Rochester Medical Group

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to ensure written competency policies were followed for 14 (Testing Personnel (TP) #1 - #14) of 14 testing personnel performing the hematology complete blood cell count (CBC) for 2 years reviewed. Findings include: 1. A record review of the "Personnel Competency Policy/Procedure" lists the following 6 categories to be reviewed during a competency assessment as follows: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed samples. f. Assessment of problem solving skills. 2. A record review for 14 (TP #1 - #14) of 14 TP the competency assessment lacked documentation for the following in the assessments in 2019 and 2020: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Direct observation of performance of instrument maintenance and function checks. c. Assessment of problem solving skills. 3. A interview on 2/08/21 at 10:18 am, the TC confirmed the competency policy was not followed to assess all six requirements from Subpart M for the 2 years reviewed. 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 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 (Casper 0155D report) and review of the American Association of Bioanalysts (AAB) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of Hematology for 2 (3rd event 2018 and 2nd event 2019) of 3 consecutive events. Refer to D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 an overall testing event score of satisfactory performance for 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 record review of Casper Report 0155D and graded proficiency testing results from American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance for the specialty of Hematology in 2 (3rd event 2018 and 2nd event 2019) of 3 consecutive testing events. Findings include: 1. Review of Casper Report 0155D and AAB proficiency testing results revealed the following scores for the specialty of hematology: Hematology PT Events Score 3rd event 2018 60% 2nd event 2019 0% -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document the weekly maintenance for the hematology Cell-Dyn Emerald instrument for 13 (November - December 2016, January - February, and April to December 2017) of 18 months reviewed. Findings include: 1. On June 6, 2018 at 10:20 AM, record review of the "Cell-Dyn Emerald Maintenance Log" listed one task to be performed weekly: "Perform weekly Checklist Reviews". 2. On June 6, 2018 at 10:20 AM, record review of the "Cell-Dyn Emerald Maintenance Log" revealed there was no documentation to show the weekly maintenance had been performed and documented for 13 (November - December 2016, January - February, and April to December 2017) of 18 months reviewed. 3. During the interview on June 6, 2018 at 10:20 AM, the laboratory liaison confirmed the weekly maintenance had not been performed and documented. 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, 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 -- 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 record review and interview, the laboratory failed to perform the calibration procedures for the Cell-Dyn Emerald hematology analyzer at least every six months for one (first six months in 2017) of two years reviewed. Findings include: 1. On June 6, 2018 at 11:35 AM, review of the calibration data for the hematology Cell-Dyn Emerald analyzer revealed the laboratory did not perform and document the calibration procedure every six months for one (first six months in 2017) of two years reviewed. 2. On June 6, 2018 at 11:35 AM when queried, the office liaison was not able to provide the surveyor with the documentation to demonstrate the calibrations had been performed every six months in 2017. 3. During the interview on June 6, 2018 at 11:35 AM, the office liaison confirmed the calibrations for the hematology analyzer were not performed and documented every six months in 2017. -- 2 of 2 --