Laboratorio Cima Camino Nuevo, Inc

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 lack of Quality Assessment (QA) activities records and laboratory general supervisor interview; it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2022 to January 2023. The findings include: a. On January 24, 2023 at 9:08 AM, the laboratory QA was requested. No QA record was available at the time of inspection. b. Since January 2022 the laboratory did not evaluate practices related to: Patient confidentiality, specimen identification and integrity, compliant investigation, communications and personnel competency. c. The laboratory general supervisor confirmed on January 24, 2023 at 9:50 AM, that the general systems QA evaluation were not available. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) records and laboratory general supervisor 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 -- interview, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for pre-analytic systems from January 2022 to January 2023. The findings include: a. On January 24, 2023 at 9:08 AM, the laboratory QA record was requested. No QA records was available at the time of inspection. b. Since January 2022 the laboratory did not evaluate practices related to: test request, specimen submission and handling, specimen referral. c. The laboratory general supervisor confirmed on January 24, 2023 at 9:50 AM, that the pre-analytic system QA evaluation were not available. 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: Based on lack of Quality Assessment (QA) records and laboratory general supervisor interview; it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for analytic systems from January 2022 to January 2023. The findings include: a. On January 24, 2023 at 9:08 AM, the laboratory QA record was requested. No QA records was available at the time of inspection. b. Since January 2021 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment, instruments, reagents, materials, specimen and reagent storage conditions, system maintenance and function checks, verification of method performance specifications, calibration, control procedures, comparison of test results, test records,

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on serum pregnancy qualitative test testing records (years 2017 to 2019) review and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that the laboratory failed to meet with the requirement for the subspecialty of Endocrinology (serum pregnancy qualitative tests) from April 22, 2018 to February 11, 2019. Refer to D 5449 (The laboratory did not include each day of testing the negative nor the positive control material when 22 patients specimens were tested and reported for serum pregnancy qualitative test from April 22, 2018 to February 11, 2019). D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on serum pregnancy qualitative test testing records (years 2017 to 2019) review 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 -- and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that the laboratory failed to include at least once a day the negative and the positive control materials when 22 patients specimens were tested and reported for serum pregnancy qualitative test from April 22, 2018 to February 11, 2019. The findings include: 1. On February 14, 2019 12:05 PM, the serum pregnancy qualitative test testing records showed that the the laboratory did not include at least once a day the negative nor the positive control materials when 22 patients specimens were tested and reported for serum pregnancy qualitative test from April 22, 2018 to February 11, 2019. 2. The technical consultant confirmed on February 14, 2019 12:05 PM, that the serum pregnancy qualitative tests testing records showed that the laboratory did not include the negative nor the positive control materials results. She stated that those control materials were include each day of testing but the controls results were not recorded each day. 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 serum pregnancy qualitative test testing records (years 2017 to 2019) review and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system for the subspecialty of Endocrinology (serum pregnancy qualitative tests) from April 22, 2018 to February 11, 2019. Refer to D 6020. D6020 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 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 serum pregnancy qualitative test testing records (years 2017 to 2019) review and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for serum pregnancy quantitative test from April 22, 2018 to February 11, 2019. Refer to D 6020 ( The laboratory director failed to ensure that the laboratory meet the requirement for the subspecialty of Endocrinology (serum pregnancy qualitative tests) from April 22, 2018 to February 11, 2019. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) -- 2 of 3 -- (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on serum pregnancy qualitative test testing records (years 2017 to 2019) review and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that technical consultant failed to ensure compliance with the requirements for analytic systems of serum pregnancy qualitative test from April 22, 2018 to February 11, 2019. Refer to D 5449 (The laboratory did not include at least once a day the negative nor the positive control materials when 22 patients specimens were tested and reported for serum pregnancy qualitative test from April 22, 2018 to February 11, 2019). 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 serum pregnancy qualitative test testing records (years 2017 to 2019) review and and interview with the technical consultant on February 14, 2019 12:05 PM, it was determined that testing personnel failed to follow quality control procedures for serum pregnancy qualitative tests from April 22, 2018 to February 11, 2019. Refer to D 5449 (The laboratory did not include at least once a day the negative nor the positive control materials when 22 patients specimens were tested and reported for serum pregnancy qualitative test from April 22, 2018 to February 11, 2019). -- 3 of 3 --