City Of Port Arthur Health Dept Lab

Summary Statement of Deficiencies D0000 During an onsite laboratory recertification inspection, the laboratory was found out of compliance with the CLIA regulations. The following condition not met was: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing (PT) records and confirmed in interview, the laboratory failed to ensure proficiency testing samples were tested in the same manner as patient samples for two of two hematology/coagulation PT events in 2023. The findings included: 1. Review of the 2023 Hematology / Coagulation PT event attestation statements had the following statement: "The undersign certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." 2. Review of the 2023 Hematology / Coagulation PT event attestations had the following testing personnel (TP) performing the test for Vaginal Wet Preparation. 2023 Event 1: 3/29/2023 TP1 and TP2 2023 Event 3: 11/8 /2023 TP1 and TP2 Surveyor asked if both testing persons review patients before resulting; the laboratory director (LD) stated that only one TP review and result Vaginal Wet Preparation. 3. In an interview on 3/13/2024 at 09:39 hours, in the laboratory, the LD confirmed that the 2023 PT for Vaginal Wet Preparation was not performed in the same manner as patients. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory documents and confirmed in interview, the laboratory failed to retain the instructions for use (IFU) for three of four kit tests performed, the Arlington Scientific RPR Card Test for Syphilis, the Syphilis Health Check for Rapid Syphilis, and the BioLytical Laboratory HIV-1/HIV-2 Antibody Test kits, for records reviewed in 2023. The findings included: 1. Review of laboratory testing included the Arlington Scientific RPR Card Test for Syphilis testing. Surveyor asked for the manufacturer's IFU and none was provided. 2. In a tour of the facilities on 3/13/2024 at 09:50 hours, the surveyor noted the following kit test available for use by staff: BioLytical INST HIV-1 / HIV-2 Antibody Test On 3/13/2024 at 10:00 hours, the Assistant Health Director stated that nurses perform the following two kit tests, as needed, on patients: Health Check for Rapid Syphilis BioLytical INST HIV-1 / HIV-2 Antibody Test The surveyor asked for the manufacturer's IFU, and none was provided. 3. In an interview on 3/13/2024 at 10:10 hours, in the laboratory, the laboratory director stated the IFU for the RPR Card Test for Syphilis was not available for personnel, and that they did not actively keep track of the testing being performed by the nurses and were unaware they needed to retain the records. 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: Based upon review of the policies and procedures, manufacturer instructions, patient test records, observations and interview of faciity personnel, the laboratory failed to meet the analytic system requirements for non waived testing in Bacteriology and Syphilis Serology. NOTE: This is a repeat deficiency from the October 2021 survey. Based on record review and confirmed in interview the laboratory failed to have a step by step policy for the receiving, testing, reporting, and review of proficiency testing samples. (See D 5401) Review of the laboratory policy titled "Wet Mount" did not include instructions for the specimen collection, labeling, storage, transportation, and criteria for specimen acceptability and rejection. (See D 5403) The laboratory failed to follow the manufacturer's instructions when performing the RPR procedure. ( see D 5411) 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on record review and confirmed in interview, the laboratory failed to have a step by step policy for the receiving, testing, reporting, and review of proficiency testing samples for records reviewed in 2022 and 2023. NOTE: This is a repeat deficienciey from the October 2021 survey. The findings included: 1. Review of the laboratory policies did not include a step-by-step procedure for the receiving, testing, reporting, and review of proficiency testing (PT) samples. On 3/13/2024 at 10:10 hours Surveyor asked the laboratory director (LD) for the PT policy, and none was provided. 2. In an interview on 3/13/2024 at 10:15 hours, in the laboratory, the laboratory director confirmed that the laboratory did not have a step by step policy for the receipt, testing, reporting, and review of PT samples. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 proficiency testing records, patient test records and interview of facility personnel found the laboratory failed to achieve an overall score of at least 80 percent in one of three Microbiology testing events for Gram Stain in 2021. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2021 found the laboratory achieved a score of 40 percent in the 2021 3rd testing event. The laboratory submitted unacceptable responses for specimens GS-12, GS-13 and GS-15. 2. Review of patient test records found the laboratory tested 31 patient specimens for Gram Stain procedures in October 2021. 3. Interview of the Laboratory Director conducted February 7, 2022 at 11:00 AM confirmed that the laboratory did not achieve a passing score of 80 percent in the API Microbiology 3rd event for Gram Stains. He went on to say that he had determined the cause of the failure was use of his homemade decolorizer. He replaced the homemade decolorizer with a commercially available decolorizer on November 1, 2021. When asked if patient specimens were assessed to determine if they might have been affected by the use of the homemade decolorizer, he stated he "did not (assess patient results ) because the controls worked". D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) 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 -- Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Review of proficiency testing records, patient test records and interview of facility personnel found the laboratory failed to undertake appropriate training and document remedial actions when the laboratory received an unacceptable score of at least 80 percent in one of three Microbiology testing events for Gram Stain in 2021. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2021 found the laboratory achieved a score of 40 percent in the 2021 3rd testing event. The laboratory submitted unacceptable responses for specimens GS-12, GS-13 and GS-15. 2. Review of patient test records found the laboratory tested 31 patient specimens for Gram Stain procedures in October 2021. 3. Interview of the Laboratory Director conducted February 7, 2022 at 11:00 AM confirmed that the laboratory did not achieve a passing score of 80 percent in the API Microbiology 3rd event for Gram Stains. He went on to say that he had determined the cause of the failure was use of his homemade decolorizer. He replaced the homemade decolorizer with a commercially available decolorizer on November 1, 2021. When asked if patient specimens were assessed to determine if they might have been affected by the use of the homemade decolorizer, he stated he "did not (assess patient results ) because the controls worked". No remedial actions and no additional training of testing personnel performing the failing event were taken. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Review of the submitted Centers for Medicare and Medicaid Services (CMS) 116 form, proficiency testing records, proficiency testing order confirmation for 2022 and interview of facility personnel found the laboratory failed to verify the accuracy of results for Potassium Hydroxide (KOH) wet mounts at least twice annually in 2020 or 2021. The findings included: 1. Review of the CMS-116 form submitted on the initial day of survey (October 6, 2021) found the laboratory reported performing an annual volume of 374 KOH wet prep tests. 2. Review of laboratory records for 2020 and 2021 found the laboratory failed to perform twice annual accuracy assessment for Wet Prep testing or be enrolled in a proficiency testing program. 3. Review of the 2022 enrollment form for participation in the American Proficiency Institute (API) proficiency testing program found the laboratory did not enroll for the KOH wet prep testing events. 4. Interview of the laboratory director conducted February 7, 2022 at 11:00 AM confirmed he did not enroll in the 2022 proficiency testing program for the KOH wet mount testing or have another means of assessing the accuracy of results at least twice annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 801 Condition: Enrollment and testing of samples 493. 1230 Condition: General Lab Systems 493. 1250 Condition: Analytic Systems 493. 1403 Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director 493. 1409 Condition: Laboratories Perfoming Moderate Complexity Testing; Technical Consultant 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 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: Review of the laboratories proficiency testing records, observations, review of patient test records and interview of facility personnel found the laboratory failed to enroll and participate in a proficiency testing program for Treponema pallidum antibodies using the Syphilis Health Check. The Findings included: 1. Review of the American Proficiency Institute Proficiency testing records for 2020 and 2021 (three events per year) found no documentation that the laboratory participated in a proficiency testing program for Treponema pallidum antibodies. 2. Observations made in the laboratory found the laboratory used the diagnostics direct Syphilis Health Check for detection of Treponemal antibodies in serum. 3. Review of patient test records found the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- laboratory tested 101 patient specimens in 2020 and 21 in 2021. 4. Interview of the laboratory director conducted October 6, 2021 at 10:22 AM confirmed the laboratory did not participate in a proficiency testing program for Treponema pallidum antibodies. 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: Review of proficiency testing records for 2020 and 2021 and interview of facility personnel found that the laboratory director and testing personnel failed to attest to the routine integration of proficiency samples into the patient workload in one of three testing events for Microbiology, and one of three testing events for Immunology in 2020. Findings were as follows: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2020 and 2021(three events per year) found the laboratory director and testing personnel had not signed the attestation statements for the 2020 3rd testing event for Immunology and the 2020 3rd testing event for Microbiology. 2. Interview of the Laboratory Director conducted October 6, 2021 conducted at 10:09 AM confirmed that attestation statements had not been signed. He stated he "doesn't usually use that page, he usually prints it out." D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Review of the laboratory's proficiency testing records and interview of facility personnel found the laboratory failed to retain proficiency testing records and attestation statements for one of five Microbiology proficiency events in 2020 and 2021, for at least two years. The findings included: 1. Review of the 2020 and 2021 American Proficiency Institute proficiency testing records ( three events per year) found the laboratory failed to retain the original proficiency testing documents and the attestation statement for the 2021 Microbiology 2nd event. 2. Interview of the Laboratory Director conducted October 6, 2021 at 10:28 AM confirmed that the original documents and the attestation statement were not available for review. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. -- 2 of 10 -- This CONDITION is not met as evidenced by: Observations,review of policies and procedures, review of the laboratory proficiency testing records and interview of facility personnel found that the laboratory failed to meet the general lab systems requirements for testing in Microbiology and Syphilis Serology. The laboratory failed to ensure that the laboratory director and testing personnel attested to the routine integration of proficiency specimens into the normal patient workload for two of 10 events reviewed. ( see D 2009) The laboratory failed to ensure that all proficiency testing records were retained for at least two years. ( see D 3037) The laboratory failed to ensure that the proficiency testing results were evaluated and review of the results was documented by the appropriate personnel. ( see D 5211) D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Review of the laboratory's proficiency testing records and interview of facility personnel found the laboratory failed to document the review of proficiency testing results for one of five Microbiology proficiency events in 2020 and 2021. The findings included: 1. Review of the 2020 and 2021 American Proficiency Institute proficiency testing records ( three events per year) found the laboratory failed to document the review for the 2021 Microbiology 2nd event. 2. Interview of the Laboratory Director conducted October 6, 2021 at 10:28 AM confirmed that he had not documented his review of the proficiency results. 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: Observations,review of policies and procedures, review of the laboratory proficiency testing records and interview of facility personnel found that the laboratory failed to have a quality assessment program failed to monitor, assess and correct problems found in maintaining the proficiency testing records. The laboratory failed to ensure that the laboratory director and testing personnel attested to the routine integration of proficiency specimens into the normal patient workload for two of 10 events reviewed. ( see D 2009) The laboratory failed to ensure that all proficiency testing records were retained for at least two years. ( see D 3037) The laboratory failed to ensure that the proficiency testing results were evaluated and review of the results was documented by the appropriate personnel. ( see D 5211) Interview of the laboratory Director conducted October 6, 2021 at 11:10 AM confirmed that the laboratory did not have a written quality assessment procedure. He stated that he "did have one at one time." -- 3 of 10 -- 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: Based on review of manufacturer's instructions, policies and procedures, personnel records, observations and interview of facility personnel the laboratory failed to meet the analytic system requirements for non waived testing in Bacteriology and Syphilis Serology. Observations, review of policies and procedures and interview of facility personnel found the laboratory failed to have a written procedure for the preparation of Gram Decolorizer used for performing Gram stain procedures on patient specimens. (See D 5403) The laboratory failed to ensure expired reagents were not used in staining of patient specimens for the Gram Stain using the EDM3 Gram Stain Set. ( see D 5417) The laboratory failed to test at least a positive and negative quality control material each day of patient testing when testing patient serum specimens for the Treponema pallidum antibodies using the Diagnostics Direct Syphilis Health Check. (See D5447) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)