Shelbyville Medical Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory technical consultant (TC); the laboratory failed to ensure participation of all testing personnel (TP) in the proficiency testing (PT) program for 6 of 6 PT events in 2018 through 2019. Findings Include: 1. College of American Pathologist (CAP) PT records from 2018 through 2019 were reviewed. 2. Review of the CAP PT attestation statements for 6 of 6 PT events in 2018 through 2019 found that TP#3, as identified on the CMS- 209 (laboratory personnel report) had performed all the events and TP#1 and TP#2, also listed on the CMS-209, had not participated in any PT events. 3. On survey date 2-20-2020, at 12:25 pm the above survey findings were confirmed by the TC. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #3 and the technical consultant (TC); the laboratory failed to follow the laboratory's Individual Quality Control Plan (IQCP) for external control procedures for 20 of 20 months reviewed. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "POC-EPOC Blood Analysis System", which stated on page 3, under the heading of "Quality Control": "Aqueous Blood Gas, Electrolyte, Metabolite and Hematocrit liquid controls are run on each new lot or shipment of Test Cards or every thirty days, whichever is more frequent. GAS-ISE1 & 3, HCT-A & B are the levels used. This plan, coupled with the attached risk assessment complete the IQCP for Epoc blood analysis system." 2. Review of quality control records for 2 of 6 patient testing dates found that external liquid GAS-ISE1 and 3 failed to be performed with a new lot of BGEM test cards when they were put into use for patient testing. Test Date BGEM Test Card Lot External Control Testing Date 06-24-2019 00-19071-10 07-10-2019 02-11-2020 00-19248-10 02-12-2020 3. Review of quality control testing found no external quality controls were performed when new lots of BGEM cartridges were put into use from July 2018 through February of 2020. 4. Interview with TP#3, on 02-20-2020, at 11:15 am, confirmed external quality controls were not ran when new lots of BGEM test cartridges were put into use. 5. On survey date 2-27-2019, at 1:00 pm, the TC confirmed the laboratory failed to follow the laboratory's IQCP procedure and perform external quality controls on each new lot of BGEM cartridges put into use for patient testing. 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 review of laboratory records and interview with the technical consultant (TC); the laboratory failed to include all the required components of a laboratory test report for 6 of 6 patient test reports reviewed. Findings Include: 1. Review of 6 of 6 patient test reports for creatinine testing found the laboratory failed to indicate the name and/or address of the laboratory where testing was performed. Patient Identification Test Date Missing Information P1 11-21-2018 No Address P2 12-13- 2018 No Address P3 03-05-2019 No Address P4 06-24-2019 No Name or Address P5 08-14-2019 No Name or Address P6 02-11-2020 No Name or Address 2. On survey date 02-20-2020, at 12:25 pm, the TC confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least -- 2 of 3 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory's technical consultant failed to ensure annual competency assessments were completed for 2 of 2 testing personnel by a qualified TC. Findings Include: 1. Review of the laboratory's policy and procedure manual policy, "Technical Consultant Responsibilities and Competency", stated on page 2 of 4 that the technical consultant is responsible for the following: "Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently." 2. Review of annual competency assessment records for testing personnel (TP) #1 and TP#3 found the competency assessments completed in 2019 or 2020 were not performed by a qualified TC. 3. During survey date 02-20-2020, at 12:25 pm, the TC confirmed the 2019 and 2020 competency assessments of TP#1 and TP#3 failed to be completed by a qualified technical consultant. -- 3 of 3 --

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 laboratory records and interview with the technical consultant (TC) #2; the laboratory failed to monitor epoc BGEM test card storage temperatures to ensure accurate and reliable storage of chemistry reagents. Findings Include: 1. Review of the laboratory procedure, "POC - EPOC BLOOD ANALYSIS SYSTEM", states "Always store Test Cards at room temperature (15C-30C). 2. Review of the laboratory's temperature logs found no documentation for storage temperature monitoring of epoc BGEM test cards. 3. On survey date 06-07-2018, at 2:00 pm, TC#2 confirmed the laboratory failed to document storage temperatures for epoc BGEM test cards. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with technical consultant (TC) #2; the laboratory failed to perform control procedures using the number and frequency specified by the laboratory's individual quality control plan (IQCP) for Creatinine testing 3 of 6 patient test reports reviewed. Findings include: 1. Review of the IQCP for creatinine testing on the epoc blood analysis system state that "Aqueous Blood Gas, Electrolyte, Metabolite and Hematocrit liquid controls are run on each new lot or shipment of Test Cards or every thirty days, whichever is more frequent." 2. Review of patient tests results found that for 3 of 6 patient results reviewed found no quality control testing was performed for epoc BGEM Test Card Lot# 18-046-20 prior to patient testing. Patient Identification Test Date P3 04-11-2018 P4 04-12-2018 P5 05-02-2018 3. Additionally, review of the epoc quality control log from March 5, 2018 through May 16, 2018 found the laboratory failed to run liquid controls every thirty days as described in the QCP from March 5, 2018 to April 9, 2018. 4. On survey date 06-07-2018, at 2:00 pm, TC #2 confirmed that external quality controls were not performed for BGEM Test Card Lot# 18-046-20 prior to patient testing for 3 of 4 patient test results reviewed and external liquid controls were not performed every 30 days as described in the QCP in March through April of 2018. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC) #2; the laboratory failed to establish a quality assessment plan and identify and correct problems with epoc testing for creatinine. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the individual quality control plan (IQCP) for creatinine testing on the epoc blood analysis system. The IQCP failed to include a Quality Assessment plan. 2. Review of epoc creatinine testing found the laboratory failed to follow the IQCP by not performing external quality controls as required. See D5445. 3. Further review of laboratory records also identified the laboratory failed to follow the IQCP by not ensuring creatinine test cartridges storage temperatures were monitored. See D5413. 4. On survey date 6-07-2018, at 2:00 pm, TC #2 confirmed the laboratory had failed to establish a Quality Assessment policy for epoc creatinine testing and identify and correct problems. 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 -- 2 of 4 -- 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 review of laboratory records and interview with technical consultant (TC) #2; the laboratory test reports failed to include the name and address of where testing was performed for 5 of 5 creatinine test reports reviewed. Findings Include: 1. Review of 5 of 5 patient test reports (Patient IDs: P2, P3, P4, P5, P6) for creatinine testing failed to indicate the following: a. The name and address of the laboratory location where the test was performed. 2. During survey date 06-07-2018, at 2:00 pm, the above findings were confirmed by TC#2. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with technical consultant (TC) #2; the laboratory failed to have a technical consultant (TC) who meets the qualification requirements of 493.1411. Findings Include: 1. The laboratory failed to have qualifying documents for 2 of 2 technical consultants, as identified on the CMS- 209 (Laboratory Personnel Report). See D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is -- 3 of 4 -- responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory technical consultant (TC) #2; 2 of 2 laboratory personnel listed on the CMS-209, as technical consultants, failed to meet the qualification requirements for the position. Findings Include: 1. Review of the CMS-209 identified 2 individuals designated as technical consultants. Review of personnel records for 2 of 2 TC's found they failed to meet the educational/experience requirements. a. TC#1 - Doctor of Medicine. No experience documenting 1 year of experience in non-waived chemistry testing provided. b. TC#2 - No educational documentation provided showing proof of a bachelor's degree in a chemical, physical, biological or clinical lab science. 2. On survey date 06-07-2018, at 2:00 pm the above findings were confirmed by TC#2. -- 4 of 4 --