Summary:
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 supervisor interview, it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2021. The findings include: 1. On August 9, 2022 at 9:43 AM, the laboratory QA record was requested. No QA records was presented, nor found by the laboratory personnel. 2. Since January 2021 the laboratory did not evaluate practices related to: Patient confidentiality, Specimen identification and integrity, complaint investigation, communications and personnel competency. 3. The laboratory supervisor confirmed on August 9, 2022 at 11:22 AM, that those evaluations were not performed nor documented. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on Quality Assessment (QA) records and laboratory supervisor interview, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for pre-analytic systems. The findings include: 1. On August 9, 2022 at 9:43 AM, the laboratory QA record was requested. No QA records was presented, nor found by the laboratory personnel. 2. Since January 2021 the laboratory did not evaluate practices related to: Test request, specimen sumbmission and handling, specimen referral. 3. The laboratory supervisor confirmed on August 9, 2022 at 11:22 AM, that those evaluations were not performed nor documented. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the Urinalysis microscopic quality control review it was determined that the laboratory did not include and not document the negative microscopic control material when 1,116 patient were processed and reported from January 2021 to December 2021. The findings include: 1. The Urinalysis quality control was review on August 9, 2022 at 11:06 am. No negative quality control material was documented. 2. The laboratory supervisor confirmed on August 9, 2022 at 11:09 am that no microcopy negative control was included from January 2021 to December 2021 when 1,116 patient were processed and reported under the microcope. 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 Quality assesment (QA) record review and laboratory supervisor interview, it was determined that laboratory failed to to evaluate and monitor the analytic system requirements since January 2021. The findings include: 1. On August 9, 2022 at 9:43 AM, the laboratory QA record was requested. No QA records was presented, nor found by the laboratory personnel. 2. 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, systemn maintenance and function checks, verification of method performance speifications, calibration, control procedures, comparison of test results, test records,