Downriver Internist Pc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to include the units of measurement for the hematology and chemistry testing in the electronic medical records (EMR) system for nine of nine patient charts audited. Findings include: 1. A record review revealed for nine of nine patient charts audited, the final testing results in the EMR did not include the units of measurement for the complete blood count (CBC- excluding the hemoglobin and hematocrit), thyroid stimulating hormone (TSH), and the lipid panel (cholesterol, triglycerides, high density lipoprotein, and low density lipoprotein [calculation), as follows: a. 404 tested on 6/25/2021 - CBC TSH, and lipid panel b. 3987 tested on 8/22 /2021 - CBC, TSH, and lipid panel c. 2367 tested on 10/08/2021 - CBC and lipid panel d. repeat testing for JL on 12/06/2021 - TSH e. 2303 tested on 2/08/2022 - CBC and lipid panel f. 3440 tested on 4/22/2022 - lipid panel g. 360 tested on 6/17/2022 - TSH h. 5578 tested on 8/05/2022 - CBC, TSH, and lipid panel i. 194 tested on 10/14 /2022 - CBC, TSH, and lipid panel 2. During the interview on 12/06/2022 at 12:15 pm, the TC confirmed the final test results in the EMR do not contain the units of measurement. 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 -- D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant j(TC), the laboratory failed to provide the educational requirements for 1 (testing personnel #2 [TP2]) of 2 testing personnel performing moderately complex hematology testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure personnel performing Complete Blood Count (CBC) testing were qualified for 1 (Testing Personnel [TP] #2) of 2 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of the laboratory's testing personnel records revealed a lack of qualification documentation for TP2. 2. An interview on 12/06/2022 at 10:578 am, the TC confirmed qualification documentation was not available for TP2. 3. The laboratory was given an additional 7 days to supply the necessary education documents. The documents were not received. -- 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: cholesterol, HDL (HDL). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events. Refer to 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the following chemistry analyte: cholesterol, high density lipoprotein (HDL) in two of three consecutive testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constitutes unsuccessful performance for cholesterol (HDL). Records show that this is a subsequent unsuccessful performance for cholesterol (HDL). cholesterol (HDL) PT event Score 3rd event 2020 60% 1st event 2020 40% 1st event 2019 40% 2nd event 2018 40% -- 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 review of the CMS database and review of the American Proficiency Institute (API) final graded proficiency testing reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte Cholesterol, High Density Lipoprotein (HDL). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API), the laboratory failed to achieve successful performance for the analyte, Cholesterol, High Density Lipoprotein (HDL), in two of three consecutive testing events. Findings include: Cholesterol HDL Event Score 1st event 2019 40% 2nd event 2018 40% -- 2 of 2 --