Ascension St John Urgent Care South Memorial

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/12/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #1, and technical consultant #2 during an exit conference performed at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's storage instructions for three of three cases of Sophia II Antigen test kits. Findings include: (1) On 09/12/2023 at 11:05 am, technical consultant #1 stated that testing was performed using the Sophia II analyzer; (a) On 09/12/2023 at 11:05, observation of the storage room located outside of the laboratory identified the following; (i) One case containing 12 Sophia 2 SARS Antigen test kits, lot #708714. The manufacturer's storage requirement, as stated on the box was 15-30 degrees C (Centigrade); (ii) One case containing 12 boxes of Strep A+ Antigen test kits, lot #708838. The manufacturer's storage requirement, as stated on the box was 15-30 degrees C (Centigrade); (iii) One case containing 12 boxes of Flu A+B Antigen test kits, lot #708494. The manufacturer's storage requirement, as stated on the box was 15-30 degrees C (Centigrade). (2) Interview with technical consultant #1 on 09/12/2023 at 11:05 am confirmed the temperature of the storage room was not being monitored. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures during the review period of January 2023 through August 2023. Findings include: (1) On 09/12/2023 at 12:05 am, technical consultant #1 stated CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) A review of the manufacturer's maintenance log showed the following required weekly maintenance procedures: (a) "Clean SRV Tray" (3) A review of maintenance logs from January 2023 through August 2023 identified no documentation weekly maintenance had been performed between: (a) 01 /14/2023 and 01/26/2023 (b) 02/21/2023 and 03/10/2023 (c) 03/10/2023 and 03/19 /2023 (d) 04/20/2023 and 04/30/2023 (e) 04/30/2023 and 05/11/2023 (f) 06/01/2023 and 06/14/2023 (g) 07/04/2023 and 07/17/2023 (4) The records were reviewed with technical consultant #1 who stated on 09/12/2023 at 12:10 am, weekly maintenance had not been documented as performed as shown above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to perform function checks as defined by the manufacturer for the iSTAT 1 analyzer during the review period of 12/01/2021 through the current date. Findings include: (1) On 09/12/2023 at 12:40 pm, technical consultant #1 stated the laboratory performed BUN, Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, and Creatinine testing using the Chem 8 + cartridge and the iSTAT 1 analyzer; (2) Review of the i-STAT Operator's manual stated in chapter 14 (quality control),"Check thermal control sensor twice a year"; (3) A review of records from 12/01/2021 through the current date identified no evidence the thermal probe checks had been performed prior to 06/07/2023; (4) The findings were reviewed with technical consultant #1 who stated on 09/12/2023 at 12:40 pm, the thermal probe checks had not been performed twice a year. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/14/2021. The findings were reviewed with the laboratory coordinator at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant 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 a review of records, manufacturer's instructions, and interview with the laboratory coordinator, the laboratory failed to retain records for at least 2 years for 1 of 18 months. Findings include: (1) On 07/14/20201 at 09:45 am, the laboratory coordinator stated to surveyor #1 CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) Surveyor #2 reviewed Levy Jenning records between January 2020 through June 2021 with the following identified: (a) Records between 03/04/2020 and 03/31/2020 were not available (3) Surveyor #2 ask the laboratory coordinator if the records between 03/04/2020 and 03 /31/2020 could be located; (4) The laboratory coordinator stated on 07/14/2021 at 11: 08 am records between 03/04/2020 and 03/31/2020 for CBC testing could not be located. Surveyor #2 could not determine if the records for the above months had been monitored and evaluated for shifts and trends for 1 of 18 months. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator, the laboratory failed to review and evaluate proficiency testing results for 1 of 8 events. Findings include: (1) On 07/14/2021, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing records (total of 8 events) and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2021 Hematology Event (i) WBC (White Blood Cell) - 3 of 5 results exhibited a positive bias (aa) HSY-03 - SDI of 2.5 (bb) HSY-04 - SDI of 2.5 (cc) HSY-05 - SDI of 2.0 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) Surveyor #2 then reviewed the records with the laboratory coordinator, and asked if the biases had been addressed. The laboratory coordinator stated on 07/14 /2021 at 11:00 am the biases had not been addressed as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory coordinator, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 4 of 18 months. Findings include: (1) On 07/14/20201 at 09:45, the laboratory coordinator stated to surveyor #1 that CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) Surveyor #2 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Clean SRV Tray (3) Surveyor #2 then reviewed maintenance records for 18 months (January 2020 through June 2021). There was no evidence the weekly maintenance had been performed: (a) Between 04/23/2020 and 05/06/2020 (b) Between 08/08/2020 and 08/20/2020 (c) Between 11/13/2020 and 11/28/2020 (d) Between 05/30/2021 and 06/17/2021 (4) Surveyor #2 reviewed the records with the laboratory coordinator, who stated on 07/14/20201 at 11:03 am, the weekly maintenance had not been performed as required. 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 a review of records and interview with the laboratory consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the -- 2 of 4 -- individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 3 of 8 competency evaluations performed and signed 3 of 9 proficiency testing attestation forms. Findings include: COMPETENCY EVALUATION (1) On 07/14/20201, surveyor #2 reviewed records for 8 persons performing moderate complexity testing in 2019, 2020, and 2021. The records showed the evaluation for 3 of 8 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #1 - The 12/20/2019 evaluation had been performed by the laboratory coordinator (this person had earned a bachelors degree in clinical laboratory science but did not have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is -- 3 of 4 -- responsible); (b) Testing Person #13 - The 08/12/2019 and 09/14/2020 evaluations had been performed by the laboratory coordinator; (c) Testing Person #28 - The 06/18 /2020 and 05/21/2021 evaluations had been performed by the laboratory coordinator; (2) Surveyor #2 explained to the laboratory coordinator that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory coordinator stated to the surveyor on 07/14/2021 at 10:58 am, the evaluations had been performed by an individual who did not meet the years of experience of a technical consultant. PROFICIENCY TESTING ATTESTATION FORMS (1) On 07 /14/20201, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing records and identified that 3 of 9 attestation statements had been signed by an individual who did not meet the minimal educational qualifications of a technical consultant or designee. The attestation statements had been signed by the laboratory coordinator (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The following attestation statements had been signed by the laboratory coordinator: (a) First 2020 Hematology Event (b) Second 2020 Hematology Event (c) Third 2020 Chemistry Core Event (2) Surveyor #2 reviewed the records with the laboratory coordinator. On 07/14/20201 at 11:01 am, the laboratory coordinator stated the attestation statements, as indicated above, had been signed and dated by an individual who did not meet the regulatory qualification requirements of a technical consultant or designee. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 07/15/19. The findings were reviewed with the laboratory coordinator at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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: Based on a review of records, written policy and interview with the laboratory coordinator, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities; (2) The surveyor asked the laboratory coordinator if a written policy to evaluate the technical consultant based on job responsibilities was available. The laboratory coordinator stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Third 2018 Hematology Event (i) RDW (Red Cell Distribution Width) - 3 of 5 results exhibited a negative bias (aa) HSY-11 - SDI of -2.5 (bb) HSY-13 - SDI of -2.2 (cc) HSY-15 - SDI of -2.1 (ii) WBC (White Blood Cell) - 4 of 5 results exhibited a positive bias (aa) HSY-11 - SDI of 4.0 (bb) HSY-12 - SDI of 2.1 (cc) HSY-13 - SDI of 2.8 (dd) HSY-15 - SDI of 2.4 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the laboratory coordinator, and asked if the biases had been addressed. The laboratory coordinator stated the biases had not been addressed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory coordinator, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) At the beginning of the survey, the laboratory coordinator stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Clean SRV Tray (3) The surveyor then reviewed maintenance records for 10 months (September 2018 through June 2019). There was no evidence the weekly maintenance had been performed: (a) Between 11/10/18 and 11/20/18 (4) The surveyor reviewed the records with the laboratory coordinator, who stated the maintenance had not been performed as required. 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 review of records and interview with the laboratory coordinator, the laboratory director failed to attest that, at the time of testing, proficiency testing -- 2 of 3 -- samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records. It was identified for 1 of 5 events, the attestation statements had been signed approximately 3 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Hematology Second event of 2018 - The samples had been tested on 07/17/18 and the attestation statement had not been signed by the laboratory director until 10/03/18; (2) The surveyor reviewed the findings with the laboratory coordinator and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 3 of 3 --