Wells Walk In Urgent Care Pllc

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: Fed - D - 2016 - 493.803 Condition: Successful participation Fed - D - 6000 - 493.1403 - Moderate Complexity Laboratory Director Fed - D - 6063 - 493.1421 Testing Personnel Fed - D - 8100 - 493.1771 - Inspection Requirements The laboratory voluntarily ceased CBC (complete blood count) testing on the Medonic M Series hematology analyzer on 11/5/18 as evidenced by their letter dated 11/8/18. 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 laboratory policies and procedures, American Board of Bioanalyts (AAB) proficiency testing records, and confirmed in interview, the individual testing the proficiency testing samples and the lab director failed to attest to the routine integration of proficiency samples into the patient workload for 5 of 6 testing events in 2017 and 2018. The findings included: 1.Based on review of the AAB proficiency testing records from 2017 and 2018 revealed the individual testing person and lab director failed to sign the attestation for for the following 5 of 6 events in 2017 and 2018 2017 Hematology/Coagulation 1st, 2nd, 3rd event 2018 Hematology /Coagulation 1st, 2nd event 2. An interview with the technical consultant on 11/14/18 at 1000 hours in the nursing station confirmed the above findings. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) 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 -- (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 review of proficiency testing records and interview of facility personnel, the laboratory failed to successfully participate in a proficiency testing program for the specialty of routine hematology. Refer to D2130 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 2017 - 2018 American Board of Bionalysts (AAB) proficiency testing (PT) records and interview of facility personnel it was revealed that the laboratory failed to participate in the 1st and 2nd hematology testing event of 2017 and first testing event of 2018. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" on the 1st and 2nd hematology testing event of 2017 and first testing event of 2018 for this facility. 2. A review of AAB proficiency testing records revealed the laboratory received a 0% for the 2017 Q1 and Q2 Hematology PT and 2018 Q1 Hematology PT for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing event 2017 Q1 and Q2 and 2018 Q1 for Hematology. 3. An interview of the managing director on 11/14/18 at 1000 hours in the nursing station confirmed the above findings. He confirmed the laboratory had failed to submit results to the proficiency testing company and that the laboratory had not performed any self-evaluation. key: CMS - Center for Medicare and Medicaid services -- 2 of 7 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Board of Bioanalysts (AAB) proficiency testing (PT) records from 2017 and 2018, and confirmed in interview, the laboratory failed to attain a satisfactory performance (score of at least 80 %) for 2 of 3 events in 2017. Findings were: 1. Review of the 2017 AAB proficiency testing records revealed 2 of 3 consecutive events when the laboratory failed to attain at least an 80% score for 6 of 6 of the following analytes. 2017 Q1 event Hematology (0%) RBC (0%) WBC (0%) Cell ID (0%) Hgb (0%) Hct (0%) Platelets(0%) 2017 Q2 event Hematology (0%) RBC (0%) WBC (0%) Cell ID (0%) Hgb (0%) Hct (0%) Platelets(0%) 2. An interview with the technical consultant on 11/7/18 at 1030 hours in the laboratory confirmed the above findings. 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 review of American Board of Bioanalysts (AAB) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to retain the proficiency testing records for 2 of 3 PT events in 2018. Findings were: 1. The CMS report 155 showed PT event scores for 2018 Q1 and 2018 Q2 events . 2. A review of proficiency testing (PT) records revealed there was no documentation of attestation statements and the instrument printouts for the PT testing performed for 2018 Q1 and Q2 events from AAB. 3. An interview with the technical consultant on 11/14/18 at 1040 hours confirmed the above findings. KEY: CMS- Center for Medicare and Medicaid Services D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on attempted review of quality control records from May to October 2018 and -- 3 of 7 -- confirmed in interview, the laboratory failed to have a quality control plan that would detect errors over time for CBC (complete blood count) testing on the Medonic M Series hematology analyzer. The findings were: 1. Review of the May to October 2018 quality control data revealed no documentation the laboratory monitored quality control data over time. The laboratory failed to document the review of Levy Jennings or statistical calculations (mean, standard deviations, and coefficient of variation), which present an overall evaluation of quality control performance, and is a tool used to evaluate the accuracy and precision of controls over time. 2. An interview with the technical consultant on 11/14/18 at 1040 hours in the nursing station confirmed the above findings. 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 instrument verification records, review of patient final reports, and confirmed in interview, the laboratory director failed to provide overall management and direction of the laboratory. Refer to D6018, D6020 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require