Allen Parish Hospital Lab

Summary Statement of Deficiencies D0000 A PT Desk Review was performed for Allen Parish Hospital, CLIA #19D0461975 on October 16, 2022. Allen Parish Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CASPER 155D form and proficiency testing evaluation from American Proficiency Institute, the laboratory failed to successfully perform in proficiency testing as evidenced by: 1. 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 2 -- laboratory failed to achieve a satisfactory score for four (4) of eight (8) Proficiency Testing events resulting in a non-initial unsuccessful participation for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 review of the CASPER 155D report and proficiency testing evaluation from American Proficiency Institute, the laboratory failed to achieve a satisfactory score of 100% for four (4) of eight (8) Proficency Testing events resulting in a non-initial unsuccessful performance for Compatibility Testing. Findings: 1. Review of the CASPER 155D report revealed the laboratory received the following scores of less than 100% for Compatibility Testing for the following four (4) of eight (8) consecutive testing events: a) 2020 event 1 for Compatibilty Testing: score of 80% a) 2020 event 3 for Compatibility Testing: score of 80% b) 2021 event 3 for Compatibility Testing: score of 60% c) 2022 event 2 for Compatibility Testing: score of 60% 2. Proficiency test evaluation were reviewed electronically on October 12, 2022 through American Proficiency Testing Institute's paperless proficiency testing to verify the above scores reported. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER 155D report for proficiency testing, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure proficiency samples are tested as required. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the CASPER155D report for proficiency testing, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve a satisfactory score for four (4) of eight (8) consecutive testing events resulting in a non-intial unsuccessful performance for 2020, 2021 and 2022. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Allen Parish Hospital, CLIA ID # 19D0461975, on May 10, 2021 through May 14, 2021. Allen Parish Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 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 493.1441 CONDITION: Laboratories Performing High Complexity Testing, Laboratory Director 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: I. Based on review of laboratory policy, proficiency testing records and interview with laboratory personnel, the laboratory failed to ensure that proficiency testing documents were signed by Testing Personnel for three (3) of fourteen (14) events reviewed. Findings: 1. Review of the laboratory's policy for Proficiency Testing (PT) revealed " The assigned testing personnel will also be required to sign and date 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 18 -- attestation statement. Attestation Statement will be signed by the Medical Director upon completion". 2. Review of the laboratory's 2019 American Proficiency Institute (API) proficiency testing (PT) records revealed the attestation statement was not signed by the Testing Personnel for the following events: a) 2019 Chemistry Miscellaneous 1st event b) 2019 Chemistry Core 2nd event c) 2019 Microbiology 2nd event 3. In interview on May 11, 2021 at 12:05 pm, Technical Consultant 2 confirmed that Testing Personnel did not sign attestation statements for the identified PT events. II. Based on review of laboratory policy and proficiency testing records as well as interview with laboratory personnel, the laboratory failed to retain attestation statements and raw data for seven (7) of twenty six (26) proficiency testing events reviewed. Findings: 1. Review of the laboratory's policy for Proficiency Testing (PT) revealed "The assigned testing personnel will also be required to sign and date the attestation statement. Attestation Statement will be signed by the Medical Director upon completion. Copies of raw data, LIS data, and quality control data on day of testing MUST be remitted along with the PT paperwork to the Laboratory Manager to keep in the PT files". 2. Review of the laboratory's 2019 and 2020 American Proficiency Institute (API) proficiency testing records revealed the laboratory did not maintain copies of the attestation statements and/or raw data for the following seven (7) of twenty six (26) PT events reviewed: a) 2019 Chemistry Core 1st event: no attestation statement seen b) 2019 Chemistry Core 2nd event: no raw data seen c) 2019 Chemistry Miscellaneous 1st event: no raw data seen d) 2019 Hematology /Coagulation 1st event: no attestation statement or raw data seen e) 2019 Immunology /Immunohematology 1st event: no attestation statement seen f) 2019 Microbiology 1st event: no attestation statement seen g) 2020 Immunology/Immunohematology 3rd event: no attestation statement seen 3. In interview on May 11, 2021 at 12:05 pm, Technical Consultant 2 stated that the Laboratory Manager was informed that the above documents were missing from the PT binder in January of 2021. Technical Consultant 2 confirmed the above documents were not maintained as required. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to successfully perform in -- 2 of 18 -- proficiency testing as evidenced by: 1. The laboratory failed to achieve a satisfactory score for two of three Proficiency Testing events resulting in a non-initial unsuccessful performance in Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 review of proficiency testing records, Casper 155D report, and interview with personnel, the laboratory failed to achieve a satisfactory score for two (2) of three (3) Proficiency Testing events resulting in a non-initial unsuccessful performance in Compatibility Testing. Findings: 1. Review of the laboratory's Proficiency Testing (PT) records and the CMS 0155D report revealed the laboratory received the following scores for Compatibility Testing resulting in failure of two (2) out of three (3) events: a) 2020 Immunohematology Event 1 for Compatibility Testing: score of 80% b) 2020 Immunohematology Event 2 for Compatibility Testing: score of 100% c) 2020 Immunohematology Event 3 for Compatibility Testing: score of 80% 2. In interview on May 11, 2021 at 12:15 pm, Technical Consultant 2 confirmed the above events resulted in an unsuccessful performance. 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 review of quality control records, manufacturer's package inserts along with interview of laboratory personnel, the laboratory failed to retain raw data to support establishment of quality control means and ranges for the current lots of Chemistry quality controls. Findings: 1. Review of the laboratory's quality control (QC) records revealed the laboratory used the following BioRad QC materials for Chemistry testing: a) BioRad Liquid Unassayed Multiqual Level 1, Lot # 56661 Expiration 2/28 /23 b) BioRad Liquid Unassayed Multiqual Level 3, Lot # 56663 Expiration 2/28/23 c) BioRad Liquichek Cardiac Marker Plus Level 1, Lot # 67611 Expiration 10/31/21 d) BioRad Liquichek Cardiac Marker Plus Level 3, Lot # 67613 Expiration 10/31/21 e) BioRad Liquichek Diabetes Level 1, Lot # 55731 Expiration 11/30/22 f) BioRad Liquichek Diabetes Level 3, Lot # 55733 Expiration 11/30/22 g) BioRad Liquichek Ethanol/Ammonia Level 1, Lot # 54341 Expiration 9/30/22 h) BioRad Liquichek Ethanol/Ammonia Level 3, Lot # 54343 Expiration 9/30/22 i) BioRad Liquichek Immunoassay Plus Level 1, Lot # 85241 Expiration 5/31/22 j) BioRad Liquichek Immunoassay Plus Level 3, Lot # 85243 Expiration 5/31/22 k) BioRad Liquichek Specialty Immunoassay Level 1, Lot # 60281 Expiration 6/30/22 l) BioRad Liquichek Specialty Immunoassay Level 3, Lot # 60283 Expiration 6/30/22 2. Review of the BioRad QC package inserts under "Assignment of Values" revealed "It is recommended that each laboratory establish its own acceptable ranges and use those -- 3 of 18 -- provided only as guides". 3. Further review of the laboratory's quality control (QC) records revealed the laboratory used established ranges, not manufacturer ranges; however, the laboratory was unable to provide surveyor with QC data to support the laboratory's means and ranges of acceptability in use. 4. In interview on May 13, 2021 at 1:37 pm, Technical Consultant 2 confirmed the laboratory did not have supporting documentation of mean and range establishments for the above Chemistry QC lots in use. 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 review of the laboratory's personnel records and interview with personnel, the laboratory failed to follow written policy to assess competency for one (1) of four (4) General Supervisors. Findings: 1. Review of the laboratory's policy for competency assessment revealed the laboratory requires an annual competency for the duties and responsibilities of the General Supervisor. 2. Review of personnel records for General Supervisor 4 revealed no annual competency for 2020. 3. In interview on May 11, 2021 at 10:26 am, the Technical Consultant confirmed that documentation of an annual competency was not in the personnel records for General Supervisor 4. 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 review of proficiency testing results and interview with personnel, the laboratory failed to successfully verify the accuracy of Acetaminophen for three (3) of four (4) consecutive proficiency testing events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) results, the laboratory received the following scores in three of four events: a) 2020 Chemistry Core 1st event: score of 60% b) 2020 Chemistry Core 3rd event: score of 0% c) 2021 Chemistry Core 1st event: score of 60% 2. In interview on May 11, 2021 at 12:15 pm, Technical Consultant 2 confirmed the above scores for Proficiency Testing results. 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. -- 4 of 18 -- This CONDITION is not met as evidenced by: Based on observation by surveyor, 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 have a complete policy and procedure manual. Refer to D5401 I. 2. The laboratory failed to perform platelet poor plasma checks every six (6) months as required by laboratory policy. Refer to D5401 II. 3. The laboratory failed to use normal donors to verify reference intervals and establish normal Prothrombin Time mean with each new lot of innovin as required by the manufacturer. Refer to D5411. 4. The laboratory failed to establish their own means and ranges for Siemens Dade Citrol Coagulation Level 1 Quality Control (QC) material utilized for Prothrombin Time (PT) testing. Refer to D5469 I 5. The laboratory failed to establish their own means and ranges for Quality Control (QC) materials utilized for Chemistry testing. Refer to D5469 II. 6. The laboratory failed to take

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Allen Parish Hospital Lab - CLIA # 19D0461975 on August 20, 2018 through August 23, 2018. Allen Parish Hospital Lab was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 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 A PT Desk Review SURVEY was performed on September 06, 2018. Allen Parish Hospital Lab - CLIA # 19D0461975 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 26 -- the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review of CMS Casper Reports 0155D and Proficiency Testing records from American Proficiency Institute (API), the laboratory failed to successfully participate in Proficiency Testing as follows: 1. The laboratory failed to achieve a satisfactory score for two of three Proficiency Testing Events resulting in an initial unsuccessful participation in Unexpected Antibody. Refer to D2172 2. The laboratory failed to achieve a satisfactory for two of three Proficiency Testing Events resulting in an initial unsuccessful participation in Compatibility Testing. Refer to D2181 D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) Failure to achieve an overall testing event score of satisfactory for 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 record review, the laboratory failed to achieve a satisfactory score for two of three Proficiency Testing Events resulting in an initial unsuccessful participation in Unexpected Antibody. Findings: 1. Review of CMS Report 0155D and American Proficiency Institute records revealed the laboratory received the following scores for Unexpected Antibody resulting in failure of two out of three events: a) 2017 Event 3: score of 60% b) 2018 Event 2: score of 60% D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 record review, the laboratory failed to achieve a satisfactory for two of three Proficiency Testing Events resulting in an initial unsuccessful participation in Compatibility Testing. Findings: 1. Review of CMS Report 0155D and American Proficiency Institute records revealed the laboratory received the following scores for Compatibility Testing resulting in failure of two out of three events: a) 2017 Event 3: score of 80% b) 2018 Event 2: score of 80% D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. -- 2 of 26 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with personnel 2 on August 23, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with personnel 2 on August 23, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 system failed to monitor, assess, and correct problems identified with the preanalytic system. Findings: 1. The laboratory failed to ensure that patient samples for Lactic Acid testing were separated within 15 minutes of collection as required by the manufacturer for six (6) of twenty eight (28) patients reviewed. Refer to D5311 I. 2. The laboratory failed to ensure that patient samples for Blood Alcohol (ETOH) testing are collected using a non-alcohol germicidal solution to cleanse the skin as required by the manufacturer for ninety four (94) of ninety four (94) patients reviewed. Refer to D5311 II. 3. The laboratory failed to ensure patient samples for Potassium (K), Phosphorous (Phos), and Glucose (Glu) are spun and separated within one (1) hour -- 3 of 26 -- according to the manufacturer for ensuring the integrity of patient samples for accurate and reliable testing for eight (8) of fifty one (51) patients reviewed. Refer to D5311 III. 4. The laboratory failed to ensure outpatient samples for laboratory testing are received in an ice chest with a cold pack according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for thirteen (13) of thirteen (13) outpatients reviewed. Refer to D5311 IV. 5. The laboratory failed to ensure patient samples for Chemistry are received in the laboratory within thirty (30) minutes according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for twenty eight (28) of one hundred thirty seven (137) patients reviewed. Refer to D5311 V. 6. The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 7. The laboratory's Quality Assurance (QA) system failed to monitor, assess, and correct problems identified with the Pre-analytic 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. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to ensure that patient samples for Lactic Acid testing were separated within 15 minutes of collection as required by the manufacturer for six (6) of twenty eight (28) patients reviewed. Findings: 1. Observation by surveyor during the tour of the laboratory on August 20, 2018 revealed the laboratory maintained a Siemens Dimension EXL with LM Chemistry Analyzer utilized for chemistry testing to include Lactic Acid testing. 2. Review of Siemens Dimension EXL with LM package insert for Lactic Acid revealed under "Specimen Collection and Handling" to centrifuge samples for Lactic Acid within 15 minutes of collection. 3. Review of a random selection of patient test records for Lactic Acid testing from March 7, 2018 through August 15, 2018 revealed the following six (6) patients were not separated within 15 minutes as required by the manufacturer. On April 4, 2018 Patient 56 was collected at 20:05, received in the laboratory at 20:27 - exceeding the 15 minute time frame by seven (7) minutes. On April 29, 2018 Patient 218 was collected at 20:05, received in the laboratory at 20:27 - exceeding the 15 minute time frame by seven (7) minutes. On May 22, 2018 Patient 219 was collected at 12:30, received in the laboratory at 12:47 - exceeding the 15 minute time frame by two (2) minutes. On June 6, 2018 Patient 93 was collected at 09: 31, received in the laboratory at 10:03 - exceeding the 15 minute time frame by seventeen (17) minutes. On June 19, 2018 Patient 220 was collected at 17:50, received in the laboratory at 18:07 - exceeding the 15 minute time frame by two (2) minutes. On July 2, 2018 Patient 221 was collected at 21:14, received in the laboratory at 21:30 - exceeding the 15 minute time frame by one (1) minute. On July 16, 2018 Patient 222 was collected at 11:19, received in the laboratory at 11:44 - exceeding the 15 minute time frame by ten (10) minutes. 4. Interviews with Personnel 2 and 3 on August 22, 2018, 2017 confirmed the six (6) patients were not separated within 15 minutes of -- 4 of 26 -- collection as required by the manufacturer. II. Based on record review and interview with personnel, the laboratory failed to ensure that patient samples for Blood Alcohol (ETOH) testing are collected using a non-alcohol germicidal solution to cleanse the skin as required by the manufacturer for ninety four (94) of ninety four (94) patients reviewed. Findings: 1. Observation by surveyor during the tour of the laboratory on August 20, 2018 revealed the laboratory maintained a Siemens Dimension EXL with LM Chemistry Analyzer utilized for chemistry testing to include ETOH testing. 2. Review of the Siemens Dimension EXL with LM package insert for ETOH revealed under "Specimen Collection and Handling" to : "Use non-alcohol germicidal solution to cleanse the skin." 3. Interview with Personnel 2 and laboratory phlebotomists on August 22, 2018 revealed patients for Blood Alcohol are routinely collected in the Emergency Room and collected routinely with cleaning the skin with an alcohol swab. Both Personnel 2 and the phlebotomists stated they were unaware that patients collected for ETOH are to be cleaned with non-alcohol germicidal. 4. Review of a random selection of patient test records for ETOH testing from May 1, 2018 through July 30, 2018 revealed the following ninety four (94) patients failed to be collected utilizing a non-alcohol germicidal solution as required by the manufacturer. On May 1, 2018: Patients 124 and 125. On May 3, 2018: Patients 126 and 127. On May 4, 2018: Patient 128. On May 6, 2018: Patient 129. On May 7, 2018: Patient 130. On May 8, 2018: Patient 131. On May 10, 2018: Patient 132. On May 13, 2018: Patient 133. On May 17, 2018: Patient 134. On May 21, 2018: Patient 135. On May 24, 2018: Patients 136 and 137. On May 25, 2018: Patients 138 and 139. On May 26, 2018: Patients 140 and 141. On May 28, 2018: Patient 142. On May 29, 2018: Patients 143 and 144. On May 30, 2018: Patient 145. On June 1, 2018: Patient 146. On June 3, 2018: Patient 147. On June 4, 2018: Patients 148 and 149. On June 5, 2018: Patient 150. On June 6, 2018 Patients 151 and 152. On June 7, 2018: Patient 153. On June 9, 2018: Patient 154. On June 10, 2018: Patients 155 and 156. On June 11, 2018: Patient 157. On June 13, 2018: Patients 158 and 159. On June 15, 2018: Patient 160. On June 16, 2018: Patient 161. On June 17, 2018: Patients 162, 163 and 164. On June 18, 2018: Patient 165. On June 19, 2018: Patient 166. On June 22, 2018: Patients 167 and 168. On June 23, 2018: Patient 169. On June 24, 2018: Patient 170. On June 25, 2018: Patients 171 and 172. On June 26, 2018: Patient 173. On June 29, 2018: Patients 174 and 175. On June 30, 2018: Patients 176 and 177. On July 2, 2018: Patients 178 and 179. On July 3, 2018: Patients 180 and 181. On July 4, 2018: Patients 182, 183, 184 and 185. On July 5, 2018: Patients 186 and 187. On July 6, 2018: Patient 188 and 189. On July 9, 2018: Patients 190, 191 and 192. On July 10, 2018: Patients 193, 194, 195 and 196. ON July 12, 2018: Patient 197. On July 14, 2018: Patient 200. On July 16, 2018: Patient 201. On July 18, 2018: Patients 202 and 203. On July 19, 2018: Patients 198 and 204. On July 21, 2018: Patient 199. On July 22, 2018: Patients 205, 206, 207 and 208. On July 23, 2018: Patients 209, 210 and 211. On July 24, 2018: Patients 212 and 213. On July 28, 2018: Patient 214. On July 29, 2018: Patient 215. On July 30, 2018: Patients 216 and 217. 5. Interviews with Personnel 2 and phlebotomists on August 22, 2018 confirmed the laboratory failed to utilize a non-alcohol germicidal solution to cleanse the skin as required by the manufacturer for the ninety four (94) patients cited above. III. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Potassium (K), Phosphorous (Phos), and Glucose (Glu) are spun and separated within one (1) hour according to the manufacturer for ensuring the integrity of patient samples for accurate and reliable testing for eight (8) of fifty one (51) patients reviewed. Findings: 1. Observation by surveyor on August 20, 2018 revealed the laboratory maintained a Siemens Dimension EXL with LM Chemistry Analyzer for : Acetaminophen (Acet), Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Ammonia (Ammon), Amylase (Amy), Total -- 5 of 26 -- Bilirubin (TBil), Direct Bilirubin (DBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Creatine Kinase MB (CKMB), Ethyl Alcohol (ETOH), Hemoglobin A1C) (HgbA1C), Triglyceride (Trig), Troponin (Trop), Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Lactic Acid (Lactic), Lipase (Lip), Magnesium (Mg), Phosphorous (Phos), Prostate Specific Antigen (PSA), Pro- Brain Natriuretic Peptide (Pro-BNP), Folate (Fol), Vitamin B12 (B12), Carbamazepine (CRBM), Vitamin D (VitD), Digoxin (Dig), Phenytoin (Dil), Lithium (Li), Salicylate (Sali), Valproic Acid (Valp), Vancomycin (Vanco) and Uric Acid (Uric). Further observation by the surveyor on August 20, 2018 noted the laboratory receiving patient samples for laboratory testing from out side facilities. 2. Review of the Siemens Dimension package inserts revealed for: a) For Potassium (K) the package insert states under "Specimen Collection and Handling" that "Specimen tubes should be centrifuged unopened and the serum or plasma should be separated within one hour after venipuncture, as prolonged contact with red cells will cause elevated K results." b) For Glucose (Glu) the package insert states under "Specimen Collection and Handling" that "Glycolysis decreased serum glucose by approximately 5% to 7% per hour in normal uncentrifuged coagulated blood at room temperature. In separated, nonhemolyzed sterile serum, the glucose concentration is generally stable for as long as 8 hours at 25 degrees Celsius and up to 72 hours at 4 degrees Celsius; variability stability is observed with longer storage conditions. Glycolysis can be inhibited and glucose stabilized for as long as 3 days at room temperature by addition of sodium iodoacetate or sodium fluoride (NaF) to the specimen." c) For Phosphorous (Phos) the package insert states under "Specimen Collection and Handling" that the "Serum or plasma should be separated from the red cells within 1 hour because erythrocytes contain phosphate concentrations several times greater than those found in the serum." 3. Review of a random selection of Patient Test Records from March 5, 2018 through August 3, 2018 revealed the laboratory failed to reject the following eight (8) patients for not meeting manufacturer's requirements for K, Phos, and Glu to be spun and have the serum or plasma separated from the cells within 1 hour: Note: Complete Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Renal Panel (Renal) includes: NA, K, CL, CO2, Glu, BUN, Creat, Alb, Phos, and CA. On March 5, 2018 Patient 225 was collected for a BMP at 13:00 and not received into the laboratory to be spun and separated until 14:04 exceeding the 1 hour time frame to be centrifuged by 4 minutes. On March 8, 2018 Patient 226 was collected for a Phos at 5:16 and not received into the laboratory to be spun and separated until 6:29 exceeding the 1 hour time frame to be centrifuged by 13 minutes. On April 6, 2018 Patient 232 was collected for a Phos at 12:15 and not received into the laboratory to be spun and separated until 13:56 exceeding the 1 hour time frame to be centrifuged by 31 minutes. On April 30, 2018 Patient 233 was collected for a Phos at 11:18 and not received into the laboratory to be spun and separated until 12:37 exceeding the 1 hour time frame to be centrifuged by 19 minutes. On May 1, 2018 Patient 234 was collected for a Renal at 10:30 and not received into the laboratory to be spun and separated until 11:52 exceeding the 1 hour time frame to be centrifuged by 22 minutes. On May 14, 2018 Patient 237 was collected for a CMP at 8:55 and not received in the laboratory to be spun and separated until 10:04 exceeding the 1 hour time frame to be centrifuged by 9 minutes. On July 27, 2018 Patient 239 was collected for a BMP at 8:05 and not received in the -- 6 of 26 -- laboratory to be spun and separated until 9:50 exceeding the 1 hour time frame to be centrifuged by 45 minutes. On August 3, 2018 Patient 240 was collected for a CMP at 15:05 and not received in the laboratory to be spun and separated until 16:12 exceeding the 1 hour time frame to be centrifuged by 7 minutes. 4. Interviews with Personnel 2 and 3 on August 22, 2018 revealed they were unaware of the one hour timeframe for K, Phos, and Glu. Personnel 2 and 3 confirmed the patients cited above exceeded the 1 hour time frame set by the manufacturer. IV. Based on observation, record review and interview with personnel, the laboratory failed to ensure outpatient samples for laboratory testing are received in an ice chest with a cold pack according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for thirteen (13) of thirteen (13) outpatients reviewed. Findings: 1. Observation by surveyor on August 20, 2018 revealed the laboratory maintained a Siemens Dimension EXL with LM Chemistry Analyzer for : Acetaminophen (Acet), Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Ammonia (Ammon), Amylase (Amy), Total Bilirubin (TBil), Direct Bilirubin (DBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Creatine Kinase MB (CKMB), Ethyl Alcohol (ETOH), Hemoglobin A1C) (HgbA1C), Triglyceride (Trig), Troponin (Trop), Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Lactic Acid (Lactic), Lipase (Lip), Magnesium (Mg), Phosphorous (Phos), Prostate Specific Antigen (PSA), Pro- Brain Natriuretic Peptide (Pro-BNP), Folate (Fol), Vitamin B12 (B12), Carbamazepine (CRBM), Vitamin D (VitD), Digoxin (Dig), Phenytoin (Dil), Lithium (Li), Salicylate (Sali), Valproic Acid (Valp), Vancomycin (Vanco) and Uric Acid (Uric). Further observation by the surveyor on August 20, 2018 noted the laboratory receiving patient samples for laboratory testing from out side facilities. 2. Review of the Laboratory's Policy and Procedure Manual under "Transfer of Specimens From Other Collection Site To Laboratory" revealed: a) Collect and label all specimens with patient's name, date, time collected and initials according to standard procedures as established in policy manual. b) Place all specimens with request form attached in zip lock bag. c) Place zip lock bag into ice chest into which a cold pack of ice has been placed. (DO NOT PLACE BLUE TOP TUBES IN ICE CHEST). d) Transport to laboratory as soon as possible after obtaining specimen to permit test processing. e) Treat all specimens as if they are capable of transmitting infectious disease. 3. Interview with Personnel 2 and the phlebotomist on August 22, 2018 revealed all samples from outside the facility are received in a ziplock bag containing the patient sample and requisition. Personnel 3 and the phlebotomists all stated that samples are not received in an ice chest with an ice pack - that all samples are received just in the zip lock bag. Personnel 2 and the phlebotomists stated they were unaware of the laboratory policy requiring outpatient samples to arrive in a ice chest with and ice pack. 4. Review of a random selection of Patient Test Records from March 5, 2018 through August 3, 2018 revealed the laboratory failed to reject the following thirteen (13) patients for not meeting manufacturer's requirements for K, Phos, and Glu to be spun and have the serum or plasma separated from the cells within 1 hour: Note: Complete Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Renal Panel (Renal) includes: NA, K, CL, CO2, Glu, BUN, Creat, Alb, Phos, and CA. On March 5, 2018 Patient 225 was collected for a BMP at 13:00 and received into the laboratory at 14:04 without being -- 7 of 26 -- in an ice chest with a ice pack. On March 8, 2018 Patient 226 was collected for a Phos at 5:16 and not received into the laboratory at 6:29 without being in an ice chest with a ice pack. On March 12, 2018 Patient 227 was collected for a BMP at 11:30 and received into the laboratory at 12:15 without being in an ice chest with a ice pack. On March 20, 2018 Patient 228 was collected for a Renal at 4:55 and received into the laboratory at 12:15 without being in an ice chest with a ice pack. On April 6, 2018 Patient 232 was collected for a Phos at 12:15 and received into the laboratory at 13:56 without being in an ice chest with a ice pack. On April 30, 2018 Patient 233 was collected for a Phos at 11:18 and received into the laboratory at 12:37 without being in an ice chest with a ice pack. On May 1, 2018 Patient 234 was collected for a Renal at 10:30 and received into the laboratory at 11:52 without being in an ice chest with a ice pack. On May 3, 2018 Patient 235 was collected for a BMP at 10:40 and received into the laboratory at 11:16 without being in an ice chest with a ice pack. On May 10, 2018 Patient 236 was collected for a BMP at 15:40 and received into the laboratory at 16:08 without being in an ice chest with a ice pack. On May 14, 2018 Patient 237 was collected for a CMP at 8:55 and received into the laboratory at 10:04 without being in an ice chest with a ice pack. On June 27, 2018 Patient 238 was collected for a CMP at 9:10 and received into the laboratory at 9:50 without being in an ice chest with a ice pack. On July 27, 2018 Patient 239 was collected for a BMP at 8:05 and received into the laboratory at 9:05 without being in an ice chest with a ice pack. On August 3, 2018 Patient 234 was collected for a CMP at 15:05 and received into the laboratory at 16:12 without being in an ice chest with a ice pack. 4. Interviews with Personnel 2 and phlebotomists on August 22, 2018 confirmed they were unaware of the laboratory policy for transporting outpatient samples in an ice chest with a ice pack. Personnel 2 and phlebotomists confirmed the patients cited above were not received in an ice chest with a ice pack. V. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Chemistry are received in the laboratory within thirty (30) minutes according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for twenty eight (28) of one hundred thirty seven (137) patients reviewed. Findings: 1. Observation by surveyor on August 20, 2018 revealed the laboratory maintained a Siemens Dimension EXL with LM Chemistry Analyzer for : Acetaminophen (Acet), Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Ammonia (Ammon), Amylase (Amy), Total Bilirubin (TBil), Direct Bilirubin (DBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatine Kinase (CK), Creatine Kinase MB (CKMB), Ethyl Alcohol (ETOH), Hemoglobin A1C (HgbA1C), Triglyceride (Trig), Troponin (Trop), Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Lactic Acid (Lactic), Lipase (Lip), Magnesium (Mg), Phosphorous (Phos), Prostate Specific Antigen (PSA), Pro- Brain Natriuretic Peptide (Pro-BNP), Folate (Fol), Vitamin B12 (B12), Carbamazepine (CRBM), Vitamin D (VitD), Digoxin (Dig), Phenytoin (Dil), Lithium (Li), Salicylate (Sali), Valproic Acid (Valp), Vancomycin (Vanco) and Uric Acid (Uric). Further observation by the surveyor on August 20, 2018 noted the laboratory receiving patient samples for laboratory testing from out side facilities. 2. Review of the Laboratory's Policy and Procedure Manual under "Specimen Delivery and Allowable Delivery Time" revealed the following "Allowable Delivery Times" for Chemistry: Body Fluids received immediately. Electrolytes received in 30 minutes. Enzymes received within 60 minutes. General Chemistry received within 30 minutes. 3. Review of a random selection of Patient Test Records from March 5, 2018 through August 3, 2018 revealed the laboratory failed to reject the following twenty eight (28) patients for not meeting the laboratory's requirements for General Chemistry to be -- 8 of 26 -- received in the laboratory within 30 minutes: Note: Complete Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Renal Panel (Renal) includes: NA, K, CL, CO2, Glu, BUN, Creat, Alb, Phos, and CA. Hepatic Panel (Hepatic) includes: Alb, TP, TBil, DBil, ALP, ALT, and AST. On October 13, 2017 Patient 6 was collected for a Hepatic at 12:15 and not received into the laboratory until 12:53 exceeding the 30 minute time frame by 8 minutes. On October 16, 2017 Patient 10 was collected for a Mg at 4:40 and not received into the laboratory until 7:18 exceeding the 30 minute time frame by 138 minutes. On December 24, 2017 Patient 15 was collected for a TSH at 6:05 and not received into the laboratory until 6:42 exceeding the 30 minute time frame by 7 minutes. On December 28, 2017 Patient 23 was collected for a Uric at 4:30 and not received into the laboratory until 6:03 exceeding the 30 minute time frame by 33 minutes. On March 5, 2018 Patient 225 was collected for a BMP at 13:00 and not received into the laboratory until 14:04 exceeding the 1 hour time frame to be centrifuged by 4 minutes. On March 8, 2018 Patient 226 was collected for a Phos at 5:16 and not received into the laboratory until 6:29 exceeding the 1 hour time frame to be centrifuged by 13 minutes. On March 20, 2018 Patient 28 was collected for a Phos and Mg at 8:51 and not received into the laboratory until 9:27 exceeding the 30 minute time frame by 6 minutes. On March 29, 2018 Patient 33 was collected for a Valp at 4:38 and not received into the laboratory until 5:37 exceeding the 30 minute time frame by 29 minutes. On March 30, 2018 Patient 40 was collected for a Lipid at 6:00 and not received into the laboratory until 6:34 exceeding the 30 minute time frame by 4 minutes. On April 1, 2018 Patient 43 was collected for a Lipid at 00:01 and not received into the laboratory until 6:41 exceeding the 30 minute time frame by 370 minutes. On April 1, 2018 Patient 45 was collected for a ETOH at 16:42 and not received into the laboratory until 19:35 exceeding the 30 minute time frame by 82 minutes. On April 1, 2018 Patient 48 was collected for a HgbA1C at 6:10 and not received into the laboratory until 6:42 exceeding the 30 minute time frame by 2 minutes. On April 3, 2018 Patient 55 was collected for a Lipid at 5:23 and not received into the laboratory until 6:03 exceeding the 30 minute time frame by 10 minutes. On April 6, 2018 Patient 59 was collected for a Phos at 12:15 and not received into the laboratory until 13:56 exceeding the 30 minute time frame by 71 minutes. On April 6, 2018 Patient 232 was collected for a Phos at 12:15 and not received into the laboratory until 13:56 exceeding the 1 hour time frame to be centrifuged by 31 minutes. On April 30, 2018 Patient 233 was collected for a Phos at 11:18 and not received into the laboratory until 12:37 exceeding the 1 hour time frame to be centrifuged by 19 minutes. On May 1, 2018 Patient 234 was collected for a Renal at 10:30 and not received into the laboratory until 11:52 exceeding the 1 hour time frame to be centrifuged by 22 minutes. On May 14, 2018 Patient 71 was collected for a Pro BNP at 8:40 and not received into the laboratory until 9:17 exceeding the 30 minute time frame by 7 minutes. On May 14, 2018 Patient 237 was collected for a CMP at 8:55 and not received in the laboratory until 10:04 exceeding the 1 hour time frame to be centrifuged by 9 minutes. On June 4, 2018 Patient 77 was collected for a Mg at 9:15 and not received into the laboratory until 9:48 exceeding the 30 minute time frame by 3 minutes. On June 5, 2018 Patient 80 was collected for a TSH at 5:00 and not received into the laboratory until 5:41 exceeding the 30 minute time frame by 11 minutes. On June 5, 2018 Patient 85 was collected for a FT4 at 6:40 and not received into the laboratory until 9:00 exceeding the 30 minute time frame by 110 minutes. On June 16, 2018 Patient 93 was collected for a Lactic at 9:31 and not -- 9 of 26 -- received into the laboratory until 10:03 exceeding the 30 minute time frame by 2 minutes. On June 4, 2018 Patient 95 was collected for a HgbA1C at 14:35 and not received into the laboratory until June 5, 2018 at 8:53 exceeding the 30 minute time frame by 1068 minutes. On June 30, 2018 Patient 110 was collected for a B12 and Folate at 6:05 and not received into the laboratory until 7:45 exceeding the 30 minute time frame by 70 minutes. On July 27, 2018 Patient 239 was collected for a BMP at 8: 05 and not received in the laboratory until 9:50 exceeding the 1 hour time frame to be centrifuged by 45 minutes. On August 3, 2018 Patient 21 was collected for a Uric at 9: 24 and not received into the laboratory until 10:04 exceeding the 30 minute time frame by 10 minutes. On August 3, 2018 Patient 240 was collected for a CMP at 15: 05 and not received in the laboratory until 16:12 exceeding the 1 hour time frame to be centrifuged by 7 minutes. 4. Interviews with Personnel 2 and 3 on August 22, 2018 revealed they were unaware of the 30 minute timeframe for General Chemistry found in the Laboratory Policy and Procedure Manual. Personnel 2 and 3 confirmed the patients cited above exceeded the 30 minute time frame set by the laboratory for receiving patient samples for General Chemistry. 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: Based on record review and interview with personnel, the laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the Laboratory's Policy and Procedure Manual failed to include a Manual for facilities that utilize the laboratory for Syphilis Serology, Routine Chemistry, Urinalysis, Endocrinology, Toxicology, Hematology/Coagulation, ABO and Rh , Antibody Screen and Crossmatch testing with detailed instructions for: (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. Further review of the Laboratory's Policy and Procedure Manual ( not made available to outside facilities) states that samples received from outside facilities are to be received: a) In a Zip Lock bag with the sample and requisition and in an ice chest with a cool pack. b) Allowable Delivery times: Chemistry: Body Fluids received immediately. Electrolytes received in 30 minutes. Enzymes received within 60 minutes. General Chemistry received within 30 minutes. Coagulation Section: Prothrombin Time received within 120 minutes. Partial Thromboplastin Time (PTT) received within 120 minutes. Hematology Section: CBC received within 60 minutes. Sedimentation Rate received within 30 minutes. Miscellaneous: Cell Count - Body Fluids received immediately. Urinalysis: Routine Urinalysis may be refrigerated up to 120 minutes. 2. Interview with personnel 2 on August 21, 2018 revealed all laboratory samples accepted from outside facilities are received in a biohazard bag with the sample and requisition. Personnel 2 revealed she was unaware of the laboratory policy for allowable delivery times for patient samples. Personnel 2 also revealed she was unaware of the manufacturer requirements for each test and was unaware of the manufacturer requirements for each test. -- 10 of 26 -- D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to establish written quality assessment policies and procedures for monitoring, identifying and correcting problems identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to establish written quality assessment policies and procedure for monitoring, identifying and correcting problems identified with preanalytic systems. 2. Problems identified in the Preanalytic System found during the survey that failed to be addressed by the laboratory: a) The laboratory failed to ensure that patient samples for Lactic Acid testing were separated within 15 minutes of collection as required by the manufacturer for six (6) of twenty eight (28) patients reviewed. Refer to D5311 I. b) The laboratory failed to ensure that patient samples for Blood Alcohol (ETOH) testing are collected using a non-alcohol germicidal solution to cleanse the skin as required by the manufacturer for ninety four (94) of ninety four (94) patients reviewed. Refer to D5311 II. c) The laboratory failed to ensure patient samples for Potassium (K), Phosphorous (Phos), and Glucose (Glu) are spun and separated within one (1) hour according to the manufacturer for ensuring the integrity of patient samples for accurate and reliable testing for eight (8) of fifty one (51) patients reviewed. Refer to D5311 III. d) The laboratory failed to ensure outpatient samples for laboratory testing are received in an ice chest with a cold pack according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for thirteen (13) of thirteen (13) outpatients reviewed. Refer to D5311 IV. e) The laboratory failed to ensure patient samples for Chemistry are received in the laboratory within thirty (30) minutes according to laboratory policy for ensuring the integrity of patient samples for accurate and reliable testing for twenty eight (28) of one hundred thirty seven (137) patients reviewed. Refer to D5311 V. f) The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 3. Interview with personnel 2 and 3 on August 23, 2018 confirmed the above findings. 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 observatio, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The -- 11 of 26 -- laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5401. 2. The laboratory failed to ensure that the correct ISI value was being utilized in the calculation for the International Normalized Ratio (INR) as required by the manufacturer for ninety seven (97) of ninety seven (97) patients reviewed. Refer to D5411. 3. The laboratory failed to verify the Laboratory Information System (LIS) for accuracy. Refer to D5421. 4. The laboratory failed to perform weekly maintenance for the Siemens Dimension EXL with LM Chemistry Analyzer for three (3) of thirty two (32) weeks reviewed. Refer to D5429. 5. The laboratory failed to perform and document two (2) levels of controls each day of patient testing for Blood Alcohol (ETOH) for two (2) of eight (8) patients reviewed. Refer to D5447. 6. The laboratory failed to complete Crossmatch (xmatch) testing for all emergency release units for one (1) of two (2) patients reviewed. Refer to D5551. 7. The laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. Refer to D5791. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies and procedures for: A. Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) What steps to take if