Reception And Medical Center Clinical Laboratory

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 4/4/22 at Reception and Medical Center, a clinical laboratory in Lake Butler, Florida. Reception and Medical Center is in not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing results and staff interview, the laboratory failed to verify the accuracy of analytes that did not receive a grade for one out of three testing events in 2021. The findings include: Review of CAP proficiency testing results showed the laboratory did not investigate the exception reason code 11 that appeared as a score for the evaluation of the results submitted for the following event: AQI-C 2021. The interview with Testing Person I on 4/4/2022 at 11:00am confirmed the laboratory failed to follow CAP guidance and perform a self-evaluation after receiving an exception code of 11. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant (Laboratory Director) failed evaluate the competency of testing personnel listed on the Laboratory's Personnel Report for 8 of 11 personnel (A, C, D, E, G, I, J, K) for 2021. The findings include: Review of personnel competency assessments showed Testing Person A, C, D, E, G, I, J, and K were assessed for competency in 2020 and 2022. There was no documentation showing competency was assessed in 2021. The interview with Testing Person I on 4/4/2022 at 11:00am confirmed the personnel competency assessments for 2021 were missing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on May 12, 2020 for Reception and Medical Center Clinical Laboratory. Reception and Medical Center Clinical Laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D 2096. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and the review of 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 -- the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 12, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, partial pressure of carbon dioxide (pCO2) and for the pH test for two out of two consecutive testing events in 2019 and 2020. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of routine chemistry. Findings include: On Mary 12, 2020 on or about 10:00 AM the College of American Pathologists (CAP) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes, partial pressure of carbon dioxide (pCO2) and pH, as shown below. Event #3, 2019 pCO2-20% pH-20% Event #1, 2020 pCO2- 0% pH-0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On May 12, 2020, on or about 10:00 AM, the College of American Pathologists (CAP) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analytes, partial pressure of carbon dioxide (pCO2) and for pH, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2096. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analytes, partial pressure of carbon dioxide (pCO2) and pH in the subspecialty of routine chemistry. Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on Mary 12, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2019 pCO2-20% pH-20% Event #1, 2020 pCO2-0% pH-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced recertification survey was conducted on 10/2/19 at Reception and Medical Center, a clinical laboratory in Lake Butler, Florida. Reception and Medial Center is in not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 a review of the Individualized Quality Control Plan (IQCP) records and interview with laboratory staff, the facility failed to document how it will monitor the pre-analytic testing process for the blood gas analyzer (Abbott i-Stat). Findings include: A review of the IQCP documentation for the blood gas analyzer showed that there was no assessment of the pre-analytic testing process and how problems will be corrected. The interview with the laboratory manager on 10/2/2019 at 11:00am confirmed the IQCP was incomplete. . 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on review of the laboratory procedure manual, IQCP, quality control records, and staff interviews, the laboratory failed to have a procedure manual and IQCP signed by the laboratory director (refer to D5407); failed to document a complete IQCP for the blood gas analyzer (refer to D5441 & D5445); failed to run quality control testing per procedure (refer to D5481); and failed to have a quality assessment procedure in place for analytic systems (refer to D5791). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Individualized Quality Control Plan (IQCP), procedure manual, and interview with laboratory staff, the laboratory failed to have the IQCP and laboratory procedure manual signed and dated by the laboratory director. Findings include: 1. The IQCP documentation provided at the time of survey did not have a date or signature showing approval by the laboratory director. 2. The record review of the procedure manual showed the laboratory director had not signed the procedure manual since 2014. Interview with the laboratory manager on 10/2/19 at 11:15 AM confirmed that the laboratory director had not signed the laboratory procedure manual or the IQCP. 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 a review of the Individualized Quality Control Plan (IQCP) records and interview with laboratory manager, the laboratory failed to document a complete IQCP for the blood gas analyzer (Abbott i-Stat). Findings include: A review of the IQCP Quality Control Plan (QCP) documentation for the blood gas analyzer showed that there was no documentation of the number, type, frequency of testing, and criteria for acceptable quality control (QC) results. The interview with the laboratory manager on 10/2/19 at 11:00am confirmed the IQCP was incomplete. -- 2 of 5 -- 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 a review of the Individualized Quality Control Plan (IQCP) records and interview with laboratory manager, the laboratory failed to document a complete IQCP for the blood gas analyzer (Abbott i-Stat). Findings include: A review of the IQCP Risk Assessment (RA) documentation for the blood gas analyzer showed that there was no assessment for the entire testing process of the required elements: specimen, test system, reagent, environment, and testing personnel. The interview with the laboratory manager on 10/2/19 at 11:00am confirmed the IQCP was incomplete. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory failed to perform blood gas quality controls (QC) that were not expired, failed to run the required internal control required by the manufacturer, and failed to run three levels of QC prior to reporting patient results. Findings Include: 1. Record review of the laboratory's Blood gas QC records for May 2019 showed on 5/9/19, 5/17/19, and 5/29 /19 the QC Level 3 used had lot number 321100 and expired on 4/30/2019. At the time of survey, the number of patients tested was unable to be determined. 2. Review of the i-Stat system manual indicated users need to "verify the performance of each analyzer on site using the Electronic Simulator once a day on the days the analyzers are in use". At the time of survey, the laboratory was unable to provide documentation to show the Electronic Simulator was ran on each day of patient testing. 3. Review of the laboratory's QC procedure indicated "weekly Trilevel 1,2 & 3 will be performed". The QC documentation on 2/27/19 showed Level 3 was not performed. The interview with the laboratory manager on 10/2/19 at 11:55am confirmed the laboratory had performed QC using expired controls, the laboratory failed to run the Electronic Simulator daily, and failed to document three levels of QC. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 3 of 5 -- 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 a review of the Individualized Quality Control Plan (IQCP) records and interview with laboratory manager, the laboratory failed to document how it will monitor the analytic testing process for the blood gas analyzer (Abbott i-Stat). Findings include: A review of the IQCP documentation for the blood gas analyzer showed that there was no assessment of the analytic testing process and how problems will be corrected. The interview with the laboratory director on 10/2/19 at 11:00am confirmed the IQCP was incomplete. . 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 a review of the Individualized Quality Control Plan (IQCP) records and interview with laboratory manager, the laboratory failed to document how it will monitor the post analytic testing process for the blood gas analyzer (Abbott i-Stat). Findings include: A review of the IQCP documentation for the blood gas analyzer showed that there was no assessment of the post analytic testing process and how problems will be corrected. The interview with the laboratory manager on 10/2/19 at 11:00am confirmed the IQCP was incomplete. 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 a review of the Individualized Quality Control Plan (IQCP) records, QC documentation, and interview with laboratory manager, the laboratory director failed to ensure complete documentation of an IQCP for the blood gas analyzer (Abbott i- Stat), failed to ensure the performance of blood gas quality controls (QC) that were not expired, failed ensure the internal control required by the manufacturer was performed daily, and failed ensure three levels of QC were performed prior to reporting patient results. Findings include: 1. A review of the IQCP Quality Control Plan (QCP) documentation for the blood gas analyzer showed that there was no documentation of the number, type, frequency of testing, and criteria for acceptable quality control (QC) results. laboratory 2. A review of the IQCP Risk Assessment -- 4 of 5 -- (RA) documentation for the blood gas analyzer showed that there was no assessment for the entire testing process of the required elements: specimen, test system, reagent, environment, and testing personnel. 3. A record review of the laboratory's Blood gas QC records for May 2019 showed on 5/9/19, 5/17/19, and 5/29/19 the QC Level 3 used had lot number 321100 and expired on 4/30/2019. At the time of survey, the number of patients tested was unable to be determined. 4. The review of the i-Stat system manual indicated users need to "verify the performance of each analyzer on site using the Electronic Simulator once a day on the days the analyzers are in use". At the time of survey, the laboratory was unable to provide documentation to show the Electronic Simulator was ran on each day of patient testing. 5. The review of the laboratory's QC procedure indicated "weekly Trilevel 1,2 & 3 will be performed". The QC documentation on 2/27/19 showed Level 3 was not performed. The interview with the laboratory manager on 10/2/19 at 11:55am confirmed the laboratory had performed QC using expired controls, the laboratory failed to run the Electronic Simulator daily, failed to have a completed IQCP, and failed to document three levels of QC. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on a review of the Individualized Quality Control Plan (IQCP), procedure manual, and interview with laboratory staff, the laboratory director failed to sign and date the procedure manual and IQCP. Findings include: 1. The IQCP documentation provided at the time of survey did not have a date or signature showing approval by the laboratory director. 2. The record review of the procedure manual showed the laboratory director had not signed the procedure manual since 2014. Interview with the laboratory manager on 10/2/19 at 11:15 AM confirmed that the laboratory director had not signed the laboratory procedure manual or the IQCP. -- 5 of 5 --