Mcleod Dr Lindaberry At Carolina Forest

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 company. 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 a desk review of proficiency testing records, the laboratory had 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 3 -- successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology and for WBC Diff analyte. Refer to D2130 and D2131 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 a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in five of six consecutive testing events in the specialty of Hematology for WBC Diff analyte. Findings included: 1. Review of the CMS 0155 report revealed the following results: Hematology 2021 - 1st Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2021 - 3rd Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 2nd Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for the WBC Diff. 2. A proficiency desk review from American Proficiency (API) 2021 and 2022 proficiency testing records confirmed the laboratory received the above results. Word Key: WBC Diff=White Blood Cell Differential D2131 HEMATOLOGY CFR(s): 493.851(g) 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 a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2021 and 2022 records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the overall specialty of Hematology in four of six consecutive testing events. Findings included: 1. Review of the CMS 0155 report revealed the following results: Hematology 2021 - 1st Event the laboratory received an unsatisfactory score of 0% for Hematology. Hematology 2021 - 3rd Event the laboratory received an unsatisfactory score of 0% for Hematology. Hematology 2022 - 1st Event the laboratory received an unsatisfactory score of 73% for Hematology. Hematology 2022 - 3rd Event the laboratory received an unsatisfactory score of 0% for Hematology. 2. A proficiency desk review from American Proficiency Institute (API) 2021 and 2022 proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 a desk review of laboratory proficiency testing performance, revealed that 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 a desk review of proficiency testing results, revealed that 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 D2130 and D2131 -- 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: During an onsite recertification survey on 03/10/2022, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API) it was determined that the laboratory failed to successfully participate in proficiency testing for the overall specialty of hematology, the analyte WBC Diff, white blood cell count (WBC), platelets (Plt), red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb) for two out of three consecutive proficiency testing events reviewed (2021, Events 1 and 3). See D2121 and D2130. D2121 HEMATOLOGY 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 -- CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During an onsite recertification survey performed on 03/10/2022, based on review of the CASPER report 155D and laboratory proficiency testing records (graded report from API), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the overall specialty of hematology, the analyte WBC Diff, white blood cell count (WBC), platelets (Plt), red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb) for two out of three consecutive proficiency testing events reviewed (2021, Events 1 and 3). The findings include: 1. Review of CASPER report 155D revealed the following proficiency scores for your laboratory: a. 2021, Event 1:overall specialty of hematology: 0% WBC Diff: 0%,WBC: 0%, Plt: 0%, RBC: 0% , Hct:0%, Hgb: 0% b. 2021, Event 3:overall specialty of hematology: 0% WBC Diff: 0%,WBC: 0%, Plt: 0%, RBC: 0% , Hct:0%, Hgb: 0% 2. The scores were confirmed upon review of the graded API reports. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During the onsite recertification performed on 03/10/2022, based on review of CASPER report 155D and graded API results, it was determined that the laboratory failed to successfully participate in proficiency testing for the overall specialty of hematology, the analyte WBC Diff, white blood cell count (WBC), platelets (Plt), red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb) for two out of three consecutive proficiency testing events reviewed (2021, Events 1 and 3), resulting in unsuccessful proficiency testing performance. See D2121. 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: -- 2 of 3 -- Based on review of the Sysmex hematology operators guide, lack of documentation and staff interview, it was determined that the laboratory failed to monitor and document acceptable room temperature and humidity recordings for eight of eight months reviewed (August 2021 through March 2022). Findings include: 1. Review of the Sysmex hematology operators guide revealed that the test kit must be stored at 2 to 30 degrees Celsius. 2. During an onsite recertification survey on 03/10/2020, there was no documented room temperatures or humidity readings available for review for eight of eight months reviewed August 2021 through March 2022). 3. The laboratory manager confirmed during an onsite interview on 03/10/2022 at 2:00pm that the laboratory been performing and reporting the Sysmex hematology test results since August 2021 and had failed to document proper room temperature and humidity recordings for eight of eight months reviewed August 2021 through March 2022). -- 3 of 3 --