Bay Clinic Llp

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on the lack of written laboratory protocol regarding a Quality Assurance (QA) plan and lack of documentation of QA monitoring events or activities for this facility, the Laboratory Director (LD) failed to ensure that there was a current written QA Plan / Procedure with active QA monitors / activities in place for this facility. Findings include: 1. Upon request for a written procedure / QA plan, none could be produced. 2. Upon request for review of written QA monitors /activities conducted for all three (3) levels of testing, within the past two (2) years, none could be produced. 3. The TS confirmed during interview at 12:30 that no written QA Plan existed nor was there any evidence of QA activities conducted bi-annually at a minimum, for 2021, 2022 or 2023 to date. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: 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 -- Based on review of testing personnel (TP 1) competency records presented for review during survey and interview with the Technical Supervisor (TS). the Laboratory Director (LD) failed to ensure TP1 had annual competency evaluations by a CLIA qualified TS or designee. Findings include: 1. Upon review of the competency file for TP 1, there were no competency records for 2022 or 2023 for any assay (both moderate and high complexity assays) TP 1 performs in this laboratory. 2. The TP 1, who is also the TS, confirmed during interview at 1:30 pm that no competency assessment for any assay that is moderate or high complexity in this laboratory had been assessed for her in 2022 or 2023 to date. 3. The laboratory reports performing 164,674 moderate and high complexity tests annually. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to ensure that laboratory testing personnel (TP) had access to a current LD signed/ dated/approved standard operating procedure manual for all tests performed in this laboratory. Findings include: 1. Upon review of the laboratory procedure manual presented during survey, it was revealed that the hematology procedure with document ID as HEM.CBC.140, titled "Criteria for Smear Review by Pathologist", for a pathology review in the case of a patient presenting with immature white blood cells or other hematologic pathophysiology on a manual blood smear for differential and cell morphology had no LD signature or date of approval. 2. The effective date of HEM.CBC.140 was December 2006. 3. The revision date last shown for HEM.CBC.140 was March 2007. 4. The "Approved By", on HEM.CBC.140, which shows it to be the Pathologists's Name and Date under the signature line, is blank. 5. TP 1 (also the TS) confirmed during interview at 1:30 pm that there was no other current approved/ signed and dated SOP for sending manual blood smears out for pathology review and that she would make the decision to send it to Pathology based on her assessment of the periphreal blood smear. 6. The laboratory reports performing 33 manual cell differential/counts in the past year and 45,366 total hematology assays annually. -- 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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) showed the laboratory had unsuccessful participation for 1st event 2021 and 3rd event 2021 for the Specialty Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records the laboratory failed to achieve an overall satisfactory score for two out of three consecutive events in the Specialty Bacteriology. Findings include: 1. AAB 1st event 2021- Bacteriology = 79% 2. AAB 3rd event 2021- Bacteriology = 44% -- 2 of 2 --