Hillside Medical Office

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the manufacturer's package insert instructions, freezer temperature logs for the time period of 7/22/22 - 8/10/22, and interview, the laboratory failed to store quality control (QC) materials under conditions consistent with the manufacturer's instructions in one of one freezers for 10 days out of 20 days. Findings: 1. Review of the Bio-Rad Liquichek Immunology Control package insert and the Bio-Rad Liquid Assayed Multiqual package insert indicated that the storage temperature range was -20 degrees Centigrade to -70 degrees Centigrade for both QC materials. These materials were first received on 7/22/22 and stored in the lab freezer. 2. Review of the "HILLSIDE MEDICAL OFFICE MAINTENANCE/QC LOG" for the temperature readings on "Lab Freezer" from 7/22/22 to 8/10/22 revealed: a. Temperatures were out of the controls' required range (-20 degrees Centigrade to -70 degrees Centigrade) for 10 days out of 20 days recorded. No temperature readings were recorded on weekend days when the facility is closed. This accounted for 6 days of the 20 day storage period. b. The "HILLSIDE MEDICAL OFFICE MAINTENANCE/QC LOG" was not updated to correct the temperature requirements of the new QC material and still listed an acceptable range of "(Less than -18 C)" 3. 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 -- Interview with the testing personnel #1 on 8/10/22 at 9:30 a.m. confirmed the laboratory failed to store QC materials under conditions consistent with the manufacturer's instructions in one of one freezers for 10 days out of 20 days. -- 2 of 2 --

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 proficiency testing records, the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute for the analyte: Chloride for two out of three consecutive proficiency testing events: 2020 Event 2 and 2020 Event 3 (refer to 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 proficiency testing from the provider API for Chemistry, the regulated analyte Chloride, revealed the following performance scores for PT: 1. Second testing event 2020 revealed a score of 40% for Chloride 2.Third testing event 2020 revealed a score of 40% for Chloride. Phone interview with the lab manager on November 4, 2020 at 4:15 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the analyte:Chloride. -- 2 of 2 --