Douglas Medical Specialists

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on Aug. 25, 2025. At the time of the review, thelaboratory was not in compliance with the ClinicalLaboratory Improvement Amendments of 1988,42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the CMS CASPER 155 report and review of the American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain 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 -- satisfactory proficiency testing (PT) participation for Total Iron Binding Capacity (TIBC) and Triglyceride (TRIG) in 2025 events 1 and 2, resulting in an initial unsuccessful participation for TIBC & TRIG. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of AAB reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 1st & 2nd events of 2025), resulting in an initial unsuccessful participation for TIBC and Trig. Findings: 1. A review of Casper Report 155 revealed the laboratory failed TIBC on the following: 2025 Event 1 TIBC Score 60% 2025 Event 2 TIBC Score 0% 2. A review of Casper Report 155 revealed the laboratory failed Trig on the following: 2025 Event 1 Trig Score 40% 2025 Event 2 Trig Score 0% 3. A review of the laboratory's AAB Reports confirmed the laboratory failed TIBC & Trig with the aforementioned scores. 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 review of the CMS CASPER 155 report and review of AAB reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. 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 review of the CMS CASPER Report 155 and the AAB 2025 events 1 & 2 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in TIBC and Trig in two consecutive testing events ( 2025 events 1 & 2), resulting in the initial unsuccessful participation for TIBC and Trig. Findings: 1. A review of Casper Report 155 revealed the laboratory failed TIBC on the following: 2025 Event 1 TIBC Score 60% 2025 Event 2 TIBC Score 0% 2. A review -- 2 of 3 -- of Casper Report 155 revealed the laboratory failed Trig on the following: 2025 Event 1 Trig Score 40% 2025 Event 2 Trig Score 0% 3. A review of the laboratory's AAB Reports confirmed the laboratory failed TIBC & Trig with the aforementioned scores. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing review was completed on February 22, 2023. 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 condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 proficiency testing review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American 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 -- Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory performance in two consecutive events ( 2nd and 3rd events of 2022), resulting in the initial unsuccessful performance for Total Bilirubin (TBIL).. Findings include: Refer to D 2096 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 review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory performance in two consecitive events ( 2nd & 3rd events of 2022), resulting in the initial unsuccessful performance for Total Bilirubin (TBIL). Findings include: 1. Review of Casper Reports 153 and 155 disclosed the laboratory failed TBIL: a. 2022 event 2 score of 60% b. 2022 event 3 score of 20%. 2. Review of the laboratory's AAB reports confirmed the laboratory failed the TBIL on the aforementioned testing events. 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 review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (2nd and 3rd events of 2022), resulting in the initial unsuccessful performance for Total Bilirubin (TBIL). 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 review using the Centers for Medicare and Medicaid -- 2 of 3 -- (CMS) Casper Reports 153 and 155 and review of the laboratory's American Association of Bioanalysts (AAB) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events ( 2nd and 3rd events of 2022), resulting in the initial unsuccessful performance for Total Bilirubin (TBIL). Refer to D 2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 22, 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 consecutive events (1st and 2nd events of 2022), resulting in the 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 -- first unsuccessful occurrence for Routine Chemistry # 245 including: Glucose #415. Findings include: Refer to D 2096 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 consecitive events (1st and 2nd event of 2022), resulting in the first unsuccessful performance for glucose, analyte # 415. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 415 Glucose on event 1 of 2022 with a score of 0% and event 2 of 2022 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanaysts (AAB) confirmed the laboratory failed glucose on Event 1and Event 2 of 2022 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 consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Glucose (Gluc), analyte # 415. 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 -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Glucose (Gluc), analyte # 415. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 415 , Gluc on event 1 of 2022 with a score of 0% and event 2 of 2022with a score of 0%. 2. . Desk review of the laboratory's proficiency testing reports from American Association of Bioanaysts (AAB) confirmed the laboratory failed glucose on Event 1and Event 2 of 2022 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a CLIA Reinstatement Survey performed on October 1, 2020, this facility was found to not be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of