Columbiana Clinic Llc

Summary Statement of Deficiencies 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 a review of the American Proficiency Institute (API) proficiency testing records for 2018 - 2020 and an interview with the Laboratory Director (who also serves as the Technical Consultant) and Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the testing personnel performing the Provider-Performed Microscopy Procedures (PPMP) [urine sediment examinations, potassium hydroxide (KOH) and vaginal wet preparations] signed the attestestion statements for eight of eight Hematology testing events, reviewed by the surveyor. The Laboratory Director failed to sign the attestation statements for Hematology Event #1, 2018 and Event #2, 2020 and Core Chemistry Event #3, 2020. The findings include: 1. A review of the API proficiency testing records for Hematology Events #1, #2 and #3 of 2018 and 2019 and Events #1 and #2 of 2020 revealed the testing personnel (the physician) of the PPMP failed to sign the attestation statements. 2. In an interview on 10/28/2020 at 11:00 AM, the LD (also the Technical Consultant) and TP #1 confirmed the provider did perform the PPMP procedures but had not signed any of the attestation statements for 2018 through the second testing event of 2020. The LD confirmed she had not signed the attestation statement for Hematology Event #1, 2018. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty 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 -- assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of 2018 - 2020 American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD), who also serves as the Technical Consultant, the laboratory failed to self-grade a platelet count (Hematology Event #1, 2019), which was not graded by API. This affected one of eight Hemtology testing events, reviewed by the surveyor. The findings include: 1. A review of Hematology PT Event #1, 2019 revealed the platelet count for specimen HEM 02 was not scored by API. The laboratory did not self-grade the result. 2. During an interview on 10/28/2020 at 12:19 PM, the LD reviewed the PT records and stated she could not remember what happened. The LD further confirmed the laboratory had not self-evaluated the results of the platelet count, when returned by API. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of 2018 - 2020 American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD), who also serves as the technical consultant, the surveyor determined the laboratory failed to implement and document

Summary Statement of Deficiencies D0000 This is the laboratory's second unsuccessful proficiency testing participation for Sodium (NA), resulting in non-initial proficiency testing participation. 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 the Casper Reports (#153/#155) and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing (PT) for Sodium (Na) for Event #2, 2017, Event #3, 2017 and Event #2, 2018. These failures resulted in non-initial proficiency testing participation for the laboratory. The findings include: 1. Previously cited, the initial unsuccessful participation: The laboratory scored 40 % 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 -- (percent) for Na for testing Event #2 of 2017, and 0 % for Na for Event #3, 2017. The zero score was due to the laboratory's untimely submission of the testing results to the proficiency testing provider. 2. A review of the Casper Reports and API proficiency testing evaluations revealed the laboratory scored 40 % for Na for Event #2, 2018, resulting in two unsuccessful performances, a non-initial PT participation. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Casper Reports (#153/#155) and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to perform satisfactorily in proficiency testing for Sodium (Na) for Events #2 and #3 of 2017 and Event #2 of 2018. These failures resulted in non-initial proficiency testing participation for the laboratory. The findings include: 1. Previously cited, the initial unsuccessful participation: The laboratory scored 40 % (percent) for Na for testing Event #2 of 2017, and 0 % for Na for Event #3, 2017. The zero score was due to the laboratory's untimely submission of the testing results to the proficiency testing provider. 2. A review of the Casper Reports and API proficiency testing evaluations revealed the laboratory scored 40 % for Na for Event #2, 2018, resulting in two unsuccessful performances, a non-initial PT participation. 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 a review of the Casper Reports (#153/#155) and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing (PT) for Sodium (Na), as evidenced by the laboratory's failures of Na for Events #2 and #3, 2017 and Event #3, 2018. These failures resulted in non- initial proficiency testing participation for the laboratory. The findings include: 1. Refer to D2016. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the Casper Reports (#153/#155) and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory director failed to ensure the laboratory's quality assessment program was maintained in a manner to identify possible errors within the laboratory systems that resulted in the laboratory's non-initial performance of proficiency testing for Sodium. The findings include: 1. Refer to D2016. Patricia Watson, BS, MT (ASCP)Licensure and Certification Supervisor -- 3 of 3 --