Jackson Hospital & Clinic

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 observations during the entrance tour, a review of temperature/humidity records, a review of the manufacturer's required environmental operating parameters, and interviews with Testing Personnel #1 and the Quality Coordinator, the laboratory failed to monitor and document room humidity for fifteen months in two Lab Rooms where patient tests were performed on the Bilirubinometer and Hematology analyzers. The findings include: 1. During the entrance tour on 12/15/2021 at approximately 9: 00 AM, the surveyor noted the room temperature monitoring device did not include a hygrometer to monitor humidity in Lab Room 1 (where the Beckman Coulter DxH 520 was located) or Lab Room 2 (where the Reichert Bilirubinometer was located). The surveyor asked Testing Personnel #1 if the laboratory monitored room humidity; Testing Personnel #1 stated she was told this was not required. 2. A review of the temperature/humidity records revealed the laboratory began using new logs without a column to record humidity in September 2020; humidity monitoring in Lab Room 1 and 2 was not documented from September 2020 until the day of the survey (9/15 /2021). 3. A review of the "Beckman Coulter DxH 500 Series Instructions for Use Manual" (in the System Overview section), at the bottom of page 1-7 revealed, "... Humidity The instrument meets performance claims when operated at a maximum of 80% relative humidity (non-condensing) at 32 degrees C [Celsius] (89.6 degrees F 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 -- [Fahrenheit])." 4. A review of the operating requirements for the Reichert Unistat Bilirubinometer on page 8 in the Operator's Manual revealed, "RH [Relative Humidity] 80% up to 31 degrees C decreasing linearity to 50% RH at 40 degrees C..." 5. During an interview on 12/15/2021 at 2:53 PM the surveyor reviewed the above manufacturer's requirements with the Quality Coordinator, Technical Consultant #1 and Testing Personnel #1, and asked why the laboratory had ceased monitoring humidity in September 2020. The Quality Coordinator stated humidity was not monitored in the other laboratories she oversaw, and she had implemented use of the new temperature log for the sake of uniformity; however she had not realized monitoring humidity was required to ensure the analyzers were operated within the manufacturer's specifications. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on reviews of patient test reports and an interview with the Quality Coordinator, Technical Consultant #1 and Testing Personnel #1, the laboratory failed to ensure patient reports included all required parameters on two of three reports reviewed. The findings include: 1. On 12/15/2021 at 2:30 PM, the surveyor reviewed the post-analytical process in the facility. Upon the surveyor's request, the Technical Consultant and Testing Personnel #1 provided three final patient reports with CBC (Complete Blood Count), Total Bilirubin, and Throat Culture results from the Athena EMR (Electronic Medical Record). Upon review, the surveyor noted there were no units of measurement for the CBC parameters or the Total Bilirubin results on two of the reports. 2. In an interview on 12/15/2021 at 2:40 PM, the surveyor reviewed the reports with the Quality Coordinator, Technical Consultant #1 and Testing Personnel #1 who confirmed the above noted findings. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory's test menu with the testing personnel, a review of CAP (College of American Pathologists) proficiency testing records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to enroll in proficiency testing to the extent of patient testing in the Microbiology specialty. This affected the survey period of the last quarter of 2016, 2017 and 2018. The surveyor reviewed twenty CAP proficiency testing evaluations. The findings include: 1. During the initial tour of the laboratory, TP #1 identified the specialties and testing done at the laboratory. When discussing the Microbiology specialty, TP #1 stated the laboratory performed "other cultures", in addition to urine and throat cultures, which were reported as growth or no-growth by the laboratory personnel (the physicians). The surveyor asked TP #1 to describe "other cultures." TP #1 stated the physicians sometimes requested cultures, such as of ear drainage, an abcess, the skin (sore or lesion), or possibly from the rectum. TP #1 further explained the testing personnel would inoculate these specimens on a sheep blood plate, and the physician would determine if there was growth. If growth occurred, the laboratory would send the sample out for identification and sensitivity. At this time, the volume counts for the tests (as listed on the CMS form #116) were discussed. TP #1 indicated 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 -- laboratory performed about thirty-two (32) "other cultures" in 2018. TP #1 also confirmed these tests were billed through insurance. 2. The CAP proficiency testing records for 2017 and 2018 did not include any proficiency testing for cultures beyond urine and throat cultures. 3. In an interview on 2/06/2019 at 1:35 PM, TP #1 confirmed again the volume of these "other cultures" as stated in paragraph one. TP #1 also stated the laboratory has been performing this testing for many years and has not changed its processes. TP #1 also confirmed the laboratory was not performing any proficiency testing for cultures of the above mentioned specimen types, other than urine and possible microbial agents of the throat. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu with the testing personnel, a review of CAP (College of American Pathologists) proficiency testing records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory director failed to ensure the laboratory enrolled in proficiency testing to the extent of patient testing in the Microbiology specialty. This affected the survey period of the last quarter of 2016, 2017 and 2018. The surveyor reviewed twenty CAP proficiency testing evaluations. The findings include: 1. Refer to D2000 (493.801) Enrollment and Testing of Samples. -- 2 of 2 --