Special Procedures Laboratory (Spl)

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the laboratory's AAB/MLE proficiency testing records in 2023 and confirmed in an interview, the laboratory failed to document 2 of 2 attestation statements for Embrology, Andrology & Fetal events. The findings were: 1. Review of the laboratory's AAB/MLE proficiency testing records in 2023 revealed no documentation of attestation statements for 2 of 2 Embrology, Andrology & Fetal events. Embrology, Andrology & Fetal events S1 2023 Embrology, Andrology & Fetal events S2 2023 2. In an interview on 2/27/2024 at 12:10 pm in a conference room, the laboratory director confirmed the above findings. Key: AAB=American Association of Bioanalysis MLE=Medical Laboratory Evaluation D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. 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 the review of the CAP proficiency testing in 2023, CAP participant summary, and confirmed in an interview, the laboratory failed to have documentation of evaluting result returned as "See Note [26]" for 1 of 2 Semen Analysis Glass Slides events. The findings were: 1. Review of the CAP proficiency testing in 2023 revealed 2 of 2 samples in 1 of 2 Semen Analysis Glass Slides events had "See Note [26]". SEM1-B 2023 Semen Analysis Glass Slides Test Method: Sperm morphology, qual SEM-15 Your Grade: See Note [26] SEM-16 Your Grade: See Note [26] 2. Review of the CAP participant summary titled Surveys and Anatomic Pathology Education Programs for Semen Analysis Glass Slides SEM1-B 2023 event reveled under Actions Laboratories Should Take when a PT Result is Not Graded revealed the following, "Code: 26 Exception Reason Code Description: Educational challenge Action Required: Review participant summary for comparative results and document performance accordingly...." 3. Review of the CAP proficiency testing for the event of SEM1-B 2023 Semen Analysis Glass Slides revealed no documentation of evaluting result for 2 of 2 samples. SEM1-B 2023 Semen Analysis Glass Slides SEM-15 Your result: Abnormal Expected result: Abnormal SEM-16 Your result: Normal Expected result: Normal 4. In an interview on 2/27/2024 at 11:45 am in a conference room, the laboratory director confirmed the above findings. Key: CAP=College of American Pathologists PT=Proficiency testing -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 4/19/22. The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1250 D5400 Analytic Systems Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2021, and staff interview, it was revealed that the laboratory failed to test proficiency samples in the same manner it tested patient samples for 1 of 2 events in 2021 for Sperm Viability. Findings include: 1. A review of the laboratory's policy titled 'Quality Control Program' revealed the following: "Proficiency testing specimens must be handled and tested in a manner identical to patient specimens. Proficiency testing specimens must be tested the same number of times that patient samples are routinely tested." 2. A review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records for S2 Andrology & Embryology 2021 (second event) revealed three separate 'Semen 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 -- Analysis Worksheets'. 3. Further review of the three worksheets revealed three different laboratory personnel tested the 2 proficiency testing samples for this event on 11/9/21. 4. An interview with the laboratory director on 4/19/22 at 10:15 a.m. in the conference room, revealed the laboratory did not have three different laboratory personnel test each patient sample for Sperm Viability testing in 2021. This confirmed the above findings. 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 a review of the laboratory's accuracy assessment records and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of two of eight tests performed by the laboratory, at least twice annually, in 2021. Findings include: 1. A review of the laboratory's accuracy assessment records titled 'Fructose Intra Lab Comparison' form and the 'Static Oxidation-Reduction Potential Worksheet' revealed the laboratory performed accuracy assessments for the two tests on the following days: Semen Fructose Test: 1/11/21 3/18/22 Oxidation- Reduction Potential (ORP) Test: 6/25/20 2. Further review of the accuracy assessment records revealed the following: Semen Fructose test - missing one accuracy assessment in 2021 ORP test- missing two accuracy assessments in 2021 3. An interview with the laboratory director on 4/19/22 at 10:55 a.m. in the conference room, after review of the records, confirmed the above findings. 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 a review of the laboratory's policies, review of laboratory records, and staff interview, it was revealed the laboratory failed to identify issues with analytic systems. Findings include: 1. The laboratory failed to have documentation of complete establishment studies for antisperm IgG and IgA antibody testing using the SpermMar Test. (refer to D5423) D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer -- 2 of 4 -- must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of the FDA website, the laboratory's establishment studies, the laboratory's testing records, and staff interview, it was revealed that the laboratory failed to have documentation of complete establishment studies for antisperm IgG and IgA antibody testing using the SpermMar Test. Findings include: 1. A review of the FDA website for categorization of tests, the SpermMar Test used for antisperm IgG and IgA antibody testing was not available for categorization of complexity, therefore the kit/test was high complexity. 2. A review of the laboratory's establishment studies for the SpermMar Test revealed the laboratory failed to have documentation of the following studies: - Accuracy - Precision - Analytical sensitivity - Analytical specificity including interfering substances - Reference intervals (normal values) - Reportable range 3. A review of the laboratory's testing records revealed the laboratory started testing for antisperm IgG and IgA antibodies in January 2021. 4. Further review of the laboratory's testing records revealed the laboratory performed 8 antisperm antibody tests in 2021 on the following patients using the SpermMar test: Patient: 0304997423 Date: 1/29/21 Patient: 0304354573 Date: 10/28/21 Patient: 0304826787 Date: 10/13/21 Patient: 0302151844 Date: 9/20/21 Patient: 0303864418 Date: 9/7/21 Patient: 0305070290 Date: 3/8/21 Patient: 0305125940 Date: 3/8/21 Patient: 0303719074 Date: 2/23/21 5. An interview with the laboratory director on 4 /19/22 at 1:00 p.m. in the conference room, after review of the records, confirmed the above findings. *NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 12/2020 D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor observation, a review of the laboratory's policies, the laboratory's records, and staff interview, it was revealed that the laboratory failed to have documentation of testing the FertiPro VitalScreen stain, used for distinguishing immotile sperm from dead sperm, for intended reactivity each day of use in 2020 and 2021. Findings include: 1. Surveyor observation of the laboratory on 4/19/22 at 12:15 p.m. found the following box of FertiPro VitalScreen stain: FertiPro VitalScreen Lot: FP21VI05 Exp: 06/2023 2. A review of the laboratory's policy titled 'Vital Stain- Semen' revealed the following: "Positive control: The average alive should be lower than 5% of the percent motility recorded in the semen analysis. Negative control: The average percent alive should be 5% or less." 3. A review of the laboratory's records revealed no documentation of the intended reactivity for the stain each day of use in -- 3 of 4 -- 2020 and 2021. 4. A review of the laboratory's testing records revealed the laboratory performed 1 VitalScreen stain in 2020 and 3 VitalScreen stains in 2021. 5. An interview with the laboratory director on 4/19/22 at 12:15 p.m. in the conference room, after review of the records, confirmed the above findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on a review of the laboratory's establishment studies and staff interview, it was revealed the laboratory director failed to ensure establishment studies were complete prior to performing patient testing. (refer to D5423) D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS 209 form, the laboratory's personnel files, and staff interview, it was revealed that the technical supervisor failed to perform competency assessments on two of three testing personnel performing high complexity testing in 2021. Findings include: 1. A review of the laboratory's submitted CMS 209 form (signed by the laboratory director on 4/19/22), revealed the laboratory identified 3 testing personnel performing high complexity testing in 2021. 2. A review of the laboratory's personnel records revealed that there was no documentation of the technical supervisor performing a competency assessment in 2021 on the following testing personnel: - Testing person #1 - Testing person #3 3. An interview with the laboratory director on 4/19/22 at 9:50 a.m. in the conference room, after review of the records, confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1240 D5300 Preanalytic Systems 493.1250 D5400 Analytic Systems Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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: Review of 2017 and 2018 proficiency testing records and interview of facility personnel found that testing personnel and the laboratory director failed to attest to the routine integration of proficiency specimens specimens into routine, patient workloads for semen analysis for four of four testing events. The findings included: 1. Review of the American Association of Bio Analysts (AAB) proficiency testing records for 2017 and 2018 found that the laboratory participated in a proficiency testing event for Sperm Viability and Andrology in Embryology (nonregulated analytes) to ensure the accuracy of results. The laboratory failed to document physical signatures of the laboratory director and testing personnel performing the proficiency event, in four of four testing events. 2. Interview of the general supervisor conducted on January 23, 2019 at 10:43 AM confirmed that electronic signatures were used and not physical signatures. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on a review of policies and procedures, competency assessment records and interview of facility personnel it was revealed that the laboratory failed to have a procedure to assess the competency of all consultants and testing personnel performing semen analysis procedures. The findings included: 1. Review of policies and procedures found there was no procedure available for review for assessing the competency of the consultants, supervisors or testing personnel. The policy for the competency assessment of testing personnel, supervisors and consultants was requested but not provided. 2. Review of personnel files found no documentation of semiannual and annual competency assessments for four of four testing personnel listed on the CMS report 209 Laboratory Personnel Report, and the general supervisor. 3. Interview of the general supervisor conducted on January 23, 2019 at 9: 33 AM confirmed that the laboratory did not have a written or electronic version of a competency assessment policy/procedure, and semiannual and annual competency assessments had not been documented for testing personnel. He went on to say at 10: 35 AM that he thought "scanning the comparisons and proficiency testing was enough.". D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Review of policies and procedures, personnel records and interview of facility personnel found that the laboratory failed to ensure that all policies and procedures had been approved , signed and dated by the current laboratory director. The findings included: 1. Review of policies and procedures found in the notebook labeled lab procedure manual found no documentation of approval by the current laboratory director for 24 of 24 policies and procedures. 2. Review of personnel records found that the current laboratory director was hired in June 25, 2018. 3. Interview of the general supervisor conducted on March 5, 2019 at 10:42 AM confirmed the Laboratory Director had not approved the procedures currently in use by testing personnel. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Review of policies and procedures, 2017 and 2018 maintenance records and interview facility personnel found that the laboratory failed to document maintenance procedures for the ventilation hood as defined in their own written procedure. The -- 2 of 5 -- findings included: 1. Review of the policy and procedure titled temperatures, levels, and preventive maintenance found on page 20 under the heading ventilation hood: "Daily: clean the interior and change the bench paper if the hood was in use. Ensure before the end of the day that the interior light is switched forum florescent to germicidal. Monthly: clean the exterior and glass shield cover. Ensure shield is at correct level. Note any corrections. Quarterly: check the auxiliary power supply. Ensure function of switches. Note corrections. Annual: contact Baylor environmental safety for annual inspections." 2. Review of the ventilation hood. Preventive maintenance and quality control records for 2017 in 2018 found quarterly maintenance procedures documented for: February 13, 2017, December 19, 2017 and January 8, 2017. There was no documentation of annual safety inspections for 2017. There were no records available for review for maintenance in 2018. 3. Interview of the general supervisor conducted at 10:43 AM on January 23, 2019 confirmed the above findings. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control records and staff interview, it was revealed the laboratory failed to test at least one quality control each eight hours of operation when analyzing patient specimens for semen analysis. The findings included: 1.Review of quality control records from March 2017, and October through December 2018 found no documentation of quality control performance on one of 31 days in October and one of 31 days in December 2018. There was no quality control documentation for October 27, 2018 with one patient specimen tested. There was no quality control documentation for December 24, 2018 with one patient specimen tested. 2. Interview of the general supervisor conducted on January 23, 2019 at 11:29 AM confirmed the above findings. He stated that one person comes in at 7:30 AM to start maintenance and perform quality control procedures. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: -- 3 of 5 -- Review of laboratory records and interview of facility personnel found that the laboratory director failed to notify the State Agency within 30 days of a change in laboratory director. (See D 8103) D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: Review of policies and procedures and interview of facility personnel found that the laboratory director failed to ensure that an approved procedure was available to assess the competency of all supervisors, consultants and testing personnel. (See D5209) D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory's written polices and procedures, and staff interview, revealed the laboratory director failed to ensure an approved procedure manual was available to testing personnel for performing semen analysis. (see D5407) D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. -- 4 of 5 -- This STANDARD is not met as evidenced by: Review of the CMS 116,personnel records and Interview of facility personnel found that the laboratory failed to notify the state agency within 30 days when a change in the laboratory director occurred. The findings included: 1. Review of the CMS 116 Application for Certification provided during the inspection found the name of the Laboratory Director differed than the name on the CLIA certificate of Compliance issued June 21, 2016 . 2. Review of personnel records found that the Laboratory director hired June 25, 2018 3. Interview of the General Supervisor conducted on January 23, 2019 at 10:22 AM confirmed that the laboratory director was hired in March, 2018 and he had not notified the State agency of the change in Laboratory Director. -- 5 of 5 --