Baptist Memorial Medical Group Inc-Ucdc

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 proficiency testing desk review from the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's American Proficiency Institute (API) 2025 Proficiency Testing (PT) records, the laboratory failed to successfully participate 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 PT for the analyte quantitative Human Chorionic Gonadotropin (HCG). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 a PT desk review of the CASPER 0155 report and the laboratory's API PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the quantitative HCG analyte for two of three consecutive testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: A score of 60% for the HCG analyte for 2025 Event One. A score of 60% for the HCG analyte for 2025 Event Three. 2. A review of the laboratory's API PT records confirmed the above findings. 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 a proficiency testing desk review of the CASPER 0155 report and the laboratory's API 2025 PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 proficiency testing desk review of the CASPER 0155 report and the laboratory's API 2025 PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2108. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to maintain the PT instrument printouts for a period of two years for two of ten PT events reviewed. The findings include: 1. A review of the laboratory's API PT records revealed the Complete Blood Count (CBC) instrument printouts were not maintained for 2023 Event Two for Hematology and 2023 Event Two for Bacteriology (Chlamydia, Gonorrhea, and Group B Strep detection on the Cepheid GeneXpert). 2. Testing person one confirmed the survey findings during an interview on 07.25.24 at 12:50 p.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory's procedure manual, API PT records, and staff interview, the laboratory failed to perform

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 participation in three out of three proficiency testing events for automated white blood cell (WBC) differential, resulting the second unsuccessful PT occurrence for the automated WBC differential analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Form 155 (CMS 155) and the laboratory's 2018 events two and three, and 2019 event one proficiency testing records, the laboratory failed to maintain satisfactory performance in three out three consecutive events for the white blood cell (WBC) differential, resulting in the second unsuccessful occurrence for the WBC differential. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory WBC differential scores: 2018 event two 53%, 2018 event three 13%, 2019 event one 60%. 2) Review of the laboratory 2018 event two evaluation report revealed unacceptable scores for WBC differential as follows: Granulocytes %- sample numbers HEM-06, Hem-07, Hem-10; Lymphocytes %-sample number HEM- 06; Monocytes/Mids %- sample numbers HEM-06, HEM-07, HEM-10, resulting in an overall score for the WBC differential of 53%. 3) Review of the laboratory 2018 event three evaluation report revealed unacceptable scores for WBC differential as follows: Granulocytes %-sample numbers HEM-11, HEM-12, HEM-13, HEM-14, HEM-15; Lymphocytes %-sample numbers HEM-11, HEM-13, HEM-14; Monocytes/Mids %- sample numbers HEM-11, HEM-12, HEM-13, HEM-14, HEM-15, resulting in an overall score for the WBC differential of 13%. 4) Review of the laboratory 2019 event one evaluation report revealed unacceptable scores for WBC differential as follows: Granulocytes %-sample numbers HEM-03, HEM-05; Monocytes/Mids% HEM-01, HEM-03, HEM-04, HEM-05, resulting in an overall score for the WBC differential of 60% and the second unsuccessful PT occurrence. The laboratory director failed to ensure successful PT compliance. 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 to maintain compliance with successful white blood cell (WBC) differential analyte proficiency testing (PT) for three consecutive events and failed to follow the approved allegation of compliance (AOC) for the WBC differential analyte, resulting in the second unsuccessful PT occurrence for the WBC differential analyte. (Refer to D6004) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or -- 2 of 3 -- she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's 2018 event two, 2018 event three, and 2019 event one proficiency testing (PT) evaluation reports and the laboratory's Allegation of Compliance (AOC), the laboratory director failed to follow the approved January 25, 2019 AOC for the WBC differential analyte, resulting in the second unsuccessful PT occurrence for the WBC differential analyte. The findings include: 1) Review of the CMS 155 report and the laboratory's 2018 event two and three, and 2019 event one PT evaluation reports revealed the WBC differential scores as follows: 2018 event two = 53%, 2018 event three = 13%, 2019 event one = 60%. 2) Review of the laboratory's AOC date January 25, 2019, in reference to a previous failure to maintain compliance with successful PT, signed by the laboratory director on February 5, 2019 revealed the following statements: "To prevent these deficiencies from reoccurring the following will be done. TP will be trained to have a second person review results before final submission is done, to prevent clerical error. Training also of TP to monitor QC results for possible trending or shifts that might suggest need for calibration. TC will monitor this clinic bi-monthly to prevent this from reoccurring." -- 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: The laboratory failed to maintain satisfactory participation in two out of three events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 PT records, the laboratory failed to maintain satisfactory performance for the WBC differential analyte, resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory scores: 2018 event two WBC differential = 53% 2018 event three WBC differential = 13% 2) Review of the laboratory's 2018 PT records revealed the following: 2018 event two: Granulocytes % sample numbers HEM-06, HEM-07 and HEM-10 scored as unacceptable; Lymphocytes % sample number HEM-06 scored as unacceptable; Monocytes/Mids % sample numbers HEM- 06, HEM-07 and HEM-10 scored as unacceptable, resulting in an overall WBC differential score of 53%. 2018 event three: Granulocytes % sample numbers HEM- 11, HEM-12, HEM-13, HEM-14, HEM-15 scored as unacceptable; Lymphocytes % sample numbers HEM-11, HEM-13, HEM-14 scored as unacceptable; Monocytes /Mids % sample numbers HEM-11, HEM-12, HEM-13, HEM-14, HEM-15 scored as unacceptable, resulting in an overall WBC differential score of 13%. -- 2 of 2 --