Jill Gibson Md, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Jill Gibson, MD, LLC, CLIA ID 19D2087106, on July 22, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of the manufacturers' storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of areas where laboratory supplies and test kits were stored. Findings: 1. Observation by surveyor during the laboratory tour on July 22, 2024 at 9:42 am revealed the following items stored without temperature monitoring: a) Receptionist area: Aptima urine specimen collection kits and Consult Diagnostics 10 SG urine reagent strips b) Hallway: Consult Diagnostics hCG Urine test cassettes 2. Review of the manufacturers' storage requirements revealed the following: a) Aptima urine specimen collection kits: storage temperature 15-30 degrees Celsius b) Consult Diagnostics urine reagent strips: storage requirement 2-30 degrees Celsius b) Consult hCG urine test cassettes: storage temperature 2-30 degrees Celsius 3. In interview on July 22, 2024 at 12:00 pm, the Office Manager stated the room temperature was not monitored in the areas where the supplies and test kits were stored. 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 -- 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 observation by surveyor, review of the manufacturers' storage requirements, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6050. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, competency assessments, and interview with personnel, the Technical Consultant failed to perform a direct observation of instrument maintenance and function checks as a part of competency assessment in 2023 and 2024 for one (1) of two (2) Testing Personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director and Testing Personnel 1 serve as testing personnel. 2. Review of Testing Personnel 1's competency assessments for 2023 and 2024 revealed the Laboratory Director, who also serves as the Technical Consultant, did not -- 2 of 3 -- perform a direct observation of instrument maintenance and function checks. The competency was signed as completed on January 31, 2023 for the BD Max and Affirm instruments and January 31, 2024 for the BD Max instrument. 3. In interview on July 22, 2024 at 12:30 pm, the Laboratory Director confirmed she did not document a direct observation of instrument maintenance for Testing Personnel 1's annual competency assessment for 2023 and 2024. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Jill Gibson MD, LLC, CLIA # 19D2087106, on October 14, 2022. Jill Gibson MD, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to ensure reagents and supplies did not exceed expiration dates. Refer to D5417. 2. The laboratory failed to ensure complete performance verification studies were performed for testing on the BD Max analyzer. Refer to D5421. 3. The laboratory failed to perform quality control (QC) for the BD Max analyzer every thirty (30) days per policy for two (2) of five (5) random months reviewed. Refer to D5445. 4. The laboratory failed to establish complete procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of policies, expired items log, and interview with personnel, the laboratory failed to ensure reagents and supplies did not exceed expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on October 14, 2022 at 9:35 am revealed the following expired items: a) BD Max Instrument Qualification Kit, Lot 9330445, Expiration Date: 2021-05-24, Quantity: three (3) kits b) BD Max Instrument Qualification Kit, Lot 9289655, Expiration Date: 2021-05-17, Quantity: two (2) kits c) BD Max Instrument Qualification Kit, Lot 0247927, Expiration Date: 2033-03-02, Quantity: one (1) kit d) Microbiologics Vaginal Panel Pool 2, Lot 6061-13, Expiration Date: 2021-04-30, Quantity: one (1) pack e) Microbiologics QC sets and Panels, Lot 8209-14, Expiration Date: 2020-11- 30, Quantity: two (2) containers f) BD Vacutainer blood collection tubes, Lot 8047611. Expiration Date: 2019-02-28, Quantity: one (1) tube 2. Review of the laboratory's "Material Management" policy revealed "The Laboratory Manager or designee will review the reagent inventory logs at least monthly to determine the need to re-order and the need to remove items from service due to expiration dating." 3. Review of the laboratory's "Expired Item Maintenance Log" revealed the laboratory performs checks weekly. In October 2022 the laboratory performed an expired item check on October 6, 2022 and October 14, 2022. 4. In interview on October 14, 2022 at 9:40 am, the office manager confirmed the identified items were expired. 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 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 observation by surveyor, review of the laboratory's policies, validation records, test menu, and interview with personnel, the laboratory failed to ensure complete performance verification studies were performed for testing on the BD Max analyzer. Findings: 1. In interview on October 14, 2022 at 9:28 am the office manager stated the laboratory began patient testing on the BD Max analyzer in April 2021. 2. Observation by surveyor during the laboratory tour on October 14, 2022 at 9:35 am revealed the laboratory utilizes the BD Max analyzer for testing of trichomonas, chlamydia, and gonorrhea. 3. Review of the laboratory's "Evaluation of Test Methods" policy revealed "At the time of introduction of a new test system or method, the laboratory is responsible for verifying the performance specification prior to reporting patient test results. The test method evaluation should include a summary of precision and accuracy, linearity for validation of reportable range and patient correlation when applicable. This evaluation should be documented, and all worksheets, instrument -- 2 of 5 -- printouts, and related documents shall be retained for the life of the method plus two years for regulatory inspection purposes. All documented data must be reviewed and approved by the lab director prior to initiating patient testing." 4. Review of the laboratory's validation records revealed the laboratory did not include the following: a) Summary to include, but not limited to, how studies were performed b) Laboratory Director's approval/signature 5. In interview on October 14, 2022 at 11:23 am, the office manager confirmed the identified items were not included in the performance verification studies. 6. Review of the laboratory's test menu revealed the laboratory performs 4,500 tests annually on the BD Max analyzer. 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 observation by surveyor, review of the laboratory's policies, control records, patient logs, and interview with personnel, the laboratory failed to perform quality control (QC) for the BD Max analyzer every thirty (30) days per policy for two (2) of five (5) random months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on October 14, 2022 at 9:35 am revealed the laboratory utilizes the BD Max analyzer for testing of trichomonas, chlamydia, and gonorrhea. 2. Review of the laboratory's "BD Max CT/GC/TV" policy under the "Quality Control" section revealed "Every Positive and Negative Controls will be ran with every new lot, every new shipment and every thirty days." 3. Review of random selection of patient test reports and corresponding QC records revealed the laboratory did not perform external QC every thirty (30) days for the following two (2) months: December 2021: QC due December 11, 2021; however, was not performed until December 16, 2021 August 2022: QC due August 6, 2022; however, was not performed until August 15, 2022 4. Further review of patient test logs revealed the laboratory reported the following patients without performance of external QC per policy: December 13, 2021: Patient 8679, Patient 11562, and Patient 28216; Total of twenty three (23) patient test results reported August 9, 2022: Patient 37495, Patient 6470, and Patient 15897; Total of twenty four (24) patient test results reported 5. In interview on October 14, 2022 at 11:30 am, the office manager stated he was unsure why the laboratory's QC performance exceeded thirty (30) days for the identified patients and months. The office manager confirmed the laboratory did not perform the external QC for the BD Max per laboratory's policy. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The -- 3 of 5 -- laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of records, and interview with personnel, the laboratory failed to establish complete procedures to monitor, assess, and correct problems, identified with the analytic system. Findings: 1. Review of the laboratory's "Quality Assessment Plan" revealed a monthly checklist that included the following monitors: Proficiency Testing Specimen Handling, Collection, Labeling, LJ and data tables Quality Control Records Temperature Logs Quality Assessment Plan

Summary Statement of Deficiencies D0000 A Certification survey was performed on February 23, 2021 at Jill Gibson MD, LLC, CLIA ID # 19D2087106. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's proficiency test records, policies, and interview with personnel, the laboratory failed to ensure Testing Personnel signed the attestation statement for two (2) of six (6) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Quality Assessment Plan" for "Proficiency Testing" revealed "Visual review of staff performing PT, review of all testing, documentation, and final report from PT provider. All testing personnel and Laboratory Director signed attestation sheet?" 2. Review of the laboratory's American Proficiency Institute (API) records for 2019 and 2020 revealed the Testing Personnel did not sign the attestation statement for the following events: 2019 Microbiology 1st Event: Testing Personnel 1 and Testing Personnel 2 did not sign 2020 Microbiology 2nd Event: Testing Personnel 2 did not sign 3. In interview on February 23, 2021 at 11:17 am, the office manager confirmed the Testing Personnel did not sign the identified attestation statements. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed 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 -- 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a written policy for the following: a) Twice a year instrument comparison of test results for the BD Max and BD Affirm instruments for Parasitology testing; to include but not limited to frequency and acceptability criteria 2. In interview on February 23, 2021 at 10:40 am, the office manager confirmed the laboratory did not have a written policy for instrument comparison of test results for Parasitology testing. 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 observation by surveyor, review of patient and maintenance logs, and interview with personnel, the laboratory failed to document the temperatures of the BD MicroProbe Lysis Block temperatures for Microbiology testing on the BD Affirm for five (5) of ten (10) days reviewed. Findings: 1. Observation by surveyor during laboratory tour on February 23, 2021 at 9:45 am revealed the laboratory utilizes the BD Affirm for testing of Trichomonas, Candida, and Gardnerella. 2. Review of the laboratory's "BD MicroProbe Lysis Block-Quality Control Log" for 2019 and 2020 and selection date review of December 7, 2020 through December 11, 2020 and January 25, 2021 through January 29, 2021 revealed temperatures were not documented for the following five days (5) sixteen (16) patients: a) December 9, 2020: b) January 25, 2021: c) January 26, 2021: d) January 27, 2021: e) January 28, 2021: 3. Review of the laboratory's patient test records revealed the following sixteen (16) patients were tested on the identified dates: a) December 9, 2020: Patient 6470 Patient 20677 Patient 26537 b) January 25, 2021: Patient 29684 Patient 2753 Patient 2511 Patient 7403 c) January 26, 2021: Patient 30626 Patient 17404 Patient 20708 d) January 27, 2021: Patient 24157 e) January 28, 2021: Patient 7784 Patient 14701 Patient 11000 Patient 2301 Patient 15672 4. In interview on February 23, 2021 at 11: 40 am, the office manager confirmed the laboratory did not document the MicroProbe Lysis Block temperatures for the identified dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 7 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation by surveyor, review of laboratory policies, and interview with personnel, the laboratory failed to ensure laboratory supplies and reagents did not exceed their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on February 23, 2021 at 9:45 am revealed the following expired items: a) Trichloroacetic Acid 50% HealthLink , Lot 8163, Exp 2020-06-12, Quantity: one (1) bottle b) McKesson Consult Diagnostics Liquid Urine Controls Diptube Style, Lot UCD5120003, Exp 2017/11, Quantity: one (1) box 2. Review of the laboratory's "Material Management" policy revealed " The Laboratory Manager or designee will review the reagent inventory logs at least monthly to determine the need to re-order and the need to remove items from service due to expiration dating." 3. In interview on February 23, 2021 at 10:00 am, the office manager confirmed the identified items were expired. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of patient logs, quality control, and interview with personnel, the laboratory failed to document the results of the internal controls for Microbiology testing on the BD Affirm for five (5) of ten (10) days reviewed. Findings: 1. Observation by surveyor during laboratory tour on February 23, 2021 at 9:45 am revealed the laboratory utilizes the BD Affirm for testing of Trichomonas, Candida, and Gardnerella. 2. Review of the laboratory's "BD Affirm VPIII Microbial Identification Testing Log" for 2019 and 2020 and selection date review of December 7, 2020 through December 11, 2020 and January 25, 2021 through January 29, 2021 revealed patient information and internal controls were not documented for the following sixteen (16) patients: a) December 9, 2020: Patient 6470 Patient 20677 Patient 26537 b) January 25, 2021: Patient 29684 Patient 2753 Patient 2511 Patient 7403 c) January 26, 2021: Patient 30626 Patient 17404 Patient 20708 d) January 27, 2021: Patient 24157 e) January 28, 2021: Patient 7784 Patient 14701 Patient 11000 Patient 2301 Patient 15672 3. In interview on February 23, 2021 at 11:17 am, the office manager stated the laboratory records the patient information, results, and internal controls on the identified log sheet for the BD Affirm. In further interview at 11:40 am, the office manager confirmed the laboratory did not document the internal controls for the identified patients. D5779