Ascension St John Clinic Urgent Care - Jenks

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/10/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2 and the laboratory coordinator at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to ensure a proficiency testing attestation statement had been maintained; and failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee for two of ten events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of 2021, 2022, and 2023 proficiency testing records identified the following for two of ten events: (a) Third 2022 Hematology Event - The attestation statement had not been maintained. (b) Third 2022 Chemistry Core Event - The attestation statement had not been signed by the laboratory director or designee. (2) The findings were reviewed with technical consultant #2 who stated on 05/10/2023 at 03:20 pm, the attestation statements had not been signed or maintained as stated above. 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 -- 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 policies and procedures, and interview with technical consultant #2, the laboratory failed to follow their policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of three persons serving as technical consultant during the review period of July 2021 through the current date. Findings include: (1) A review of the laboratory policy titled, "Technical Consultant Competency" stated, "The Technical Consultant will be evaluated on their ability to perform the responsibilities established by the Urgent Care's accrediting agency. The technical consultant will be evaluated at least annually"; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of July 2021 through the current date identified competencies, based on job responsibilities, had not been documented as performed until 05/10/2023 for one of three persons listed as technical consultant on Form CMS- 209; (3) The findings were reviewed with technical consultant #2 who stated on 05/10 /2023 at 11:10 am, the competency for the technical consultant had not been performed during the review period until 05/10/2023. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 and interview with the laboratory coordinator, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 05/10/2023 at 01:15 pm identified the following expired collection tubes that appeared to be available for use: (a) Four Becton Dickinson Vacutainer Trace Element Serum tubes (lot #1350359) with an expiration date of 12/31/2022; (b) Six Becton Dickinson Vacutainer Serum tubes (lot #1236631) with an expiration date of 01/31/2023. (2) Interview with the laboratory coordinator on 05/10/2023 at 01:20 pm, confirmed the blood collection tubes would rarely be used to collect patient blood samples to send to the reference laboratory, however, the tubes were available for use. 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) -- 2 of 4 -- (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 a review of records and interview with technical consultant #2 and the laboratory coordinator, the laboratory failed to demonstrate the performance specifications for one of one replacement analyzer. Findings include: (1) On 05/10 /2023 at 04:10 pm, technical consultant #2 stated the following: (a) The laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (b) The laboratory began using iSTAT 1 (serial number 399431) to replace iSTAT 1 (serial number 399412) on 11/07/2022. (2) A review of records in 2022 identified no evidence the performance specifications (i.e., accuracy, precision, reportable range) had been demonstrated for the replacement iSTAT 1 analyzer; (3) The findings were reviewed with technical consultant #2 who stated on 05/10/2023 at 04:20 pm, the laboratory had not demonstrated the performance specifications for the replacement analyzer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and the laboratory coordinator, the laboratory failed to perform calibration verification procedures at least once every six months for one of one test system during the review period of July 2021 through the current date. Findings include: (1) On 05/10/2023 at 10:35 am, the laboratory coordinator stated the laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (2) A review of records from July 2021 through the current date identified no evidence calibration verification had -- 3 of 4 -- been performed at least once every six months during the review period; (3) The records were reviewed with technical consultant #2 who stated on 05/10/2023 at 04:05 pm, calibration verification procedures had not been performed every six months. 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 laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and the laboratory coordinator, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for one of one test system during the review period of July 2021 through the current date. Findings include: (1) On 05 /10/2023 at 10:35 am, the laboratory coordinator stated the following: (a) The laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (b) An IQCP (Individualized Quality Control Plans) had been developed for the test system. (2) A review of the IQCP for the test system identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plan) were to be performed on an annual basis; (3) A review of records for the test system from July 2021 through the current date identified no documentation that annual QA reviews had been performed during the review period; (4) The records were reviewed with technical consultant #2 and the laboratory coordinator. Both stated on 05/10/2023 at 04:35 pm, annual QA reviews had not been documented as performed for the above test system. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/29/2021. 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 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 and interview with the laboratory coordinator, the laboratory failed to follow written technical consultant competency policy based on the job responsibilities as listed in Subpart M for 3 of 3 technical consultants. Findings include: (1) The surveyor reviewed personnel records for competency assessments performed during 2019 and 2020 There was no evidence competencies had been performed for technical consultant #1, technical consultant #2, and technical consultant #3 based on job responsibilities; (2) The surveyor asked the laboratory coordinator if a written policy to evaluate the technical consultant, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory coordinator stated to the surveyor on 06/29/2021 at 12: 50 pm, a policy to evaluate the technical consultant annually based on job responsibilities was written but had not been performed in 2019 and 2020. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 -- 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 8 of 13 months. Findings include: (1) On 06/29/2021 at 10:10 am, 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 13 months (January 2020 through January 2021). There was no evidence the weekly maintenance had been performed: (a) Between 01/20/2020 and 02/10/2020 (b) Between 02/17/2020 and 03/02/2020 (c) Between 03/02/2020 and 04/06/2020 (d) Between 04/06/2020 and 04/28/2020 (e) Between 06/09/2020 and 06/22/2020 (f) Between 11/10/2020 and 11/22/2020 (g) Between 12/01/2020 and 12/22/2020 (h) Between 12/22/2020 and 01/14/2021 (4) The surveyor reviewed the records with the laboratory coordinator, who stated on 06/29/2021 at 01:15 pm, 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 coordinator, 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 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 -- 2 of 4 -- 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 7 of 15 competency evaluations performed and 1 of 7 proficiency testing attestation forms. Findings include: COMPETENCY EVALUATION (1) On 06/29/2021, the surveyor reviewed records for 15 persons performing moderate complexity testing in 2019, 2020, and 2021. The records showed the evaluations for 7 of 15 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #1 - The 01/05/2020 and 01/20/2021 evaluations 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 responsible); (b) Testing Person #5 - The 01/23/2020 and 12/18/2020 evaluations had been performed by the laboratory coordinator; (c) Testing Person #6 - The 08/21 /2020 evaluation had been performed by the laboratory coordinator; (d) Testing Person #9 - The 05/26/2020 and 05/25/2021 evaluations had been performed by the laboratory coordinator; (e) Testing Person #10 - The 04/02/2020 and 03/10/2021 evaluations had been performed by the laboratory coordinator; (f) Testing Person #11 - The 05/11/2020 and 04/27/2021 evaluations had been performed by the laboratory coordinator; (g) Testing Person #12 - The 08/27/2020 evaluation had been performed by the laboratory coordinator. (2) The surveyor 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 06/29/2021 at 01:10 pm, 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 06/29/2021, the surveyor reviewed 2020 and 2021 proficiency testing records and identified that 1 of 7 attestation statements had been signed by an -- 3 of 4 -- individual who did not meet the minimal educational qualifications of a technical consultant or designee. The attestation statement 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 statement had been signed by the laboratory coordinator: (a) First 2021 Chemistry Core Event (2) The surveyor reviewed the records with the laboratory coordinator. On 08/19/2021 at 12:25 pm, the laboratory coordinator stated the attestation statement, 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 The initial survey was performed on 06/14/19. The findings were reviewed with technical consultant #1 and 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 and technical consultant #1, 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 and technical consultant #1 if a written policy to evaluate the technical consultant based on job responsibilities was available. The laboratory coordinator and technical consultant #1 stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. 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 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 -- determined under 493.1253. 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 Hematology. Findings include: (1) At the beginning of the survey, the laboratory coordinator stated CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's instructions for verifying morphology flags obtained on the analyzer: (a) "AG (Platelet Flag) (Platelet Aggregate Code)" (i). Action - "1. Check specimen for clots. If clotted, results are invalid. 2. If no clots are present, rerun specimen. 3. OK TO REPORT if AG flag remains and the platelet result is within normal range of 150-480." (ii). Reporting - "DO NOT REPORT if AG flag remains and value is not within normal range, send lavender and blue specimens to RML." (b) "WL (WBC error flag but will flag the Diff also)" (i) Action - "1. Do Autorinse and Assure Background Counts are within limits. 2. Check specimen for clots. If clotted, results are invalid. 3. If no clots are present, rerun the specimen. 4. If WL flag stil remains and /or specimen has clots then results are invalid-DO NOT REPORT." (ii) Reporting - "DO NOT REPORT at all if WL flag remains send lavender and blue specimens to RML." (3) The surveyor randomly reviewed 21 patient records containing flags from CBC testing performed during July 2018, October 2018, January 2019, March 2019, and May 2019. For 2 of 21 records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flag: (a) Patient #1 - AG flag reported on patient testing performed on 10/24/18 at 09:19 am, with a platelet result of 607; (b) Patient #2 - WL flag reported on patient testing performed on 05/23/19 at 09:06 am (4) The surveyor reviewed the records with laboratory coordinator who stated the flags obtained for the above patients had not been documented as verified. 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 a review of records, procedure manual, and interview with the laboratory coordinator, the laboratory failed to ensure the verified reportable ranges were used by the laboratory. Findings include: (1) On the first day of the survey, the laboratory coordinator stated the laboratory began using the Sysmex XP-300 analyzer to perform routine CBC (Complete Blood Count) testing beginning 05/21/18; (2) The surveyor reviewed the validation records for the analyzer. The reportable range was verified as follows: (a) Hemoglobin 0.0 - 21.6 g/dL (b) Hematocrit 0 - 59 % (3) The surveyor then reviewed the laboratory computer system and identified the following reportable ranges used by the laboratory were wider than the verified reportable ranges: (a) -- 2 of 3 -- Hemoglobin 7 - 25 g/dL (b) Hematocrit 20 -70 % (4) The surveyor reviewed the results with the laboratory coordinator who stated the laboratory computer system's reportable range were wider than the verified reportable ranges. 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 CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs: (a) Weekly Maintenance (i) Clean SRV Tray (3) The surveyor then reviewed maintenance records from July 2018 through May 2019. There was no evidence the weekly maintenance had been performed: (a) Between 07/17/18 and 08/11/18 (b) Between 08/11/18 and 08/29/18 (c) Between 09/11 /18 and 10/01/18 (d) Between 11/01/18 and 12/01/18 (e) Between 12/01/18 and 12/11 /18 (f) Between 01/14/19 and 02/05/19 (g) Between 02/12/19 and 02/26/19 (h) Between 02/26/19 and 03/05/19 (i) Between 03/05/19 and 03/26/19 (j) Between 04/09 /19 and 05/06/19 (4) The surveyor reviewed the records with the laboratory coordinator, who stated the weekly maintenance had not been documented as performed as indicated above. -- 3 of 3 --