Imc Diagnostic And Medical Clinic

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Application for Certification (CMS-116), a review of Personnel records, and an interview with the General Supervisor, the Technical Consultant failed to evaluate competency annually for Testing Personnel performing Serum Human Chorionic Gonadotropin (hCG) and Serum Mononucleosis testing. This was noted for eight out of eight previously qualified Testing Personnel from the date of the last survey, 8/31/22, to the date of the current survey, 2/15/2024. The findings include: 1. A review of the laboratory's current CMS-116 form noted Serum hCG and Serum Mono on the testing menu. 2. A review of Personnel records revealed annual competency assessments for all eight Testing Personnel for the year 2023. No evidence of competency assessment for Serum hCG and Serum Mono testing was available. 3. During an interview on 2/14/2024 at 11:24 AM, the General Supervisor confirmed the above findings. 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 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 a review of the validation documentation for the current lot number of Innovin Prothrombin Time (PT) reagent on the Sysmex CA-620 analyzer, a review of the product insert, and an interview with the General Supervisor, the surveyor determined the laboratory failed to ensure all information was entered in the instrument when the new lot number (#) of Innovin was implemented, and failed to ensure validation procedures included manual checks of the INR (International Normalized Ratio) calculation on the instrument. This was noted on one of one lot numbers of PT reagent in use. The findings include: 1. During the entrance tour on 8 /30/2022 at approximately 11:30 AM, the General Supervisor stated coagulation testing (PT [Prothrombin Time] and PTT [Partial Thromboplastin Time]) was performed on the new Sysmex CA-620. The surveyor requested a review of the current lot # and ISI (International Sensitivity Index) of Innovin reagent on the instrument. The Supervisor provided an instrument printout with the following: PT 06 /23/2022 [The date the new lot # was entered] PT INN 549797 [The Lot # of Innovin in use] 05/11/2024 [The Innovin expiration date] NORMAL 10.00 sec [The Normal Patient Mean] ISI 1.04 2. On 8/31/2022 at 9:40 AM, the surveyor requested the package insert and the validation records for the current lot # of Innovin reagent. The General Supervisor provided the Innovin package insert and data from 25 normal patients used for the calculation of the Normal Patient Geometric Mean (NPGM) which equaled 10.03552, rounded to 10.0 seconds. However, the surveyor noted the package insert and the NPGM calculation were for Innovin Lot #564610, Expiration 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 -- Date-01/20/2025 with an ISI of 1.04, not Lot #549797, Expiration Date-05/11/2024 as viewed on the instrument printout during the entrance tour. 3. During an interview on 8/31/2024 at 9:45 AM, the surveyor reviewed the above information with the General Supervisor, and asked about the discrepancy. The Supervisor investigated and stated on 6/23/2022 she had carefully updated the Sysmex CA-620 with the new NPGM (10.0) and ISI (1.04) for Innovin Lot #564610, however she had forgotten to update with the new Lot #/Expiration, so the previous reagent Lot #/Expiration remained in the system. 4. As the interview continued at 9:55 AM, the surveyor asked if the laboratory manually checked the INR (International Normalized Ratio) calculation on the instrument when implementing a new lot number of Innovin. The General Supervisor confirmed she had not because she did not know it was required. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 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 a review of the CMS (Centers for Medicare and Medicaid) CASPER reports, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully participate in Valproic Acid proficiency testing for two consecutive testing events, Event #3, 2021 and Event #1, 2022. These two consecutive failures resulted in initial unsuccessful proficiency testing. The findings include: Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to satisfactorily perform in Valproic Acid proficiency testing for two consecutive testing events, Event #3, 2021 and Event #1, 2022. These two consecutive failures resulted in initial unsuccessful proficiency testing. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following: a) Valproic Acid, Event #3, 2021 60 % b) Valproic Acid, Event #1, 2022 60 % These two consecutive failures resulted in initial unsuccessful proficiency testing. 2. During a telephone interview on May 10, 12:58 PM, the testing personnel stated she was aware of the failures. She further explained she believe the failures resulted from mixing errors (bubbles in the specimens). -- 2 of 2 --