Prime Care Medical-Henderson

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, laboratory records, and interview with testing personnel number one, the laboratory failed to retain intermittent patient test records for at least two years in 2018, 2019, and 2020. The findings include: 1) Observation of the laboratory on March 4, 2020 at 8:15 a.m. revealed a microscope in use for patient testing for urine microscopy and wet preps. 2) Review of patient numbers five, six, seven, eight, nine and ten revealed patient testing for both urine microscopic and wet prep performed in 2018, 2019, and 2020. 3) Review of laboratory records revealed no retention of the paper used for recording the results of the urine microscopic and wet prep prior to entering the results into the laboratory electronic medical record. 4) Interview with the lead testing personnel on March 4, 2020 at 8:35 a.m. confirmed the laboratory failed to retain all analytic records for at least two years in 2018, 2019, and 2020. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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: The laboratory failed to maintain satisfactory participation i two out of three events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analytes. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated white blood cell (WBC) differential for two out of three events (2018 event two and 2019 event one) resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS 155 report revealed failing scores for the Automated WBC differential as follows: 2018 event two score=0%; 2019 event one score =0%. 2) Review of the 2018 event two PT evaluation report revealed the following: Granulocytes-Sample numbers HEM-01, HEM-02, HEM-03, HEM-04, HEM-05-Scored as unacceptable; Lymphocytes-Sample numbers HEM-01, HEM-02, HEM-03, HEM-04, HEM-05- Scored as unacceptable; Monocytes/Mids-Sample numbers HEM-01, HEM-02, HEM- 03, HEM-04, HEM-05-Scored as unacceptable; resulting in an overall score of 0%. 3) Review of the 2019 event one PT evaluation report revealed the following: Granulocytes-Sample numbers HEM-06, HEM-07, HEM-08, HEM-09, HEM-10- Scored as unacceptable; Lymphocytes-Sample numbers HEM-01, HEM-02, HEM-03, HEM-04, HEM-05-Scored as unacceptable; Monocytes/Mids-Sample numbers HEM- 01, HEM-02, HEM-03, HEM-04, HEM-05-Scored as unacceptable; resulting in an overall score of 0%. -- 2 of 2 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Hematology /Coagulation proficiency testing (PT) performance evaluation report for 2016 event 2 and 2017 event 1, the laboratory failed to evaluate unacceptable scores for the white blood cell count (WBC) and red blood cell count (RBC) analyte in 2016 and 2017. The findings include: 1. Review of the API PT performance evaluation report for 2016 event 2 revealed an unacceptable score for WBC for sample number HEM-08. Review of performance indicated by lab director's signature with no