Rhea Clinic Pc

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 review of the laboratory procedure manual, employee personnel records for 2021, 2022, and 2023, and interview with the lead testing person, the laboratory failed to have personnel policies for assessing competency that was in compliance with the regulations in subpart M. The findings include: 1) Review of the laboratory procedure manual and competency assessment documentation forms revealed the following that was not included in the testing personnel competency assessment policy: initial training and demonstration of accuracy semiannual competency during the first year of testing annual competency thereafter assessment of problem solving skills blind testing 2. Review of testing personnel files revealed the following for the Cell Dyn Emerald Complete Blood Count instrument: testing person #1: began patient testing in January 2021, no documentation of initial training with demonstration of accuracy, no blind testing and no problem solving for competency performed in 2021, 2022 and 2023. testing person #2: began patient testing in March 2022, no semiannual competency, no blind testing and no problem solving for competency performed in 2022 and 2023. testing person # 3: began patient testing in August 2021, no documentation of initial training with demonstration of accuracy during training, no annual competency for 2022, no documentation of blind testing or problem solving for competency performed 1/04/2022 and 1/03/2022 . testing person #4: annual competencies performed 8/18/2021, 1/04/2022, and 1/03/2023 did not include documentation of blind testing or problem solving. 3) Interview on January 12, 2023 at 1:25 p.m. with the lead testing person confirmed the testing personnel competency procedure was not in compliance with subpart M of the regulations when it did not 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 -- include requirement for initial training and demonstration of accuracy during training, requirement for semiannual competency during the first year of testing, annual competency thereafter and documentation did not include assessment of problem solving skills or blind testing on the competency assessment forms. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers For Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), personnel file and an interview with the lead testing person, the Technical Consultant (TC) failed to perform and document semi-annual competency evaluation for 3 of 5 testing personnel in 2021 and 2022. The findings include: 1. Review of the laboratory's Form CMS-209 revealed five testing personnel performing moderate complexity testing. 2. Review of testing personnel files revealed no semi-annual competency evaluation results for the following: testing person #2: began patient testing in January 2021. testing person #3: began patient testing in March 2022. testing person # 4: began patient testing in August 2021. 3. Interview with the lead testing person on January 12, 2023 at 1:25 pm confirmed that no semi-annual competency evaluation performed and documented for three of five testing person in 2021 and 2022. -- 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the hematocrit analyte in 2019 event two and 2020 event one, resulting in the first unsuccessful PT occurrence for the hematocrit analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a desk review of the Center for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's 2019 and 2020 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance in two out of three PT events for the hematocrit analyte, resulting in the first unsuccessful PT occurrence for the hematocrit analyte. The finding include: 1) Review of the CMS 155 report revealed unsatisfactory scores for the hematocrit analyte as follows: 2019 event two = 0% 2020 event one = 60% 2) Review of the laboratory's proficiency testing records revealed the following: 2019 event two: sample numbers SYX-6, SYX-7, SYX-8, SYX-9, and SYX-10 scored as unacceptable for the hematocrit analyte, resulting in overall score of 0%. 2020 event one: sample numbers HD-2 and HD-3 scored as unacceptable for the hematocrit analyte, resulting in an overall score of 60%, and the first unsuccessful PT occurrence for the hematocrit analyte. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the 2018 and 2019 proficiency testing (PT) records and interview with testing personnel number one, the laboratory testing personnel performing the wet prep and urine microscopic results did not sign the attestation statement. The findings include: 1) Review of the 2018 events one, two, three, 2019 events one and two PT records revealed the testing personnel signatures on the PT attestation statement were not testing personnel that were performing the wet prep and microscopic results. 2) Interview on July 23, 2019 at 10:20 a.m. with testing personnel number one confirmed the providers perform the wet prep and urine microscopic examinations, but did not sign the PT attestation statements. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory quality assessment (QA) procedure, the 2018 proficiency testing (PT) records, and interview with testing personnel number one, the laboratory failed to verify the accuracy of the urine microscopic analyte in 2018. The findings include: 1) Review of the QA procedure revealed no procedure for verifying Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- the urine microscopic analyte accuracy twice a year. 2) Review of the 2018 PT records revealed no participation in 2018 events one and two, and a score of 50% for event three. 3) Interview on July 23, 2019, at 11:30 am with testing personnel number one confirmed the urine microscopic analyte did not receive scores in 2018 events one and two and a 50% score in event three. There is no verification of accuracy for the urine microscopic analyte in 2018. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the temperature logsheets and interview with the office manager, the laboratory failed to document the temperature of the refrigerator, in 2017, 2018 and 2019. The findings include: 1) Observation on July 23, 2019 at 10:05 a.m. of the laboratory revealed two refrigerators in use, number one labeled for the laboratory, number two labeled for the reference laboratory. The laboratory complete blood count (CBC) quality control (QC) samples were maintained in the number two refrigerator. 2) Review of the 2017, 2018 and 2019 temperature logsheets revealed refrigerator temperature documentation for one refrigerator. 3) Interview on July 23, 2019 at 11:50 a.m. with office manager confirmed the number two refrigerator belonged to the reference laboratory and that the laboratory stored the CBC QC samples in the number two refrigerator. The laboratory did not record the temperature of the number two reference laboratory refrigerator in 2017, 2018 and 2019. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the complete blood count (CBC) records and interview with testing personnel number one, the laboratory failed to establish, perform and document a maintenance and/or function check protocol, in 2019. The findings include: 1) Review of the CBC records revealed the mainteance and/or function check for the Abbot Cell Dyn Emerald was not established and documented beginning May 2019 to current survey date, July 23, 2019. 2) Interview on July 23, 2019, at 11:10 a. m. with testing personnel number one confirmed the maintenance logsheet for the -- 2 of 6 -- Abbott Cell Dyn Emerald was not established for the maintenance and/or function checks documentation, beginning May 2019. There is no documentation of the maintenance and/or function checks. 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: The laboratory director failed review, approve, sign and date the verification of performance specifications (Refer to D6013); failed to ensure the PT results were returned to the PT agency (Refer to D6017); failed to perform and document proficiency testing