Winston Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing program. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 surveyor desk review of the laboratory proficiency testing (PT) records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory failed to achieve satisfactory performance in two of two testing events (2024-Event 1, and 2024-Event 2) resulting in unsuccessful participation in routine chemistry for TOTAL CHOLESTEROl. Refer to D2096. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8 /12/2024, the laboratory has not successfully performed proficiency testing for TOTAL CHOLESTEROL in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for TOTAL CHOLESTEROL: TOTAL CHOLESTEROL: Year 2024-1st Event 0% Year 2024-2nd Event 60% 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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 surveyor desk review of the laboratory proficiency testing records (graded -- 2 of 3 -- copies from the American Proficiency Institute and CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9/12/2023, the laboratory failed to maintain satisfactory performance in two of three testing events (2022-Event 3 and 2023-Event 2) resulting in unsuccessful participation for Prothrombin Time. Refer to D2130. 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 -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9 /12/2023, the laboratory has not successfully performed proficiency testing for Prothrombin Time in two of three testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Prothrombin Time: Prothrombin Time: Year 2022- 3rd Event 0% Year 2023-2nd Event: 60% -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 1. Based on review of the Laboratory Policy and Procedure Manual, interview with the general supervisor on 9/24/20 at 10:00 a.m., and lack of documentation of calibration of the Clay Adams Sero-Fuge II centrifuge, used in ABO/Rh testing, the laboratory failed to follow its Centrifuge Calibration Procedure since the last survey on 4/18/18. Findings include: Review of the Laboratory Policy and Procedure Manual revealed the Centrifuge Calibration Procedure states, "The blood bank centrifuge is to be verified every 6 months by the technical consultant for proper performance." There was no documentation of calibration of the Clay Adams Sero-Fuge II centrifuge since the last survey on 4/18/18. In an interview on 9/24/20 at 10:00 a.m., the general supervisor confirmed there was no documentation of calibration of the centrifuge since the last survey. 2. Based on review of the Laboratory Policy and Procedure Manual, lack of documentation of speed and timer checks for the Clay Adams Sero- Fuge II centrifuge since the last survey on 4/18/18, and interview with the general supervisor on 9/24/20 at 10:00 a.m., the laboratory failed to establish a written procedure for speed and timer checks for the Clay Adams Sero-Fuge II centrifuge, used in ABO/Rh testing. Findings include: Review of the Laboratory Policy and Procedure Manual revealed no written procedure for performing speed and timer checks for the Clay Adams Sero-Fuge II centrifuge. In an interview on 9/24/20 at 10: 00 a.m., the general supervisor confirmed there was no written procedure for performing speed and timer checks for the Clay Adams Sero-Fuge II centrifuge. 3. Based on review of the Laboratory Policy and Procedure Manual, the Ortho Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Workstation Reference Guide, and the ID-Tipmaster Repetitive Dispense Pipettor Instructions for Use, the laboratory failed to establish written procedures for Ortho Workstation centrifuge speed and timer checks, incubator temperature and timing checks, and ID-Tipmaster Repetitive Dispense Pipettor maintenance and quality checks. Refer to D5431 (Failure to perform function checks since the last survey.) 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 review of manufacturer's instructions for the Sysmex CA-620 coagulation system, documentation of establishment of the geometric mean of the normal patient reference range, and observation of the Normal Value in the Sysmex CA-620 coagulation system on 9/23/20 at 10:30 a.m., the laboratory failed to follow manufacturer's instructions for INR (International Normalized Ratio) calculation for Dade Innovin prothrombin time (PT) reagent Lot #549766, put in use for patient PT testing on 5/11/20. A total of 166 patient PT/INR results were reported since 5/11/20, according to the laboratory information system. Findings include: Manufacturer's instructions for the Sysmex CA-620 coagulation system state to use the geometric mean of the normal patient reference range for INR calculation. Review of documentation of the calculation of the geometric mean of the normal patient reference range for Dade Innovin PT reagent Lot #549766 revealed the geometric mean was calculated at 10.7. On 9/23/20 at 10:30 a.m., the Normal Value observed in the Sysmex CA-620 coagulation system for calculation of patients' INR was 10.3. A total of 166 patient PT/INR results were reported since 5/11/20, according to the laboratory information system. 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: 1. Based on review of the Reference Guide for the Ortho Workstation, used in antibody screening and compatibility testing, interview with the general supervisor on 9/24/20 at 9:30 a.m., and lack of documentation of Ortho Workstation centrifuge speed and timing verification and incubator temperature and timing verification, the laboratory failed to perform and document these function checks since the last survey on 4/18/18. Findings include: Review of the Ortho Workstation Reference Guide revealed the Qualification Procedures state that the centrifuge must not be used if speed is outside of specification or if the timer is out of specification. The Qualification Procedures also state that the incubator temperature must read 37 degrees Celsius plus or minus 2 degrees and the incubator must not be used if the -- 2 of 3 -- timer is out of specification. There was no documentation of Ortho Workstation centrifuge speed and timing verification or of incubator temperature and timing verification since the last survey on 4/18/18. In an interview on 9/24/20 at 9:30 a.m., the general supervisor confirmed there was no documentation of these function checks since the last survey. 2. Based on review of the Instructions for Use for the Micro Typing System (MTS) ID-Tipmaster repetitive dispense pipettor, used in antibody screening and compatibility testing, interview with the general supervisor on 9/24/20 at 10:15 a.m., and lack of documentation of pipettor maintenance or quality checks, the laboratory failed to perform and document MTS ID-Tipmaster repetitive dispense pipettor maintenance and quality checks since the last survey on 4/18/18. Findings include: Review of the MTS ID-Tipmaster repetitive dispense pipettor Instructions for Use revealed the manufacturer recommends that the maintenance procedure should be performed at regular intervals and after the maintenance procedure, a Quality Check should be performed to check the volume. There was no documentation of performance of the maintenance procedure or Quality Check since the last survey on 4 /18/18. In an interview on 9/24/20 at 10:15 a.m., the general supervisor confirmed there was no documentation of the maintenance procedure or Quality Check since the last survey. 3. Based on review of the Instruction Manual for the Diamond Pro 10- microliter single channel pipettor, used in antibody screening and compatibility testing, interview with the general supervisor on 9/24/20 at 10:15 a.m., and lack of documentation of pipettor calibration, the laboratory failed to perform and document calibration of the pipettor since the last survey on 4/18/18. Findings include: Review of the Instruction Manual for the Diamond Pro 10-microliter single channel pipettor revealed the manufacturer recommends checking the calibration at least once a year. There was no documentation of calibration of the pipettor since the last survey on 4/18 /18. In an interview on 9/24/20 at 10:15 a.m., the general supervisor confirmed there was no documentation of calibration of the Diamond Pro 10-microliter single channel pipettor since the last survey. -- 3 of 3 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 3/28/19, the laboratory has not successfully participated in proficiency testing for FREE THYROXINE. Findings include: Our records indicate the following proficiency testing scores for your laboratory for FREE THYROXINE: PROFICIENCY TESTING PROVIDER: American Proficiency Institute FREE THYROXINE: Year 2018 3rd Event 60% Year 2019 1st Event 60% 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 -- Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 3/28/19, the laboratory has not successfully participated in proficiency testing for FREE THYROXINE. Findings include: Our records indicate the following proficiency testing scores for your laboratory for FREE THYROXINE: PROFICIENCY TESTING PROVIDER: American Proficiency Institute FREE THYROXINE: Year 2018 3rd Event 60% Year 2019 1st Event 60% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance -- 2 of 2 --