Poplar Healthcare, Pllc

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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of two of five rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 9/28/22 at 08:15 AM five rooms containing items with a temperature storage requirement , the office, Pre GPP, GPP Set up, PCR GPP and storage room all separated by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the Pre GPP, the GPP Set Up, and PCR GPP were presented. C) During a tour of the laboratory on 9/28 /22 at 10:30 am, eight boxes of Magna Pure Processing cartridges with a storage temperature requirement of 2 degrees C. to 30 degrees C. lot # 20018531 expiration date 2023-11-30 and 2 boxes of Magna Pure Processing cartridges with a storage temperature requirement of 2 degrees C. to 30 degrees C. lot # 21435438 expiration date 2024-05-31 were observed in the storage room and 18 bottles of Bio Code Buffer A lot # 06-03067 expiration dates 2023-03-31 with a storage temperature requirement of 2 degrees C. to 30 degrees C. were observed in the office D) Upon request, the laboratory could not present the temperature records for the storage room and the office in which the supplies identified above were stored,. E) In an interview on 9/28 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 -- /22 at 10:34 am the laboratory staff member, identified as number one on the Entrance /Exit Conference attendance record, stated that the daily temperature of the two rooms in which the supplies, identified above, were stored had not been monitored and recorded.. -- 2 of 2 --

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of CMS form 209, personnel records for eight of eight testing personnel, and interviews with laboratory staff, it was determined the laboratory director failed to specify, in writing, which examinations and procedures each individual was authorized to perform and whether supervision was required. Survey findings follow: A. A review of CMS form 209 revealed the names of eight laboratory testing personnel performing moderate complexity testing. B. A review of personnel records, revealed there were no signed authorizations to perform moderate complexity testing for three of eight laboratory testing personnel (#4, #7, and #8) as listed on the CMS form 209. C. Upon request, the laboratory could not provide signed authorizations for testing personnel ( #3, #7, and #8) as listed on CMS form 209 to perform moderate complexity testing. D. In an interview at 1500 on 10/6/2020, the quality assurance coordinator confirmed there was no written authorization from the laboratory director stating which tests the testing personnel (#4, #7 and #8)) on the CMS form 209 are authorized to perform. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --