Phillips County Hospital

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview with the general supervisor (GS) #1, the laboratory director failed to review, sign and date the Proficiency Testing Attestation Statement forms for nine out of 31 events from January 1, 2022, to June 18, 2024 Findings: 1. Review of API's Proficiency Testing Attestation Statements lacked Laboratory Director's signature, and date for the following proficiencies: 2022 Chemistry Core - 3rd Event 2022 Immunology /Immunohematology 3rd Event 2022 Chemistry - Miscellaneous-2nd Event 2022 Hematology/Coagulation 3rd Event 2023 Immunology/Immunohematology 3rd Event 2024 Hematology/Coagulation 1st Event 2024 Microbiology 1st Event 2024 Immunology/Immunohematology 1st Event 2. Review of API's Attestation Statement for 2023 Microbiology 2nd Event lacked the Laboratory Director's and Testing Personnel's signatures and dates. 3. Interview with GS #1 on June 18, 2024, at 10:00 AM confirmed the laboratory director failed to review, sign and date nine out of 31 Proficiency Testing Attestation Statement forms from January 1, 2022, to June 18, 2024. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) records, CMS-209 Personnel Report Form, personnel files, and policy and procedures, the laboratory failed to perform annual competencies for their testing personnel, general supervisor, and technical supervisor (D5209), failed to review and evaluate ungraded proficiency results obtained from the proficiency testing company and document the review process (D5211), and failed to follow their procedure to complete a

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of Immunohematology records, policy and procedure, and interview with General Supervisor (GS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and returned blood and blood products not used for transfusion from March 23, 2021, to August 24, 2022 Findings: 1. Review of Immunohematology records lacked documentation of temperatures for blood and blood products upon receipt of new shipments and for unused blood or blood products returned to the laboratory. 2. Review of Criteria for Returning and Reissuing of Blood Products policy revealed, "Unit must be returned to Blood Bank Refrigerator within 30 minutes of the documented time of check out and the temperature of the unit must be less than 10C. The temperature will be checked by wrapping the unit around a thermometer and taking the temperature 3 minutes later." and "must be documented in the Blood Bank Worksheet book." 3. Interview with GS #1 on August 23, 2022 at 11:00 AM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and returned blood or blood products not used for transfusion. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 a review of chemistry, serology, immunology, and blood bank records and procedures, the laboratory failed to perform external quality controls as dictated by their IQCP procedure (Refer to D5401); failed to have the laboratory director approve the method performance specifications for the new blood gas analyzer and procedure prior to reporting patient test results. (Refer to D5421); failed to perform function checks for pipettes and centrifuges (Refer to D5435); and failed to consistently document the required information, including visual inspection for blood or blood products issued or returned for reissue. (See D5553); failed to record daily temperatures and perform quarterly alarm checks (See D5555); and failed to develop a quality assessment plan to identify, correct, and prevent problems from recurring (See 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: Based on record review, policy and procedures, and interview, the laboratory failed to follow written procedures for performing quality control at the frequency dictated by their Individualized Quality Control Plans (IQCP) for the DCA Vantage analyzing microalbumin and creatinine, Consult Diagnostics Mononucleosis Cassette, Serum hCG (Combo Cassette) and H. pylori cassette from June 2021 to August 2022. Findings: 1. Review of IQCPs for DCA-Vantage Microalbumin/Creatinine Urine, Consult Diagnostics Mononucleosis Cassette, Serum hCG (Combo Cassette) and H. pylori cassette revealed, 2 levels of QC is to be performed for "new lot/new shipment and monthly thereafter". 2. Review of microalbumin/creatinine (M/C) quality control (QC) Log lacked QC records for September and October of 2021 and January, February, March, May and June of 2022. 3. Review of Serology and Immunology External QC Log lacked QC records for the following months: a. Serum and Urine QC for February, March and April of 2022 b. Mononucleosis QC for September, October of 2021, January, February, March, April, June, July and August of 2022 c. H. pylori QC for July, September, October, November of 2021 and January, February, March, April, May, June and August of 2022 4. Interview with GS #1 on August 24, 2022, at 2:20 PM confirmed the laboratory failed to perform QC as dictated by their IQCP for microalbumin, creatinine, mononucleosis, Serum hCG and H. pylori. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it -- 2 of 6 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer operator's manual, and interview with the General Supervisor (GS) #1, the laboratory failed to have the laboratory director evaluate and approve the performance specifications of the OPPTI CCA TS2 blood gas analyzer and procedure prior to reporting patient test results. Findings: 1. Observed OPTI CCA-TS2 Analyzer available to test analytes: pH, carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), sodium (Na+), potassium (K+), ionized calcium (Ca++), chloride (Cl-), glucose (Glu), blood urea nitrogen (BUN), lactate (Lac), total hemoglobin concentration (tHb) and hemoglobin oxygen saturation (SO2) in the laboratory. 2. Review of operator's manual states, "OPTI Medical recommends the following as a minimum testing frequency of QC materials; SRC levels 1 and 3 at least 1x per day in operation and OPTI Check or OPTI Check Plus Liquid Controls 1-month intervals and with each new shipment of cassettes". 3. No Individualized Quality Control Plan (IQCP) study or procedure was available for review to allow for less than the required testing of one control every eight hours. 4. The verification evaluation and instrument manual used as the procedure for the OPPTI CCA TS2 blood gas analyzer lacked review and approval by laboratory director prior to patient testing. 5. Interview with the (GS) #1 on August 24, 2022, at 4: 30 PM, confirmed these findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of maintenance documentation, policy and procedures, and interview with General Supervisor (GS) #1 the laboratory failed to establish and follow procedures to perform function checks to verify the accuracy of five pipettes and seven centrifuges from January 1, 2021, to August 24, 2022. Findings: 1. Observation of the centrifuges available for use lacked calibration labels to include revolutions per minute (RPM) and timer function checks. 2. Review of Blood Bank Maintenance Checklist and Scheduled Centrifuge Maintenance Checklist lacked documentation of biannual timer and tachometer checks for seven centrifuges. 3. Review of Inter-Mountain Biomedical Services pipet verification documents lacked verification records for year 2021 and 2022. 4. Review of Quality Control policy -- 3 of 6 -- revealed QC-QA frequency intervals for centrifuges are semi-annually and lacks a description for the frequency of verification for pipettes. 5. An interview with the GS#1 on August 24, 2022, at 3:40 PM, confirmed these findings. 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: Based on review of policy and procedures, records and interview with General Supervisor (GS) #1, the laboratory failed to consistently document the required information including visual inspection checks for 24 out of 36 units of blood or blood products released for transfusion or returned for reissue from January 11, 2021, to August 24, 2022. Findings: 1. Review of "Issuing of Blood for Transfusion" policy revealed visual inspections are performed when "Units are received by the laboratory; RN checks out a unit of blood to be transfused; Preparing to return to ARC; and Preparing to transfer to another medical facility." 2. Review of "Criteria for Returning and Reissuing of Blood Products" policy states "Unit must have been checked out from our Blood Bank refrigerator and documented properly in the Blood Bank Worksheet book" and "The unit's return to the Blood Bank Refrigerator must be documented in the Blood Bank Worksheet book, with a note on the next line stating that it was returned + why.". 3. Review of "Transfusion Service Testing Record" log lacked one or more of the required information for either units released (component, issued by, visual inspection, issued to, date/time of units) or returned (date/time, technologist, disposition, reason why) on the following dates: 01/18/2021, 2/15/2021, 3/2/2021, 3/5/2021, 6/24/2021, 10/0720/21, 10/8/2021, 10/18/2021, 12/01/2021, 1/17 /2022, 3/7/2022, 3/23/2022, 07/29/2022, 4. Interview with GS #1 on August 24, 2022, at 11:30 AM, confirmed these findings. 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: Based on review of the blood bank's policy and procedures, records of blood bank's refrigerator and freezer alarm checks for 2021, daily temperature logs for November 2021 and March 2022, and an interview with the General Supervisor (GS) #1, the laboratory failed to record daily temperature and perform and document quarterly alarm inspection checks for 1 of 1 blood bank refrigerator and freezer.. Findings: 1. Review of "Quality Control" policy for "QC-QA Frequency Intervals" revealed, the -- 4 of 6 -- frequency of blood bank refrigerator's alarm activation for visual and audible is quarterly. 2. Review of the "Blood Bank Maintenance Checklist and Scheduled Centrifuge Maintenance Checklist" records revealed, alarm checks for the blood bank refrigerator and freezer are scheduled "Quarterly (Due March, June, Sept, Dec)" and lacked documentation of alarm checks for year 2021. 3. Review of Blood Bank Refrigerator-Temperature policy revealed, "Daily, 2 temperatures must be checked, recorded and initialed on the Blood Bank Monthly Temperature Log.", 4. Review of Blood Bank Monthly Temperature Log for JULY 2022 lack entry for days 7/10, 7/23,7 /24 and 7/25 and for November 2021 lack entry for 11/9, 11/25, 11/26, 11/27 and 11 /28. 5. An interview with GS #1 on August 24, 2022, at 11:50 a.m. confirmed these findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review, policy and procedures, and interview with General Supervisor (GS) #1, the laboratory failed to establish a quality assessment plan that identifies and corrects problems and prevent their recurrence related to their Individual Quality Control Plan (IQCP) required frequency to perform quality control for microalbumin, creatinine, mononucleosis, urine and serum human chorionic gonadotropin (HCG), and H. pylori, daily temperature logs for the storage of blood and blood products, inspection and documentation requirements for the issue and reissue of blood and blood products for transfusion, functions checks of pipettes and centrifuges from January 1, 2021 to August 24, 2022. Findings: 1. Review of Blood Bank Maintenance Checklist and Scheduled Centrifuge Maintenance checklist lack review for quality assessment. 2. Review of Blood Bank Monthly Temperatures for November 2021 and March 2022 lacked documentation for "Reviewed by" and "Date". 3. Review of IQCPs for DCA-Vantage Microalbumin/Creatinine Urine, Consult Diagnostics Mononucleosis Cassette, Serum hCG (Combo Cassette) and H. pylori cassette revealed, "The Quality Assessment is an ongoing review of the QC process." 4. Review of M/C QC Log DCA Vantage lacks review for quality assessment. 5. Review of Serology and Immunology External QC Log revealed "External QC: Perform with each new kit lot number and each new shipment date" and does not address requirements for monthly QC for HCG, Mononucleosis and H. pylori and lacks review for quality assessment. 6. No

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: Based on review of personnel files, policy and procedures, and interview with the general supervisor (GS)#1, the laboratory failed to follow their QA/QI Guidelines procedure to perform annual personnel assessments for the technical supervisor (TS) and 1 of 3 testing personnel (TP) in 2019; and for the technical supervisor and 3 of 3 testing personnel in 2020. Findings include: 1. Review of personnel files lacked documentation of annual assessments for TS#1 and TP#1 in 2019, and for TS#1, TP#1, TP#2 and TP#3 in 2020. 2. Review of QA/QI Guidelines states "Asses all personnel at 6 months and 1 year, then annually thereafter, by using unknown specimens in all areas in which a tech performs patient and/or proficiency testing." 3. Interview with GS #1 on 3/23/2021 at 11:00 AM, confirmed the laboratory failed to perform annual assessment for personnel listed above for 2019 and 2020. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review of 2019, 2020 instrument comparison documentation and interview with the general supervisor (GS)#1, the laboratory failed to perform instrument comparison for the analyzers, VITROS 350 and ePOC Blood Gas for basic metabolic panel testing two times a year. Findings: 1. Review of laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies twice a year for VITROS 350 and ePOC Blood Gas system analyzers performing sodium, potassium, chloride, ionized calcium, total CO(2), glucose, blood urea nitrogen (BUN) and creatinine analyte testing for 2019 and 2020. 2. Interview with general supervisor GS#1 on March 23, 2021 at 3:00 PM confirmed the laboratory failed to perform twice a year instrument comparison -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an offsite proficiency desk review conducted on 2/26/2020, deficiencies were cited for Phillips County Hospital in Malta, MT. 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for partial thromboplastin time (PTT) and prothrombin time (PT) for two of three events (event 2 and event 3 of 2019), resulting in unsuccessful proficiency testing performance. See D2130 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: 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: {D2130} Based on review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for partial thromboplastin time (PTT) and prothrombin time (PT), durimg two of three events in 2019. The findings include: 1. During a review on 2/27/2020 at 2:30 p.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Phillips County Hospital with unsuccessful proficiency testing scores for PTT and PT. 2. During a review on 2/27/2020 at 2:30 p.m. of the CMS-155 report, the American Proficiency Institute (API) reported a score of 20% for PTT and PT for event 1 of 2019 and 40% for PTT and PT for event 3 of 2019. 3. On 3/06/2020 at 3:24 p.m., staff member A, emailed verification of the unsatisfactory results for event 2 and 3 of 2019. 4. On 3/09/2020 at 8:30 a.m., staff member A, stated the results did not print off in the same order/sequence as API therefore were reported incorrectly for event 2 of 2019, and the wrong analyzer was chosen when reporting results for event 3 of 2019. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 3/26/18-3/27/18, deficiencies were cited for Phillips County Hospital in Malta, MT. 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: Based on observation, record review, and interview, the laboratory failed to follow the laboratory policy and procedure for microalbumin/creatinine from 3/22/16 to 3/26/18. The findings include: 1. On 3/26/18 at 1:15 p.m., a DCA Vantage was observed in the laboratory. 2. On 3/26/18 at 1:15 p.m., staff member A stated microalbumin/creatinine was performed on the DCA Vantage. 3. A review on 3/27/18 at 8:35 a.m. of the Phillips County Hospital microalbumin/creatinine (M/C) quality control (QC) Log for the DCA Vantage documented controls run on 12/30/16, 2/14/17, 4/24/17, 6/3/17, 8/9 /17, 10/13/17, 10/26/17, and 1/2/18. 4. A review on 3/27/18 at 8:35 a.m. of the Phillips County Hospital Individual Quality Control Plan (IQCP) for DCA-Vantage Microalbumin/Creatinine Urine Policy and Procedure stated in the Quality Control Plan to run test panels "at new lot/new shipment and monthly there after." 5. On 3/27 /18 at 8:35 a.m., staff member D stated the controls were not run monthly. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the current laboratory director failed to approve, sign, and date two of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/27/18 at 1:35 p.m. of the Phillips County Hospital IQCP for DCA-Vantage Microalbumin/Creatinine Urine and IQCP for Antimicrobial Susceptibility Testing and Organism Identification Microscan System were not signed as approved by the current laboratory director. 2. On 3/27/18 at 1:35 p.m., staff member A stated the previous laboratory director had signed approval. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to follow manufacturer directions for establishing a new patient mean for one of two lots of recombiplastin reagent reviewed. The findings include: 1. On 3/26/18 at 1:15 p.m., an Instrumentation Laboratory (IL) ACL Elite analyzer was observed in the laboratory. 2. On 3/26/18 at 1:15 p.m., staff member A stated prothrombin times (PT) were performed on the IL ACL Elite analyzer. 3. A review on 3/26/18 at 5:00 p.m. of the calculations for the patient mean normal value was not documented for the previous lot of recombiplastin (lot number N0160676) used from approximately 1/2017 through 3/2018. 4. On 3/26/18 at 5:00 p.m., staff member A stated the new lots are ordered and shipped at the end of the calendar year and started in use at the beginning of the year. 5. A review on 3/27/18 at 7:40 a.m. of the IL ACL Elite analyzer manufacturer instructions included instructions that the mean normal range "needs to be verified on each lot change of PT reagent as per your laboratory regulating agency." 6. A review on 3/27/18 at 7:40 a.m. of the Phillips County Hospital ACL Elite Calibration Policy and Procedure included instructions to calculate the mean of the patient PT values once a year and when instructed to calibrate from IL. It also stated to "retain worksheet and file with the calibration paperwork in the Coulter IL ACL Instruments Validation Documentation, Maintenance, Service, and Calibration binder." D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system -- 2 of 5 -- performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to include the number of controls in two of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/27/18 at 1:35 p.m. of the Phillips County Hospital IQCP for DCA-Vantage Microalbumin/Creatinine Urine Quality Control Plan lacked the number of controls performed. 2. On 3/27/18 at 1:35 p.m., staff member A stated the number was not in the IQCP. 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: Based on record review and interview, the laboratory failed to include testing personnel potential failures and sources of error due to testing personnel in three of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/27/18 at 1:35 p.m. of the Phillips County Hospital IQCP for DCA- Vantage Microalbumin/Creatinine Urine, IQCP for Alere Triage-D-Dimer, and IQCP for Antimicrobial Susceptibility Testing and Organism Identification Microscan System all lacked testing personnel potential failures and sources of error due to testing personnel. 2. On 3/27/18 at 1:35 p.m., staff member A stated the IQCPs did not address the personnel. 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: Based on observation, record review, and interview, the laboratory failed to maintain an audible alarm system for blood storage and perform regular inspections of the alarm system from 3/22/16 to 3/26/18. The findings include: 1. A review on 3/27/18 at 11:10 a.m. of the Phillips County Hospital Laboratory Blood Bank Maintenance Checklist quarterly refrigerator alarm checks for 2017 documented missing alarm -- 3 of 5 -- checks, incomplete alarm checks, alarms going off at inappropriate temperatures without