Reliant Medical Group Surgical Specialties At

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on policy review and interview, the laboratory failed to follow maintenance protocol for laboratory equipment as evidenced by the following: Microscope maintenance: a) Procedure review on 10/14/20 revealed microscope maintenance was to be performed annually. b) Review of microscope maintenance documentation revealed that maintenance was to be performed on 4/13/20 but, as of the date of the survey, had not yet been performed. Airfiltronix ductless fume hood maintenance: a) Review of filter change requirements for the fume hood indicated that filters were to be changed annually. b) Review of documentation for the filter changes revealed that the filter was due to be changed in January of 2020 but, as of the date of the survey, had not yet been performed. The radiology and laboratory site supervisor confirmed in an interview on 10/14/20 at 10:55 AM that maintenance on the microscope and fume hood had not been completed as required. . 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 -- D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on observation, the laboratory director failed to provide a safe environment in which employees are protected from chemical and biological hazards as evidenced by the following: On the day of the survey in the presence of the laboratory director and supervisor of ancillary services, it was observed that there was no permanently mounted eyewash which would provide fifteen minutes of continuously flowing water near the laboratory area. The supervisor of ancillary services confirmed in an interview on 10/14/20 at 11:00 AM that there was no permanently mounted eyewash available in the laboratory area. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Reliant Medical Group Surgical Specialties at Worcester Medical Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on an interview, the laboratory failed to have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. The laboratory did not provide, upon request, all information and data needed by the CMS agent to make a determination of the laboratory's compliance with the 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 -- applicable requirements of this part as evidenced by the following: a) The laboratory's written policy for frozen section slide review is to perform "Quarterly random checks of five slides by pathologists in the Reliant Medical Group Histopathology Lab". b) During the time of the survey the laboratory was unable to provide documentation to verify the laboratory's ongoing quality assessment of histopathology diagnoses for calendar years 2016 and 2017. Based on the lack of records the CMS agent was unable to make a compliance determination regarding the quality assessment of histopathology diagnoses portion of the laboratory operation. -- 2 of 2 --