 HEMATOLOGY 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 -- CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a PT desk review of CMS PT and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Hemoglobin (Hgb). The following scores were assigned: 2019 first event = 0% This is considered unsatisfactory PT performance. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology. The following scores were assigned: 2019 first event = 73% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Cell I.D./WBC Diff. The following scores were assigned: 2019 first event = 40% 2019 second event = 0% This is considered unsuccessful PT performance. 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 PT desk review of the PT CMS data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Cell I.D./WBC Diff., Hgb and the speciality Hematology. Refer to D6016. -- 2 of 3 -- 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 PT desk review of the PT CMS data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Cell I.D./WBC Diff., Hgb and the speciality Hematology. The following scores were assigned: Cell I.D./WBC Diff. 2019 first event = 40% 2019 second event = 0% This is considered unsuccessful PT performance. Hemoglobin (Hgb) 2019 first event = 0% Specialty Hematology. 2019 first event = 73% This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of College of American Pathologists (CAP) Proficiency Testing (PT) records and confirmed in an interview with the laboratory supervisor /testing person and the laboratory administrator, the laboratory failed to retain CAP PT signed attestation forms, for the second and third events in 2017 and for the first and second events in 2018. 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 --