Salem Womens Clinic Lab

Summary Statement of Deficiencies 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 Laboratory's procedure manual, personnel records, and other laboratory documents for Quality Control (QC), temperature and Quality Assurance (QA), the Laboratory Director (LD) failed to fulfill the duties of the LD. Findings include: See D6020, D6030, D6032, D6046 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and 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 two (2) Individual Quality Control Plans (IQCP's) in place at this facility during survey, and interview with the Laboratory Director (LD), it was noted that both IQCP's were lacking a developed Quality Control Plan (QCP) and Quality Assessment Plan (QAP) review. Findings include: 1. Upon review of the two IQCP's used by this facility, it was noted that both lacked a complete IQCP, as they did not have evidence of review of two ( 2) of the requisite parts of an IQCP. 2. Upon review of the IQCP for the Beckton Dickson (BD) Affirm test system, it was noted that the date of the risk assessment was 11/21/2017. Upon request for past written 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 -- review of the BD Affirm IQCP Risk assessment dated 11/21/2017, none could be produced. 3. Upon review of the IQCP for the Cepheid GenX for Chlamydia trachomatis and Neiserria gonorrhea test system, it was noted that the date of the risk assessment was 11/21/2017. Upon request for past written review of the Cepheid Gen X for Chlamydia trachomatis and Neiserria gonorrhea Risk Assessment dated 11/21 /2017, none could be produced. 4. The LD confirmed during interview at 12:00 pm that there was no written detail for quarterly or annual review of QCP or QAP for the two IQCP's currently in use 5. The laboratory reports performing 1682 assays that involve these instruments and organisms annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual presented during survey and interview with the Laboratory Director (LD) and testing personnel #1 (TP #1), the LD failed to have a written procedure for competency assessment of TP performing moderate complexity testing which includes infectious agents listed by the State of Oregon as "Reportable Conditions". Findings include: 1. Upon review of the laboratory's procedure manual presented during survey, no procedure for competency assessment for all TP performing moderate complexity could be produced. 2. Upon review of the laboratory's procedure manual presented during survey, no procedure for reporting "reportable conditions" to the State of Oregon Public Health Lab or the County Public Health Lab could be produced. 3. Oregon state law says: "The laboratory must report to the local health department or state, the "reportable conditions"as indicated in OAR Chapter 333, Division 018". 4. Upon request for written documentation of competency assessment for TP #1 for 2024 and 2025 to date, none could be produced. 5. Upon request for written documentation of reportable conditions that had been reported to the Public Health Authorities in 2024 and 2025 to date, no written log or other documentation of reporting could be produced. 5. The LD and TP#1 confirmed during onsite interview @ 12:00 pm. that there is currently no procedure for competency assessment nor for "Reportable conditions". 6. The lab reports performing 14,752 moderate complexity assays annually. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the Laboratory Director (LD), the LD failed to create and maintain a current list with designation of duties for all persons authorized to perform any phase of laboratory testing. Findings include: 1. Upon request for a current list of all Medical Assistants (MA's) who are responsible for laboratory post analytical communication with Public Health officials for Reportable Conditions diagnosed at this lab, none could be produced. 2. Upon request for the procedure the MA's are taught to follow for reporting Reportable Conditions to Public Health Officials, none could be produced. 3. The sole testing personnel (TP #1), who performs all the moderate complexity testing in this lab, did not have a current written designation of duties. 4. On site interview with the LD at 12:00 pm, confirmed there was no current and inclusive designation of duties for all persons involved involved in any phase of laboratory testing. 5. The laboratory reports performing 14,752 laboratory assays annually. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on request for written competency assessments for the one (1) testing personnel (TP #1), the Techical Consultant (TC), (also the Laboratory Director or LD), failed to ensure TP #1 had annual competency assessments for moderate complexity testing. Findings include: 1. Upon request for written competency assessments for TP #1 who performs moderate complexity testing in this lab, none could be produced for 2024 or 2025 to date. 2. The laboratory currently uses three (3) instruments to perform moderately complex testing. 1. The Cepheid Genex for Chlamydia trachomatis and Neisseria gonorrhea 2. The Becton Dickson (BD) Affirm for Candida species, Gardnerella vaginalis and Trichomonas vaginalis. 3. The Roche Cobas e 411, currently performing nine (9) different endocrinology assays. 3. Interview with the LD (also the TC) and TP #1 at 12:00 pm confirmed that there was no written competency documentation for any of the moderate complexity tests run by TP #1 for 2024 and 2025 to date. 4. The laboratory reports performing 14,752 moderate complexity assays annually. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Proficiency testing (PT) records for 2021, 2022 and 2023 and interview with testing personnel (TP #1) and the Laboratory Director (LD), the laboratory failed to ensure that the attestation form was filled in and signed by the LD. Findings include: 1. Fifteen (15) individual PT testing events were reviewed during survey August 1, 2023. Zero out of fifteen (15) testing event attestations had been signed off by the LD. 2. Upon review of the PT records for 2021, event #3 for Immunology, no signed attestation by the LD could be produced. 3. Upon review of the PT records for 2022 for Chemistry, Microbiology, and Immunology (3 events for each specialty), it was revealed that none of the twelve (12) PT testing events for 2022 had been attested to / signed by the LD. 3. Upon review of the PT testing events for 2023 Chemistry (2 events), Microbiology (2 events) and Immunology (1 event) received year to date, it was revealed that none of the five (5) events had been attested to / signed by the LD. 5. Interview with the LD and TP#1 at approximately 1330 confirmed that the attestation for each of the fifteen (15) PT events reviwed during survey had not been signed by the LD. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

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: Record review of the American Proficiency Institute (API) proficiency testing reveals that your laboratory has unsuccessful proficiency testing for General Immunology. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 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: Proficiency testing (PT) desk review of the American Proficiency Institute (API) PT shows unsatisfactory performance of two out of three events for the analyte Anti - human immonodeficiency virus (HIV). Findings include: 1 API 2nd Event 2019 Anti- HIV - 0%. 2. API 1st Event 2020 Anti-HIV - 0% -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) records and discussions with the staff the laboratory failed to enroll in PT for the regulated analytes performed using the Roche Cobas e 411 Chemistry Analyzer. Findings include: 1. The surveyor requested and the laboratory failed to provide PT testing results for the following regulated analytes. These analytes were TSH, Free Thyroxine, Triiodothronine and PSA. 2. The laboratory started in house testing of patients samples for these analytes April 2018. 3. The testing personnel was not aware that the laboratory needed to enroll in PT for these analytes. 4. The Laboratory Director and the testing personnel concurred with these findings 03/04/2019 at 12:00PM. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on review of Proficiency Testing records and discussion with the staff the laboratory failed to verify the accuracy of the test or procedure twice annually for the unregulated analytes performed using the Roche Cobas e411 Chemistry Analyzer. Findings include: 1. The surveyor requested and the laboratory failed to provide biannual verification of the test system for the following non regulated analytes. Vitamin B12, Vitamin D, Estradiol, Testosterone,TPO, FSH and SHBG. for 2018 and 2019. 2. The Laboratory Director and the testing personnel concurred with these findings 03/04/2019 at 12:00PM. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records and discussion with the staff the laboratory failed to perform calibration verification every six months for the analytes performed using the Roche Cobas E411 Chemistry Analyzer. Findings include: 1. The surveyor requested and the laboratory failed to provide documentations of calibration verifications for the following analytes. Vitamin B 12, Vitamin D, TPO (Thyroid Peroxidase Antibody), Estradiol, FSH (Follicle Stimulating Hormone), PSA (Prostate Specific Antigen), Testosterone, TSH (Thyroid Stimulating Hormone), SHBG (Sex Hormone Binding Globulin), Free T3 and Free T4. 2. The last documented calibration verifications were performed 12/13/2017. 3. The Laboratory Director and the full time testing personnel concurred with these findings on 03/04/2019 at 12:00 PM. -- 2 of 2 --