Alger Pediatrics, P C

Summary Statement of Deficiencies D0000 D0000 A recertification survey was completed on February 24, 2021. During the survey, it was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: Bacteriology- 42 CFR 493.1201 D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on document review and interview with the Office Manager and the Laboratory Director, the laboratory failed to meet Bacteriology requirements as specified in 493.1230 through 493.1256. Findings include: 1. The laboratory failed to follow the manufacturer's instructions for the Henry Schein OneStep+ Strep A Dipstick Test. Refer to D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to follow the manufacturer's instructions for the Henry Schein OneStep+ Strep 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 -- A Dipstick Test for 16 (14 rectal swabs and 2 vaginal swabs) of 16 swabs collected in 2 years of documents reviewed. Findings include: 1. A review of the manufacturer's instructions states, "The One Step+ Strep A Dipstick Test is for in vitro diagnostic use only. The test should be used for the detection of Strep A antigen in throat swab specimens only." 2. A review of the "Strep Culture" log revealed for 16 (14 rectal swabs and 2 vaginal swabs) of 16 swabs collected the manufacturer's instructions were not followed for an acceptable specimen source as follows: a. rectal swab 1/11 /2019 - negative b. rectal swab 1/11/2019 - negative c. vaginal swab 11/20/2019 - negative d. rectal swab 11/11/2019 - positive e. rectal swab 11/1/2019 - positive f. rectal swab 3/8/2019 - negative g. rectal swab 5/2/2019 - positive h. rectal swab 1/13 /2021 - negative i. rectal swab 12/24/2020 - negative j. rectal swab 1/8/2021 - negative k. rectal swab 11/21/20 - negative l. rectal swab 2/4/2020 - negative m. vaginal swab 1 /17/2020 - negative n. rectal swab 1/13/2020 - negative o. rectal swab 1/10/2020 - positive 3. When queried on 2/24/2021 at 10:35 am, the OM was unaware that sources other than throat were being collected for the strep screen test. 4. A interview on 2/24 /2021 at 10:35 am, the OM confirmed the laboratory was using specimen sources outside the manufacturer's instructions. D5785

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 review of the CMS database and review of the College of American Pathologists (CAP) final proficiency testing program reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of microbiology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 review of the CMS database and review of the College of American Pathologists (CAP) proficiency testing program reports, the laboratory failed to achieve satisfactory performance for microbiology bacteriology throat culture identification in 2 out of 2 consecutive testing events. Findings include: Throat culture identification PT Event Score 3rd event 2018 60% 1st event 2019 40% -- 2 of 2 --