Wayne Health - Canfield And Tolan Park

Summary Statement of Deficiencies D0000 A recertification survey was performed on May 12, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003) for the following condition-level deficiency: 493.801 Condition: Enrollment and testing of samples. 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 record review and interview with the technical consultant, the laboratory failed to enroll in proficiency testing for its Human Immunodeficiency Virus (HIV) testing and missed two (2024 event one and 2025 event one) of six proficiency testing events reviewed. Findings include: 1. A review of the laboratory's HIV proficiency testing records revealed a lack of participation in 2024 event one and 2025 event one. 2. An interview on 5/12/25 at 10:05 am with the technical consultant confirmed the laboratory had not enrolled in 2024 and 2025 in time to receive the first events of each year. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- (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 record review and interview with the technical consultant, the laboratory director and testing personnel failed to attest to the routine integration of the samples into the patient workload for one (2024 VM-C) of four proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' proficiency testing records revealed a lack of signed attestations attest to the routine integration of the Human Immunodeficiency Virus (HIV) proficiency testing samples into the patient workload during event 2024 VM-C. 2. The surveyor requested the missing attestation forms on 5/12/25 at 10:08 am and 10:17 am and they were not made available. 3. An interview on 5/12/25 at 11:50 am with the technical consultant confirmed the signed attestation statements for the event 2024 VM-C were not present. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to retain proficiency testing records for at least two years for two (2023 VM-B and 2024 VM-B) of four proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' proficiency testing records revealed a lack of graded results, attestation statements, results generated by the laboratory, and documented reviews of proficiency testing performance for 2023 VM-B and 2024 VM-C. 2. The surveyor requested the missing documentation on 5/12 /25 at 10:17 am and was provided with the graded results printed from the proficiency testing provider's website, which lacked attestation statements, results generated by the laboratory, and documented reviews of proficiency testing performance. 3. An interview on 5/12/25 at 11:50 am with the technical consultant confirmed the lack of proficiency testing records for the events listed above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the technical consultant revealed the laboratory failed to ensure its potassium hydroxide (KOH) reagent used in performing KOH preparations had not exceeded expiration dates for one of three bottles observed. Findings include: 1. On 5/12/25 at 8:59 am, the surveyor observed a bottle of KOH -- 2 of 3 -- reagent near the microscope with the expiration date of 10/1/22. 2. An interview on 5 /12/25 at 10:37 am with the technical consultant confirmed the bottle had exceeded its expiration date. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to accurately transmit patient test results for its Human Immunodeficiency Virus (HIV) testing for one (patient #2) of five HIV patient test records reviewed. Findings include: 1. A review of the laboratory's patient testing log revealed patient #2 received testing using the Alere Determine HIV 1/2 Antigen and Antibody Combo test kit on 4/23/25 with the following results: a. Antibody: Reactive b. Antigen: Nonreactive 2. A review of the test report for patient #2 revealed a section stating "Result: HIV 1/2 Ag/Ab Combo: positive" but did not specify whether the antigen or antibody portion of the test was positive. 3. An interview on 5/12/25 at 11:33 am with the technical consultant confirmed the test report did not specify whether the antigen or antibody portion of the test was positive for patient #2. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2 (TC2), the laboratory failed to retain report forms used by the laboratory to record proficiency testing results and the attestation statement signed by the analyst and the laboratory director for at least 2 years for 1 (2nd Event 2022) of 3 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed a lack of documentation of the College of American Pathologists' Proficiency Testing 2nd Event in 2022 for viral markers. 2. The surveyor requested documentation of the proficiency testing event documentation on 3/21/23 at 10:44 am and the report forms used by the laboratory to record proficiency testing results and the attestation statement signed by the analyst and the laboratory director were not made available. 3. Email correspondence on 3/22/23 at 1:46 pm with TC2 confirmed the laboratory had not retained report forms used by the laboratory to record proficiency testing results and the attestation statement signed by the analyst and the laboratory director for the 2nd event in 2022. ***This is a repeat deficiency from the 8/31/15, 9/17/19, and 9/22 /21 surveys.*** 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 -- 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 record review and interview with Technical Consultant #2 (TC2), the laboratory failed to follow its competency assessment policy for testing personnel competency for 4 (Testing Personnel #2, 3, 7, and 8) of 8 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's personnel competency records revealed the following testing personnel lacked competency assessments: a. TC2/Testing Personnel #8 had no record of competency assessments performed in 2022. b. Testing Personnel #2 with a start date of 10/13/21, had one competency assessment performed on 10/17/22. No documentation of competency assessments performed at least semiannually within the first year of testing. c. Testing Personnel #3 with a start date of November 2021, had one competency assessment performed on 10/19/22. No documentation of a second competency assessment performed at least semiannually within the first year of testing. d. Laboratory Director /Testing Personnel #7 had no record of competency assessments performed in 2022. 2. A review of the laboratory's "Quarterly QA Checklists" from September 2021 to February 2023 revealed one of the checklist criteria was, "Are all testing personnel evaluated at six months after beginning patient testing and then at least annually thereafter?" and each checklist had an "SH" for these criteria indicated as reviewed. 3. A review of the laboratory's "Wayne State University Physician Group STD Clinic Laboratory" policy revealed a section titled "Competency Assessment" that was blank. 4. An interview on 3/21/23 at 10:36 am with TC2 confirmed the testing personnel listed above did not have competency assessments performed at six months after beginning patient testing and then at least annually thereafter for the testing personnel listed above. ***This is a repeat deficiency from the 8/31/15 and 9/22/21 surveys.*** 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. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2 (TC2), the laboratory failed to verify its Wet Preparation and Potassium Hydroxide (KOH) Preparation testing at least twice annually for 1 (2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed verification of accuracy testing for Wet Preparations and KOH Preparations was performed on 3/14/23 and 9 /21/21. 2. The surveyor requested verification of accuracy documentation for testing performed in 2022 on 3/21/23 at 10:42 am and it was not made available. 3. An interview on 3/21/23 at 10:42 am with TC2 confirmed the laboratory had not verified the accuracy of its Wet Preparation and KOH Preparation testing in 2022. ***This is a repeat deficiency from the 9/17/19 survey.*** -- 2 of 4 -- D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2 (TC2), the laboratory failed to follow its policy for maintaining its pipette used in Alere HIV-1/2 Ag/Ab Combo testing for 20 (August 2021 to March 2023) of 21 months reviewed. Findings include: 1. A review of the laboratory's "STD Laboratory Equipment Maintenance" policy revealed a section titled "Pipettes" stating, "Pipettes will be calibrated at least once a year by Precision Biomedical Services. A maintenance log will be signed after maintenance has occurred." 2. A review of the laboratory's documentation for pipette maintenance revealed the most recent time service was performed on the pipette was 7/21/21. 3. An interview on 3/21/23 at 10:39 am with TC2 confirmed the laboratory had not performed annual maintenance for the pipette used in Alere HIV-1/2 Ag/Ab Combo testing at least annually. ***This is a repeat deficiency from the 9/17/19 survey.*** D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2 (TC2), the Laboratory Director failed to ensure the quality assessment program was maintained and identified failures in quality as they occurred when quality control was not performed for the Alere HIV-1/2 Ag/Ab Combo test kit for 1 (7/16/22) of 12 testing dates reviewed. Findings include: 1. A review of the laboratory's

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #1 (TP1), the laboratory failed to establish safety procedures to ensure protection from hazardous materials for 1 (TP1) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. The surveyor observed TP1 eating in laboratory on 11/2/21 at 9: 14 am. 2. An interview on 11/2/21 at 9:14 am with TP1 confirmed they were eating in the laboratory. 3. A review of the laboratory's safety policies revealed a lack of policy about eating and drinking in the laboratory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 a lack of documentation and interview with Technical Consultant #1 (TC1), the laboratory failed to enroll in an approved proficency testing program for Anti-Human Immunodeficiency Virus (Anti-HIV) testing for 2 (September 2019 to September 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed a lack of documentation of enrolling in an approved proficiency testing program for the laboratory's "Rapid HIV 1/2 Ag /Ab" testing listed on the test menu. 2. An interview on 9/22/21 at 9:02 am with TC1 confirmed the laboratory had not enrolled in an approved proficiency testing program for its HIV testing. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency 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 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to maintain the attestation statement for 1 (2020 Event G-C) of 1 testing event reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' (CAP) proficiency testing records revealed a lack of attestation for the performance of Syphilis Serology testing in Event G-C of 2020. 2. An interview on 9/22/21 at 12:39 pm with TC1 confirmed the attestation for the event listed above was not available. ***This is a repeated deficiency from the 9/17/19 recertification survey.*** 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 record review and interview with Technical Consultant #1 (TC1), the laboratory failed to assess testing personnel competency for 2 (Testing Personnel #2 and #3) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency assessment records revealed Testing Personnel #2 and #3 did not have competency assessments performed in 2020. 2. A review of the laboratory's "Quarterly QA Checklists" from 10/1/19 to 8/12/21 revealed one of the checklist criteria was, "Are all testing personnel evaluated at six months after beginning patient testing and then at least annually thereafter?" and each checklist had a "Y" for these criteria indicated as reviewed. 3. An interview on 9/23/21 at 9:16 am with TC1 confirmed the testing personnel listed above did not have competency assessments performed in 2020. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet applicable preanalytic system requirements and correct identified problems. Findings include: 1. -- 2 of 4 -- The laboratory failed to follow urine specimen labeling policies. Refer to D5311 A. 2. The laboratory failed to establish specimen labeling procedures for Wet Prep and Potassium Hydroxide (KOH) examinations Refer to D5311 B. 3. The laboratory failed to follow its specimen collection procedure for vaginal specimens. Refer to D5311 C. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with Testing Personnel #1, the laboratory failed to follow urine specimen labeling policies for 2 of 2 urine specimens observed. Findings include: 1. A review of the laboratory's "STD Clinic Laboratory" procedure revealed a section titled "ORDERS FOR LABORATORY TESTS" stating, "Specimens should be labeled by the staff member collecting the specimen at the time of collection." and "Patients self -collecting specimens must be given a urine container or swabs that are prelabeled with first and last name and birthday and specimen source." 2. The surveyor observed two urine cups with the patient labels on the lid and not on the specimen on 9/22/21 at 9:19 am. 3. An interview on 9/22/21 at 9:19 am with TP1 confirmed the specimens had not been labeled with the patient information. B. Based on observation, record review, and interview with Testing Personnel #4, the laboratory failed to establish specimen labeling procedures for Wet Prep and Potassium Hydroxide (KOH) examinations for one of two observations of Wet Prep and KOH examinations observed. Findings include: 1. A review of the laboratory's "Wet Prep" procedure revealed it did not mention the labeling of patient specimen slides. 2. The surveyor observed TP4 perform a Wet Prep and KOH examinations with unlabeled patient slides on 9/22/21 at 9:20 am. 3. An interview on 9/22/21 at 9:23 am with TP4 confirmed the slides did not have patient identifiers. C. Based on observation, record review, and interviews, the laboratory failed to follow its specimen collection procedure for vaginal specimens for one of two observations of Wet Prep and Potassium Hydroxide (KOH) examinations. Findings include: 1. The surveyor observed TP5 perform Wet Prep and KOH examinations on 9/22/21 at 10:42 am. 2. An interview on 9/22/21 at 10:42 am with TP5 revealed the specimen was collected by the patient. 3. A review of the laboratory's "Wet Prep" procedure revealed a section titled "Specimen Collection" stating, "Place approximately 0.5ml of 0.90% nonbacteriostatic normal saline in a small test tube (i.e.10x75mm). The saline must be at room temperature. Collect vaginal material on a swab by rubbing the vaginal wall or by collecting material from the posterior forices, and emulsify in saline." 4. An interview on 9/22/21 at 12:40 pm with Technical Consultant #1 confirmed the laboratory does not accept patient- collected Wet Prep and KOH examination specimens for testing. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the Laboratory Director failed to ensure the quality assessment program was maintained and identified failures in quality as they occurred when quality control was not performed for the Alere HIV-1/2 Ag/Ab Combo test kit and Rapid Plasmin Reagin (RPR) Syphilis testing for 8 (12/26/19, 11/5/20, 11/12/20, 1/6/21, 1/11/21, 1/20/21, 1 /21/21, and 2/12/21) of 18 testing dates reviewed. Findings include: 1. A review of the laboratory's

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 record review of the CMS database and the College of American Pathologists (CAP) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the subspecialty of syphilis serology. Findings include: A review of the CMS database and the CAP proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the subspecialty syphilis serology. Refer to D2067 and D2074. D2067 SYPHILIS SEROLOGY 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 -- CFR(s): 493.835(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of the CMS database the College American Pathologists (CAP) proficiency testing reports, the laboratory failed to participate in 2 (1st event 2020 and 2nd event 2020) of 2 testing events for the subspecialty syphilis serology, which is unsatisfactory performance resulting in a testing event score of 0%. Findings include: Unsatisfactory performance for 2 of 2 overall testing events for the failure to participate in the subspecialty syphilis serology constitutes unsuccessful performance. Syphilis Serology PT Events Score 1st event 2020 0% 2nd event 2020 0% D2074 SYPHILIS SEROLOGY CFR(s): 493.835(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 unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the College of American Pathologists (CAP) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the subspecialty syphilis serology for 2 (1st and 2nd events in 2020) out of 2 consecutive testing events. Findings include: 1. A record review of the CMS database and CAP proficiency testing reports revealed unsatisfactory performance for 2 out of 2 consecutive testing events: Syphilis Serology PT Event Score 1st event 2020 0% 2nd event 2020 0% -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to obtain attestation statements signed by the laboratory director and testing personnel for 4 (2019 G-A, 2018 G-C, 2018 G-B, 2018 G-A) of 6 testing events reviewed. Findings include: 1. A review of the College of American Pathologists' proficiency testing forms for syphilis serology testing revealed a lack of attestation statements for the following testing events: a. 2019 G-A b. 2018 G-C c. 2018 G-B d. 2018 G-A 2. An interview on 9/17/19 at 11:30 am with TP2 confirmed attestation statements were not signed by the laboratory director and testing personnel. **This is a repeat deficiency from the 8/31/15 survey** 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 6 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to perform verification of accuracy for wet-mount preparation testing for 2 (September 2017 to September 2019) of 2 years. Findings include: 1. A record review revealed a lack of twice annual verification of accuracy for wet-mount preparation testing. 2. An interview on 9/17/19 at 1:27 pm with the Office Manager confirmed verification of accuracy of wet-mount preparation testing was not available. 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 record review and interview with Testing Personnel #1 (TP1), the laboratory failed to follow established general laboratory systems quality assessment policies and procedures for 2 (September 2017 to September 2019) of 2 years. Findings include: 1. A record review of the "Quality Assessment Manual for Rapid HIV Testing" procedure revealed a section stating, "The site coordinator must perform a review of test records and client charts on a quarterly basis to ensure that laboratory results are accurately transcribed into client charts." 2. On 9/17/19 at approximately 12:00 pm, the surveyor requested documentation of general laboratory systems quality assessment activities performed by the laboratory. 3. An interview on 9/17/19 at approximately 12:00 pm with TP1 confirmed documentation of general laboratory systems quality assessment activities were not available. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform function checks on the pipette, centrifuge, microscope, and rotator. Refer to D5433. 2. The laboratory failed to establish the number, type and frequency of testing control materials used in syphilis serology testing. Refer to D5441. 3. The laboratory failed to perform quality control each day of syphilis serology testing and Human Immunodeficiency Virus (HIV) testing. Refer to D5449. D5433 MAINTENANCE AND FUNCTION CHECKS -- 2 of 6 -- CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #2 (TP2), the laboratory failed to perform function checks on the pipette, centrifuge, microscope, and rotator for 1 (due March 2019) of 2 years. Findings include: 1. A tour of the laboratory on 9/17/19 at 8:54 am revealed the following equipment had past calibration expiration: b. Fisher brand Elite pipetter, last documented calibration 4/4 /17. c. Nikon Eclipse E100 microscope, expired March 2019. d. Clay Adams Nutator rotator, expired March 2019. 2. A review of the "STD Laboratory Equipment Maintenance" policy revealed the following equipment maintenance procedures: a. "Microscopes will receive maintenance once a year." b. "Pipettes will be calibrated at least once a year." c. "Centrifuge will receive maintenance once a year." 3. An interview on 9/17/19 at 9:07 am with TP2 confirmed the above mentioned maintenance was not completed annually according to laboratory policy. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interviews with Testing Personnel #1 (TP1) and Testing Personnel #2 (TP2), the laboratory failed to establish the number, type, and frequency of testing control materials used in syphilis serology testing for 2 (September 2017 to September 2019) of 2 years. Findings include: 1. A review of the "RPR Testing for Syphilis" procedure revealed a section titled "Quality Control" stating, "Controls with graded reactivity should be included in each test run to confirm optimal reactivity of the antigen. If control samples do not yield the expected response, the assay should be considered invalid and the assay repeated. If the repeat assay does not elicit the expected results for the control samples, discontinue use of the kit and contact ASI Technical Services." 2. A review of the Arlington Scientific, INC ASI RPR Card Test package insert's "Quality Control" section states, "Quality control requirements must be performed in accordance with applicable local, state, and/or federal regulations or -- 3 of 6 -- accreditation requirements and your laboratory's standard Quality Control Procedures." 3. In an interview on 9/17/19 at 11:18 am, TP2 stated syphilis serology quality control testing was performed weekly. 4. An interview on 9/17/19 at 12:23 pm with TP1 confirmed the "RPR Testing for Syphilis" procedure did not contain the number, type, and frequency of testing control materials. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . A. Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to perform quality control each day of syphilis serology testing for 6 (patients number 1-6) of 6 patients reviewed. Findings include: 1. A record review of the Arlington Scientific, INC ASI RPR Card Test kit package insert revealed a section titled "Quality Control" stating, "quality control requirements must be performed in accordance with applicable local, state, and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control Procedures." 2. A patient chart review and "Syphilis Serology Quality Control RPR" log review revealed the following patients had syphilis serology testing performed on days quality control testing had not been documented: a. Patient #1 on 8/2/19 b. Patient #2 on 6/27/19 c. Patient #3 on 3/15/19 d. Patient #4 on 8/21/18 e. Patient #5 on 3/29/18 f. Patient #6 on 11/30/17 3. In an interview on 9/17/19 at 11:18 am, TP2 stated syphilis serology rapid plasma reagin (RPR) quality control was performed weekly. 4. An interview on 9/17 /19 at 11:18 am with TP2 confirmed syphilis serology RPR quality control testing was not performed each day of patient testing. B. Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to perform quality control testing each day of Human Immunodeficiency Virus (HIV) testing for 4 (4/12/19, 9/10 /19, 9/11/19, and 9/12/19) of 260 days reviewed. Findings include: 1. A record review of the laboratory's "HIV Rapid Testing: Alere Determine HIV- 1/2 Ag/Ab Combo" procedure revealed a section stating, "Waived testing for whole blood fingerstick samples only. (Venipuncture whole blood, serum, and plasma samples require a Moderate Complexity designation and, therefore, cannot be used in testing sites having only a waived designation)." 2. A record review of the laboratory's "HIV Rapid Testing: Alere Determine HIV- 1/2 Ag/Ab Combo" procedure revealed a section titled "Frequency of Controls" stating, "For sites testing more than 25 clients per day (high-volume), controls are to be run once each day of testing. For all other sites, including sites testing fewer than 25 clients per day (low-volume), controls can be run once per week when testing is performed." 3. A record review of the "Alere Determine HIV- 1/2 Ag/Ab Combo" package insert revealed a section stating, "CLIA Complexity: Moderate For Venous Whole Blood, Serum, and Plasma Samples." 4. A record review of HIV quality control testing logs and HIV patient testing logs revealed quality control was not recorded for the following days: a. 9/10/19, 4 patients tested b. 9/11/19, 4 patients tested c. 9/12/19, 6 patients tested d. 4/12/19, 4 patients tested 5. In an interview on 9/17/19 at 9:51 am, TP2 stated venipuncture whole blood specimens were tested. 6. An interview on 9/17/19 at 10:54 am with TP2 confirmed quality control had not been performed for the days listed above. -- 4 of 6 -- D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that 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: . Based on review of the CMS database and review of the College of American Pathologisits (CAP) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the bacteriology analyte: gram stain. Findings include: Review of the CMS database and the CAP final graded proficiency testing reports showed unsatisfactory performance for two of two proficiency testing events for the bacteriology analyte: gram stain. Refer to D2028. D2028 BACTERIOLOGY 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the College of American Pathologists (CAP) proficiency testing reports, the laboratory failed to achieve an overall satisfactory performance for the bacteriology analyte: gram stain in two of two consecutive testing events. Findings include: Gram Stain PT Event Score 3rd event 2017 0% 2nd event 2017 0% -- 2 of 2 --