Optim Medical Center - Tattnall

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 14, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) documents from American Proficiency Institute (API), and confirmed by staff interviw the laboratory failed to submit their testing scores for the 2021, 2nd event for specialty Hematology, subspecialty Complete Blood Count (CBC). Findings: 1. A review of the API PT documents confirmed the laboratory failed to submit the results for the 2nd event of 2021 Specialty-Hematology, Subspecialty-CBC. 2. Interview with the Laboratory General Supervisor (LGS) , on 02/14/2023 in the hospital conference room, at approximately 11am , confirmed the above aftermentioned statement. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 -- 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) documents from American Proficiency Institute (API), and confirmed by staff interview, the Laboratory Director (LD) failed to ensure that results for 2021, 2nd event, Specialty-Hematology , Subspecialty- Complete Blood Count (CBC) was submitted within the time frames established by the PT program. Findings: 1. Review of the APT PT evaluation report of the results for 2021, 2nd event for CBC, the laboratory received a score of 0%, due to non- participation. 2. Staff interview with the Laboratory Manager (LM), on 2/14/ 2023 at approximately 1pm, in the hospital conference room, confirmed the above aforementioned statesment. The LM also stated that she was unaware that the results entered in the API system did not transmit. The LD had been notified as soon as they received the evaluation report with the score of 0%. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 19, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) procedure and QC documents for the Radiometer ABL 80 analyzer used for testing Arterial Blood Gases (ABG's) , review of QC records for D-dimer testing performed using the Alere Triage Meter and staff interview , the laboratory failed to perform two levels of controls with different concentrations at least once each day patient specimens were assayed. Findings: 1. Review of the QC procedure and QC documents for the ABL 80 ABG analyzer revealed the laboratory only performed external liquid control monthly or when a new lot number was placed into use and did not perform two external controls of different concentrations each day of patient testing. 2. Interview with the laboratory general supervisor and respiratory therapy supervisor (see CMS 209) on March 19, 2019 at 2 pm in the area where ABG testing is performed confirmed the laboratory was not performing two levels of different concentrations of external controls at least once each day patient specimens were assayed. They also confirmed an Individualized Quality Control Plan (IQCP) had not been performed. 3. Review of QC records for D- dimer testing performed on the Alere Triage meter revealed QC was only performed 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 -- monthly and when a new kit or lot number was placed into use. 4. Interview with the laboratory general supervisor (see CMS 209) on March 19, 2019 at 2 pm in the area where D-dimer testing is performed confirmed the laboratory was not performing two levels of different concentrations of controls at least once each day patient specimens were assayed and also confirmed an Individualized Quality Control Plan (IQCP) had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 9, 2018. 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 American Proficiency Institute (API) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2018 resulting in the first 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 -- unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: Refer to D 2155 D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. 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 American Proficiency Institute (API) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2018 resulting in unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes #865 ABO, #875 D(RHO) and #895 compatibility testing on event 2 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the three analytes listed above on event 2 of 2018 for failure to participate, resulting in 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 American Proficiency Institute (API) proficiency testing (PT) report, the laboratory director failed to ensure the laboratory maintained satisfactory performance in event 2 of 2018 resulting in the first unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. 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 -- 2 of 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) report, the laboratory director failed to ensure the laboratory maintained satisfactory performance in event 2 of 2018 resulting in unsuccessful occurrence for ABO blood group analyte # 865, Rhesus type D(RHO) analyte # 875, and compatibility testing, analyte # 895. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes #865 ABO, #875 D(RHO) and #895 compatibility testing on event 2 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the three analytes listed above on event 2 of 2018 with scores of 0% for failure to participate, resulting in unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 1, 2018. 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 from American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd 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 -- event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for partial pressure of oxygen (PO2) Blood gas. Findings include: Refer to D 2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for partial pressure of oxygen (PO2) blood gas, analyte # 325. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed PO2, analyte # 325 on event 3 of 2017 with a score of 60% and event 1 of 2018 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute(API) confirmed the laboratory failed PO2 on Event 3 of 2017 and Event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --