Five Rivers Medical Center

Summary Statement of Deficiencies 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: Review of personnel records, lack of documentation and interview with laboratory staff members determined that annual (and/or twice annually during the first year of employment) competency determinations were not performed for two of five personnel listed on the CMS 209 form which were reviewed. Findings follow: A) Review of personnel records revealed that no competency evaluations were presented for the laboratory staff member (# 3 on the CMS 209 form) who began employment in the laboratory on December 2022, no competency evaluations were presented for the laboratory staff member (# 5 on the CMS 209 form) who began employment in August 2022. B) Upon request the laboratory was unable to produce records of comptency assessment performed in 2023 on the staff members identified above. C) In an interview on 4/24/24 at 2:40 p.m. the laboratory staff member (# 1 on the CMS 209 form) stated that competency evaluations for the personnel identified above were not available. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Observation, review of temperature records, lack of documentation and interview demonstrated that the laboratory failed to monitor the temperature on each day of operation in one of five rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 4/24 /24 at 01:40 p.m.., the surveyor observed five separate rooms (Main laboratory, Covid Room, Microbiology, Respiratory Therapy, and supply storeroom) containing laboratory items with a temperature storage requirement. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the Covid Room. C) During a tour of the laboratory on 4/26/24 at 10:40 a.m. the surveyor observed 12 boxes of Gene X Pert Xpress Cov-2/RSV/Flu Plus reagents with a storage temperature requirement of 2 degrees Centigrade (C.) to 28 degrees C. in the Covid Room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored. E) In an interview on 4/26/24 at 10:40 a.m., the laboratory staff member (# 1 on form CMS 209) confirmed that temperature records for the Covid Room were not kept. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Observations made during a tour of the laboratory, demonstrated the laboratory had supplies available for use when they had exceeded their expiration date. Survey findings follow: A) During a tour of the laboratory at 11:00 a.m.on 4/26/24 the surveyor observed, two sodium citrate "blue top" blood collection tubes lot number 3111761 with expiration date of 2024-1-31, and one sodium citrate "blue top" blood collection tube lot number 3136119 with expiration date of 2024-2-29 available for use in a phlebotomy blood collection tray when they had exceeded their expiration date. B) In an interview on 4/26/24 at 11:05 a.m., the laboratory staff member (# 1 on the CMS 209 form) confirmed that the items identified above had exceeded the expiration date and were available for use. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the -- 2 of 4 -- laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of the policy titled, "Quality Control Program", a review of the BioRad Liquichek Cardiac Markers Plus Control manufacturer's requirements, and a review of the Roche Diagnostics Cobas e 411 quality control (QC) documentation, as well as interviews with laboratory staff, determined the laboratory failed to use correct statistical parameters to calculate criteria for acceptability of QC for one of two tests reviewed in which BioRad Liquichek Cardiac Markers Plus Control was the quality control material. Survey findings include: A) The "Quality Control Program" policy states, "Acceptable ranges will be established for these controls for all procedures. Control results will be evaluated as follows: Accept the results obtained if both control reads between +/- 2 SD (standard deviation) from the mean. Reject the run and troubleshoot the method involved if one or both controls are greater than +/- 2 SD from the mean or if procedural or electronic controls "fail". B) BioRad quality control instructions for use (as stated on their quality control website QCnet My e-Inserts) state, "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides." C) Through a review of Roche Diagnostics Cobas e 411 quality control (QC) documentation, it was determined the laboratory entered an incorrect range for the acceptable range for Troponin (TR) assays due to a decimal point placement error resulting in the acceptable range reading ten times greater than the correct range and an effective SD used being +/- 20 SD instead of +/- 2SD. The SD used to define the acceptable range for level one TR (lot # 00067691) controls was 0.101 instead of the correct value of 0.0101. This error was reflected in all TR level assays from February through November 2023. D) In an interview, at 8:30 a.m. on 4 /26/24, employee #1 (as listed on the form CMS-209) confirmed the laboratory policy states the laboratory will use a +/- 2 SD range for quality control and further confirmed the laboratory used the incorrect SD to establish acceptable range for TR assays from February through November 2023. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of the laboratory's policy and procedure for "Testing Refrigerator Alarms", the continuous monitoring charts for the blood bank refrigerator and plasma storage freezer, records of the blood bank refrigerator and plasma storage freezer alarm checks, lack of documentation and interview demonstrated that the laboratory failed to perform periodic alarm checks for the blood bank blood storage refrigerator and plasma storage freezer for the calendar year 2023 Findings follow: A) Review of the laboratory's policy and procedure for "Testing Refrigerator Alarms" revealed "the -- 3 of 4 -- alarm on each blood-storage refrigerator should be checked periodically to ensure it functions properly, quarterly alarm checks are appropriate". B) Review of the laboratory documentation for blood bank refrigerator alarm check revealed that no alarm check was documented in 2023 and review of the plasma storage freezer documentation for alarm checks revealed that one alarm check was documented in March 2023. C) Review of the continuous temperature monitoring charts for 2023 revealed that no documentation of alarm checks was present for the blood storage refrigerator or the plasma storage freezer . D) Upon request, the laboratory was unable to provide documentation of blood bank refrigerator or plasma freezer alarm checks performed other than the single instance in March 2023 E) In an interview on April 26 2024 at 10:40 a.m., the laboratory staff member ( # 1 on the CMS 209 form,)stated that the laboratory had only performed one alarm check on the plasma freezer and no alarm checks on the blood storage refrigerator in 2023. . D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Review of personnel files for five testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize one of five testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for five testing personnel listed on form CMS-209 (Personnel #'s 2, 3, 5, 8, and 9) the surveyor determined employee number 3 (as listed on the form CMS-209), with a date of hire of 12/8/22, failed to have written authorization, from the laboratory director, to perform moderate complexity testing without direct supervision. B) In an interview, at 2:40 p.m.. on 4/24/24, laboratory employee #1 (as listed on the form CMS-209) confirmed the lack of written authorizations to test for employee # 3 (on form CMS 209). -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the 2023 CMS Casper Reports 096D, 0153D, and the College of American Pathologists (CAP) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for the analyte Tobramycin. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2119. D2118 TOXICOLOGY CFR(s): 493.845(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2023 CMS Casper Reports 0155D and 0153D, and CAP proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte tobramycin. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte tobramycin in the first proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte tobramycin in the second proficiency testing event of 2023. D2119 TOXICOLOGY CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance 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 2023 CMS Casper Reports 0155D and 0153D, and CAP proficiency testing results, it was determined the laboratory failed to have overall satisfactory participation in proficiency testing for the subspecialty of toxicology. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 75% for the subspecialty of toxicology in the first proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 75% for the subspecialty of toxicology in the second proficiency testing event of 2023. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of 2023 proficiency testing events, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory -- 2 of 3 -- director must-- (e)(4)(i) Ensure that 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 2023 proficiency testing events, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Toxicology test of tobramycin and the subspecialy of toxicology. Refer to D2118 and D2119. -- 3 of 3 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the policy titled, "Quality Control Program", a review of the BioRad Liquichek Cardiac Markers Plus Control manufacturer's requirements, and a review of the Roche Diagnostics Cobas e 411 quality control (QC) documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to use statistical parameters to calculate criteria for acceptability of QC for one of two tests reviewed in which BioRad Liquichek Cardiac Markers Plus Control was the quality control material. Survey findings include: A. The "Quality Control Program" policy states, "Acceptable ranges will be established for these controls for all procedures. Control results will be evaluated as follows: Accept the results obtained if both control reads between +/- 2 SD (standard deviation) from the mean. Reject the run and troubleshoot the method involved if one or both controls are greater than +/- 2 SD from the mean or if procedural or electronic controls "fail". B. BioRad quality control instructions for use (as stated on their quality control website QCnet My e-Inserts) 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 -- state, "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides." C. Through a review of Roche Diagnostics Cobas e 411 quality control (QC) documentation, it was determined the laboratory used the package insert range as the acceptable range for N- Terminal Pro-Brain Natriuretic Peptide (NT-ProBNP). The manufacturer's package insert for BioRad Liquichek Cardiac Markers Plus Control LT states the NT-ProBNP quality control range for Level 1 (lot 67671) was 61.8 to 134 pg/ml. Quality control range listed for Level 3 (lot 67673) was 1911 to 4300. The ranges listed in use by the laboratory, for Level 1 and Level 3, on the Roche Diagnostics Cobas e 411 quality control (QC) documentation were the same ranges as on the package inserts. D. In an interview, at 9:53 on 7/7/2022, employee #2 (as listed on the form CMS-209) confirmed the laboratory policy states the laboratory will use a +/- 2 SD range for quality control and further confirmed the laboratory used the package insert ranges instead of calculating a +/- 2 SD range for NT-ProBNP. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of five randomly selected personnel files for testing personnel in the blood gas laboratory, a review of the Cardiopulmonary Policy and Procedure Manual, lack of documentation, and interviews with blood gas laboratory personnel, it was determined the laboratory director failed to give four of five personnel reviewed, written authorization to perform blood gas testing. Survey findings include: A. Through a review of five randomly selected personnel files out of eleven blood gas lab testing personnel, it was determined that four of the five personnel files (personnel #13, #17, #19, and #20 as listed on the CMS-209) lacked documentation that the testing person was authorized to perform arterial blood gas testing. B. The Cardiopulmonary Policy and Procedure Manual included a policy titled, "Arterial Blood Gas Puncture Authorization". The policy included the name of personnel #13 but did not include the signature of the laboratory director. The policy did not include a date revised to indicate that it was revised prior to the last laboratory director signature of the policy and procedure manual. C. In an interview, at 10:00 on 7/8 /2022, the blood gas laboratory supervisor (listed as laboratory employee #10 on the CMS-209) confirmed that the only authorizations for personnel there were no written authorizations for personnel #17, #19, and #20 and that the authorization for employee #13 was not signed by the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of 2018 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for the analyte of Blood Urea Nitrogen (BUN) as evidence by: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2087. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: . Based on review of 2018 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) testing results, it was determined the laboratory had a subsequent unsuccessful performance for the analyte Blood Urea Nitrogen (BUN). Failure to achieve satisfactory performance for the analyte BUN in three consecutive testing events, as cited at D2087. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of 2018 CMS Casper Reports 153d and 155D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory had a subsequent unsuccessful performance for the analyte of Blood Urea Nitrogen (BUN) as evidenced by: A. The laboratory received a score of 0% for the analyte BUN in the first proficiency testing event of 2018. B. The laboratory received a score of 60% for the analyte BUN in the second proficiency testing event of 2018. C. The laboratory received a score of 0% for the analyte BUN in the third proficiency testing event of 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of 2018 Proficiency Reports, it was determined the laboratory director failed to ensure that

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of 2018 CMS Casper Reports 0155D, 0153D, and the College of American Pathologist proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte of Blood Urea Nitrogen (BUN). As evidenced by: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of 2018 CMS Casper Reports 0155D and 0153D and CAP proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte of TBlood Urea Nitrogen (BUN). As evidenced by: A. The laboratory received a sore of 0% in first proficiency testing event of 2018 for the analyte BUN. B. The laboratory received a score of 60% in the second proficiency testing event of 2018 for the analyte BUN. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2018 proficiency testing results, it was determined the Laboratory Director failed to ensure that

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through a review of the policies and procedures for Arterial Blood Gas testing and through interviews with staff, it was determined the blood gas procedures had not been approved, signed, and dated by the current laboratory director. Findings include: A. A review of written policies and procedures revealed the laboratory director did not sign procedure manual for Cardiopulmonary or the individual procedures for Critical Values in Blood Gases, the Arterial Blood Gas Analysis Procedure, or the Policy for Daily Review of Blood Gas and Quality Control Reports. B. In an interview at 1:20 on 2/21/2018, laboratory employee #9 confirmed the laboratory director had not signed the blood gas policies and procedures. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of Emergency Requests for Uncrossmatched Blood for 2017, and interview it was determined that the request for release of uncrossmatched blood in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- two of two units released on an uncrossmatched basis in 2017 were not signed by the requesting physician as required at 21 CFR 606.160(b)(3)(v). Findings follow: A. Review of Emergency Requests for Uncrossmatched Blood for the calendar year 2017 revealed that two units of uncrossmatched blood products (Units #W2055 17 244738 and W2049 17 275974) were released for patient #1199224 on 7/10/2017 and that requests were not signed or counter signed by the requesting physician but were only signed by nursing personnel. B. In an interview on 2/21/2018 at 10:47 a.m., laboratory employee #2 (as listed on the CMS 209 form) confirmed that the request for emergency release of uncrossmatched blood forms had been signed by nursing staff and not by the physician. D5783