Corvallis Clinic, Pc Laboratory,The

Summary Statement of Deficiencies 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 identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance (QA) procedure (SOP) and interview with the laboratory's three (3) Technical Supervisors (TS) and one (1) Technical Consultant (TC), the laboratory failed to establish and follow a current QA Standard Operating Procedure (SOP). Findings include: 1. Upon review of the QA SOP in the procedure manual presented for review during survey, the SOP stated the lab staff and the Laboratory Director (LD) would all meet quarterly to discuss QA. 2. When asked for evidence of these meetings for 2023 and 2024, none could be produced. 3. Interview at 2:30 pm, with three (3) TS's and one (1) TC confirmed that the QA procedure in the procedure manual was outdated and not being followed as written, using the data collection forms in the SOP. 4. The laboratory reports performing 796,069 moderate and high complexity assays annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Upon review of the laboratory's procedure for Vaginal Wet mounts and Potassium Hydroxide (KOH) mounts and interview with the Microbiology Technical Supervisor (TS), it was revealed that the laboratory did not have a policy or procedure specific to the providers performing these assays in the Obstetrics department of the facility. Findings include: 1. Upon request for the laboratory's Vaginal Wet Mount and KOH procedure, it was revealed that the procedure produced pertained to laboratory staff only and not other providers performing these assays outside of the laboratory in the Obstetrics Department of this facility that are under this CLIA certificate. 2. Upon review of competency assessment records of the three providers performing Vaginal Wet Mounts and KOH mounts, it was revealed that zero (0) out of three (3) providers were in compliance with competency assessment assignments. 3. Interview with the Microbiology TS on 09/25/2024 at 12:30 pm revealed that no procedure specific to the three (3)providers performing Vaginal Wet mounts, Fern testing and KOH mounts, including the frequency and expectation of competency assessment participation. During the same interview with the TS, it was revealed that the three (3) providers had recently suggested patient self collected vaginal swabs for these assays, so a policy/procedure for patient self collected vaginal swabs was requested. None could be produced. The Microbiology TS confirmed the laboratory had no knowledge of a procedure for patient self collected vaginal swabs. 4. The number of Vaginal Wet mounts and KOH mounts performed by these three (3) providers could not be determined. 5. See D6012 D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel records and interview with three (3) Technical Supervisors (TS) and one (1) Technical Consultant, the Laboratory Director (LD) failed to ensure that an approved written and current list of all laboratory personnel performing any or all three (3) phases of laboratory testing and competency assessment was signed, approved and available for review. Findings include: 1. Upon request for a current list of all testing personnel (TP) and technical laboratory personnel performing pre-analytical, analytical and post analytical testing, none could be produced. 2. Interview with the three (3) TS's and one (1) TC at 1030 on 09/25 /2024 confirmed that there was no current LD approved written document designating who can do what in this laboratory. 3. The laboratory reports performing 796,069 moderate and high complexity assays annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 4 -- 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 review of the laboratory's Quality Assurance (QA) plan and interview with laboratory three (3) Technical Supervisors (TS) and one (1) Technical Consultant (TC), the Laboratory Director (LD) failed to ensure a current signed and approved QA plan was in place. Findings include: 1. See D5291 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: Based on review of competency assessment assigned to three (3) providers performing Potassium Hydroxide (KOH) Vaginal wet mounts and FERN testing in the Obstetrics department, the Laboratory Director (LD) failed to ensure that the providers complied with the requisite competency assessments assigned to them for 2023 and 2024. Findings include: 1. Review of the MTS on line training assigned to each of the providers revealed the following: Provider # 1 Assignments for dates back to 01/1/2020 up to date of survey revealed that provider # 1 performed 0 out of 10 competency assignments for Vaginal Wet Prep. Provider # 1 Assignments for dates back to 07/1/2021 up to date of survey revealed that provider # 1 performed 0 out of 7 competency assignments for Vaginal KOH prep. NO FERN competency assignments for this provider. Provider # 2 Assignments for dates back to 01/1/2020 up to date of survey revealed that provider # 2 performed 1 out of 8 competency assignments for Vaginal Wet Prep. Provider # 2 Assignments for dates back to 01/1/2021, up to date of survey revealed that provider # 2 performed 1 out of 8 competency assignments for Vaginal KOH prep. Provider # 2 Assignments for dates back to 01/1/2020, up to date of survey revealed that provider # 2 performed 3 out of 10 competency assignments for the FERN test. Provider # 3 Assignments for dates back to 01/1/2021 up to date of survey revealed that provider # 3 performed 0 out of 8 competency assignments for Vaginal Wet Prep. Provider # 3 Assignments for dates back to 01/1/2021 up to date of survey revealed that provider # 3 performed 0 out of 8 competency assignments for Vaginal KOH prep. Provider # 3 Assignments for dates back to 01/1/2021, up to date of survey revealed that provider # 3 performed 0 out of 8 competency assignments for the FERN test. 2. Interview with the the Technical Supervisors (3) confimed that the three (3) Obstetrics providers did not attempt or complete the assigned competency assessments for Vagina Wet Preps, Vaginal KOH mounts or Fern testig, assigned twice per year on the MTS on line training site. 3. Request for test number of the three (3) assays being performed by the three (3) providers annually, none could be confirmed as providers do not always log these tests done bedside, per nursing personnel on the floor An estimate was given at four (4) per month. -- 3 of 4 -- D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel competency records provided during survey and interview with laboratory technical staff, the Laboratory Director (LD) failed to specify in writing, the duties of each supervisor and testing personnel. Findings include: 1. Request for a current list of duties and responsibilities of each person (name, not title) performing pre-analytic, analytic, and post analytic activities in this laboratory, none could be produced. 2. During summation for survey ending 09/25 /2024, the LD confirmed there was no current list of duties and testing allowed for each laboratory staff member (identified by name and not title) at this time. 3. The laboratory reports performing 796,069 moderate and high complexity tests annually. -- 4 of 4 --

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 College of American Pathologists (CAP) proficiency testing showed the laboratory had unsuccessful participation for two consecutive events in 2021 for the specialty Endocrinology. Refer to D2099 and D2107. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of College of American Pathology (CAP) Proficiency testing shows the laboratory failed to attain an overall of 80 percent in Endocrinology. Findings include: 1. 2nd event of 2021 - Endocrinology = 0%. 2. 3rd event of 2021 - Endocrinology = 75%. D2107 ENDOCRINOLOGY CFR(s): 493.843(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: Record review of proficiency testing (PT) from College of American Pathologist (CAP reveals that the laboratory had two consecutive unsuccessful performance for the analyte Cortisol. Findings include: 1. 2nd Event 2021 - Cortisol = 0% 2. 3rd Event 2021 - Cortisol = 0% -- 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 College of American Pathologists (CAP) proficiency testing showed the laboratory had unsucessful participation for three(3) of three (3) consecutive events in 2021 for the analyte total bilirubin. Refer to D2087. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and phone conversation with the Technical Supervisor (TS) the laboratory had unsuccessful performance in three (3) of three (3) consecutive events in 2021 for the analyte total bilirubin. Finding include: 1. CAP 1st Event 2021 - total bilirubin = 0% 2. CAP 2nd Event 2021 - total bilirubin = 0% 3. CAP 3rd Event 2021 - total bilirubin = 0% 4. This was confirmed by the TS during our phone conversation 11/30/2021 @ 16:58 PM. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Proficiency Testing (PT) records the Laboratory Director (LD) did not fulfill his responsibilities to provide overall management and direction of the laboratory. Refer to D6091 and D6092. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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: Review of the College of American Pathologists (Excel) (CAP) proficiency testing (PT) showed the laboratory had unsuccessful participation for the 1st and 2nd events 2021 for the analyte Total Bilirubin. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the College of American Pathologist (CAP) proficiency testing (PT) showed the laboratory had unsuccessful participation for the 1st and 2nd events of 2021 for the analyte Total Bilirubin (TBIL). Findings include: 1. 1st event 2021 , Total Bilirubin (TBIL) = 0% 2. 2nd event 2021, Total Bilirubin (TBIL) = 0% -- 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: Review of the College of American Pathologists (Excel) (CAP) proficiency testing (PT) shows laboratory had unsuccessful participation for the 2nd event of 2017 and 1st event of 2018 for Triiodothyronine in Endocrinology. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Record review of proficiency testing from College of American Pathologist (EXCEL) reveals that your laboratory has had unsuccessful performance for the test Triiodothyronine. The findings are: Triiodothyronine 2nd event 2017 60% Triiodothyronine 1st event 2018 0% -- 2 of 2 --