Hamilton Physician Group Murry Campus

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 23, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event of 2016 and 3rd event of 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 -- 2016), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815.; Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: Refer to D 2130 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful performance for Chemistry #245 including: ALT (SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. on event 3 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2020 and Event 1 of 2021 resulting in the first unsuccessful performance. 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. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Association of Bioanalysts (AAB), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: Cell ID or white blood cell differential (WBC DIFF) # 765, red blood cell count (RBC) #775, hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805, platelets (PLT) # 815. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the -- 2 of 4 -- laboratory failed with the following scores: Hematology #760 Event 3 of 2020 and 1 of 2021 a score of 0% on both events WBC DIFF # 765 Event 3 of 2020 and 1 of 2021 a score of 0% on both events RBC # 775 Event 3 of 2020 and 1 of 2021 a score of 0% on both events HCT # 785 Event 3 of 2020 and 1 of 2021 a score of 0% on both events HGB # 795 Event 3 of 2020 and 1 of 2021 a score of 0% on both events WBC # 805 Event 3 of 2020 and 1 of 2021 a score of 0% on both events PLT # 815 Event 3 of 2020 and 1 of 2021 a score of 0% on both events 2. Desk review of the laboratory's proficiency testing reports from AAB confirmed the laboratory failed event 3 of 2020 and 1 of 2021 resulting in the first unsuccessful performance. 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: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events ( 3rd event of 2020 & 1st event of 2021), resulting in the first unsuccessful occurrence for Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815; Chemistry #245 including: ALT (SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815, PTT -- 3 of 4 -- #835, PT #845; Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. on event 3 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2020 and Event 1 of 2021 resulting in the first unsuccessful performance. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on a CLIA Certifcation Survey performed on August 14, 2018 this facility was found to be non- compliant with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. 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 and interview with testing personnel (TP), the lab failed to monitor room temperature (RT) and relative humidity (RH) per the manufacturer's manual. Findings include: 1. Review of the temperature charts provided revealed the Beckman Coulter ACT Diff 2 required RT and RH be maintained at specific ranges. 2. Interview with TP #1 (CMS 209 form) on 08/14/18 in the lab at approximately 3:21 PM, confirmed the RT/RH was not monitored. 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. 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 observation and interview with testing personnel (TP), the lab failed to calibrate the LabCorp Horizon Mini E centrifuge per the procedure manual. Findings include: 1. Observation during the lab tour revealed the LabCorp Horizon Mini E centrifuge was last calibrated on October 19, 2015. 2. Interviews with TP #1 (CMS 209 form) on 08/14/18 in the lab at approximately 3:21 PM, confirmed the centrifuge had not been calibrated since 10/19/15. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on review of personnel documents and interviews with the office manager and testing personnel, the laboratory failed to employ a qualified person to fulfill the position of Technical Consultant (TC). Findings include: 1. Review of personnel documents revealed the lab director (LD) did not qualify for the position of TC. 2. Interview with the corporate manager and TP#1 (CMS 209) on 8/14/18 at 1:15 PM in the corner office confirmed the LD did not have the experience to fulfill the duties of TC. -- 2 of 2 --