City Of El Paso Department Of Public Health

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 22, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing (PT) records, the facility failed to achieve 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 -- successful performance in three of three consecutive testing events for the specialty of General Immunology in 2022 and 2023, resulting in a non-initial unsuccessful performance. Refer to D2084 and D2085. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2022 and 2023, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for three of three consecutive testing events for the analyte Anti- HIV. Findings were: 1. A review of the CASPER Report 155 listed the following scores for the 2022 and 2023 General Immunology PT events: 2022 General Immunology Event 2, analyte Anti-HIV: 0% General Immunology Event 3, analyte Anti-HIV: 0% 2023 General Immunology Event 1, analyte Anti-HIV: 60% 2. A proficiency desk review of AAB proficiency testing records from 2022 and 2023 confirmed that the laboratory received the following Anti-HIV scores: 2022 General Immunology Event 2, analyte Anti-HIV: 0% General Immunology Event 3, analyte Anti-HIV: 0% 2023 General Immunology Event 1, analyte Anti-HIV: 60% D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2022 and 2023, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for three of three consecutive testing events for the specialty of General Immunology. Findings were: 1. A review of the CASPER Report 155 listed the following scores for the 2022 and 2023 General Immunology PT events: 2022 General Immunology Event 2: 0% General Immunology Event 3: 0% 2023 General Immunology Event 1: 60% 2. A proficiency desk review of AAB proficiency testing records from 2022 and 2023 confirmed that the laboratory received the following General Immunology scores: 2022 General Immunology Event 2: 0% General Immunology Event 3: 0% 2023 General Immunology Event 1: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for three of three events for the specialty of General Immunology in 2022 and 2023. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for the specialty of General Immunology for three of three events in 2022 and 2023, resulting in non-initial unsuccessful performance. Refer to D2084 and D2085. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 28, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing (PT) records, the facility failed to achieve 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 -- successful performance in two of two consecutive testing events for General Immunology in 2022, resulting in unsuccessful performance. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalyst (AAB) proficiency testing (PT) records from 2022, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the specialty of General Immunology. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CASPER Report 155 listed the following scores for the 2022 General Immunology PT events 2 and 3: 2022 General Immunology Event 2: 0% General Immunology Event 3: 0% 2. A proficiency desk review of AAB proficiency testing records from 2022 confirmed that the laboratory received the following General Immunology scores for the 2022 PT 2nd and 3rd events: 2022 General Immunology Event 2: 0% General Immunology Event 3: 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalyst (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for two of two events for General Immunology in 2022. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalyst (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for General Immunology for two of two events in 2022. Refer to D2084. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Review of the manufacturer's instructions, CMS 116, patient reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions for disseminating all authorized fact sheets when using the CDC Influenza SARS- CoV-2(Flu SC2) Multiplex Assay as defined in the Conditions of Authorization for Use. The findings included: 1. Review of the manufacturer's instructions found on page 33 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using your product must include with the test result reports,all authorized Fact Sheets." 2. Review of the CMS 116 found the laboratory recorded an annual volume of 6344 SARS- COV-2 tests performed. 3. Review of patient reports found the laboratory did not include instructions to providers on where to obtain the fact sheets or included copies of the authorized fact sheets. 4. Interview of the General Supervisor on the CMS report 209 Laboratory Personnel Report conducted August 3, 2022 at 09:22 AM confirmed that the laboratory did not include the authorized Fact Sheets with the patient test results for SARS COV-2 using the CDC Influenza SARS-CoV-2(Flu SC2) Multiplex Assay as defined in the Conditions of Authorization for Use. D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) If control materials are not available, the laboratory must have an alternative 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 -- mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Review of the manufacturers instructions for use for the QuantiFERON-TB GOLD PLUS (QFT_PLUs) ELISA, the laboratory's own written procedure, patient test records and interview of facility personnel found the laboratory failed to determine the appropriate control materials and frequency of testing control materials when testing patient specimens for tuberculosis. The findings included: 1. Review of the manufacturers instructions for the QuantiFERON-TB GOLD PLUS (QFT_PLUS) ELISA found on page 34 found: " Each laboratory should determine appropriate types of control materials and frequency of testing in accordance with Local, State, Federal, or other applicable accrediting organizations. External quality assessment and alternative validation procedures should be considered. Note: Plasmas spiked with recombinant IFN-y have shown reductions of up to 50% in concentration when stored at either 2C to 8C and 20C." 2. Review of the laboratory's own written policy found on page 19:" Each laboratory should determine appropriate types of control materials and frequency of testing in accordance with Local, State, Federal, or other applicable accrediting organizations. External quality assessment and alternative validation procedures should be considered. Note: Plasmas spiked with recombinant IFN-y have shown reductions of up to 50% in concentration when stored at either 2C to 8C and 20C. A known negative sample and a known positive sample will be used as alternate quality control since a commercial control is not available." 3. Review of patient test records found the laboratory tested 124 specimens for tuberculosis using the QuantiFERON-TB GOLD PLUS (QFT_PLUS) ELSA between April 1, 2022 and June 30 2022, without using a known positive and negative sample as external quality controls. 4. Interview of testing personnel conducted August 3, 2022 confirmed it was the laboratory's procedure to use previously tested specimens as positive and negative quality control materials which were frozen for future use. After the move to the new location in March of 2022, it was noted these specimens may have been compromised and were not producing results as expected. The laboratory contacted the manufacturer and were informed they could meet the quality control requirements using a standard from the previously used kit, but did not state the lot number needed to be different from the lot number in use. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory director failed to specify in writing the duties and responsibilities for eight of eight testing personnel, and the procedures they were authorized to perform. The findings included: 1. Review of the -- 2 of 3 -- CMS report 209 Laboratory Personnel Report found the laboratory designated eight testing personnel performing high complexity testing. 2. Review of personnel files found no written authorization of procedures for each of the eight testing personnel. 3, Interview of the General Supervisor conducted August 2, 2022 at 10:10 AM confirmed the laboratory did not have a written delegation of duties for each testing person to define which procedures they were authorized to perform. -- 3 of 3 --

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. 1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director 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 review of the laboratory testing records, CMS report 155, and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for Mycobacteriology in 2021. The findings included: 1. A review of facility proficiency testing records found no documentation of the laboratory being enrolled in or participating in a CMS approved proficiency testing program for Mycobacteriology 2021. 2. Review of patient test records found the laboratory tested 212 patient specimens for Mycobacteriology using the Quantiferon TB Gold test between January 1, 2021 and June 29, 2021 3. Review of the CMS report 155 found no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 4. Interview of the Lead Medical Lab Scientist conducted on June 29, 2021 at 08:47 AM confirmed that the laboratory did not enroll in, or participate in a proficiency testing program for Mycobacteriology in 2021. 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 -- 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: Review of the CMS form 209 Laboratory Personnel Report, policies and procedures, personnel files and interview of facility personnel found that the laboratory failed to have a procedure to assess the competency of all testing personnel , supervisors and consultants performing Quantiferon Gold Tuberculosis (TB) procedures in 2019, 2020 or 2021. THIS IS A REPEAT DEFICIENCY FROM THE 02/2012 INSPECTION The findings included: 1. Review of the CMS 209 Laboratory Personnel Report found the Laboratory Listed five Testing Personnel, one Technical Supervisor, one Clinical Consultant and one general supervisor performing Quantiferon Gold Tuberculosis (TB) procedures. 2. Review of policies and procedures found on page 2 of the policy titled Quality Management program under the heading procedure - "All new employees will receive formal orientation and training in all areas of responsibility and must demonstrate competency before being allowed to work independently. Competency is assessed within the first 6 months of hire and annually thereafter for all employees". 3 . Competency assessment records for all personnel were requested on June 29, 2021 at 09:38 AM. There were no competency assessment records available for review as follows: a. Testing person one had no competency assessments available for review to ensure his competency was assessed in 2019, 2020, or 2021. b. Testing person one was also designated as the technical supervisor and the general supervisor(effective March 2020). c. No semiannual competency assessments were available for review for testing person 3 ( hired 01/06/2020) There were no competency assessments available for review to ensure the technical supervisor and the general supervisor had been evaluated and deemed competent for the responsibilities of their positions. 4. Interview of the lead Medical Lab Scientist conducted June 29, 2021 at 10:27 AM confirmed that competency assessments for testing person one and the technical consultant were not available for review. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview of facility personnel, the laboratory failed to have a quality assessment program to identify and correct problems in general Lab systems. THIS IS A REPEAT DEFICIENCY FROM THE 08 /2016 INSPECTION The laboratory failed to enroll in a proficiency testing program for Gram Stain and Syphilis Serology in 2021. (See D 2000) The laboratory failed to have a procedure to assess all testing personnel, consultants and supervisors. ( See D 5209) -- 2 of 5 -- D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Review of personnel files, laboratory records, quality control records and interview of facility personnel found the laboratory director failed to provide overall management and technical direction. Findings Included: 1. The laboratory Director failed to notify the state agency when testing for subspecialties and specilties were removed from the testing offered. 2. The laboratory director failed to ensure that they laboratory was enrolled in an HHS approved proficiency testing program for each specialty and subspecialty tested by the laboratory. (See D6088) 3. The laboratory director failed to ensure that the quality assessment programs had been established and maintained to assure the quality of laboratory testing. (See D6094) 4.The laboratory director failed to ensure that policies and procedures were established for monitoring the performance and competency of testing personnel, supervisors and consultants. (See D6103) D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Review of proficiency testing records, patient test records and interview of facility personnel found the laboratory director failed to ensure the laboratory was enrolled in a CMS approved proficiency testing program for Mycobacteriology in 2021. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, manufacturer's instructions,verification records, and interview a facility personnel, the laboratory director failed to establish and maintain a quality assurance program for Mycobacteriology ( See D5291) tHIS IS A REPEAT DEFICIENCY FROM THE 08/2016 INSPECTION 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 -- 3 of 5 -- 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 the CMS report 209, personnel records and interview of facility personnel found the laboratory director failed to ensure that the procedure used to assess the competency of personnel included the assessment of all testing personnel, supervisors, and consultants. (see D5209) D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Review of the CMS form 209 Laboratory Personnel Report, policies and procedures, personnel files and interview of facility personnel found that the Technical supervisor failed to assess the competency of all testing personnel , supervisors and consultants performing Quantiferon Gold Tuberculosis (TB) procedures in 2019, 2020 or 2021. The findings included: 1. Review of the CMS 209 Laboratory Personnel Report found the Laboratory Listed five Testing Personnel, one Technical Supervisor, one Clinical Consultant and one general supervisor performing Quantiferon Gold Tuberculosis (TB) procedures. 2. Review of policies and procedures found on page 2 of the policy titled Quality Management program under the heading procedure - "All new employees will receive formal orientation and training in all areas of responsibility and must demonstrate competency before being allowed to work independently. Competency is assessed within the first 6 months of hire and annually thereafter for all employees". 3 . Competency assessment records for all personnel were requested on June 29, 2021 at 09:38 AM. There were no competency assessment records available for review as follows: a. Testing person one had no competency assessments available for review to ensure his competency was assessed in 2019, 2020, or 2021. b. Testing person one was also designated as the technical supervisor and the general supervisor(effective March 2020). c. No semiannual competency assessments were available for review for testing person 3 ( hired 01/06/2020) 4. Interview of the lead Medical Lab Scientist conducted June 29, 2021 at 10:27 AM confirmed that competency assessments for testing person one and semiannual competency assessments for testing person three were not available for review. 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. -- 4 of 5 -- This STANDARD is not met as evidenced by: Review of the CMS form 209 Laboratory Personnel Report, policies and procedures, personnel files and interview of facility personnel found that the Technical supervisor failed to assess the competency of all testing personnel , supervisors and consultants performing Quantiferon Gold Tuberculosis (TB) procedures at least annually in 2019, 2020 or 2021. The findings included: 1. Review of the CMS 209 Laboratory Personnel Report found the Laboratory Listed five Testing Personnel, one Technical Supervisor, one Clinical Consultant and one general supervisor performing Quantiferon Gold Tuberculosis (TB) procedures. 2. Review of policies and procedures found on page 2 of the policy titled Quality Management program under the heading procedure - "All new employees will receive formal orientation and training in all areas of responsibility and must demonstrate competency before being allowed to work independently. Competency is assessed within the first 6 months of hire and annually thereafter for all employees". 3 . Competency assessment records for all personnel were requested on June 29, 2021 at 09:38 AM. There were no competency assessment records available for review as follows: a. Testing person one (hired 08/16 /2016) had no competency assessments available for review to ensure his competency was assessed in 2019, 2020, or 2021. b. Testing person one was also designated as the technical supervisor and the general supervisor (effective March 2020), with no competency assessments available for review for the responsibilities of those positions. c. No competency assessment performed in 2019, 2020, or 2021 available for review for testing person 2 ( hired 10/23/2006). d. No competency assessment was available for review for the clinical consultant. 4. Interview of the lead Medical Lab Scientist conducted June 29, 2021 at 10:27 AM confirmed that competency assessments were not available for review. -- 5 of 5 --

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observations, review of maintenance records, policies and procedures and interview of facility personnel, the laboratory failed to have a unidirectional workflow for PCR testing and a procedure to monitor and prevent contamination. Findings included: 1. Observations made during the tour of the facility found that the laboratory performed each stage of testing in separate rooms, traveling through the same hallway between steps in the testing procedure. a. The raw specimens contained in Viral transport medium were received in the Food Lab. Accessioning of the specimens was done on the last counter of the food lab. They were then stored in the food lab refrigerator until testing begins. b. Specimens were brought from the food lab refrigerator, down the hallway to the BSL3 room for extraction. Once the extraction process was complete, they were placed in the refrigerator of the BSL3 room. c. The Tech would then exit the BSL3 room and go down the hallway to the Dust Free Room where reagents were prepared. d. The tech would leave the Dust Free Room and return to the BSL 3 room to obtain specimens. e. Specimens were then brought down the hallway to the Food lab hood on the first counter for reagent addition and covering of the plates. f. Plates were then taken from the food lab down the hallway to the Bio- watch lab for testing. 2. Review of maintenance records found no documentation of wipe tests of areas were amplification procedures were employed. 3. Review of the CDC procedure for Influenza found on page 11 bullet 3_ " Amplification technologies such as PCR are sensitive to accidental introduction of product from previous amplifications reactions. Incorrect results could occur if either the clinical specimen or the real-time reagents used in the amplification step become contaminated 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 2 -- accidental introduction of amplification product (amplicon). Workflow in the laboratory should proceed in a unidirectional workflow>" 4. Interview of testing personnel conducted on July 24, 2018 at 2:49 PM confirmed that the laboratory did not perform wipe tests of areas where amplification procedures were done to detect and prevent contamination of PCR testing, and that the laboratory did not have a unidirectional workflow. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the operator's manual for the Hologic Gen-Probe Panther, review of environmental records, and interview with facility personnel, the laboratory failed to monitor the humidity operating requirements for the analyzer for 11 of 11 days between July 9th, 2018 and July 24th, 2018. The findings included: 1. Based on review of the Hologic Gen-Probe Panther, under Specifications and Requirements, the operator's manual states the following: "Environmental Requirements Relative Humidity Operating: 20 - 85% non-condensing." 2. Based on review of laboratory environmental records, the laboratory recorded eleven (11) operating temperatures between July 9th, 2018 and July 24th. The laboratory did not record humidity levels during the 11 of 11 measurements. 3. In an interview at 14:00 hours in the Panther room, the General Supervisor stated the laboratory had recently become aware of the humidity requirement but had not been able to order the proper monitoring devices. -- 2 of 2 --