Central Healthcare Laboratory

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 review of the laboratory test records on 04/21/2021 at 1:00 p.m. (survey date) for ten (10) randomly selected patients results from 01/22/2019 to 04/20/2021, proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to enroll and participate in a proficiency testing (PT) program that meets the criteria in subpart H of 42 CFR part 493 and is approved by HHS. The findings included: 1. The laboratory performed routine chemistry testing [(serum creatinine (CR), sodium (Na) and potassium (K)] using the i-STAT 1 portable non-waived analyzer and failed to show evidence of enroll in a PT program for routine chemistry testing events using a CMS approved PT program for 2019 and 2020 (which meets the criteria in subpart H of 42 CFR part 493). The laboratory analyzed and reported routine chemistry patient test results during the approximate time of non-enrollment in a proficiency testing (PT) program. 2. The laboratory staff confirmed on 04/21/2021 4:00 p. m. that patient test results were reported for the routine chemistry analytes serum creatinine, sodium, and potassium yet the laboratory had not enrolled in an accredited PT program for 2019 and 2020. 3. The laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- annual testing declaration (04/20/2021) estimated total volume of 1,000 routine chemistry (serum creatinine) results as well as in 2019 a total of nine (9) sodium and potassium were resulted and reported. 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 review of ten (10) randomly selected patient (PT) test results on 04/21/2021 at 1:00 p.m. (survey date) for serum creatinine (CR), sodium (Na) and potassium (K) using the i-STAT 1 portable non-waived analyzer from 01/22/2019 to 04/20/2021, patient final testing report (medical records), and interview with a laboratory staff, it was determined that on patients testing records reviewed, the laboratory failed to establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimem from the time of collection or receipt of the specimen through completion of testing and reporting of results. The findings included: 1. Review of one (1) patient results on 04/02/2019, PT # 218999 for CR, Na and K transcribed on patent test result log were not documented in the final patient report (MR). 2. On 04/21/2021, 4:00 p. m., the laboratory staff confirmed that the manually transcribed patient test results found on the patient's test log not documented in the patient's final report (MR). 3. The laboratory annual testing declaration (04/20 /2021) estimated total volume of 1,000 routine chemistry (serum creatinine) results as well as in 2019 a total of nine (9) sodium and potassium were resulted and reported. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review of the laboratory's hematology activated clotting time low range testing (ACT-LR) test records on 04/21/2021 at 1:00 p.m. (survey date), for eight (8) randomly selected patient reports from 01/08/2019 to and an interview with the laboratory staff on 04/21/2021, the laboratory failed to establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1), "to at least twice annually verify the accuracy of any test or procedure it performs that is not included in subpart I". The findings included: 1. The laboratory failed to enroll in a proficiency testing (PT) program or verify by an alternative performance the accuracy of the ACT-LR tests performed in 2019. 2. The laboratory staff confirmed on 04/21 /2021 at 4:00 p.m. that the laboratory failure to perform and document twice annual verification for the ACT-LR tests reported and resulted in 2019. 3. Based on the laboratory staff declaration on 04/21/2021 estimated 70 ACT-LR tests were reported and resulted in 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT -- 2 of 7 -- CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of eighteen (18) random patient reports on 04/21/2021 at 1:00 p.m (survey date) for serum creatinine (CR), sodium (Na) and potassium (K) and activated clotting time low range (ACT-LR) testing from 01/08/2019 to 04/20/2021, review of quality control documents, written laboratory policies and procedures and an interview with the laboratory staff, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. The finding included: 1. On 04/21/2021 (survey date) no documentation could be retrieved to show that the laboratory had followed a written policy for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified. This correction process must involve identification and resolution of the problem, and development of policies that will prevent recurrence. Policies for preventing problems that have been identified must be written as well as communicated to the laboratory personnel, other staff, and clients. (See laboratory's i- STAT 1 analyzer's procedure: VII: "SPECIMEN REQUIREMENTS A., and XI. "REPORTING RESULTS" A-D. and ACT-LR Hemochron signature elite procedure: Results B. "Reporting Results, C. "Procedures for Abnormal Results, D. "Calculations" and E. "Results Review") 2. The laboratory staff confirmed on 04/21 /2021 at 4:0 0 p. m. that the laboratory did not follow a written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. 3. The annual testing declaration 03/20/2021 estimated 1,000 for serum creatinine (CR), sodium (Na) and potassium (K) as well as seventy (70) ACT-LR in 2019 test results reported. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor's review of quality control (QC) testing records on 04/21/2021 at 1: 00 p.m. (survey date) for serum creatinine (CR), sodium (Na) and potassium (K) performed on the i-STAT 1 portable non-waived analyzer, 10 randomly selected patients test records from 01/22/2019 to 04/20.2021, and interview with the laboratory -- 3 of 7 -- staff, the laboratory failed to perform QC each day of patient testing or to establish an IQCP (Individual Quantity Control Plan). The findings include: 1. Laboratory QC testing records could not be retrieved to showed that the laboratory performed QC for each day of patient testing or established an Indicvidaul Quality control Plan IQCP. See D-5445 (i-STAT 1 portable non-waived analyzer procedure) 2. On 14/21/2021 at 4:00 p.m. the laboratory staff confirmed that the laboratory had not run QC everyday of patient testing or established an IQCP. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control (QC) records for serum creatinine (CR), sodium (Na) and potassium (K) testing using i-STAT 1 portable non-waived analyzer and an interview with the laboratory staff on 04/21/2021 at 1:00 p.m. (survey date), it was determined that the laboratory failed to perform control procedures as defined per manufacturer's guidelines, or CLIA regulation 493.1256 (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" (d)(3) "At least once each day patient specimens are assayed or examined perform the following for:" (whichever is more stringent). The laboratory also had not instituted an alternate "Individual Quality Control Plan" (IQCP) including Risk Assessment, Quality Control and Quality Assessment. The findings included: 1. Manufacturer's guidelines under IX. "QUALITY CONTROL" C. Aqueous (external) Controls stated: "2. Once a week, test cartridges with the appropriate controls on the one i-STAT 1, rotating the i-STAT used on a regular basis. 3. Values that are outside the manufacture's acceptance range must be repeated and

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition for General Laboratory Systems was not met. The laboratory failed to follow the written laboratory policy and procedure to assess employee competency (See D6054); failed to at least twice annually (D6053), verify the accuracy of any test or procedure it performs that is not included in subpart I of this part (See D5217); and failed to follow written policies and procedures to monitor, assess, and when indicated, correct problems identified in the general laboratory systems (D5391, D5891). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on interview with the laboratory personnel on August 01, 2018 (survey date), review of twelve randomly (12) patient testing records from 06/14/2016 to 07/26 /2018, the laboratory failed to verify testing accuracy of the ACT-LR/heparin test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- performed on the Hemochron Jr. Signature analyzer at least twice annually for the years 06/14/ 2016, 2017 to August 01, 2018. The findings included: a. The laboratory was unable to provide documentation or previous records for verification of the ACT- LR/heparin testing accuracy at least twice annually from 2016 to August 2018. b. The laboratory personnel (manager) on August 01, 2018, 12:00 AM (survey date) affirmed that the laboratory failed to verify the accuracy of the test twice annually. c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on request, review of random patient sampling test orders, and interview with the testing personnel, it was determined that the laboratory failed to have a written or electronic request (ER) for patient testing from an authorized person. The findings included: a. For two (2) out of twelve (12) random patient (Pt) testing records from 06 /14/2016 to 07/26/2018, the laboratory analyzed and reported ACT-LR/heparin tests without a written or electronic request (ER) for patient testing from an authorized person. No records could be retrieved in the EMR (electronic Medical Record) system. Refer to laboratory test worksheet: Pt # Date of testing 58376 03/12/18 No record/request in the EMR 58846 03/21/18 No record/request in the EMR b. A laboratory personnel (manager) and testing personnel affirmed 08/01/2018, 12:00 AM (survey date) that the laboratory has no documentation to show for a written or electronic request for the above patient test results from an authorized person. c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures, twelve (12) random patient testing records from 06/14/2016 to 07/26/2018, and interview it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems for 2016 and 2018 to the date of the survey. The findings include: a. The Surveyor requested on August 08, 2018 (survey date) for documentation of the laboratory's ongoing preanalytic review process that encompasses all the facts of the laboratory's technical and non-technical functions, the laboratory failed to provide a written policies and procedures or documentation of review to monitor the quality of the preanalytic for the ACT-LR/heparin test laboratory system. b. During an interview -- 2 of 8 -- on October 24, 2017, 12:00 AM (survey date) a laboratory personnel (manager) confirmed the lack of written preanalytic policies and procedures or documentation of preanalytic quality assessment of the ACT-LR/heparin test on the Hemochron Jr. Signature analyzer. c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review and the lack of quality control (QC) records, twelve (12) random patient testing records from 06/14/2016 to 07/26/2018 and interview with a laboratory staff (manager) and a testing personnel, it was determined that the laboratory failed to document and performs each quantitative procedure, include two control materials of different concentrations. The findings included: a. The laboratory performs ACT-LR /heparin test on the Hemochron Jr. Signature analyzer. The laboratory did not analyze and perform each quantitative procedure, include two control materials of different concentrations when patient testing for the period cited, nor was an equivalent individual quality control program (IQCP) set up to monitor QC. b. The testing personnel (manager) affirmed 08/01/2018, 12:30 AM that the laboratory did not have documentation to show of each quantitative procedure, include two control materials of different concentrations. c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually and the reliability and quality of the patient results reported could not be assured. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory test records for six (6) of twelve (12) random patient (Pt) testing records from 06/14/2016 to 07/26/2018, and interviews with laboratory personnel, the laboratory failed to maintain a record system for positive identification, date of specimen testing and identification of the personnel performing testing. The findings include: a. The patient ACT-LR/heparin test worksheets lacked complete patient identification (unique identifiers) and/or date of testing. Refer to laboratory patient test worksheet: Date Pt# Deficiency 1/31/17 Pt # 1 No ID of staff performing -- 3 of 8 -- test 1/31/17 Pt # 2 No ID of staff performing test 3/04/17 Pt # 3 No ID of staff performing test 6/12/18 Pt # 4 Lack of Pt identifiers 6/12/18 Pt # 5 Lack of Pt identifiers None Pt # 6 No date of testing b. A laboratory personnel (manager) and a testing person affirmed on 08/01/2018, 12:00 AM (survey date) the aforementioned omissions; and thus, the failure to maintain records of accurate patient ACT-LR /heparin test records (documentation). c. The reliability and quality of ACT-LR /heparin test results reported could not be assured. Based on the stated annual test volume, the laboratory reported approximately 400 ACT-LR/heparin tests annually. 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 staff interviews on 08/01/2018 and review of test procedures twelve (12) random patient testing records from 06/14/2016 to 07/26/2018, it was determined that the laboratory failed to ensure that test reports included pertinent information required for interpretation as reference ranges specific to the patient population (gender/age) specific(s), if applicable and test performed. The findings included: 1a. Review of the laboratory's final patient test reports [electronic medical record (ERM)] showed that the laboratory failed to include pertinent information required for interpretation for ACT-LR/heparin tests. There was no information provided for "reference" and (patient population/gender/age) ranges specific(s), if applicable noted on the patient's final test report. . 1b. The laboratory staff affirmed on 08/01/2018 12:00 AM (survey date) that the patients' final test reports (ERM) failed to ensure that test reports included pertinent information required for interpretation. 2a. Review of the laboratory's final patient test reports (EMR) showed that the laboratory failed to ensure that the patients' test results were recorded the EMR. The laboratory scans into the EMR the patient final test reports. Refer to laboratory test worksheet: Test date PT# Test results 1. 03/04/17 81071 Heparin not in EMR 2. 03/21/17 58376 ACT-LR /heparin not in EMR 3. 03/21/17 58846 ACT-LR/heparin not in EMR 4. 03/21/17 85210 ACT-LR/heparin not in EMR 5. 04/24/18 536770 ACT-LR/heparin not in EMR 2b. The laboratory personnel (manager) and a testing person affirmed on 08/01 /2018 12:00 AM (survey date) that the patients' final test reports (ERM) failed to ensure that patients' test results were recorded the ERM. 2c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually. 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. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, random review of twelve (12) patient records from 06/14/2016 to 07/26/2018, and an interview, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic quality assessment systems for 2016 and 2018 to the date of the survey. The Findings include: a. The surveyor requested on 08/02/108 (survey date) documentation of ongoing quality assessment (QA) for the postanalytic system includes assessing practices/issues related to test report monitoring and evaluating the accuracy and completeness of the laboratory's test reports and the laboratory's turn-around times and procedures for notification of the test results. b. The laboratory personnel (manager) affirmed 08/01/108, 12:00 AM (survey date) that the laboratory did not have the written policy and procedure to assess, monitor and correct problem in the postanalytic ACT-LR/heparin test systems. c. The laboratory's testing declaration form, signed by the laboratory Director on July 26, 2018, stated that the laboratory performs approximately 250 ACT-LR/heparin tests annually. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result report, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of 42 CFR part 493. The findings included: See D-5217 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on interview with the laboratory staff, review of policies/procedures, quality control documents, instrument printouts, and twelve (12) random patient testing records from 06/14/2016 to 07/26/2018, it was determined that the laboratory director failed to ensure that a quality control program was established and maintained to assure quality test results. The findings included: a. The laboratory director failed to -- 5 of 8 -- ensure that a written quality control policy that was followed by the laboratory and