Lakeview Specialty Hospital & Rehab

Summary Statement of Deficiencies 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 proficiency testing desk review of the federal Certification and Survey Provider Enhanced Reports (CASPER) 0153D and 0155D Proficiency Testing (PT) and graded copies of American Proficiency Institute (API) Proficiency Testing (PT) records, and interview with laboratory staff, the laboratory failed to successfully obtain an overall 100% satisfactory testing event score in PT for the Activated Partial Thromboplastin Time (aPTT) analyte (0835) in the specialty of Hematology for two out of three events for 2023-3 and 2024-2 (refer to D2130) resulting in unsuccessful PT performance. This deficiency (D2016) was previously cited on January 10, 2022. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review of the federal Certification and Survey Provider Enhanced Reports (CASPER) 0153D and 0155D proficiency testing reports and graded copies of American Proficiency Institute (API) proficiency testing (PT) records, and interview with laboratory staff, the laboratory failed to obtain an overall 100% satisfactory PT scores for two out of three events for the Activated Partial Thromboplastin Time (aPTT) analyte (0835) in the Hematology Specialty in events 2023-3 and 2024-2 which resulted in unsuccessful PT performance. Findings include: 1. Review of PT records in the federal CASPER reporting system and the 0153D and 0155D reports on September 3, 2024 showed the laboratory had unsatisfactory performance for aPTT testing for PT events 2023-3 and 2024-2. Event 2023-3, score 0% Event 2024-2, score 60% 2. Desktop review of graded copies of API PT evaluation reports and phone interview with laboratory personnel (Staff A) September 4, 2024 at 2:00 PM, confirmed the unsatisfactory scores for aPTT testing for two out of three PT events which results in unsuccessful performance in PT for aPTT testing. 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 proficiency testing desk review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and graded copies of American Proficiency Institute(API) Proficiency Testing (PT) records, the laboratory failed to obtain satisfactory PT scores for the Activated Partial Thromboplastin Time (aPTT) analyte (0835) in the specialty of Hematology for two out of three events for 2023-3 and 2024-2 which resulted in unsuccessful PT performance. The laboratory director did not ensure the laboratory did not fail two out of three PT events. (Refer to D6019). D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Item 1 Based on surveyor review of laboratory procedures and records, and interview with the laboratory manager, staff A, testing personnel did not follow procedures for calibration verification for two of two Abbott I-Stat chemistry analyzers. Findings include: 1. Review of the "i-STAT CHEM 8' procedure stated the following: " Calibration verification is also performed Every 6 months On any new or replacement device before being clinically used. After major maintenance or service. As part of the troubleshooting process when controls reflect an unusual trend or are consistency of range. And as recommend by the manufacturer." 2. Review of calibration verification records showed calibration verification in July 2023 and July 2024, with no additional calibration verification performed in January 2024. 3. Interview with staff A on July 23, 2024, at 2:25 PM confirmed testing personnel did not follow the procedure for calibration verification on the Abbott I-Stat chemistry analyzer. Item 2 Based on surveyor review of laboratory procedures and records, and interview with the laboratory manager, staff A, testing personnel did not follow procedures for calibration verification for one of one Abbott I-Stat chemistry analyzers that was taken out of service for major service on the analyzer. Findings include: 1. Review of the "i-STAT CHEM 8' procedure stated the following: " Calibration verification is also performed Every 6 months On any new or replacement device before being clinically used. After major maintenance or service. As part of the troubleshooting process when controls reflect an unusual trend or are consistency of range. And as recommend by the manufacturer." 2. Review of deviation logs showed I-Stat analyzer, serial number 380580, was removed from service August 22, 2023, for failures with 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 -- the electronic simulator, and placed back into service on October 11, 2023. 3. Review of calibration verification records showed no documentation that a calibration verification had been performed prior to putting the analyzer back into service. 4. Interview with staff A on July 23, 2024, at 2:25 PM confirmed testing personnel did not follow the procedure for calibration verification on the Abbott I-Stat chemistry analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, observation of the CELL-DYN Emerald hematology analyzer, and interview with testing personnel, the laboratory did not retain the date the current box of diluent was put into use on the CELL-DYN analyzer. Findings include: 1. Review of laboratory records showed two reagent logs in use in the laboratory. The 'CELL-DYN Emerald Diluent Log' showed the current diluent in use was lot 1324, opened on February 17, 2022 and expired on August 31, 2022. A second diluent log from the analyzer, printed on February 1, 2022 showed the most recent entry on the log was September 8, 2021, lot number 1260, expiration date March 31, 2022. 2. Observation of the diluent in use on the CELL-DYN analyzer on September 14, 2022 at 12:27 PM showed the diluent was lot 1260 and that the diluent expired on March 31, 2022. 3. Interview with testing personnel (staff A) on September 14, 2022 at 12:45 PM confirmed the records did not show when the current box of diluent was installed on the analyzer and revealed staff A was not able to retrieve a current report from the analyzer. During further interview staff A said a service technician installed the current box of diluent on the analyzer when the technician was on site to resolve issues with the analyzer and found the diluent was empty. Staff A confirmed the laboratory had no documentation of the site visit of the service technician. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with testing personnel, the laboratory did not meet the requirements specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. Findings include: 1. The laboratory did not document software updates for the two i-STAT analyzers in 2021 or 2022. See D5429. D5429 is a repeat deficiency previously cited on January 5, 2015. 2. The laboratory did not perform and document thermal probe function checks every six months as required for two i-STAT analyzers used in the laboratory. See D5431. 3. The laboratory did not test external quality control materials every 30 days in 2021 as required by their individualized quality control plan (IQCP) for testing performed on two i-STAT analyzers. See D5445 Item 1. 4. The laboratory did not perform external quality control testing on lot numbers of test cartridges prior to use for patient testing. See D5445 Item 2. D5445 is a repeat deficiency previously cited on November 30, 2016. 5. The laboratory did not evaluate and define the relationship between test results obtained on the two i-STAT analyzers in 2021 or 2022. See D5775. D5775 is a repeat deficiency previously cited on January 5, 2015. 6. The laboratory did not perform an annual quality assessment review of their IQCP for testing on the i-STAT analyzers in 2021. See D5791. D5791 is a repeat deficiency previously cited on October 4, 2018. D5016 is a repeat deficiency previously cited on January 5, 2015. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records, procedures, and manufacturer's instructions, observation of reagents, supplies and instruments, and interview with testing personnel, the laboratory did not meet the requirements specified in 493.1230 through 493.1256. Findings include: 1. The laboratory did not label hematology controls with reduced open expiration dates. See D5415. D5415 is a repeat deficiency previously cited on March 13, 2013. 2. The laboratory used expired diluent on the CELL-DYN analyzer for patient testing. See D5417. 3. The laboratory did not perform and document calibration or calibration verification of the CELL-DYN analyzer in 2021. See D5437. 4. The laboratory used two lot numbers of PT/INR (prothrombin time / international normalized ratio) test cartridges with the i-STAT analyzers for patient testing without testing external controls. See D5445 Item 2. D5445 is a repeat deficiency previously cited on November 30, 2016. D5024 is a repeat deficiency previously cited on March 13, 2013. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints -- 2 of 17 -- and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the laboratory does not have a system to record problems and the investigation of complaints. Findings include: 1. Review of laboratory records showed no evidence of documentation of complaints or problems in the laboratory. 2. Interview with testing personnel (staff A) on September 14, 2022 at 3:15 PM revealed a patient was tested with the CELL-DYN Emerald hematology analyzer and an abnormal high white cell count was reported. The test was also sent to a reference laboratory and the white cell count was normal. Testing at a later date showed the same results; the white cell count was high when tested on the CELL-DYN analyzer and normal when sent to the reference laboratory. Staff A confirmed this situation occurred after service of the CELL-DYN analyzer on June 15, 2022 and confirmed there was no documentation of the problem or the

Summary Statement of Deficiencies 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for Chloride, Carbon Dioxide (CO2) total, Creatinine, Glucose, Blood Gases (pCO2, pH, pO2), Potassium, Sodium and Urea Nitrogen (BUN) analytes in the Specialty of Chemistry for events 2021-2 and 2021-3. See D2096. D2096 ROUTINE CHEMISTRY 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 -- 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for Chloride (CL), Carbon Dioxide (CO2) total, Creatinine, Glucose, Partial pressure of Carbon Dioxide (pCO2), Potential Hydrogen (pH), Partial pressure of Oxygen (pO2), Potassium (K), Sodium (NA) and Urea Nitrogen (BUN) analytes in the Specialty of Chemistry for events 2021-2 and 2021-3. Findings include: 1. Review of the PT records in the CASPER reporting system showed the laboratory failed two consecutive PT events for the following analytes in the Specialty of Chemistry: Analyte / 2021-2 / 2021-3 CL / 0% /0% CO2 total / 0% / 0% Creatinine / 0% / 0% Glucose / 0% / 0% pCO2 / 0% / 0% pH / 0% / 0% pO2 / 0% / 0% K / 0% / 0% NA / 0% / 0% BUN / 0% / 0% 2. Review of the WSLH PT evaluation reports on January 10, 2022 confirmed the failed PT scores for CL, CO2 total, Creatinine, Glucose, pCO2, pH, pO2, K, NA and BUN analytes in the Specialty of Chemistry. This results in failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is an unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing records for 2020 and interview with a technical consultant, the laboratory did not participate in an approved proficiency- testing program for one year before designating a different program for chemistry and hematology. Findings include: 1. Review of proficiency testing records from 2020 showed the laboratory participated in the American Academy of Family Physicians (AAFP) program for chemistry and hematology in event one. The laboratory participated in the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing chemistry and hematology program for events two and three. 2. Interview with the technical consultant on December 8, 2020 at 7:40 AM, confirmed the laboratory did not participate in the AAFP chemistry and hematology proficiency testing programs for one year prior to switching to the WSLH chemistry and hematology proficiency testing programs. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of proficiency testing (PT) records and procedures, and interview with the technical consultant, the laboratory director has not attested to the routine integration of the PT samples into patient workload using the laboratory's routine methods for two of three events in 2020. Findings include: 1. Review of the PT records show the laboratory director has not signed (or delegated the responsibility for signing to the technical consultant) the attestation statements for event one and event two of 2020. 2. Review of the "Proficiency Testing" procedure stated, "The laboratory director must sign the result submission form". 3. Interview with the technical consultant on December 8, 2020 at 8:10 AM confirmed the laboratory director did not sign the attestation statements for two of three events in 2020. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor interview with the hospital Chief Executive Officer (CEO), the laboratory does not have a technical consultant who meets the qualification requirements of 493.1411 of this subpart. Findings include: 1. The laboratory does not have a technical consultant who meets the qualification requirements of 493.1411 of this subpart. See D6034 and D6035. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of records and interview with the Chief Executive Officer (CEO), the laboratory does not have a qualified technical consultant employed. Findings include: 1. Surveyor review of complaint intake records from April 22, 2020 identified the technical consultant had resigned. 2. Interview with CEO on May 4, 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 -- 2020 at 10:30 AM confirmed the laboratory does not have a technical consultant employed. 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 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 surveyor review of records and interview with the Chief Executive Officer (CEO), the laboratory does not have a qualified technical consultant. Findings include: 1. Surveyor review of complaint intake records from April 22, 2020 identified the technical consultant had resigned. 2. Interview with CEO on May 4, 2020 at 10:30 AM confirmed the laboratory does not have a qualified technical consultant, and also confirmed the laboratory director is not qualified to function as a technical consultant. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) records and interview with testing personnel, the laboratory did not evaluate the results for CKMB (creatine kinase-muscle/brain fraction) testing in the first two 2017 PT events. Findings include: 1. Review of proficiency testing records from events one and two in 2017 show the CKMB results were not graded by the PT provider. No documented review of these results by the laboratory is evident. 2. Interview with testing personnel, staff A, on October 4, 2018 at 10:00 AM confirmed the laboratory did not verify the accuracy of CKMB results from events one and two in 2017. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless 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 laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with testing personnel, the laboratory did not perform calibration verification every six months on the i-STAT analyzers in 2017. Findings include: 1. Review of the calibration verification records for the i-STAT analyzers show the following dates of calibration verification testing for CKMB (creatine kinase-muscle/brain fraction), Troponin, BNP (B-type natriuretic peptide) and the G3+ cartridge for Blood Gas testing: Test: Dates calibration verification performed CKMB: May 2, 2017 / March 1, 2018 Troponin: May 2, 2017 / March 2, 2018 BNP: May 3, 2017 / December 5, 2017 G3+: May 3, 2017 / December 5, 2017 2. Interview with testing personnel, staff A, on October 4, 2018 at 11:45 AM confirmed calibration verification was not performed every six months in 2017 as required. 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 surveyor review of laboratory records and interview with testing personnel, the laboratory did not document problems identified in the analytic systems to monitor, assess and correct identified problems. Findings include: 1. Review of quality control records for CKMB (creatine kinase-muscle/brain fraction) showed no quality control testing was documented in September 2018. No documentation showing evaluation of the lack of quality control testing or resolution of the problem is available. 2. Interview with testing personnel, staff A, on October 4, 2018 at 10:55 AM revealed the laboratory ran out of CKMB reagent in September and was unable to order reagents until the end of the month. Further interview confirmed there was no documentation of when CKMB testing was not available, assessment of the issues involved, the impact to patient care, or a plan to prevent recurrence. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, test records and logs, and interview with testing personnel, testing personnel did not follow the laboratory's procedures for documenting critical test results. Findings include: 1. Review of the "Reporting Critical Lab Values" procedure shows critical results are documented on the Critical Result Log. 2. Comparison of test records for patient one from September 6 and 7 with the Critical Lab Log showed two of two critical CKMB (creatine kinase- muscle/brain fraction) results were not recorded on the Critical Result Log. 3. Interview with testing personnel, staff A, on October 4, 2018 at 11:30 AM confirmed the laboratory's procedures for maintaining records of critical patient test results were not followed. -- 3 of 3 --