Dr John Howard Jr Md Psc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 04/18/2023 and the facility was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the procedure manual, personnel records and interview, the laboratory failed to establish a written policy to assess employee competency for 2 of 2 tests (CBC hematology and bilirubin chemistry) performed in the laboratory. Findings included: Review of the laboratory procedure manual revealed there was not a written policy or procedure that revealed how employee competency would be assessed. In an interview on 04/18/2023 at 2:15 PM, Testing Personnel (TP) #1 stated the laboratory did not have a written policy or procedure on how employee competency was evaluated. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory 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: Based on a desk review of chemistry proficiency testing results from the American Proficiency Institute (API) proficiency testing agency on 11/3/2021, the laboratory failed to successfully participate in the thyroid-stimulating hormone (TSH) certified analyte in two testing events. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 11/3/2021, the laboratory failed to successfully achieve satisfactory performance for the thyroid-stimulating hormone (TSH) certified analyte in two (2) testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the thyroid-stimulating hormone (TSH) in the first (1) testing event of 2021. 2. The laboratory failed to achieve a satisfactory performance for the thyroid-stimulating hormone in the third (3) testing event of 2021 -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview on 10/24/2018, the laboratory failed to ensure the results of control materials were within acceptable ranges prior to reporting patient results for three of fifteen (15) days for Vitamin B12 testing reviewed in October, 2017. The laboratory reported a total of thirteen (13) patient Vitamin B12 results on 10/17/2017, 10/19/2017, and 10/23/2017 when controls were out of the acceptable range. Findings include: Three patient Vitamin B12 results were reported 10/17/2017. Level 1 and Level 3 fell outside the laboratory's acceptable limits. Three patient Vitamin B12 results were reported 10/19/2017. Level 1 and Level 3 fell outside the laboratory's acceptable limits. Seven patient Vitamin B12 results were reported 10/23/2017. Level 1 and Level 3 fell outside the laboratory's acceptable limits. Interview with the Technical Consultant at 11:55 AM 10/24/2018, revealed the laboratory failed to have a system in place to ensure quality control results were within the laboratory's acceptable limits prior to reporting patient results. D5783