Jody L Kelly Md & Associates L L C

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 records and personnel interviews; the laboratory failed to retain all printouts and transcribed data for microbiology testing for 12 of 12 months in 2020, affecting 3,548 patient test results. Findings Include: 1. Review of patient test records for Chlamydia Trachomatis and Neisseria Gonorrhea testing on the Cepheid GeneXpert analyzer found no instrument printout records were retained for two of two testing dates reviewed. Patient Identification Test Date P4 12-22-2020 P5 09-21-2020 2. Review of patient test results for Candida, Gardnerella, and Trichomonas testing on the BD VPIII Affirm test system found no transcribed patient testing result records were retained for two of two testing dates reviewed. Patient Identification Test Date P9 12-23-2020 P10 09-21-2020 3. Surveyor requested instrument print outs and transcribed data for the four patient test results reviewed on 6-8-2022 at 10:26 am with testing personnel (TP) #1, as identified on the CMS-209. 4. Interview with TP#1 on 6-8-2022 at 10:26 am, stated they were unable to locate transcribed patient testing records for BD VPIII affirm testing and instrument print- outs from the Cepheid GeneXpert for the year 2020. 5. Review of patient test volume records found the laboratory perform 3,548 patient tests in the specialty of microbiology in the year 2020. 6. Interview with TP#1 on 6-8-2022, at 12:40pm confirmed the above findings. 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 D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to meet the requirements specified in 493. 1230 through 493.1256 and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to demonstrate it can obtain performance specification comparable to those established by the manufacturer for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on two Cepheid GeneXpert Dx analyzers. See D5421. 2. The laboratory failed to perform quality controls for both Cephied GeneXpert analyzers as specified by the laboratory's individual quality control plan (IQCP) for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing in 2019. See D5445. 3. The laboratory failed to follow the manufacturer's instructions for handling and performing quality controls for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid GeneXpert in 2019. See D5479. 4. The laboratory failed to establish a system to bi-annually evaluate the relationship between Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) test results on the two Cepheid GeneXpert Dx analyzers. See D5775. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by 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 7 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #2; the laboratory failed to demonstrate it can obtain performance specification comparable to those established by the manufacturer for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on two Cepheid GeneXpert Dx analyzers. Findings Include: 1. Direct observation of laboratory testing equipment during a tour of the laboratory facility, on 10-03-2019, at 9:36 am, identified two Cepheid GeneXpert Dx analyzers, serial numbers 831860 and 831868. 2. Review of the policy and procedure manual identified the policy, "Validation of Automated Test Methods", which outlined that each new test system will be evaluated for within run precision, day-to-day precision, accuracy, linearity for validation of the reportable range, and parallel studies. 3. Review of the CT/NG Xpert individual quality control plan (IQCP) revealed the laboratory tests for CT/NG on the Cepheid using both urine samples collected in the CT/NGURINE-50 collection kit and vaginal /endocervical samples collected with a CT/NGSWQAB-50 collection kit. 4. Review of the verification of performance documentation revealed the laboratory failed to follow the "Validation of automated test methods" policy. The laboratory failed to evaluate both Cepheid GeneXpert Dx analyzers for CT/NG testing as well as verification of performance for both specimen types tested, urine and vaginal /endocervical. 5. Review of test volume records revealed the laboratory performed 726 tests for CT/NG from March 2019 through September of 2019. 6. On survey date 10-03-19, at 3:00 pm, TP#2 confirmed verification of performance documentation failed to evaluate each analyzer and both specimen types (urine and vaginal /endocervical) for CT/NG testing on the Cepheid GeneXpert Dx analyzers. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #2; the laboratory failed to perform quality controls for both Cephied GeneXpert analyzers as specified by the laboratory's individual quality control plan (IQCP) for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing in 2019. Findings include: 1. Direct observation of laboratory testing equipment during a tour of the laboratory facility, on 10-03-2019, at 9:36 am, identified two Cepheid GeneXpert Dx analyzers, serial numbers 831860 and 831868. 2. Review of the IQCP for CT/NG testing on the Cepheid GeneXpert Dx analyzers stated, "External controls -- 2 of 7 -- (one NG positive, one CT positive, and one negative) will be assayed with each new lot, new shipment, and every 30 days after the lot/shipment is in use, as well as after system maintenance and software upgrades." 3. Review of patient testing for 5 of 5 patient results reviewed revealed that external quality control testing failed to be performed on the lot of cartridges in use on the analyzer that was used for patient testing. Patient Identification Test Date Analyzer for Patient Testing Quality Control Lot in Use C1 04-30-2019 831868 or "A" Ran on 831860 or "B" on 4-30-2019 C2 06- 25-2019 831860 or "B" Ran on 831868 or "A" on 6-17-2019 C3 07-26-2019 831860 or "B" Ran on 831868 or "A" on 7-10-2019 C4 09-05-2019 831868 or "A" Ran on 831860 or "B" on 8-28-2019 C5 10-02-2019 831860 or "B" Ran on 831868 or "A" on 9-18-2019 3. Review of test volume records revealed the laboratory performed 726 tests for CT/NG from March 2019 through September of 2019. 4. On survey date 10- 03-2019, at 3:00 pm, TP #2 confirmed that external quality controls were not performed for both Cepheid GeneXpert Dx analyzers with each new lot/shipment of cartridges as described in the IQCP. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to follow the manufacturer's instructions for handling and performing quality controls for Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid GeneXpert in 2019. Findings include: 1. Review of the individual quality control plan (IQCP) for CT/NG testing on the Cepheid GeneXpert Dx analyzers stated, "External controls (one NG positive, one CT positive, and one negative) will be assayed with each new lot, new shipment, and every 30 days after the lot/shipment is in use, as well as after system maintenance and software upgrades." 2. Review of the Xpert CT/NG assay procedure revealed external quality control materials should be loaded directly into the sample chamber of a test cartridge. 3. Review of quality control testing results for external quality control testing on the Cepheid GeneXpert Dx analyzers revealed the external positive controls for NG and CT were ran in the same cartridge simultaneously. 4. Interview with TP#2 on 10-3-2019 at 1:00 pm confirmed external control materials are transferred into CT /NGSWAB-50 collection tube media to increase the number of uses of control material. Additionally, the positive controls for CT and NG are combined together into one CT/NGSWAB-50 collection tube and then loaded into a single cartridge and used for external quality control purposes. 5. Review of test volume records revealed the laboratory performed 726 tests for CT/NG from March 2019 through September of 2019. 6. On survey date 10-03-2019, at 3:00 pm, TP #2 confirmed manufacturer's instructions were not followed for the handling of external quality controls for CT/NG testing on the Cepheid GeneXpert analyzers. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 3 of 7 -- instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #2; the laboratory failed to establish a system to bi-annually evaluate the relationship between Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) test results on the two Cepheid GeneXpert Dx analyzers. Findings include: 1. Direct observation of laboratory testing equipment during a tour of the laboratory facility on 10-03-2019 at 9:36am identified two Cepheid GeneXpert Dx analyzers, serial numbers 831860 and 831868. 2. Review of the laboratory procedure manual revealed the laboratory failed to establish a system to bi-annually evaluate the relationship between CT/NG testing on the two Cepheid GeneXpert Dx analyzers. 3. On survey date 10-03-2019, at 3:00 pm, TP #2 confirmed the laboratory failed to establish a system to bi-annually evaluate the relationship between CT/NG testing on the two Cepheid GeneXpert Dx analyzers. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory director failed to provide the overall management and direction in accordance with 493.1407. Findings Include: 1. The laboratory director (LD) failed to ensure verification of performance procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics were acceptable for urine and vaginal/endocervical Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid GeneXpert Dx analyzers.. See D6013. 2. The laboratory director (LD) failed to ensure testing personnel are performing Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing as required on the Cepheid GeneXpert Dx analyzers. See D6014. 3. The laboratory director (LD) failed to ensure 2 of 4 testing personnel performing Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid GeneXpert Dx analyzers had the appropriate training. See D6029. 4. The laboratory director (LD) failed to specify in writing the duties and responsibilities for 4 of 4 testing personnel. See D6032. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance -- 4 of 7 -- characteristics of the method; This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory director (LD) failed to ensure verification of performance procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics were acceptable for urine and vaginal/endocervical Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid GeneXpert Dx analyzers. Findings Include: 1. The LD failed to ensure verification of performance was adequate for both Cepheid GeneXpert Dx analyzers used for CT/NG patient testing with urine and vaginal/endocervical spemicems. See D5421. 2. On survey date 10-03-2019, at 3:00 pm, the surveyor's findings were confirmed by TP#2. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review laboratory records and interview with testing personnel (TP) #2; the laboratory director (LD) failed to ensure testing personnel are performing Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing as required on the Cepheid GeneXpert Dx analyzers. Findings Include: 1. The LD failed to ensure external quality control was performed as described in the laboratory's individual quality control plan (IQCP) for both Cepheid GeneXpert Dx analyzers. See D5445. 2. The LD failed to ensure external quality control reagents were used as described in the laboratory's Xpert CT/NG procedure. See D5479. 3. On survey date 10-03-2019, at 3: 00 pm, the surveyor's findings were confirmed by TP#2. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review laboratory records and interview with testing personnel (TP) #2; the laboratory director (LD) failed to ensure 2 of 4 testing personnel performing Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) testing on the Cepheid -- 5 of 7 -- GeneXpert Dx analyzers had the appropriate training. Findings Include: 1. Testing personnel training records were reviewed for CT/NG testing on the Cepheid GeneXpert Dx analyzers. 2. Review of training records revealed 2 of 4 testing personnel, listed on the CMS-209 (Laboratory Personnel Report), failed to have documented training for CT/NG testing on the Cepheid GeneXpert Dx test system. 3. Review of test volume records revealed the laboratory performed 726 tests for CT/NG from March 2019 through September of 2019. 4. On survey date 10-03-2019, at 3:00 pm, the surveyor's findings were confirmed by TP#2. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review laboratory records and interview with testing personnel (TP) #2; the laboratory director (LD) failed to specify in writing the duties and responsibilities for 4 of 4 testing personnel. Findings Include: 1. Review of laboratory personnel records revealed the laboratory director failed to specify in writing the duties and responsibilities for 4 of 4 TP, which identifies the examinations and procedures each individual is authorized to perform and whether or not a consultant/director review is required prior to reporting patient test results. 2. On survey date 10-03-2019, at 3:00 pm, the surveyor's findings were confirmed by TP#2. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the technical consultant (TC) failed to provide the technical oversight in accordance with 493.1413. Findings Include: 1. The technical consultant failed to ensure 2 of 2 new testing personnel (TP) received documented competency assessments semiannually during the first year of testing. See D6053. 2. The technical consultant (TC) failed to ensure 2 of 2 established testing personnel (TP) received documented competency assessments annually in 2019 by a qualified TC. See D6054. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 6 of 7 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the technical consultant failed to ensure 2 of 2 new testing personnel (TP) received documented competency assessments semiannually during the first year of testing. Findings Include: 1. Review of the laboratory personnel report (CMS-209) identified 2 new moderate complexity testing personnel (TP), TP#1 and TP#4. 2. Review of competency assessment records revealed TP#1 received 1 competency assessment in 2018 (6th month) for VPIII Affirm testing but no second competency assessment was completed in the first year of testing. 3. Review of competency assessment records revealed TP#4's second competency assessment in July of 2019 was competed by TP#3 who failed to qualify as a technical consultant. 4. On survey date 10-03-2019, at 3:00 pm, TP#2 confirmed that semi-annual competency assessments were not completed for 2 of 2 new TP by a qualified technical consultant. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the technical consultant (TC) failed to ensure 2 of 2 established testing personnel (TP) received documented competency assessments annually in 2019 by a qualified TC. Findings Include: 1. Review of the laboratory personnel report (CMS-209) identified 2 established moderate complexity testing personnel (TP), TP#2 and TP#3. 2. Review of competency assessment records for TP#2 revealed TP#2's annual competency assessment was completed by TP#4, who failed to meet the qualification requirements as a technical consultant. 3. Review of competency assessment records for TP#3 revealed TP#3's annual competency assessment was completed by TP#4, who failed to meet the qualification requirements as a technical consultant. 4. On survey date 10- 03-2019, at 3:00 pm, TP#2 confirmed that annual competency assessments for TP#2 and TP#3 were not completed by qualified technical consultants. -- 7 of 7 --