Steamboat Medical Group

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory failed to assess the competency of testing personnel (TP) after their initial competency but within their first 6 months of employment; assess or establish a written policy or procedure for assessing the competency of personnel in the positions of Clinical Consultant (CC), Technical Consultant (TC), and General Supervisor (GS) since the laboratory's last survey on 12 /02/2020. The laboratory conducts approximately 3,657 tests annually. Findings include: 1. A review of the laboratory's personnel files, and policies and procedures manual, revealed the laboratory was assessing initial and annual competency on newly hired TP, but not assessing competency at least 6 months after initial competency was assessed, nor had established a policy or procedure to assess competency of newly hired TP at least 6 months after their initial competency was assessed. 2. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for one out of one of the CC, one out of one of the TC, and one out of one GS listed on the CMS-209 Form since the last survey was conducted on 12/02 /2020. The laboratory conducts approximately 3,657 tests annually. 3. Based on an interview with the GS, on February 15, 2024, at approximately 12:30 PM, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency within 6 months of newly hired TP after completing their initial competencies, and failed to assess the competency of, or 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 -- establish a written policy or procedure to assess the competency of personnel in the positions of CC, TC, and GS. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory director (LD) failed to ensure that the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 12/02/2020. The laboratory conducts a total of approximately 3,697 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with the GS on February 15, 2024, at approximately 11:45 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology prior to their use in the laboratory. -- 2 of 2 --

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 a routine proficiency test desk review of the CMS-155 report for proficiency testing performance and an interview with the practice administrator, the laboratory failed to achieve satisfactory performance scores for hematology and platelets for two consecutive events (Event 2 and Event 3 in 2022). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 review of proficiency testing scores from the American Proficiency Institute (API) and telephonic communication with the practice administrator, the laboratory failed to achieve satisfactory scores of at least 80 percent for hematology and platelet testing performed on Event 2 and Event 3 in 2022, resulting in unsuccessful performance. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 04/13/2023, at 12: 09 PM, revealed the hematology testing score for Event 2 in 2022 was 71% and for Event 3 in 2022 was 73%; the platelet testing score for Event 2 in 2022 was 40% and for Event 3 in 2022 was 60%. 2. Telephonic communication with the practice administrator on 04/17/2023, at 8:30 AM, confirmed the two consecutive unsuccessful proficiency test scores for hematology and platelet testing due to laboratory errors. -- 2 of 2 --