Caro Community Hospital

Summary Statement of Deficiencies D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: . Based on record review and interview with the general supervisor, the technical supervisor failed to directly observe routine patient gram staining performance as part of testing personnel competency assessments for two (December 2023 to December 2025) of two years reviewed. Findings include: 1. A review of the laboratory's testing personnel competency assessments for cerebrospinal fluid gram stain testing revealed a lack of documentation of direct observations of patient gram staining for testing personnel #1-#9. 2. A review of the laboratory's "Competency" policy revealed a section stating, "All testing personnel must be evaluated to assure they acquire and maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. Competency evaluations will include: 1. Direct observation 2. Monitoring the recording and reporting of testing results 3. Review of intermediate test results or worksheets, QC records, proficiency testing results, and preventative maintenance 4. Direct observation of performance of instrument maintenance and function internal blind testing samples, or external proficiency testing samples 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or eternal proficiency testing samples 6. Assessment of problem-solving skills." 3. An interview on 12/9/25 at 1:49 pm with the general supervisor confirmed direct observations of gram staining performance were not performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 record review and interview with General Supervisor (GS) #1, the laboratory failed to establish and implement policies and procedures to assess the competency of personnel serving the roles of Clinical Consultant (CC), Technical Consultant (TC), Technical Supervisor (TS), General Supervisor (GS), and Testing Personnel (TP) job responsibilities for 22 (April 2022 to January 2024) of 23 months reviewed. Findings include: 1. A review of the laboratory's personnel records revealed a lack of documentation for the competency assessments for the CC, TC, TS, GS, and TP job responsibilities. 2. A review of the "Competency Policy" revealed a lack for assessing federal regulatory responsibilities for the CC, TC, TS, GS, and TP. 3. An interview on 1/08/24 at 1:54 pm, GS#1 confirmed the laboratory had not established or implemented a policy or procedure for assessing competency for job responsibilities for the roles listed above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least 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 5 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #1, the laboratory failed to perform calibration verification at least every 6 months for Aspartate Aminotransferase (AST) for 1 (July 2022) of 4 calibration verification testing events reviewed. Findings include: 1. A review of the laboratory's "Dimension EXL Verification/Linearity" policy revealed a section stating, "Each level demonstrates a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for the purpose of determining linearity, calibration verification and verification of reportable range for the following analytes: Chloride, Sodium, Potassium, Calcium, and AST." 2. A review of the laboratory's calibration verification data from 2022 and 2023 revealed a lack of calibration verification data for AST during the July 2022 event. 3. An interview on 1/8/24 at 1:47 pm with General Supervisor #1 confirmed the laboratory did not have calibration verification data for AST from the July 2022 event. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS) #2, the laboratory failed to establish a procedure and test its peripheral blood smear staining materials for predictable staining characteristics at least each day of patient testing for 22 (April 2022 to January 2024) of 23 months reviewed. Findings include: 1. A record review revealed a lack of a procedure to perform and document the peripheral blood smear staining material for quality. 2. When queried, GS#2 was unable to provide the surveyor the documentation requested. 3. An interview on 1/08/2024 at 11:57 am, GS#2 confirmed the laboratory had not established a procedure or practice of documenting its peripheral blood smear intended staining characteristics each day of patient testing. D5503 BACTERIOLOGY -- 2 of 5 -- CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #1, the laboratory failed to perform control procedures for its gram stains for 2 (week of 3/9/22 and 7/6 /22) of 2 weeks the laboratory had performed patient testing. Findings include: 1. A review of patient test records revealed the laboratory performed 2 patient Cerebrospinal Fluid (CSF) gram stains total between 2022 and 2023: a. Patient #1 performed on 3/9/22. b. Patient #2 performed on 7/6/22. 2. A review of the laboratory's "Gram Stain Policy" revealed a section titled "Quality Control" stating, "Weekly and with each new lot number prepare a smear of E. coli (ATCC 25922) and Staph epidermidis or Staph aureus (ATCC 25923)." 3. The surveyor requested documentation of control procedures performed using gram staining materials for the patients listed above on 1/8/24 at 12:49 pm. 4. An interview on 1/18/24 at 12:49 pm with General Supervisor #1 confirmed the laboratory had not performed and documented gram stain control procedures at least weekly for the patients listed above. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview, the Technical Consultant (TC) #1 as listed on the CMS-209 failed to ensure the 6-month (semi-annual) competency assessment for 1 (#6) of 8 Testing Personnel (TP) were performed and documented for the moderately complex hematology coagulation testing. Findings include: 1. Record review of the TP competency assessments revealed a lack of documentation for the 6- month assessment for 1 (TP#6) of 8 TP performing coagulation. 2. An interview on 1 /08/2024 at 9:53 am, TC#1 confirmed there was no documentation for the semi- annual coagulation competency assessment for TP#6. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor (GS) #1, the Technical Supervisor (TS) failed to perform the semiannual immunohematology competency assessment for 1 (Testing Personnel # 6) of 8 personnel listed on the CMS-209. Findings include: 1. A record review of the testing personnel competency -- 3 of 5 -- assessments revealed the 6-month immunohematology assessment was performed by Testing Personnel #1 for 1 (Testing personnel #6) of 8 assessments reviewed. 2. An interview on 1/08/2024 at 1:54 pm, GS1 confirmed the immunohematology 6-month assessment for Testing Personnel #6 was not performed by a qualified Technical Supervisor. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with General Supervisor #1, the laboratory failed to ensure personnel performing highly complex testing met the testing personnel qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure personnel performing high complexity testing were qualified as testing personnel. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training -- 4 of 5 -- appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS) #1, the laboratory failed to ensure testing personnel performing high complexity hematology, chemistry, and immunohematology testing were qualified for 2 (Testing Personnel (TP) #6 and #7) of 8 TP listed on Form CMS-209. Findings include: 1. A review of testing personnel credentials revealed a lack of documentation showing TP #6 and #7 was qualified to perform high complexity hematology, chemistry, and immunohematology testing. 2. An interview on 1/08/2024 9:53 am, General Supervisor #1 confirmed TP #6 and #7 were lacking documentation to show they were qualified to perform high complexity testing. 3. The laboratory was given 7 days to provide the documents and they were not made available. -- 5 of 5 --

Summary Statement of Deficiencies 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: . Based on observation and interview with the General Supervisor #1 (GS1), the laboratory failed to use 3 (red top Becton Dicken drawing tubes) of 3 specimen collection supplies before the expiration date found in the laboratory drawing station. Findings include: 1. During a tour of the laboratory on 04/11/2022 at 9:32 am, the surveyor observed 3 of 3 specimen collection supplies still in circulation in the laboratory drawing station past their expiration dates. 2. An interview on 04/11/2022 at 9:32 am, the GS1 confirmed the above supplies were still in circulation past their expiration dates. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- . Based on observation, lack of documentation, and interview with General Supervisor #1 (GS1), the laboratory failed to establish a maintenance protocol for its centrifuges for 2 (April 2020 to April 2022) of 2 years reviewed. Findings include: 1. The surveyor observed the Clearpoint Diagnostic centrifuge located in the specimen collection area of the laboratory making loud noises while in operation on 4/11/22 at 9: 02 am. The centrifuge had a sticker on the side noting service was performed in April 2021 and due in July 2021. 2. The surveyor requested documentation of centrifuge maintenance on 4/11/22 at 9:33 am and it was not made available. 3. The surveyor requested the centrifuge maintenance policy on 4/11/22 at 2:26 pm and it was not made available. 4. An interview on 4/11/22 at 2:35 pm with GS1 confirmed documentation of maintenance for centrifuges and a policy for the performance of centrifuge maintenance was not available. 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 record review and interview with General Supervisor #1 (GS1), the laboratory failed to perform and document the visual inspection of red blood cells immediately before distribution in accordance with 21 CFR 606.160(b)(3)(ii) for 3 (Patients FLTB3935, FLT3615, and SFFY0365) of 4 patient transfusion records reviewed. Findings include: 1. A review of the laboratory's "Blood Bank" policy revealed a section titled, "Visual Inspection of Blood" stating, "Each unit of blood is inspected when initially circulated. All units in circulation are inspected daily. Each unit is inspected again when it is selected for crossmatching. Each unit is inspected when it is issued." 2. A review of patient transfusion records revealed a lack of documentation of visual inspections performed immediately before distribution for the following patients: a. Patient FLTB3935 receiving two units packed red blood cells on 1/27/22. b. Patient FLT3615 receiving two units of packed red blood cells on 8/4/21. c. Patient SFFY0365 receiving one unit of packed red blood cells on 5/27/20. 3. An interview on 4/11/22 at 11:00 am with GS1 confirmed documentation of the visual inspection of blood products immediately before distribution was not available. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the immunohematology compatibility testing. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 2 proficiency testing events. Refer to D2181 D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for 2 (3rd 2020 and 1st 2021) of 2 testing events for the immunohematology compatibility testing. Findings include: Compatibility Testing PT Event Score 3rd event 2020 80% 1st event 2021 60% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor (GS) 1 and GS2, the laboratory failed to retain the microbiology blood culture manufacturer's certificate of compliance for 2 (January 2018 to January 2020) of 2 years. Findings include: 1. Record review of the microbiology blood culture bottles revealed the laboratory did not retain the manufacturer's certificate of compliance with each new lot and/or shipment of blood culture bottles. 2. When queried on 01/15/2020 at approximately 1: 55 pm, GS2 stated that central supply is unpacking and delivering the bottles to the lab and the certificate of compliance was not a part of the delivery. 3. During the interview on 01/15/2020 at 1:55 pm, GS1 and GS2 confirmed the certificate of compliance for the blood culture bottles was not retained for 2 of 2 years. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on observation, record review, and interview with General Supervisor #1 (GS1) and General Supervisor #2 (GS2), the laboratory failed to label an aliquot of Bio-Rad Lyphochek Immunoassay Plus Control level 3 with the expiration date for one vial in use. Findings include: 1. An observation made by the surveyor on 1/15 /2020 at 9:02 am revealed an aliquot in the laboratory's chemistry freezer labeled "Immunoassay + 3" with the date made being 12/30/2019, but no expiration date was indicated on the container. 2. A record review of the package insert for the Bio-Rad Lyphochek Immunoassay Plus Control revealed that, when reconstituted and frozen, the stability for all analytes is 20 days. 3. An interview on 1/15/2020 at 1:49 pm with GS1 and GS2 confirmed an expiration date was not present on the vial of quality control. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on manufacturer's package insert and interview with the General Supervisor (GS) 1 and GS2, the laboratory failed to calibrate the blood bank Antibody screening and identification, ABO blood grouping and Rh phenotyping, Compatibility testing, Reverse serum grouping and antigen typing MTS Dispensers (0.5 and 1.0) for 2 (January 2018 to January 2020) of 2 years in use. Findings include: 1. Manufacturer's package insert for the MT Dispenser (repetitive Dispenser of 0.5 or 1.0 ml) states under Calibration Check - "A calibration check should be done as part of a routine laboratory quality control schedule and after each repair." Further review of the insert revealed "Calibration of the MTS Dispenser is set by the manufacturer and cannot be adjusted by the user." Contact Ortho Clinical Diagnostics, Inc. for assistance. 2. When queried on 01/15/2020 at 1:38 pm, GS1 and GS2 were not able to provide the surveyor documentation of the calibrations for 2 of 2 years. 3. During the interview on 01/15/2020 at 1:38 pm, GS1 and GS2 confirmed the laboratory did not perform and document the MTS Dispenser calibrations for 2 years. B. Based on procedure manual review, record review, and interview with General Supervisor (GS) 1 and GS2, the laboratory failed to establish and implement thermometer calibrations for 2 (January 2018 to January 2020) of 2 years in use. Findings include: 1. Procedure manual review revealed the laboratory did not establish a policy for the function checks for the calibration of thermometers. 2. When queried on 01/15/2020 at 2:30 pm for the calibration records, GS2 was unable to produce the documentation for the surveyor. 3. During the interview on 01/15/2020 at 2:30 pm, GS1 and GS2 confirmed the laboratory failed to establish and implement a thermometer calibration function check. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with General Supervisor #1 (GS1) and General Supervisor #2 (GS2), the laboratory failed to test quality control materials in the same manner as patients for Acetone testing for 2 (January 2018 to January 2020) of 2 years. Findings include: 1. An observation by the surveyor on 1/15 /2020 at 9:02 am revealed a bottle of K-Check tablets, used in testing for Acetone, in the laboratory. 2. A record review of the laboratory's established "Acetone" policy revealed a section stating, "Acetest reagent tablets are primarily used to test for the presence of ketones in urine, serum, plasma." 3. A record review of the K-Check tablets package insert revealed a section titled "Quality Control for serum, plasma, or whole blood" stating, "Laboratories should follow the applicable government regulations and local guidelines for quality control. The control intervals should be adapted to each laboratory's requirements. The recommended serum controls can be purchased. At least a positive and negative control must be run each time a new bottle of K-Check is opened. A positive control for urine can also be prepared by diluting 50 microlitres of acetone fo 40 mL of distilled water. The preparation should be comparable to "small" on the color chart." 4. A record review of the K-Check tablets package insert revealed a section titled "Quality Control for Urine (CLIA waived)" stating, "Perform QC with each test run. Follow the instructions under the "Procedure" section of the product insert." 5. A record review of the laboratory's established "Acetone" policy revealed a section titled "Quality Control" stating, "Run each day of patient testing. Positive control- MAS Urinalysis Level 1, Negative control- MAS Urinalysis Level 3." 6. An interview on 1/15/2020 at 12:18 pm with GS1 and GS2 confirmed the laboratory was testing patient urine, serum, and plasma specimens, but only performing quality control with the urine matrix. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on document review and interview with General Supervisor (GS) 1 and GS2, the laboratory failed to check each batch of media for physical characteristics, sterility, ability to support growth, select and/or inhibit specific organisms or produce a biochemical change for each new lot of Remel MacConkey Agar, Chocolate, and Blood Agar with sheep blood for 2 (January 2018 to January 2020) of 2 years of bacteriology testing. Findings include: 1. Record review revealed a lack of documentation for the media quality control checks for each new lot and/or shipment of MacConkey agar, Chocolate, and Blood agar with sheep blood media for 2 of 2 years of review. 2. When queried on 01/15/2020 at 1:55 pm, GS2 stated that the media is quality controlled at the main hospital and then transported to the satellite lab. 3. During the interview on 01/15/2020 at 1:55 pm, GS1 and GS2 confirmed the quality -- 3 of 4 -- control is performed at the main hospital and that no verification of that testing is transported with the media to the satellite office and that the physical characteristics of the media were not documented when the media arrived at the satellite lab. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #1 (GS1) and General Supervisor #2 (GS2), the laboratory director failed to establish a quality assessment procedure to monitor preanalytic, analytic, and postanalytic systems in the established Individualized Quality Control Plan for 2 (January 2018 to January 2020) of 2 years. Findings include: 1. A record review of the laboratory's established Individualized Quality Control Plan (IQCP) revealed a lack of quality assessment procedures to monitor, assess, review and correct problems identified in serum human chorionic gonadotropin (hCG) and D-dimer testing. 2. The surveyor requested the IQCP quality assessment plan on 1/15/2020 at 2:35 pm and it was not made available. 3. An interview on 1/15/2020 at 2:35 pm with GS1 and GS2 confirmed the laboratory director did not establish a quality assessment plan as part of the IQCP. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --