Urgent Care For Children - Vestavia

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 3/15/2022 at Urgent Care for Children. Based on a review of the Horiba Micros 60 (Hematology analyzer) calibration records, Quality Control (QC) records, User Manual, control package insert, patient result logs, and an interview with the Laboratory Manager, the laboratory failed to monitor and evaluate the quality of the calibration and quality control being performed on the Horiba Micros 60 analyzer and to ensure a properly working analyzer. Due to the potential for serious injury or death when it is unknown if the analyzer is properly working, the surveyor called an Immediate Jeopardy (IJ) on 3/15 /2022 at 1:00 PM. [Refer to D5400, D5437, D5481, and D5785.] The surveyor provided the IJ template to the Laboratory Manager, and received a voluntary statement, on 3/15/2022 at 2:30 PM, to suspend testing on the Horiba Micros 60 analyzer, until analytic processes are remediated. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of American Academy of Family Physicians (AAFP) Proficiency Testing (PT) records and an interview with the Laboratory Manager, the laboratory failed to retain all proficiency testing records for at least 2 years. This was noted for three out of six testing events. The findings include: 1. A review of AAFP PT records revealed 2020 - A, 2020 - B, and 2020 - C Events could not be located during the survey. 2. During an interview on 03/15/2022 at 10:25 AM, the Laboratory Manager confirmed the 2020 PT Binder could not be located. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of American Academy of Family Physicians (AAFP) Proficiency Testing (PT) records and an interview with the Laboratory Manager, the laboratory failed to provide evidence of review and evaluation of PT results. This was noted five out six testing events. The findings include: 1. A review of AAFP PT records revealed the laboratory failed to retain the 2020 PT records (events A, B, and C). For 2021 - A and 2021 - B events the laboratory failed to provide evidence of review and evaluation of the PT results. 2. During an interview on 3/15/2022 at 10:51 AM, the Laboratory Manager confirmed the 2020 PT Binder could not be located. Also, she confirmed the two events in 2021 did not have documentation of review and evaluation of PT results. 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 a review of the Horiba Micros 60 (Hematology analyzer) calibration records, Quality Control (QC) records, User Manual, control package insert, patient result logs, and an interview with the Laboratory Manager, the laboratory failed to monitor and evaluate the quality of the calibration and QC being performed on the Horiba Micros 60 analyzer and to ensure a properly working analyzer. From September 2020 to January 2022, the laboratory performed 6 patient Complete Blood Counts (CBC). Due to the evidence of this condition, an Immediate Jeopardy (IJ) was called on 03/15/2022 at 1:00 PM. An adverse outcome resulting in serious injury, harm, or death to patients is likely to occur if the following laboratory failures are not corrected: a) failure to follow the manufacturer's instructions to verify the calibration by running acceptable QC (refer to D5437). b) failure to ensure QC was acceptable before reporting patient test results (refer to D5481). c) failure to document

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of scores for the AAFP (American Academy of Family Physicians) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Office Manager, the surveyor determined the laboratory failed to satisfactorily perform in Hematology proficiency testing on two consecutive testing events, 2020-Event #3 and 2021-Event #1. These failures resulted in an initial unsuccessful performance in proficiency testing. The findings include: 1. A review of the CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory scored zero percent (0 %) for Hematology (Complete Blood Count [CBC] testing) for 2020-Event #3 and 2021-Event #1. These two consecutive failures 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 -- resulted in an initial unsuccessful performance in proficiency testing. 2. During an interview on 5/24/2021 at 9:32 AM, the Office Manager confirmed the laboratory had failed to perform and submit the results for the 2020-Event #3 and 2021-Event #1 surveys within the timeframe prescribed by the PT provider, and had received scores of 0 % . 3. In an e-mail received by the CLIA surveyor on 5/24/2021, the Office Manager confirmed the 2020-Event #3 survey was due on 10/28/2021, and the 2021- Event #1 survey was due on 3/25/2021. No patient CBC testing was performed in the two-week period prior to the survey due-dates, however the laboratory failed to notify the proficiency testing provider patient testing had temporarily ceased. . D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of scores for the AAFP (American Academy of Family Physicians) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Office Manager, the surveyor determined the laboratory failed to submit results within the timeframes prescribed by the PT provider on two consecutive testing events, 2020-Event #3 and 2021-Event #1. The findings include: 1. A review of the CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory scored zero percent (0 %) for Hematology (Complete Blood Count [CBC] testing) for 2020-Event #3 and 2021-Event #1. 2. During an interview on 5/24/2021 at 9:32 AM, the Office Manager confirmed the laboratory had failed to perform and submit the results for the 2020-Event #3 and 2021-Event #1 surveys within the timeframe prescribed by the PT provider, and had received scores of 0 %. 3. In an e-mail received by the CLIA surveyor on 5/24/2021, the Office Manager confirmed the 2020-Event #3 survey was due on 10/28/2021, and the 2021- Event #1 survey was due on 3/25/2021. No patient CBC testing was performed in the two-week period prior to the survey due-dates, however the laboratory failed to notify the proficiency testing program within the specified time frames of the suspension of patient CBC testing and the circumstances associated with failure to perform the PT. . D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of scores for the AAFP (American Academy of Family Physicians) -- 2 of 3 -- proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Office Manager, the surveyor determined the laboratory failed to satisfactorily perform in Hematology proficiency testing on two consecutive testing events, 2020-Event #3 and 2021-Event #1. These failures resulted in an initial unsuccessful performance in proficiency testing. The findings include: 1. A review of the CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory scored zero percent (0 %) for Hematology (Complete Blood Count [CBC] testing) for 2020-Event #3 and 2021-Event #1. These two consecutive failures resulted in an initial unsuccessful performance in proficiency testing. 2. During an interview on 5/24/2021 at 9:32 AM, the Office Manager confirmed the laboratory had failed to perform and submit the results for the 2020-Event #3 and 2021-Event #1 surveys within the timeframe prescribed by the PT provider, and had received scores of 0 % . The Office Manager further confirmed the laboratory had not notified AAFP with an acceptable reason for not performing the PT. . D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of scores for the AAFP (American Academy of Family Physicians) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Office Manager, the Laboratory Director failed to ensure the laboratory submitted PT results within the timeframes prescribed by AAFP on two consecutive testing events, 2020-Event #3 and 2021-Event #1. The findings include: 1. Refer to D2123. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 3 of 3 --