Eureka Springs Hospital

Summary Statement of Deficiencies 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 upon review of laboratory policy and procedure, the manufacturer's user manual for the Beckman AU 480 chemistry analyzer and the Beckman Access chemistry analyzer, quality control (QC) results for complete blood cell count (CBC) analysis for May and June 2025, QC records for prothrombin time (PT) assays for May and June 2025, QC rescords for arterial blood gas (ABG) assays for May and June 2025, laboratory temperature/humidity records for May and June 2025, patient test results, lack of documentation, and interviews with laboratory staff, the laboratory failed to meet analytic system requirements as evidenced by: 5413: The laboratory failed to monitor humidity in rooms in which instruments with an operational humidity requirement were used. 5463: The laboratory failed to rotate the performance of QC among testing personnel. 5481: The laboratory reported ABG determination results when QC results were unacceptable and reported a CBS test result before QC was performed. 5537: The laboratory failed to perform QC for ABG analysis within eight hours of patient testing. 5545: The laboratory failed to perform QC for PT analysis within eight hours of patient testing. 5783: The laboratory failed to document

Summary Statement of Deficiencies D0000 This is the CLIA complaint survey of the laboratory conducted on 11/22/2024. At the time of the survey of the hospital laboratory, the lab had no qualified personnel approved to perform moderate or high complexity testing and had ceased testing. Additional information was received on 11/25/2024. No changes in the findings. 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 the CMS-209 and personnel records presented to the surveyor, as well as interviews with staff, the laboratory director failed to provide overall management and direction by not employing testing personnel who were competent to perform laboratory testing as cited at: D6029 - The laboratory director failed to employ two of two testing personnel who were competent to perform laboratory testing D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can 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 -- perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the CMS-209 and personnel records presented to the surveyor, as well as interviews with staff, the laboratory director failed to employ two of two testing personnel who were competent to perform laboratory testing. A. A review of CMS-209 dated 11/22/2024 revealed two laboratory employees listed as testing personnel (#2, and #3 as listed on the form CMS-209). B. A review of personnel records for Employee #2 revealed the only competency evaluation in the record was not signed by the laboratory director and the employee was not marked as competent on 17 of 33 items evaluated. C. A review of personnel records presented to the surveyor for Employee #3 revealed the last competency assessment for Employee #3 was dated 2018. D. In an interview, at 10:37 on 11/22/2024, the interim CEO confirmed there were no other records presented for review for laboratory employee #2 or #3. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS-209 and personnel records presented to the surveyor, as well as interviews with staff, the technical consultant failed to evaluate one of two testing personnel annually after the first year of employment. A. A review of CMS- 209 dated 11/22/2024 revealed two laboratory employees listed as testing personnel (#2, and #3 as listed on the form CMS-209). B. A review of personnel records for Employee #3 revealed the last annual competency assessment in the personnel file was dated 2018. D. An interview, at 10:37 on 11/22/2024, the interim CEO confirmed there were no other records presented to the surveyor for employee #3. D6069 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(a) Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. This STANDARD is not met as evidenced by: Based on review of the CMS-209 and personnel records presented to the surveyor, as well as interviews with staff, one of two testing personnel were not authorized to perform laboratory testing. A. A review of CMS-209 dated 11/22/2024 revealed three laboratory employees listed as #1, #2, and #3. Employee #1 is listed as the laboratory director. Employees #2 and #3 are listed as testing personnel. B. A review of personnel records for Employee #2 revealed competency evaluation was not signed by the laboratory director and there was no other document giving authorization to -- 2 of 3 -- perform laboratory testing. C. An interview, at 10:37 on 11/22/2024, the interim CEO confirmed there were no records of employee #2 being authorized, by the laboratory director, to perform testing. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through observation, review of the hospital's IQCP for prothrombin time (PT) and activated partial thromboplastin time (PTT) performed on the Accriva Hemochron coagulation analyzer, review of external QC results for PT and PTT testing, lack of documentation, and interview it was determined that the laboratory did not document the performence of external quality control (QC) as required in the IQCP. Findings follow: A) During a tour of the laboratory on 7/26/23 at 9:15 a.m. PT reagent lot # A3CPT 001 and PTT reagent lot # M2JCC 019 were observed in the laboratory reagent refrigerator. B) Review of the laboratory's IQCP for PT and PTT testing on the Accriva Hemochron coagulation analyzer revealed that "external QC will be performed for each new lot and/or shipment of reagents and with each new operator and every 30 days". C) Review of the external QC log for PT and PTT testing revealed that no documentation of external QC results were identified for lot # A3CPT 001 and lot # M2JCC 019. D) In an interview on 7/26/23 at 9:40 a.m., laboratory staff member ( # 8 on the CMS 209 form) confirmed that the lots A3CPT 001 and M2JCC 019 were the lots currently in use for PT and PTT testing and documentation of the date the reagents were put into use and documentation of external QC identified for those lot #'s of reagents was not present. 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 -- D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Through observations made during a tour of the laboratory, review of the FDA Access Data website, lack of documentation, and interviews with staff, it was determined the laboratory failed to document semi-annual test comparison for testing performed on the Beckman Coulter AU480 Chemistry Analyzer and the I-Stat Analyzer. Findings follow: A) During an initial tour of the laboratory at 1:15 p.m. on 7 /25/2023, the surveyor observed a Beckman Coulter AU480 Chemistry analyzer and an I-Stat analyzer in the Chemistry section of the laboratory. B) In an interview on 7 /27/2023 at 10:03 a.m., the laboratory staff members (#2 and #3 on the CMS-209) stated that the I-Stat serves as a secondary analyzer to the Beckman Coulter AU 480 analyzer for the analytes on the Chem 8+ I-Stat cartridge ( sodium, potassium, chloride, calcium, glucose, blood urea nitrogen, total carbon dioxide and creatinine). C) Review of the FDA Access Data website revealed that the I-Stat Chem 8 + cartridge is categorized as "moderately complex". D.) The surveyor requested documentation of semi-annual comparison of tests performed on both the Beckman Coulter Au480 and the I-Stat Chem 8+ cartridge . None was provided. E) In an interview at 11:03 a.m. on 7/27/2023 the laboratory staff member ( #2 as listed form CMS-209) stated the semi-annual comparison of the Beckman Coulter AU480 and I- Stat analyzer, for those analytes performed in common, was not performed by the Laboratory. -- 2 of 2 --

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 review of quality control (QC) reports for January 2021, review of the manufacturer's package insert instructions for Biorad Multiqual and Biorad Liquicheck QC material and interview it was determined that the laboratory failed to establish its own QC target and acceptable range values for 31 of 31 days reviewed. Findings follow: A) Review of the QC reports for January 2021 and the manufacturer's package inserts for Biorad Multiqual levels 1 & 3 lot# 45830 and Biorad Liquicheck levels 1 & 3 lot# 8522 revealed that the target and acceptable range used by the laboratory to evaluate QC results were identical to the range of means provided in the manufacturer's package inserts. B) Review of the manufacturer's package insert instructions for both the Biorad Multiqual and Biorad Liquicheck QC materials revealed that "it is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides". C) In an interview on 9/8 /21 at 10:47 AM the laboratory staff member, identified as number 3 on the CMS 209 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 -- form, confirmed that the laboratory utilized the target and ranges published in the manufacturer's package insert to evaluate QC acceptability and did not establish their own. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through observation, review of tests classifications on the FDA.gov website, review of Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) quality control records for April 2021 through July 2021, lack of documentation, patient result reports and interview it was determined that the laboratory failed to perform external quality control (QC) within eight hours of patient testing for 48 of 48 PT analyses performed. Finding follow: A) In an initial tour of the laboratory at 11:15 AM on 9/7/21 an Accriva Hemochron instrument was observed in the laboratory and the laboratory staff member, identified as number 3 on the CMS 209 form, stated that the Accriva Hemochron instrument was recently put into use to perform PT and PTT testing. B) Review of tests classifications on the FDA website revealed that PT and PTT tests performed on the Accriva Hemochron instrument were classified as moderate complexity. C) Review of QC records for April 2021 through July 2021 revealed that external QC was performed only one time each month. D) Review of patient test results revealed that 48 PT tests were performed from 4/27/21 to the date of the survey and none of the assays were performed within eight hours of external QC performance. E) In an interview on 9/8/21 at 10:00 AM the laboratory staff member, identified as number 3 on the CMS 209 form stated that it was thought that the Accriva Hemochron performed waived category testing and that they followed manufacturer's instruction by performing external QC for evey lot and shipment of test cartridges and once per month. F) Upon request the laboratory was unable to provide an IQCP for PT assays performed on the Accriva Hemochron analyzer and on 9/8/21 at 10:00 AM the laboratory staff member, identified as number 3 on the CMS 209 form, said that they had not established an IQCP for the Accriva Hemochron analyzer. D5783

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Through interview, review of the Roche Coaguchek manuafacturer's insert, review of laboratory charge reports, "Coaguchek finger stick PT log" , patient medication histories and lack of documentation it was determined that the laboratory failed to use the Roche Coaguchek coagulation analyzer as directed in the manufacturer's instructions when performing prothrombin time testing for ten of nineteen patients with prothrombin time testing from March 9, 2019 through May 7, 2019. Findings follow: A) In an interview on May 7, 2019 at approximately 01:15 PM the technical consultant, identified as number 2 on the CMS 209 form stated that the laboratory no longer performs moderately complex coagulation testing but only performs prothrombim time and INR testing on the (waived classified) Coaguchek instrument and refers all partial thromboplastin time testing to the referral laboratory. B) Review of the Roche Coaguchek manufacturer's insert revealed that "any failure to follow test system instructions, including those for limitations/intended use results in use that is considered high complexity and subject to all applicable CLIA requirements", and "the Coaguchek system is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy". C) Review of the Laboratory Charge Log revealed that prothrombin time testing was performed on nineteen different patients, identified on a separate patient identification list, beween March 9, 2019 and May 7, 2019. D) Review of the "Coaguchek finger-stick PT log" revealed that the prothrombin times for the nineteen patients identified above were performed on the Coaguchek instrument. D) Review of the patient's medication histories in the patient's medical records revealed that ten of patients with prothrombin Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- time testing, identified on a separate patient identification list, had no history of warfarin therapy. E) Upon request, the laboratory could not produce test establishment documentation which would support using the Coaguchek as a highly complex methodology. F) In an interview on May 9, 2019 at approximately 11:00 AM the technical consultant, identified as number 2 on the CMS 209 form, and the testing personnel, identified as number 3 on the CMS 209 form, confirmed that prothrombin time tests were performed using the Coaguchek analyzer upon order with no regard of the patient's medication history or reason for the test order and that method establishment for using the Coaguchek as a highly complex method had not been accomplished. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . 1. Through a review of the policy and procedure manual, Osmetech Opti-Check Blood Gas Analyzer user manual, temperature records for 2018 and 2019, observations, lack of documentation, as well as interviews with staff, it was determined the Blood Gas laboratory failed to monitor temperatures and humidity that are essential for the proper storage of supplies and the operation of Blood Gas analyzer. As evidence by: A. A review of the Blood Gas policy and procedure manual revealed the laboratory failed to define ranges for room temperature and humidity. B. A review of the user manual for the Osmetech Opti-Check Blood Gas Analyzer appendix A revealed the technical specifications of the analyzer " Operating temperature 10-32 degrees Celsius (50-90 degrees Fahrenheit) and humidity 5% -95%." C. A review of temperature records for 2018 (12 of 12 months) revealed the Blood Gas laboratory failed to document daily room temperatures and humidity 20 of 31 days in January 2018; 15 of 28 days in February 2018; 13 of 31 days in March 2018; 16 of 30 days in April; 18 of 31 days in May 2018; 24 of 30 days in June 2018; 19 of 31 days in July 2018; 24 of 31 days in August 2018; 23 of 30 days in September 2018; 28 of 31 days in October 2018; 30 of 31 days in November 2018 and 28 of 31 days in December 2018. D. A review of temperature records for 2019 (4 of 4 months) revealed the Blood Gas laboratory failed to document daily room temperatures and humidity 29 of 31 days in January 2019; 24 of 28 days in February 2019; 30 of 31 days in March 2019 and 30 of 30 days in April 2019. E. During a tour of the Blood Gas laboratory on 5/8/2019 at 1500, the surveyor observed the following stored at room temperature: Osmetech Opti-Check Blood Gas Analyzer, one box of Opti- Check B Cassette (Lot # 903100 expires 9/2019 storage temperature 15-30 degrees Celsius) one box of Opti-Check Quality Controls (lot # 8223 expires 5/2020 storage temperature 15-30 degrees Celsius). F. In an interview on 5/8/2019 at 1500, Blood Gas laboratory personnel #1 (as listed on CMS form 209) confirmed the laboratory did not define ranges for room temperature and humidity and the laboratory failed to document daily room temperatures and humidity. 2. Through a review of the user manuals for Beckman Coulter Hematology Analyzer, Alere Triage Boisite Chemistry -- 2 of 5 -- Analyzer, and Ortho Vitros 350 Chemistry Analyzer, temperature records for 2018 and 2019, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to monitor humidity conditions that are essential for the proper operations of the Hematology and Chemistry analyzers. As evidenced by: A. A review of the user manual section "Specifications" for the following analyzers revealed Beckman Coulter Hematology analyzer operating temperature 15-30 degrees Celsius and Humidity 10%-85%: Alere Triage Chemisty analyzer operating temperature 15- 30 degrees Celsius and Humidity 10%-85%: Ortho Vitros 350 Chemistry analyzer operating temperature 15-30 degrees Celsius and Humidity 15%-75%. B. A review of the temperature records for 2018 (12 of 12 months) and 2019 (4 of 4 months) revealed the laboratory were not monitoring Humidity conditions. C. The surveyor requested Humidity for 2018 and 2019. None was provided. D. In an interview on 5/08/2019 at 1530 laboratory personnel #3 (as listed on CMS form 209) confirmed the laboratory were not monitoring humidity conditions. 35659 . 3. Through observation, lack of documentation and interview it was determined that room temperature was not documented in two of three rooms in which supply items with storage temperature requirement were stored. Findings follow: A) In a tour of the laboratory on May 8, 2019 at approximately 02:00 PM the following items with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in a separate phlebotomy room ; 70 BD Na Citrate blood collection tubes lot# B19013 expiration date 2020-01- 04, 270 BD EDTA blood collection tubes lot# 9004576 expiration date 2020-05-31, 50 BD Heparin blood collection tubes lot# B19013FS expiration date 2020-04-14, 3800 BD Serum blood collection tubes lot# 9059672 expiration date 2020-07-31, and 300 BD SST blood collection tubes lot# 9049992 expiration date 2020-02-29. B) Upon request, the laboratory was unable to provide room temperature records for the room identified above. C) In an interview on May 8, 2019 at approximately 03:00 PM, the testing personnel identified as number 3 on the CMS 209 form, confirmed that the room temperature of the room identified above was not documented. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Through a review of the Osmetech Opti-Check Blood Gas Analyzer user manual, 2018 and 2019 maintenance logs, lack of documentation, and interviews with Respiratory staff, it was determined the Respiratory laboratory failed to perform quarterly maintenance as specified by the manufacturer. As evidence by: A. A review of the user manual for Osmetech Opti-Check Blood Gas analyzer section 6.3 " "Quarterly Maintenance Performing the tHb Calibration" revealed: "the tHb chamber must be calibrated quarterly." B. A review of maintenance records for Osmetech Blood Gas analyzer for 2018 (4 of 4 quarters) revealed the quarterly maintenance was only performed in April of 2018 (1 of 4 quarters). C. The surveyor requested documentation of quarterly maintenance for the first quarter ( January, February and March) third quarter (July, August and September) and four quarter (October, November and December ) of 2018. None was provided. D. In an interview on 5/8 /2019 at 1430 Respiratory personnel #1 (as listed on CMS form 209) confirmed the laboratory failed to performed quarterly calibration of tHb chamber. -- 3 of 5 -- D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (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 the laboratory policy for "Emergency Issue of Blood", review of "Release for Uncrossmatched Blood" forms, lack of documentation, and interview it was determined that the laboratory failed to ensure and keep records of post release crossmatches on units released under emergency release protocol on four of four units released since January 1, 2019. Findings follow: A) In an interview on May 7, 2019 at approximately 01:30 PM, the technical consultant, identified as number 2 on the CMS 209 form, stated that the hospital laboratory has no blood bank crossmatching capabilities and patients seen in the emergency room that require transfusions are given O negative packed red blood cells (PRBC) on emergency release protocol and immediately transferred to a receiving hospital. B) Review of the laboratory policy for "Emergency Issue of Blood" revealed that the laboratory "will be 100% emergency of blood only" and "the facility will keep on hand O negative units only to be used for emergency release of blood" and "any requests for an out-patient transfusion will require that the patient be referred to another facility that has a full blood bank service". No mention of a method to follow-up with a post release crossmatch is addressed in the policy. C) Review of emergency release forms revealed that the laboratory released four units of packed RBC's under emergency release protoocol to three separate patients since January 1, 2019. The receiving patients and unit numbers are documented on a separate "Blood Bank Patient and Blood Unit" identification list. D) Upon request, the laboratory was unable to provide documentation of post-release crossmatch results for the patients and units cited above. E) In an interview on May 9, 2019 at approximately 10:45 AM, the testing personnel identified as number 3 on the CMS 209 form stated that no record was kept or sought from the hospital to which patients had been transferred. This was confirmed by the technical consultant, identified as number 2 on the CMS 209 form, during the exit conference on May 9, 2019 at approximately 11:45 AM. 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. -- 4 of 5 -- This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for "Blood Bank Alarm", records of the blood bank refrigerator alarm checks, observation, lack of documentation and interview it was determined that the laboratory failed to perform blood storage refrigerator alarm checks for the period of May 8, 2017 through May 8, 2019 inclusive. Findings follow: A) Review of the laboratory's policy and procedure for "Blood Bank Alarm" revealed that the blood bank refrigerator has an alarm that sounds at the nursing station in the event of malfunction since the laboratory is not staffed on a 24 hour per day seven day per week basis. B) Review of the laboratory documentation for blood bank refrigerator alarm check revealed that the last documented alarm check was performed on May 8, 2017. C) Upon request, the laboratory was unable to provide documentation of blood bank refrigerator alarm checks performed since May 8, 2017. D) During a tour of the laboratory on May 8, 2019 at approximately 03:00PM, six units of packed red cells with the blood type of O negative, (unit numbers; W0451 19 402647, W0451 19 402168, W0451 19 402700, W0451 19 252682, W0451 10 204455, and W0451 19 204705) were observed in the blood bank refrigerator. E) In an interview on May 8, 2019 at approximately 03:00 PM, the testing personnel, identified as number three on the CMS 209 form, stated that the laboratory keeps six units of O negative packed red cells available at all times for emergency release and that no blood bank refrigerator alarm checks had been performed since May 8, 2017. -- 5 of 5 --