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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 Quality Assessment (QA) activities records review and laboratory technical supervisor interview, it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2022. The findings include: a. On November 1, 2022 at 12:07 PM, the laboratory QA was requested. b. Since January 2022 the laboratory did not evaluate practices related to: Patient confidentiality c. The laboratory technical supervisor confirmed on November 1, 2022 at 12:10 PM that the laboratory failed to evaluate and monitor the Patient confidentiality. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) activities records review and interview with the laboratory technical supervisor; it was determined that the laboratory fail to evaluate and monitor de post analytic system requirements. The findings include: a. On 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 -- November 1, 2022 at 12:07 PM the laboratory QA was requested. b. On November 1, 2022 at 12:18 PM the post analytic system was reviewed. The laboratory has established that the evaluation of patient result, turn around time and verification of corpuscular index (hematology) were going to be evaluated and monitored every 3 months. The laboratory has established that the evaluation of transcription of results (manual to computer) were going to be evaluate and monitor every 6 months. c. Review of the QA evaluations on November 1, 2022 at 12:18 PM, showed that evaluations of the patient test results were not performed as schedule on March 2022 nor June 2022. Review of the QA evaluations on November 1, 2022 at 12:18 PM, showed that evaluations of the turn around time were not performed as schedule on March 2022 nor June 2022. Review of the QA evaluations on November 1, 2022 at 12: 18 PM, showed that evaluations of the corpuscular index (hematology) were not performed as schedule on March 2022 nor June 2022. Review of the QA evaluations on November 1, 2022 at 12:26 PM, showed that evaluations of the transcription of results (manual to computer) were not performed as schedule on June 2022. d. On November 1, 2022 at 12:36 PM the laboratory technical supervisor confirmed that the laboratory failed to evaluate and monitor the post analytic system requirements. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Quality Assesstment (QA) recors reviewed and laboatory director failed to ensure compliance with QA requirements. Refer to D5291, D5891. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on manufacturers instructions, general immunology quality control records review (in years 2020-2021) and laboratory general supervisor interview at 10:30 AM on May 27, 2021, it was determined that the laboratory failed to perform Mycoplasma IgM test as required by manufacturer's instructions by Meridian Immunocard IgM method. The findings include: 1. The manufacturers establishes that the Mycoplasma IgM test must be performed at room temperature between 22 C to 25 C . 2. Review of general immunology records from January 2020 to January 2021, the records showed that the laboratory processed and reported thirty-three (33) Mycoplasma IgM patient's tests that was performed at temperatures below of range in the following twenty- four (24) days: Date temp.C # samples 4/16/20 21.0 1 4/19/20 21.0 2 4/21/20 21.0 1 4/22 /20 21.0 1 4/24/20 21.0 2 4/26/20 21.0 1 5/13/20 21.0 1 5/16/20 21.0 3 5/17/20 21.0 1 5/20/20 21.0 1 5/25/20 21.0 1 5/28/20 21.0 1 6/1/20 21.0 1 6/3/20 21.0 1 6/4/20 21.0 1 6/12/20 21.0 1 6/24/20 21.0 1 7/1/20 21.0 1 7/11/20 21.0 1 7/18/20 21.0 1 7/24/20 21.0 2 7/27/20 21.0 3 8/3/20 21.0 1 8/4/20 21.0 3 3. The laboratory processed and reported thirty-three (33) Mycoplasma IgM patient's samples those days. 4. The laboratory general supervisor confirmed on May 27, 2021 that the laboratory performed Mycoplasma IgM tests below the range established by the manufacturer's those days. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on manufacturers instructions, general immunology quality control records review (in years 2020-2021) and laboratory general supervisor interview at 10:30 AM on May 27, 2021, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5413. The finding includes: 1. The laboratory failed to perform Mycoplasma IgM test as required by manufacturer's instructions by Meridian Immunocard IgM method. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, general immunology quality control records review (in years 2020-2021) and laboratory general supervisor interview at 10:30 AM on May 27, 2021, it was determined that the laboratory failed to perform Mycoplasma IgM test as required by manufacturer's instructions by Meridian Immunocard IgM method. The findings include: 1. The manufacturers establishes that the Mycoplasma IgM test must be performed at room temperature between 22 C to 25 C. 2. Review of general immunology records from January 2020 to January 2021, the records showed that the laboratory processed and reported thirty-three (33) Mycoplasma IgM patient's tests that was performed at temperatures below of range in twenty-four (24) days. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on manufacturers instructiions, general immunology quality control records review(years 2020-2021) and laboratory general supervisor interview at 10:30 AM on May 27, 2021, it was determined that the general supervisor did not assure that quality control procedures were followed as established by the manufacturers instructions by the testing personnel. Refer to 5413. -- 2 of 2 --

Summary Statement of Deficiencies 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 hematology calibration records review, manufacturer's instructions and laboratory general supervisor interview on January 3, 2019 at 11:00 A.M., it was determined that the laboratory failed to perform the calibration procedures with at least the frequency recommended by the manufacturer (annually) for the hematology tests performed by the Sysmex KX-21N system. The findings include: 1. The laboratory uses a Sysmex KX-21N hematology system for CBC (Complete blood count) patient's tests. 2. The manufacturer's instructions establishes that a calibration is to be performed by a Sysmex technical service representative on an annual basis. 3. From January 2017 to December 2018, the calibration records showed that the laboratory did not perform at least annually the calibration procedures for the Sysmex KX-21N hematology system. The last calibration verification for Sysmex KX-21N system was performed on October 2017. 4. The laboratory general supervisor confirmed on January 3, 2019 at 11:00 A.M., that the laboratory failed to perform annually the calibration procedures for Sysmex KX-21N system. 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 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on calibration records review, manufacturer's instructions and laboratory general supervisor interview on January 3, 2019 at 11:00 A.M., it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1.The laboratory failed to perform the calibration procedures with at least the frequency recommended by the manufacturer (annually) for the hematology tests performed by the Sysmex KX-21N system. Refer to D5437. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on calibration records review, manufacturer's instructions and laboratory general supervisor interview on January 3, 2019 at 11:00 A.M., it was determined that laboratory general supervisor failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory failed to perform the calibration procedures with at least the frequency recommended by the manufacturer (annually) for the hematology tests performed by the Sysmex KX-21N system. Refer to D5437. -- 2 of 2 --