Lane Regional Medical Center

Summary Statement of Deficiencies D0000 A Validation Survey was performed at Lane Regional Medical Center, CLIA ID # 19D0689385 on February 10, 2020 through February 13, 2020. Lane Regional Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCES: 42 CFR 493.1240 CONDITION: Preanalytic systems 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant 42 CFR 493.1421 CONDITION: Laboratories Performing Moderate Complexity Testing; Testing Personnel 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 record review and interview with personnel, the laboratory failed to retain the competency assessment supporting documentation for laboratory personnel for 2018. Findings: 1. Review of the laboratory's personnel records binder for 2018 revealed the laboratory did have a summary sheet to show assessments and documentation to support the competency assessments performed on testing personnel for 2017; however, the records did not have the supporting documentation for the 2018 competency assessments. 2. In interview on February 10, 2020 at 11:46 am, Personnel 2 stated the previous general supervisor maintained the competency records. Personnel 2 further stated the 2018 supporting documentation must have been destroyed instead of the 2017 documentation. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 25 -- 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Technical Supervisor, Technical Consultant and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed the following: a) Personnel 2 serves as Technical Supervisor, Technical Consultant, and General Supervisor b) Personnel 3 serves as Technical Consultant and General Supervisor c) Personnel 5 serves as General Supervisor 2. Review of the laboratory's policy manual revealed the laboratory did not include competency assessment criteria or frequency of performance for personnel serving as Technical Supervisor, Technical Consultant and General Supervisor. 3. Review of personnel records revealed the laboratory did not perform competency assessments for personnel serving as Technical Supervisor, Technical Consultant and General Supervisor. 4. In interview on February 11, 2020 at 2:35 pm, Personnel 2 stated the laboratory did not have a policy for competency assessment for Technical Supervisor, Technical Consultant, and General Supervisor. Personnel 2 confirmed competency assessments were not performed for the identified personnel. II. Based on record review and interview with personnel, the laboratory failed to follow procedures for testing personnel competency assessments. Findings: 1. Review of the laboratory's "Annual Evaluation of Competency" policy revealed "The laboratory evaluates the competency of its personnel on an annual basis. Technical Staff are evaluated twice within the 1st year and annually thereafter. Each employee has a competency log sheet and cover page. The log sheet includes each method and/or instrument competency. Each competency is based on the six CLIA mandated methods of evaluation. Each tech assessment is reviewed by the Lab Manager and Lab Director. Assessments can be done by the Chief Tech/General Supervisor". 2. Further review of the laboratory's competency assessment forms revealed the laboratory utilizes a spreadsheet as the form for assessments performed. 3. Review of personnel records for the 2019 revealed the laboratory documented assessments on a spreadsheet; however, the laboratory did not include a summary of the six (6) criteria of evaluation required and the supporting documentation. 4. In interview on February 10, 2020 at 11:46 am, Personnel 2 confirmed the laboratory did not have a summary of competency assessment or the supporting documentation for 2019. 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 and interview with personnel, the laboratory failed to verify the accuracy of all non-regulated analytes at least twice annually. Findings: 1. Review of the laboratory's "Non-Regulated Analytes" policy revealed "Non-regulated PT testing should be performed every six months. Documentation should be performed -- 2 of 25 -- within the calendar month it is due. As testing is performed, the form will be updated to indicate the month in which the next event must take place". 2. Review of the laboratory's records revealed the laboratory did not verify the accuracy of the following test: Manual Eosinophil and Clotest. 3. In interview on February 11, 2020 at 1:30pm, Personnel 2 confirmed the laboratory did not verify Manual Eosinophil counts or Clotest twice annually or realize these were not covered in proficiency testing selections. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory's system failed to monitor, assess, and correct problems identified with the preanalytic system. Findings: 1. The laboratory failed to ensure patient samples for Lactic Acid are separated within 15 minutes according to the manufacturer for eighteen (18) of one hundred ninety (190) patients reviewed. Refer to D5311 I. 2. The laboratory failed to ensure patient samples are separated within two (2) hours as required by manufacturer. Refer to D5311 II. 3. The laboratory failed to perform patient samples for Partial Thromboplastin Time (PTT) testing within four (4) hours of collection as required by the manufacturer for five (5) of one hundred eleven (111) patients reviewed. Refer to D5311 III. 4. The laboratory failed to ensure patients were analyzed within thirty (30) minutes of collection for Arterial Blood Gas (ABG) for thirteen (13) of three hundred ninety two (392) patients reviewed. Refer to D5311 IV. 5. The laboratory failed to ensure patients were analyzed within four (4) hours of collection according to the manufacturer for the Biofire Filmarray Respiratory Panel for two (2) of thirty-four (34) patients reviewed. Refer to D5311 V. 6. The laboratory failed to ensure patient samples for Ammonia testing are separated immediately and analyzed within 30 minutes according to the manufacturer for twenty (20) of seventy- seven (77) patients reviewed. Refer to D5311 VI. 7. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. 8. The laboratory's system failed to monitor, assess, and correct problems, identified with the preanalytic system. Refer to D5391. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. -- 3 of 25 -- This STANDARD is not met as evidenced by: I. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Lactic Acid are separated within 15 minutes according to the manufacturer for eighteen (18) of one hundred ninety (190) patients reviewed. Findings: 1. Observation by surveyor on February 10, 2020 at 3:08 pm revealed the laboratory performed Lactic Acid testing on the following two (2) chemisry analyzers: a) Siemens Dimension Vista Chemistry analyzer b) Siemens Atellica CH analyzer 2. In interview on February 11, 2020 at 3:45 pm, Personnel 2 stated the laboratory performs Lactic Acid patient samples on both the Siemens Dimension Vista and Atellica CH analyzers. 3. Review of the Siemens Dimension Vista Lactic Acid package insert revealed "Blood is best collected without stasis in a container of sodium fluoride/potassium oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes". 4. Review of the Siemens Atellica CH Lactic Acid package insert revealed "Collect blood from a stasis free vein and store it in an ice bath. Separate the plasma by centrifugation within 30 minutes. Assay the sample immediately". 5. Review of patient records for Lactic Acid from November 1, 2019 through January 31, 2020 revealed the laboratory did not receive the following eighteen (18) of one hundred ninety (190) patients within 15 minutes in order to separate as required by the manufacturer: a) November 6, 2019 - Patient number L0307245 was collected at 05:00 am and received at 05:53 am (exceeding the fifteen (15) minutes required by the manufacturer by thirty-eight (38) minutes) b) November 8, 2019 - Patient number L0221466 was collected at 02:15 am and received at 02:39 am (exceeding the fifteen (15) minutes required by the manufacturer by nine (9) minutes) c) November 12, 2019 - Patient number L0137261 was collected at 02:10 am and received at 02:52 am (exceeding the fifteen (15) minutes required by the manufacturer by twenty-seven (27) minutes) d) November 18, 2019 - Patient number L0260098 was collected at 14:18 pm and received at 14:58 pm (exceeding the fifteen (15) minutes required by the manufacturer by twenty-five (25) minutes) e) November 22, 2019 - Patient number L0022951 was collected at 12:25 pm and received at 14:00 pm (exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour twenty (20) minutes) f) November 28, 2019 - Patient number L0103613 was collected at 05:35 am and received at 06:23 am (exceeding the fifteen (15) minutes required by the manufacturer by thirty-three (33) minutes) g) November 29, 2019 - Patient number L0229728 was collected at 04:20 am and received at 04:47 am (exceeding the fifteen (15) minutes required by the manufacturer by twelve (12) minutes) h) December 3, 2019 - Patient number L0036369 was collected at 23:18 pm and received at December 4, 2019 at 00:38 am (exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour five (5) minutes) i) December 4, 2019 - Patient number L0198631 was collected at 04:07 am and received at 05:27 am (exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour five (5) minutes) j) December 11, 2019 - Patient number L0225169 was collected at 21:15 pm and received at 21:39 pm (exceeding the fifteen (15) minutes required by the manufacturer by nine (9) minutes) k) December 17, 2019 - Patient number L0104424 was collected at 22:16 pm and received at 22:40 pm (exceeding the fifteen (15) minutes required by the manufacturer by nine (9) minutes) l) December 18, 2019 - Patient number L0080360 was collected at 21:20 pm and received at 21:45 pm (exceeding the fifteen (15) minutes required by the manufacturer by ten (10) minutes) m) December 23, 2019 - Patient number L0141190 was collected at 16:46 pm and received at 17:16 pm (exceeding the fifteen (15) minutes required by the manufacturer by fifteen (15) minutes) n) January 2, 2020 - Patient number L0249411 was collected at 13:54 pm and received at 15:21 pm (exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour twelve (12) minutes) o) January 8, 2020 - Patient -- 4 of 25 -- number L0195900 was collected at 23:00 pm and received at 23:47 pm (exceeding the fifteen (15) minutes required by the manufacturer by thirty-two (32) minutes) p) January 9, 2020 - Patient number L0257411 was collected at 03:00 am and received at 03:24 am (exceeding the fifteen (15) minutes required by the manufacturer by nine (9) minutes) q) January 23, 2020 - Patient number L0093008 was collected at 18:38 pm and received at 19:20 pm (exceeding the fifteen (15) minutes required by the manufacturer by twenty-seven (27) minutes) r) January 27, 2020 - Patient number L0035718 was collected at 18:42 pm and received at 19:12 pm (exceeding the fifteen (15) minutes required by the manufacturer by fifteen (15) minutes) s) January 29, 2020 - Patient number L0183555 was collected at 00:40 am and received at 01:06 am (exceeding the fifteen (15) minutes required by the manufacturer by eleven (11) minutes) 6. In interview on February 11, 2020 at 3:45 pm, Personnel 2 stated patient samples were only performed on the Dimension Vista whenever the Atellica CH analyzer was in downtime at various time daily. Personnel 2 confirmed the identified samples were not received within the fifteen minutes required. 7. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 632 Lactic Acid tests annually. II. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples are separated within two (2) hours as required by manufacturer. Findings: 1. Obsevation by surveyor during laboratory tour on February 13, 2020 at 8:45 am revealed the laboratory utilizes the Siemens Atellica Chemistry analyzer for Creatinine (CREA) testing. 2. In interview on February 13, 2020, Personnel 2 stated the laboratory receives patient samples from outside facilities such as Home Health, Nursing Homes, and Doctor's offices. Personnel 2 further stated the patient samples from Home Health facilities are received uncentrifuged. 3. Review of the Siemens Atellica package inserts revealed under "Collecting the Samples" that "Serum or plasma should be physically separated from cells as soon as possible with a maximum limit of 2 hours from the time of collection". 4. Review of Home Health test requisitions for patient testing from February 2, 2020 through February 10, 2020 revealed the laboratory received patient samples for basic metabolic panel and comprehensive metabolic panel which includes Creatinine (CREA) for the following three (3) of eight (8) patients reviewed: a) Patient L0020304: one (1) SST BD vacutainer tube and one (1) red BD vacutainer tube collected on February 3, 2020 at 12:34 pm and received at 18:59 pm (exceeding the two (2) hours required by manufacturer by four (4) hours twenty five (25) minutes) b) Patient L0132848: one (1) SST BD vacutainer tube collected on February 3, 2020 at 12:34 pm and received at 15:44 pm (exceeding the two (2) hours required by manufacturer by one (1) hour ten (10) minutes) c) Patient L0304279: one (1) gold BD vacutainer tube collected on February 5, 2020 at 18:30 pm and received at 20:45 pm (exceeding the two (2) hours required by manufacturer by fifteen (15) minutes) 5. In interview on February 13, 2020 at 9:00 am, Personnel 2 confirmed the identified patient samples were received uncentrifuged exceeding the manufacturer's requirements. III. Based on observation, record review and interview with personnel, the laboratory failed to perform patient samples for Partial Thromboplastin Time (PTT) testing within four (4) hours of collection as required by the manufacturer for five (5) of one hundred eleven (111) patients reviewed. Findings: 1. Observation by surveyors during laboratory tour on February 10, 2020 at 1:41 pm revealed the laboratory utilizes the Siemens Sysmex CA 660 coagulation analyzer for Partial Thromboplastin Time (PTT) testing. 2. Review of the Sysmex CA 600 package insert under "Specimen Storage" revealed "APTT test within 4 hours of collection". 3. Review of patient records for PTT testing from January 1, 2020 through January 15, 2020 revealed the laboratory did not perform patient testing within four (4) hours of collection for the following five (5) of one hundred eleven (111) patients reviewed: a. Patient L0306492: collected on January 1, 2020 at 21:32 pm and received on January 2, 2020 at 02:06 am (exceeding the four (4) -- 5 of 25 -- hours required by the manufacturer by thirty four (34) minutes) b. Patient L0056587: collected on January 2, 2020 at 17:10 pm and received on January 2, 2020 at 22:22 pm (exceeding the four (4) hours required by the manufacturer by one (1) hour thirty two (32) minutes) c. Patient L0111514: collected on January 7, 2020 at 09:15 am and received on January 7, 2020 at 13:45 pm (exceeding the four (4) hours required by the manufacturer by thirty (30) minutes) d. Patient L0064871: collected on January 9, 2020 at 12:26 pm and received on January 9, 2020 at 17:27 pm (exceeding the four (4) hours required by the manufacturer by one (1) hour one (1) minute) e. Patient L0189501: collected on January 10, 2020 at 11:05 am and received on January 10, 2020 at 15:45 pm (exceeding the four (4) hours required by the manufacturer by forty (40) minutes) 4. In interview On February 12, 2020 at 2pm, Personnel 2 confirmed the above patients were not tested within 4 hours as required by the manufacturer. 5. Review of the Task 1 & 3 form provided to surveyors revealed the laboratory performs 3,048 PTT tests annually. IV. Based on observation, record review and interview with personnel, the laboratory failed to ensure patients were analyzed within thirty (30) minutes of collection for Arterial Blood Gas (ABG) for thirteen (13) of three hundred ninety two (392) patients reviewed. Findings: 1. Observation by surveyors during laboratory tour on February 10, 2020 at 1:30 pm revealed the laboratory utilizes the following analyzers for Arterial Blood Gas (ABG) testing: a. Siemens RapidLab 1264 analyzer b. Siemens RapidPoint 405 analyzer 2. Review of the Siemens Rapidlab 1200 and RapidPoint 405 package inserts under "Handling and Storing Samples" revealed "Analyze the sample as soon as possible to minimize oxygen consumption. Plastic syringes should not be iced, but kept at room temperature as long as the blood is analyzed within 30 minutes of collection". 3. Review of patient records for Arterial Blood Gas (ABG) testing from February 2019, July 2019 and December 2019 revealed the laboratory did not perform patient testing within thirty (30) minutes of collection for the following thirteen (13) of three hundred ninety two (392) patients reviewed: a. Patient L0023909: collected on February 12, 2019 at 14:20 pm and analyzed on February 12, 2019 at 16:37 pm (exceeding the thirty (30) minutes required by the manufacturer by one (1) hour forty six (46) minutes) b. Patient L0177449: collected on February 18, 2019 at 03:42 am and analyzed on February 18, 2019 at 04:24 am (exceeding the thirty (30) minutes required by the manufacturer by sixteen (16) minutes) c. Patient L0177449: collected on February 18, 2019 at 09:05 am and analyzed on February 18, 2019 at 10:00 am (exceeding the thirty (30) minutes required by the manufacturer by fifty (50) minutes) d. Patient L0206045: collected on February 25, 2019 at 13:23 pm and analyzed on February 25, 2019 at 14:00 pm (exceeding the thirty (30) minutes required by the manufacturer by ten (10) minutes) e. Patient L0109167: collected on February 27, 2019 at 05:45 am and analyzed on February 27, 2019 at 06:58 am (exceeding the thirty (30) minutes required by the manufacturer by four (4) hours fifty four (54) minutes) f. Patient L0078031: collected on February 27, 2019 at 20:26 pm and analyzed on February 27, 2019 at 21:58 pm (exceeding the thirty (30) minutes required by the manufacturer by one (1) hour three (3) minutes) g. Patient L0121828: collected on July 3, 2019 at 04:00 am and analyzed on July 3, 2019 at 04:41 am (exceeding the thirty (30) minutes required by the manufacturer by eleven (11) minutes) h. Patient L0267691: collected on July 5, 2019 at 01:40 am and analyzed on July 5, 2019 at 02:36 am (exceeding the thirty (30) minutes required by the manufacturer by thirty four (34) minutes) i. Patient L0277469: collected on July 19, 2019 at 05:45 am and analyzed on July 19, 2019 at 06:20 am (exceeding the thirty (30) minutes required by the manufacturer by five (5) minutes) j. Patient L0277469: collected on July 23, 2019 at 09:20 am and analyzed on July 23, 2019 at 10:06 am (exceeding the thirty (30) minutes required by the manufacturer by sixteen (16) minutes) k. Patient L0277469: collected on July 23, 2019 at 18:00 pm and analyzed -- 6 of 25 -- on July 23, 2019 at 18:37 pm (exceeding the thirty (30) minutes required by the manufacturer by seven (7) minutes) l. Patient L0074936: collected on December 1, 2019 at 05:00 am and analyzed on December 1, 2019 at 06:12 am (exceeding the thirty (30) minutes required by the manufacturer by forty two (42) minutes) m. Patient L0067657: collected on December 4, 2019 at 14:30 pm and analyzed on December 4, 2019 at 15:38 pm (exceeding the thirty (30) minutes required by the manufacturer by forty one (41) minutes) 4. In interview on February 12, 2020 at 15:00 pm, Personnel 2 confirmed the identified patients were not analyzed as required by the manufacturer. 5. Review of the Task 1 & 3 provided to surveyors revealed the laboratory performs 4,249 ABG tests annually. V. Based on observation, record review and interview with personnel, the laboratory failed to ensure patients were analyzed within four (4) hours of collection according to the manufacturer for the Biofire Filmarray Respiratory Panel for two (2) of thirty-four (34) patients reviewed. Findings: 1. Observation by surveyors during laboratory tour revealed the laboratory utilized the Biofire Filmarray analyzer for respiratory panel testing. 2. Review of the Biofire Filmarray Respiratory Panel package insert under "Transport and Storage" revealed "Specimens in VTM should be processed and tested as soon as possible. If storage is required, specimens in VTM can be held at room temperature (18-30 degrees Celsius) for up to 4 hours". 3. Review of patient records for the Biofire respiratory panel from June 2, 2019 through June 16, 2019 revealed the laboratory did not perform testing within four (4) hours as required by the manufacturer for the following two (2) of thirty four (34) patients reviewed: a. Patient L0303271: collected on June 5, 2019 at 10:57 am and received on June 6, 2019 at 03:46 am (exceeding the four (4) hours required by manufacturer by eleven (11) hours forty nine (49) minutes) b. Patient L0146074: collected on June 7, 2019 at 14:20 pm and received on June 7, 2019 at 19:57 pm (exceeding the four (4) hours required by manufacturer by one (1) hour thirty seven (37) minutes) 4. In interview on February 12, 2020 at 11am, Personnel 2 confirmed the above samples were not tested within 4 hours. Personnel 2 also stated the laboratory was not aware of the 4 hour stability limitation for the respiratory panel. 5. Review of the Task 1 & 3 form provided to surveyors revealed the laboratory performs 1,321 respiratory panels annually. VI. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Ammonia testing are separated immediately and analyzed within 30 minutes according to the manufacturer for twenty (20) of seventy-seven (77) patients reviewed. Findings: 1. Observation by surveyor on February 11, 2020 at 3:08 pm revealed the laboratory performs Ammonia testing on the Siemens Atellica CH analyzer and the Siemens Dimension Vista chemistry analyzer. 2. In interview on February 11, 2020 at 3:45 pm, Personnel 2 stated Ammonia patient samples are performed on both analyzers. 3. Review of the Siemens Atellica CH and Dimension Vista Lactic Acid package inserts revealed "The tube should be completely filled, stored tightly capped on ice and centrifuged without delay. Samples should be analyzed within 30 minutes of centrifugation". 4. Review of patient records for Ammonia from November 1, 2019 through January 31, 2020 revealed the laboratory did not separate and analyze patient samples within 30 minutes for the following twenty (20) of seventy-seven (77) patients reviewed: a) November 1, 2019: Patient L0255299 was collected at 04:00 am and received at 11:20 am - exceeding the thirty (30) minutes required by the manufacturer by six (6) hours fifty (50) minutes b) November 1, 2019: Patient L0203753 was collected at 06:00 am and received at 13:31 pm - exceeding the thirty (30) minutes required by the manufacturer by seven (7) hours one (1) minute c) November 5, 2019: Patient L0307211 was collected at 05:00 am and received at 09:24 am - exceeding the thirty (30) minutes required by the manufacturer by three (3) hours fifty-four (54) minutes d) November 6, 2019: Patient L0304093 was collected at 08:40 am and received at 11: 43 am - exceeding the thirty (30) minutes required by the manufacturer by two (2) -- 7 of 25 -- hours thirty-three (33) minutes e) November 8, 2019: Patient L0045008 was collected at 05:00 am and received at 08:50 am - exceeding the thirty (30) minutes required by the manufacturer by three (3) hours twenty (20) minutes f) November 27, 2019: Patient L0118459 was collected at unknown time and received at 12:54 pm - exceeding the thirty (30) minutes required by the manufacturer by unable to determine g) December 2, 2019: Patient L0255299 was collected at 02:30 am and received 09:13 am - exceeding the thirty (30) minutes required by the manufacturer by six (6) hours thirteen (13) minutes h) December 3, 2019: Patient L0061524 was collected at 05:55 am and received 09:39 am - exceeding the thirty (30) minutes required by the manufacturer by three (3) hours fourteen (14) minutes i) December 4, 2019: Patient L0308028 was collected at 05:00 am and received 10:00 am - exceeding the thirty (30) minutes required by the manufacturer by four (4) hours thirty (30) minutes j) December 4, 2019: Patient L0304093 was collected at an unknown time and received at 12:19 pm - exceeding the thirty (30) minutes required by the manufacturer by unable to determine k) December 9, 2019: Patient L0165935 was collected at 06:00 am and received at 10:24 am - exceeding the thirty (30) minutes required by the manufacturer by three (3) hours fifty-four (54) minutes l) December 13, 2019: Patient L0264131 was collected at 12:34 pm and received at 13:11 pm - exceeding the thirty (30) minutes required by the manufacturer by seven (7) minutes m) December 21, 2019: Patient L0059761 was collected at 11:30 am and received at 12:08 pm - exceeding the thirty (30) minutes required by the manufacturer by eight (8) minutes n) December 26, 2019: Patient L0244159 was collected at 11:23 am and received at 12: 32 pm - exceeding the thirty (30) minutes required by the manufacturer by thirty-nine (39) minutes o) January 2, 2020: Patient L0043066 was collected at 14:44 pm and received at 17:36 pm - exceeding the thirty (30) minutes required by the manufacturer by two (2) hours twenty-two (22) minutes p) January 6, 2020: Patient L0255299 was collected at 03:00 am and received at 09:06 am - exceeding the thirty (30) minutes required by the manufacturer by five (5) hours thirty-six (36) minutes q) January 7, 2020: Patient L0043637 was collected at 04:18 am and received at 07:02 am - exceeding the thirty (30) minutes required by the manufacturer by two (2) hours fourteen (14) minutes r) January 7, 2020: Patient L0304093 was collected at 05:00 am and received at 08:07 am - exceeding the thirty (30) minutes required by the manufacturer by two (2) hours thirty-seven (37) minutes s) January 14, 2020: Patient L0058207 was collected at 11:10 am and received at 14:33 pm - exceeding the thirty (30) minutes required by the manufacturer by two (2) hours fifty-three (53) minutes t) January 17, 2020: Patient L0210703 was collected at 14:15 pm and received at 15:35 pm - exceeding the thirty (30) minutes required by the manufacturer by fifty (50) minutes u) January 31, 2020: Patient L0309387 was collected at 04:30 am and received at 07:15 am - exceeding the thirty (30) minutes required by the manufacturer by two (2) hours fifteen (15) minutes 5. In interview on February 11, 2020 at 03:45 pm, Personnel 2 confirmed the identified samples noted above were not separated and analyzed as required by the manufacturer. 6. Review of the task 1&3 form provided to surveyor revealed the laboratory performs 300 Ammonia test annually. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: -- 8 of 25 -- Based on record review and interview with personnel, the laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. In interview on February 11, 2020 at 3:08 pm, Personnel 2 stated the laboratory provides services to outside facilities such as Doctor's offices, Nursing Homes, and Home Healths. 2. Review of a random selection of the "Lane RMC Test Dictionary" for outside facilities versus the manufacturer assay instructions revealed the laboratory did not address the following examples (not meant to be an inclusive list): a) Glycohemoglobin (HGB A1C) Laboratory manual: Whole blood specimen; 1 mL volume; Lavender container; special instructions-mix well by inverting several times Siemens Atellica CH: Specimens may be stored for up to 48 hours at room temperature, for up to 7 days at 2-8 degrees celsius, or stored frozen for up to 21 months (with one freeze-thaw) at -70 degrees celsius b) B-Natriuetic Peptide (BNP) Laboratory manual: Plasma specimen; 2 mL volume; Green container-if performed at Lane; Lavender-if performed at Labcorp or Quest Siemens Atellica CH: Collect blood samples in EDTA collection tubes and mix gently; For optimal recovery of BNP values, it is suggested that uncentrifuged whole blood samples be tested within 24 hours; After centrifugation, store separated plasma samples at 2-8 degrees celsius until testing; It is suggested that plasma be tested within 24 hours c) Creatine Kinase (CK) Laboratory manual: Plasma or Serum specimen; 1 mL volume; Green, Gel, or SST separator tube Siemens Atellica CH: Serum or plasma should be physically separated from cells as soon as possible with a maximum limit of 2 hours from the time of collection; specimens should be stored up to 4 hours at 25 degrees celsius or for up to 5 days at 2-8 degrees celsius or stored frozen for up to 2 months at -20 degrees celsius d) Creatinine (CREA) Laboratory manual: Plasma or Serum specimen; 1 mL volume; Green, Gel, or SST separator tube Siemens Atellica CH: Serum or plasma should be physically separated from cells as soon as possible with a maximum limit of 2 hours from the time of collection; Separated serum and plasma specimens may be stored for up to 24 hours at room temperature (18-26 degrees celsius) or for up to 7 days at 2-8 degrees celsius or stored frozen for up to 3 months at -20 degrees celsius or colder. e) Ammonia (AMM) Laboratory manual: Plasma specimen; 2 mL volume; Green container; special instructions-place sample on ice, avoid hemolysis, do not remove top Siemens Atellica CH: Separated specimens may be stored for up to 2 hours at 2-8 degrees celsius. Tube should be completely filled, stored tightly capped on ice and centrifuged without delay. Samples should be analyzed within 30 minutes of centrifugation. f) Lactic Acid (LAC) Laboratory manual: Plasma specimen; 2 mL volume; Gray container; special instructions-transport on ice Siemens Atellica CH: Sodium Fluoride is the preferred anticoagulant; collect blood from a stasis-free vein and store it in an ice bath; Separate the plasma by centrifugation within 30 minutes. A delay in separation can lead to an increase in lactate values. Assay the sample immediately. g) Thyroid Stimulating Hormone (TSH) Laboratory manual: Plasma or Serum specimen; 1 mL volume; Green, Gel or Serum separator tube Siemens Atellica CH: Serum should be physically separated from cells as soon as possible with a maximum limit of 2 hours from the time of collection; Separated specimens are stable for 24 hours at room temperature or 2 days at 2-8 degrees celsius 3. In interview on February 13, 2020 at 9:00 am, Personnel 2 confirmed the laboratory manual for outside facilities did not reflect the manufacturer's 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 -- 9 of 25 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory's system failed to monitor, assess, and correct problems, identified with the preanalytic system. Findings: 1. The laboratory failed to ensure patient samples for Lactic Acid are separated within 15 minutes according to the manufacturer for eighteen (18) of one hundred ninety (190) patients reviewed. Refer to D5311 I. 2. The laboratory failed to ensure patient samples are separated within two (2) hours as required by manufacturer. Refer to D5311 II. 3. The laboratory failed to perform patient samples for Partial Thromboplastin Time (PTT) testing within four (4) hours of collection as required by the manufacturer for five (5) of one hundred eleven (111) patients reviewed. Refer to D5311 III. 4. The laboratory failed to ensure patients were analyzed within thirty (30) minutes of collection for Arterial Blood Gas (ABG) for thirteen (13) of three hundred ninety two (392) patients reviewed. Refer to D5311 IV. 5. The laboratory failed to ensure patients were analyzed within four (4) hours of collection according to the manufacturer for the Biofire Filmarray Respiratory Panel for two (2) of thirty-four (34) patients reviewed. Refer to D5311 V. 6. The laboratory failed to ensure patient samples for Ammonia testing are separated immediately and analyzed within 30 minutes according to the manufacturer for twenty (20) of seventy- seven (77) patients reviewed. Refer to D5311 VI. 7. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to ensure the policy and procedure manual contained complete policies and procedures. Refer to D5403. 2. The laboratory failed to use normal donors as required by manufacturer to verify reference interval and establish normal Prothrombin Time (PT) mean with each new lot of innovin. Refer to D5411. 3. The laboratory failed to have complete performance specification verification studies for the Siemens Atellica Chemistry analyzer. Refer to D5421. 4. The laboratory failed to perform quality control every week (seven days) as required by the Individualized Quality Control Plan (IQCP) for Arterial Blood Gas (ABG) testing. Refer to D5445 I. 5. The laboratory failed to perform monthly Quality Control (QC) as required by the laboratory's Individualized Quality Control Plan (IQCP) for Acteone testing. Refer to D5445 II. 6. The laboratory failed to perform monthly Quality Control as required by the laboratory's Individualized Quality Control Plan (IQCP) for the Biofire Filmarray System. Refer to D5445 III. 7. The laboratory failed to establish its own expected range of responses for Activated Clotting Time (ACT) quality control (QC) material. -- 10 of 25 -- Refer to D5469. 8. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)