Medhelp Lakeshore Pc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of proficiency testing scores obtained from the national database and verified with the testing personnel on-site. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 proficiency testing records obtained from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the testing personnel on-site, the laboratory failed to successfully participate in a Proficiency Testing program for the Hematology analyte Platelet (PLT). This was noted for two out of three events reviewed in 2023. The fingings include: 1. Refer to D2130 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 a review of the American Proficiency Institute (API) proficiency testing (PT) records on 3/12/2024, the laboratory failed to achieve satisfactory performance for Platelet in two of three 2023 testing events. The findings include: 1. A review of the API PT results revealed unsuccessful performance for Platelet for two out of three consecutive PT events, as follows: A) Year 2023 - 1st Event: 0% B) Year 2023 - 3rd Event: 60% 2. During an interview on 3/12/24 at 10:15 AM, Testing Personnel #1 confirmed the above findings. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty 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 the API (American Proficiency Institute) proficiency testing (PT) records, a review of

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, 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 (PT) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all testing personnel who performed patient testing during 2020. This was noted for three out of three Chemistry and Hematology PT events. During 2020, nine out of fifteen Testing Personnel listed on the CMS - 209 Laboratory Personnel Report were performing patient testing in the laboratory. The findings include: 1. A review of the API PT records determined Testing Personnel #3 performed 2020 Chemistry and Hematology 1st, 2nd, and 3rd Events. 2. During an interview on April 27, 2022 at 1: 30 PM, Testing Personnel #1 confirmed the above findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of documentation for Quality Assessment, a review of 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 3 -- Quality Control and Quality Assurance Guidelines for Quality Assurance procedure, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to implement and follow the written policy and procedure for quality assessment activities. This was noted from previous survey (08/29/2019) to current survey (04/27/2022). The findings include. 1. The laboratory lacked documentation for Quality Assessment monitors. 2. A review of Laboratory Quality Control and Quality Assurance Guidelines for Quality Assurance procedure revealed under Quality Assessment Process "...B. Frequency of review: 1. Establish a schedule or plan of monitoring...C.

Summary Statement of Deficiencies 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 API (American Proficiency Institute) proficiency testing records and an interview with the General Laboratory Manager (GLM), the surveyor determined the laboratory failed to implement and document