Health Central Clinical Laboratory

Summary Statement of Deficiencies D0000 An unannounced complaint survey was conducted on 09/30/19-10/2/19 at Health Central Clinical Laboratory. The laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified at 4:30 PM on 10/02 /19. The laboratory reported patient test results on a patient with sperm present in their urine sample without performing a manual microscopic review. The laboratory failed to validate the method to method comparison of instrument to manual microscopic examination, (D5400). The following Conditions were not met: D5400 - 493.1250 Analytic Systems D5800 - 493.1290 Postanalytic Systems D6076 - 493.1441 Laboratory Director D6168 - 493.1487 Testing Personnel D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure positive identification at the time of collection, and integrity of patient specimens at the time of arrival in the laboratory. Findings: 1. Review of the ""Events Details with Cause and Actions Taken by Department" report printed on 9/30/19 showed that from 7/1/19 to 8/31/19 there were 27 out of 40 events reported that were listed as "Sub Category Name: Specimen Labeling Issue." The "Laboratory Mislabeled Specimens" report shows in 2017 there were 45 mislabeled specimens, in 2018 there were 61 mislabeled specimens and from January through August 2019 there were 57 mislabeled specimens. The "Laboratory Mislabeled Specimen" states the 2019 target is a 10% reduction (61 x 10% = 6.1). The laboratory has already missed their target and still Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- have 4 months of data not included in the total number of mislabeled specimens for 2019. During an interview on 9/30/19 at 12:45 PM, Operation Manager Risk Management acknowledged that they had a specimen labeling problem. 2. Review of the "Events Details with Cause and Actions Taken by Department" report printed on 9 /30/19 from 7/1/19 to 8/31/19 showed that there were no records available to show what happened to the labeled wet prep collected on 8/6/19. Event ID# Lab-203031 is regarding a GC (Gonorrhea/Chlamydia) and Wet Prep for Patient #6. The Event Description reports that the GC swab was unlabeled, the nurse was called, and the nurse stated, "GC was done by ME." The Event Description also stated the "Wet prep swab was labeled, however, GC swab was not." Examination of the patient's test results showed results for the Neisseria gonorrhoeae and Chlamydia trachomatis but no results for the wet prep. No test results were available on the wet prep. During an interview on 9/30/19 at 3:10 PM, the Interim Laboratory Manager acknowledged that the Events Details noted they had a wet prep sample on Patient #6. During an interview on 10/1/19 at 10:45 PM, the LIS (Laboratory Information System) Coordinator stated the computer showed only the GC collection information. The wet prep was canceled by the computer system after one week. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Findings: Cross Reference D5401. Based on record review and interview, the laboratory failed to follow laboratory's procedure on the Iriscell Urinalysis Analyzer. Cross Reference D5411. Based on record review and interview, the laboratory failed to follow manufacturer's instructions on the Iriscell Urinalysis Analyzer. Cross Reference D5775. Based on record review and interview, the laboratory failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of urine at least twice annually. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow laboratory's procedure on the Iriscell Urinalysis Analyzer. Findings: The laboratory's procedure titled "Iriscell Urinalysis System" noted to return to the microscope for confirmation -- 2 of 10 -- of sperm. A review of the 6 patients (#1, #2, #3, #4, #5, #6) that Iriscell identified as flagged for possible presence of sperm from 7/26/19 to 7/29/19 showed that 3 patients' (#1, #3, #6) test results reported sperm and no comment was made stating a manual microscopic examination was performed. An email sent out 7/30/19 at 11:33 AM to laboratory staff by the Hematology Supervisor read, "Sperms and Trichomonas identified by the Iris should be confirmed microscopically before releasing the results. Also please remember to add a comment of the confirmation." Review of urinalysis patients whose test results reported the presence of sperm from 7/31/19 to 8/31/19 showed that 5 (#7, #11, #12, #14, #15) out of 9 patients' (#7, #8, #9, #10, #11, #12, 13, #14, #15) microscopic examinations were not documented. There is no way to determine if the manual microscopic examinations were performed. During an interview on 9/30/19 at 11:10 AM, Hematology Supervisor acknowledged that testing personnel were required to microscopically confirm the presence of sperm and that there were no comments for patients #1, #3, and #6. During an interview on 9/30/19 at 3:30 PM, the LIS (Laboratory Information System) Coordinator acknowledged that patients #7, #11, #12, #14, and #15 did not have any comments listed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow manufacturer's instructions on the Iriscell Urinalysis Analyzer. Findings: The Iriscell's operation manual chapter 7 read, "An effective verification process should be put in place by the laboratory to avoid incorrectly reporting positive sperm counts on certain specimens that due to gender and /or age considerations may result in a criminally reportable event." A review of the 6 patients (#1, #2, #3, #4, #5, #6) that Iriscell identified as flagged for the possible presence of sperm from 7/26/19 to 7/29/19 showed that 3 patients's (#1, #3, #6) test results reported sperm and no comments were made verifying a manual microscopic examination was performed. An email sent out 7/30 /19 at 11:33 AM to laboratory staff by the Hematology Supervisor stated "Sperms and Trichomonas identified by the Iris should be confirmed microscopically before releasing the results. Also please remember to add a comment of the confirmation." Review of urinalysis patients whose test results reported the presence of sperm from 7 /31/19 to 8/31/19 showed that 5 (#7, #11, #12, #14, #15) out of 9 patients (#7, #8, #9, #10, #11, #12, 13, #14, #15) microscopic examinations were not documented. There is no way to determine if the manual microscopic examinations were performed. During an interview on 9/30/19 at 11:10 AM, Hematology Supervisor acknowledged that testing personnel were required to microscopically confirm the presence of sperm and there were no comments for patients #1, #3, and #6. During an interview on 9/30/19 at 3:30 PM, the LIS (Laboratory Information System) Coordinator acknowledged that patients #7, #11, #12, #14, and #15 did not have any comments listed. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 3 of 10 -- instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document the comparison of the two methodologies used to perform the microscopic evaluation of urine at least twice annually. Findings: Review of the quality control documentation revealed that the laboratory failed to perform and document comparisons between the Iriscell urinalysis analyzer's microscopic examination and the manual microscopic examinations. Initial calibration records for the Iriscell were dated 11/24/14. During an interview on 9/30/19 at 3:00 PM, the Hematology Supervisor stated that method to method comparison for urine microscopic examinations had not been done since the initial calibration. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor, evaluate and correct problems in the Postanalytic systems. Findings: Cross Reference D5821. Based on record review and interview, the laboratory failed to issue a corrected report. Cross Reference D5891. Based on record review and interview, the laboratory's Quality Assessment program failed to correct problems in the Postanalytical System. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to promptly issue a corrected report to the authorized person using the test results. Findings: Review of the "Event Details with Cause and Actions Taken by Department," showed that for Event ID# Lab-201969 (Patient #6) was subcategorized as "Incorrect Test Results Reported." Review of test results printed on 9/30/19 at 2:54 PM, for Patient #6, showed that urinalysis test results still reported the presence of sperm and there was -- 4 of 10 -- no comment noting the presence of the sperm could not be verified because a microscopic examination of the urine was not performed. During an interview on 10/1 /19 at 5:03 PM, the Laboratory Manager acknowledged that the laboratory test results had not been changed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory's Risk Management program failed to correct a problems in Postanalytical System. Findings: Review of the "Events Details with Cause and Actions Taken by Department," report printed on 9/30/19 showed that from 7/1/19 to 8/31/19 there were only 2 (Event ID# Lab-201969 and Lab-202776) out of 40 events that contained comments on Cause and Action Taken. The "Events Details with Cause and Actions Taken by Department" report showed there were 27 out of 40 events with specimen labeling issues. The "Events Details with Cause and Actions Taken by Department" report failed to address what happened to the wet prep (Event ID# Lab-203031). 1. Event ID# Lab-201969 (Patient #6) showed the form failed to identify the Severity, the Level of Harm, the Time of Call to the physician, Recommendation, and Cause. The Event Details reported the severity as "6, Undetermined or Potential Injury." The Event Details reported the Level of Harm as "05. An event occurred that required monitoring to confirm that it resulted in no harm and/or required intervention to prevent harm." The Risk Assessment failed to identify the harm caused as a result of incorrect test results. The Event Details failed to list the Time of Call to the physician and did not specify the date of the notification. The Event Details reported nothing in recommendations. The Event Details reported the Cause as, "Unknown at this time." The Event Details report Event Description failed to include that as a result of the incorrect test results, Patient #6 was subjected to unnecessary procedure including a rape kit and full assessment, and additional testing on 8/6/19 for gonorrhoeae and chlamydia. The Event Details reported the Action Taken as "Other (describe in "Add Notes")." The "Unusual Occurrence and