Northeastern Health System, Tahlequah

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/15,16,17,18/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the senior director of ancillary services, technical consultant #1, technical consultant #2, and technical consultant #3 during an exit conference performed at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records; and the laboratory, blood bank, and general nursing policy and interview with general supervisor #1 the facility failed to ensure written policies were followed for preventing transfusion reactions for two of five units reviewed. Findings include: (1) On 04/17/2024 at 2:30 pm, general supervisor #1 stated that the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)); (2) The policy "Blood and Blood Products Transfusion and Reaction" defined the parameters of issuing blood products from the blood bank; (3) The surveyor reviewed the policy which stated: (a) "The blood transfusion will be documented in the Electronic Health Record (EHR). Protocol detailing nursing requirement prior and during infusion are listed in the Insusion section. Required documentation points of the transfusion include: (i) Person starting the transfusion (ii) Person verifiying the transfusion (iii) Blood band number (iv) Type of product (v) Transfusion start time (vi) Transfusion stop time (vii) Vital signs for pre-infusion, 15 minutes after start of infusion and post infusion (vii) The person stopping the 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 -- transfusion (viii) Volume of product infused (b) "Transfusion of red blood cells will be completed within 4 hours" (c) "Transfusions must be started, or the blood returned to the Blood Bank, within 30 minutes from the time the blood is signed out of the blood bank." (4) A review of transfusion records for five units of blood transfused with general supervisor #1 identified for two or five units transfused, the policy was not followed by nursing personnel: (a) Unit #W091023413240 - The unit was checked out from the blood bank at 6:10 pm and was started at 6:57 pm, 47 minutes after leaving the bood bank (b) Unit #W091023 - The unit was checked out from the blood bank at 6:36 pm and there was no documentation of when the transfusion was completed; (5) Interview with general supervisor #1 on 04/17/2024 at 02:30 pm confirmed the facility failed to ensure the policy was being followed as written. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with technical consultant #1, the laboratory failed to have a written policy that included assessing the competency of the general supervisors, based on the position responsibilities as listed in Subpart M, for three of three persons. Findings include: (1) On 04/16/2023, a review of the policy titled, "Competency Assessment" identified no evidence it included assessing the competency of the general supervisors; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of 2022 through the current date identified competencies, based on job responsibilities, had not been performed for three of three persons listed as general supervisor after 01/25/2022; (3) The findings were reviewed with technical consultant #1 who stated on 04/16/2024 at 09:20 am, the policy did not include assessment of the general supervisors and competencies had not been performed after 01/25/2022. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with general supervisor #1, the laboratory failed to ensure 13 of 13 boxes of ChemTrak Unassayed Chemistry quality control materials were stored as required by the manufacturer. Findings include: (1) On 04/15/2024 at 2:00 pm observation of the contents of the Helmer Blood Bank freezer identified the following materials: (a) Seven boxes of MAS -- 2 of 5 -- ChemTRAK H Unassayed chemistry control materials level three, lot #CHU24083A (b) Six boxes of MAS ChemTRAK H Unassayed chemistry control materials level one, lot #CHU24081A (2) The storage requirement, as stated on the bottles for the materials was -15 to -25 degrees C (Celsius); (3) Observation of the freezer digital temperature display (which included a current temperature reading and minimum /maximum temperature readings) on 04/15/2024 at 02:34 pm identified the following: (a) The current temperature reading was -26.3 degrees C (b) The minimum temperature reading was -30.4 degrees C (c) The maximum temperature reading was -11.0 degrees C (4) The findings were reviewed with general supervisor #1 who stated on 04/15/2024 at 2:36 pm, the observed freezer temperature was not within the manufacturer's storage requirement. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's package insert, and interview with technical consultant #1 and technical consultant #2, the laboratory failed to ensure QC (quality control) materials were not used beyond the open vial expiration date for three of seven lot numbers reviewed from August 2023 through February 2024. Findings include: (1) On 04/15/2024 at 02:50 pm, technical consultant #1 stated the following: (a) The laboratory performed Body Fluid and Cerebrospinal Fluid Manual Cell Counts; (b) Two levels of Streck Cell-Chex controls were performed each eight hours of patient testing. (2) On 04/18/2024, a review of the Streck Cell-Chex package insert stated "Open vial stability 30 days"; (3) A review of "Hematology Body Fluid Control Logs" for seven lot numbers of QC materials used from August 2023 through February 2024 identified the materials had been used beyond the open vial expiration dates for three of seven lot numbers reviewed as follows: (a) Low control lot #30930411 and high control lot #30930413 used for patient testing from 08/03/2023 through 08/20/2023. The open vial expiration date as documented on the log was 08 /17/2023; (b) Normal control lot #30930412 and high control lot #30930413 used for patient testing from 10/02/2023 through 10/24/2023. The open vial expiration date as documented on the log was 10/03/2023. (3) A review of patient test logs confirmed results had been reported on 08/20/2023 and 10/24/2023 when expired QC materials had been utilized; (4) The records were reviewed with technical consultant #1 and technical consultant #2 who stated on 04/18/2024 at 10:04 am, the controls had been used beyond the open vial expiration dates. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with -- 3 of 5 -- technical consultant #1 and technical consultant #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing quarterly maintenance procedures on two of two Roche Cobas 6000 analyzers during the review period of September 2023 through February 2024. Findings include: (1) On 04/15/2024 at 02:57 pm, technical consultant #1 stated the following: (a) Routine chemistry and immunoassay tests were performed using two Roche Cobas 6000 analyzers denoted by the laboratory as "Sam" and "Dean"; (b) The analyzers consisted of two modules each (Cobas e 601 and Cobas c 501). (2) On 04/16/2024, a review of the manufacturer's maintenance logs identified the following required quarterly maintenance procedures: (a) Cobas e 601 Module (i) "Replace e 601 pinch valve tubing" (b) Cobas c 501 Module (i) "Replace ISE pinch valve tubing" (ii) "Replace ISE sipper tubing" (iii) "Clean ultrasonic mixers" (3) A review of maintenance logs from September 2023 through February 2024 for "Sam" and "Dean" identified no documentation quarterly maintenance had been performed between: (a) 09/07/2023 and 02/28/2024 (4) The records were reviewed with technical consultant #1 and technical consultant #2 who stated on 04/16/2024 at 12:28 pm, the quarterly maintenance had not been documented as performed as shown above. 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 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 a review of records and interview with technical consultant #1, the laboratory failed to perform calibration verification procedures at least once every six months for one of three blood gas analyzers during the review period of February 2023 through the current date. Findings include: (1) On 04/16/2024 at 10:30 am, technical consultant #1 stated the following was performed in the Respiratory Therapy department: (a) Blood Gas (pH, pCO2, pO2), Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Lactate, Creatinine, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin testing using the ABL 800 analyzer; (b) Blood Gas (pH, pCO2, pO2), Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Lactate, Creatinine, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin testing using the ABL 90 -- 4 of 5 -- analyzer (denoted by the laboratory as ABL 90-15) stored and utilized at the point of care in ICU (Intensive Care Unit); (c) Blood Gas (pH, pCO2, pO2), Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Lactate, Creatinine, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin testing using the ABL 90 analyzer (denoted by the laboratory as ABL 90-14) stored in the main laboratory. (2) A review of records from February 2023 through the current date identified no evidence calibration verification had been performed at least once every six months for one of three analyzers as follows: (a) ABL 90-14 - Not performed between 02/07/2023 and 10 /19/2023 (3) The records were reviewed with technical consultant #1 who stated on 04 /16/2024 at 12:20 pm, calibration verification procedures had not been performed every six months as shown above. 47979 Based on a review of records and interview with technical consultant #1, the laboratory failed to perform calibration verification procedures at least once every six months for one of 15 analytes requiring calibration verification using the Roche Cobas 6000 analyzer during the review period of January 2023 through the current date. Findings include: (1) On 04/15/2024 at 02:57 pm, technical consultant #1 stated Testosterone testing was performed using the Roche Cobas 6000 analyzer (denoted by the laboratory as "Dean"); (2) A review of calibration records for 2023 identified the calibration procedures for the above analyte was performed with less than three levels of calibrators. Therefore, calibration verification procedures using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of records from January 2023 through the current date identified calibration verification had not been performed for Testosterone between 02/04/2023 and 10/26/2023; (4) The records were reviewed with technical consultant #1 who stated on 04/16/2024 at 02:52 pm, calibration verification procedures had not been performed every six months as shown above. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/18,19,20,21,22/2022. The findings were reviewed with laboratory director, technical consultant #1, technical consultant #2, system quality and risk officer, and vice-president of ancillary services during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records, manufacturer's instructions, and interview with the respiratory therapy supervisor and technical consultant #1, the laboratory failed to follow the manufacturer's instructions for Blood Gas testing for four of five test reports. Findings include: (1) On 04/18/2022 at 02:40 pm, technical consultant #1 stated Blood Gas (pH, pCO2, pO2) testing was performed on the following: (a) ABL 90 Radiometer (b) ABL 800 Flex Radiometer (2) A review of the manufacturer's instructions for both analyzers stated, under the section titled, "Storage time and temperature recommendations": (a) "Plastic syringe" (i) "If it not possible to analyze the sample immediately, analyze it within 30 minutes"; (ii) "Samples with expected high pO2 values or for special studies like shunt studies, should be analyzed immediately or within 5 minutes". (3) A review of patient testing records on 11/17 /2021, 12/07/2021, 03/04/2022, 04/08/2022, and 04/18/20222 revealed the following for four of five patient test reports (NOTE: Result time correlates to time sample tested): (a) ABL 90 Radiometer (i) Patient Report #2000544739 - The collection date and time were not documented and the result date and time were 11/17/2021 at 03:19 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- am; (ii) Patient Report #2000564628 - The collection date and time were not documented and the result date and time were 12/07/2021 at 08:26 pm; (iii) Patient Report #2000647851 - The collection date and time were not documented and the result date and time were 04/18/2022 at 05:06 pm. (b) ABL 800 Flex Radiometer (i) Patient Report #2000623235 - The collection date and time were not documented and the result date and time were 03/04/2022 at 04:37 am. (4) The findings were reviewed with the respiratory therapy supervisor who stated on 04/19/2022 at 02:55 pm, the laboratory could not prove the specimens were collected and tested within the timeframe required by the manufacturer. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to review and evaluate proficiency testing results for one of 27 events. Findings include: (1) On 04/19/2022, a review of 2020 and 2021 proficiency testing records revealed the following failure: (a) First 2020 Chemistry Miscellaneous Event (i) Urine Calcium - The laboratory failed the result for one of five samples (UC- 01). (2) A review of the records revealed there was evidence proving the failure had been addressed; (3) The records were reviewed with technical consultant #1 who stated on 04/19/2022 at 01:15 pm,

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/21,22,23,24/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, cardiopulmonary department director, AVP of quality, safety, and accreditation, AVP of clinical nursing, AVP operational nursing, technical consultant #1, and laboratory manager during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1 and the laboratory manager, the laboratory failed to ensure attestation statements were signed by the laboratory director or designee, or analyst(s) for 4 of 20 events. Findings include: (1) On the second day of the survey, surveyor #1 and surveyor #3 reviewed 2018 and 2019 proficiency testing records, with the following identified: (a) Third 2018 Hematology/Coagulation Event - The attestation statement had not been signed by the analyst(s); (b) Third 2018 Chemistry Core Event - The attestation statement had not been signed by the analyst(s); (c) First 2019 Hematology/Coagulation Event - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- The attestation statement had not been signed by the laboratory director or designee; (d) Third 2019 Hematology/Coagulation Event - The attestation statement had not been signed by the laboratory director/designee. (2) Surveyor #1 reviewed the records with technical consultant #1 and the laboratory manager. Both stated the attestation statements had not been signed by the the laboratory director or analyst(s), as indicated above. D2015 was cited on the recertification survey performed on 03/12, 13,14,15,16/18. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1 and the laboratory manager, the laboratory failed to review and evaluate proficiency testing results for 1 of 20 events. Findings include: (1) On the second day of the survey, surveyor #1 and surveyor #3 reviewed 2018 and 2019 proficiency testing records and identified the following failures: (a) Second 2018 Chemistry Miscellaneous Event (i) Body Fluid Cholesterol - The laboratory failed the results for 2 of 3 samples (BCH-04 and BCH-06); (ii) Body Fluid pH (quantitative) - The laboratory failed the result for 1 of 3 samples (BCH-05); (iii) Parathyroid Hormone - The laboratory failed the result for 1 of 3 samples (IAT-06). (2) The records were then reviewed further by the surveyors. There was no evidence

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 a desk review of proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program in the subspecialty of Endocrinology for the analyte TSH. Findings include: (1) The laboratory failed to achieve satisfactory performance in two of three consecutive testing events for the analyte TSH (Thyroid Stimulating Hormone). Refer to D2105 and D2107. 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 -- D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for the analyte TSH. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2018 and the second event in 2019. Refer to D2107. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The survey was performed on 03/12,13,14,15,16/2018 The findings were reviewed with the vice president of patient care, assistant vice president of ancillary services, technical consultant #1, technical consultant #2, and technical consultant #3 during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1215; D5024: Hematology 493.1405; D6000: Laboratory Director, Moderate Complexity Testing 493.1409; D6033: Technical Consultant 493.1421; D6063: Testing Personnel, Moderate Complexity Testing 493.1441; D6076: Laboratory Director, High Complexity Testing D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the second day of the survey, surveyor #2 reviewed 2016, 2017 and 2018 proficiency testing records. The following was identified for 7 of 30 testing events: (a) First 2016 Immunohematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 24 -- Event (i) The attestation was not signed by the laboratory director or designee (b) Second 2016 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (c) Third 2016 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (d) First 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (e) Second 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (f) Third 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (g) Third 2017 Hematology/Coagulation Event (i) The attestation was not signed by the laboratory director or designee (2) The findings were reviewed with technical consultant #1 who stated the attestations were not signed as indicated above. 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 a review of records, policies and procedures, manufacturer's instructions, and interview with technical consultant #1, technical consultant #2, and technical consultant #3, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to ensure that written procedures no longer in use had been discontinued. Refer to D5409; (2) The laboratory failed to ensure the verified reportable ranges for a new coagulation analyzer were used by the laboratory. Refer to D5421; (3) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (4) The laboratory failed to follow the manufacturer's specifications for establishing normal reference intervals for a new coagulation analyzer. Refer to D5479; (5) The laboratory failed to test one control material each 8 hours of operation; and failed to test patient and control specimens in duplicate when performing manual counts using a hemacytometer. Refer to D5543; (6) The laboratory failed to perform two levels of control material each 8 hours of operation on the coagulation analyzer. Refer to D5545; (7) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. NOTE: D5024 was cited on the previous recertification survey performed on 04/26-28/16 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, and interview with technical consultant #1, the laboratory failed to have written policies and procedures for assessing employee competency. Findings include: (1) On the first day of the survey, surveyor #2 reviewed the laboratory's policies and procedures. A policy that explained how -- 2 of 24 -- employees were assessed for competency could not be located; (2) Surveyor #2 asked technical consultant #1 if a competency policy was available for review. Technical consultant #1 stated a policy had not been written. NOTE: For non-waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. The policy/procedure for evaluating competency must include, but is not limited to: *Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing *Monitoring the recording and reporting of test results *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records *Direct observation of performance of instrument maintenance and function checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, surveyor #2 reviewed 2016, 2017 and 2018 proficiency testing records and identified the following failures, in which